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Allergy Therapeutics PLC (AGY)     

banjomick - 01 Feb 2016 13:59

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Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

Chart.aspx?Provider=Intra&Code=AGY&Size=460&Skin=RedWhite&Scale=0&Type=2&Cycle=MINUTE1&Layout=Intra;IntraDate&E&Ind=VOLMA(60);&Layout=Intra;IntraDate&E=UK&YFormat=&XCycle=Hour2&Fix=1&SV=0Chart.aspx?Provider=EODIntra&Code=AGY&Size=460&Skin=BlackBlue&Type=2&Scale=0&Span=YEAR1&MA=&EMA=&OVER=&IND=VOLMA;&XCycle=&XFormat=&Layout=2Line;Default;Price;HisDate&SV=0

NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

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banjomick - 18 Feb 2016 08:23 - 2 of 159

RNS Number : 3979P
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Patient enrolment completed in US Phase IIb study of GrassMATAMPL

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces it has completed patient enrolment for its Phase IIb dose-finding study, G204, in the US. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy ("SCIT") administered prior to the grass pollen season. Total patient enrolment for the Phase IIb study was 250 patients and headline data is expected at the end of the first half of 2016, paving the way for the US Phase III study.

GrassMATAMPL is developed from Allergy Therapeutics' successfully marketed Pollinex Quattro Grass product and is a unique adjuvanted SCIT in which a grass allergen extract is chemically modified to form a standardised allergen ('allergoid') preparation. This is bound to microcrystalline tyrosine ("MCT") and combined with the adjuvant Monophosphoryl lipid A (MPL), enabling the reduction of allergenicity whilst maintaining immunogenicity. The product design allows for an effective cumulative dose to be attained in up to six weeks, avoiding continuous administration, as required by conventional SCIT products, over a year or more. The SCIT market in the US is worth approximately $2 billioni.



G204 is a dose-finding study using, for the first time, two mobile environmental exposure chambers based in Cincinnati and in New Jersey Shore. The chambers are inflatable laboratories that enable subjects with grass pollen allergy to be exposed to a constant concentration of pollen for periods of three hours over four consecutive days. Their great advantage is that they can be used outside of the grass pollen season for accurate dose selection studies.



The G204 study was preceded by a safety study, G102, of two new higher doses of GrassMATAMPL compared with placebo, which completed on 22 October 2015. No systemic adverse events were seen in this study with only mild local reactions to the injections.



Tim Higenbottam, Research & Development Director of Allergy Therapeutics, said:

"We have completed recruitment in the G204 US study within schedule., We are confident that the results will build on the previous positive data for our MATAMPL studies and, combined with the commercial success of Pollinex Quattro in Europe, this will prepare the ground for entry in to the high value US market. GrassMATAMPL has the potential to become the best in class ultra-short course SCIT in the US market and we look forward to reporting headline data at the end of the first half of 2016."

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banjomick - 23 Feb 2016 07:51 - 3 of 159

23 February 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Notice of Interim Results


Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, will issue its interim results for the six month period ended 31 December 2015 on Tuesday 8th March 2016.

A meeting for analysts will be held at 9:30am at the offices of Panmure Gordon at 1 New Change, London, EC4M 9AF. Manuel Llobet, Chief Executive Officer, and Ian Postlethwaite, Chief Financial Officer, will provide an update on the Company with a Q&A session which will be accessible remotely via a live conference call. The details of the call will be provided in the statement on Tuesday 8th March.

http://www.moneyam.com/action/news/showArticle?id=5218102

banjomick - 23 Feb 2016 08:00 - 4 of 159

Missed this from last Thursday:

Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019

Published on Feb 18, 2016


Tim Higenbottam, R&D director at hay fever vaccine specialist Allergy Therapeutics (LON:AGY) tells Proactive Investors GrassMATAMPL is one of its two most advanced products in development.
He hopes the company will be in a position to start phase III studies at some point this year.
The company aims to launch the ground-breaking and "exciting" grass pollen allergy treatment in 2019 after all the trials are completed and the treatment is approved.


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banjomick - 24 Feb 2016 08:43 - 5 of 159

Allergy Therapeutics PLC
24 February 2016

Hardman & Co issues research report on Allergy Therapeutics

Development progress: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. It has an underlying profitable and cash generative business despite its lead product being available only on a 'Named Patient' basis. However, protocols agreed with EU and US regulators are in place to get Pollinex Quattro approved as a biological. The US opportunity is enormous and only two players have short-course treatments. There is a valuation mis-match between AGY and its peers, which either have no growth or little marketing experience, which provides scope for considerable upside towards our risk-adjusted DCF valuation of 89p per share.

Please click here for the full report:

http://www.hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/24-02-16-development-progress


http://www.moneyam.com/action/news/showArticle?id=5219069

banjomick - 04 Mar 2016 13:51 - 6 of 159

This looks to be confirmation from Inflamax Research Inc. themselves on the study that was previously reported by AGY 18th February 2016:

Inflamax Research Inc. Announces the Successful Completion of Enrollment for the First Multi-center, Mobile Environmental Exposure Chamber (mEEC™) Study

Inflamax Research Inc., today announces the successful completion of patient enrollment in first US Phase II multi-center mEEC™ dose-ranging study with Grass MATAMPL immunotherapy for patients suffering from seasonal grass allergy (ClinicalTrials.gov NCT02582073) for Allergy Therapeutics

Toronto, ON (PRWEB) March 04, 2016


This is a landmark clinical study and is the first allergy immunotherapy study to utilize the mEEC™ in the United States. Inflamax’s unique and world leading technology was used to recruit and study patients in two separate locations in Neptune, New Jersey and Cincinnati, Ohio. The unique challenge in enrolling before the start of the tree season in the Northeast US was met with the deployment of Inflamax’s unique Online Central Recruiting Update Platform (OCRUP™). The data from this study will be instrumental in the launch of the Phase III program prior to end of 2016 utilizing Inflamax’s mEEC™ system in several locations within the United States. We also wish to thank the 20 investigator sites in Ohio, Kentucky, New Jersey, New York and Pennsylvania.

“Allergy trials rely on mother nature to produce consistent pollen concentrations to elicit adequate levels of symptoms in order to prove dose-response or efficacy. Unfortunately, climate change and variability in patient exposure in their everyday lives can lead to large variabilities and recruitment delays should the environment, weather, and other factors, not produce consistently. The novel mEEC™ technology enables study designs and endpoints to be infinitely more robust and allows for studying allergen-specific therapies, such as immunotherapy. The mEEC™ model is designed to provide consistent allergen exposure, over time, significantly reducing data variability and compliance compared to traditional field studies”, commented Dr. Anne Marie Salapatek, Chief Scientific Officer at Inflamax Research Inc.

Allergy Therapeutics® is a specialty pharmaceutical company focused upon the development of treatments for allergy. Allergy Therapeutics has an existing sales base of approximately £40 million per annum, an MHRA-approved manufacturing capability, as well as an established sales and marketing infrastructure in several major European markets. In addition, the Company has a number of novel compounds which have already undergone initial clinical evaluation and, once registered, could potentially revolutionize the treatment of allergy.

Inflamax Research is a global full-service, CRO specializing in allergy, respiratory, ocular and dermatology Phase I-IV research, led by world-known, key-opinion leaders. Inflamax has a strong scientific capability and publishes extensively in peer-reviewed journals. Inflamax’s Clinical Trial Management group has experience in conducting large multi-center trials in these, and other, therapeutic areas. Inflamax offers full-service including study design/concept development, medical writing, site management, monitoring, data management, statistics, and CSR development.

http://www.prweb.com/releases/2016/03/prweb13247151.htm

banjomick - 08 Mar 2016 08:33 - 7 of 159

***PLEASE CLICK LINK AT BOP FOR FULL RESULTS***

08 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")

Interim Results for the six months ended 31 December 2015


Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces unaudited interim results for the six months ended 31 December 2015.

Highlights

Financial highlights

· Revenue increased by 12% at constant currency to £31.5m (H1 2015: £28.2m)* and reported revenue increased by 3% to £29.0m (H1 2015: £28.2m)

· R&D expenditure increased to £6.5m (H1 2015: £1.1m) as the two Phase II studies in Germany and the US were successfully progressed

· Fundraising of £11.5m (gross) successfully completed with placing of 41,005,500 ordinary shares in the Company to invest in new product development, strengthen the balance sheet and accelerate growth

· Cash balance bolstered to £33.2m (H1 2015: £8.0m)



Products and pipeline highlights

· Increasing market share in all major markets

· Spanish Alerpharma acquisition fully integrated

· US Phase II study for GrassMATAMPL (marketed in Europe as Pollinex Quattro Grass product) initiated in December 2015 - on track for data read out in H2 2016

· PQ Birch204 Phase II study patient enrolment completed - results expected in H2 2016

· Acquisition of Virus Like Particles ("VLP") technology licence for the development of a potential new injectable vaccine immunotherapy treatment for allergy sufferers, with peanut as the lead project

· Positive house dust mite study results for Acarovac - July 2015


Post period end highlights


· US Grass MATAMPL study fully recruited according to plan in February 2016



Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said:

"The first half of this year has seen continued momentum with our product sales continuing to outperform the market with further market share gains across Europe. We delivered 12% revenue growth at constant currency. This double-digit growth against a (broadly) flat market has been driven by a combination of our winning proposition of lifestyle enhancing short course aluminium-free vaccines boosted by our successful sales strategy.

"Our business is gaining significant scale and momentum in Europe through both organic and acquisitive growth and we expect this to continue as we further invest in our commercial infrastructure and prepare to take our products over to the US. We eagerly await the data from two ongoing Phase 2 studies for GrassMATAMPL and PQ Birch204 which are both due to report later in 2016.‎"

* Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.


Joint Statement from the Chairman and Chief Executive Officer

Operating Review

Overview

During the first six months of the year, the Company's revenues grew 12% (at constant currency) compared to 11% at the end of June 2015, and against flat or low growth markets in Europe. Allergy Therapeutics' robust level of double digit top line growth at constant currency is due to the benefits offered to patients of a short course, aluminium-free, therapy which is enabling the Company to outperform its competitors and grow its market share in Europe. Geographically, the major contributing markets to the Company's growth have been Germany and Spain, followed by The Netherlands, the UK and Austria.

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banjomick - 08 Mar 2016 09:43 - 8 of 159

Video supporting today's Interim Results:

https://player.vimeo.com/video/158104723?title=0&byline=0&portrait=0&autoplay=1&wmode=transparent

banjomick - 17 Mar 2016 09:08 - 9 of 159

17 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Board change


Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Ian Postlethwaite, Finance Director, has resigned from the Company to pursue a new opportunity. Ian will remain as a Director of the Company and Finance Director for up to six months to allow time for a suitable successor to be appointed and for an orderly handover. The Board has commenced a search for his successor and a further announcement will be made in due course.

Peter Jensen, Chairman of Allergy Therapeutics, said: "Ian has been the Finance Director for 14 years and a significant contributor to the success of the Company. During this time Allergy Therapeutics has listed on AIM, achieved a number of financial goals including two fund raisings in 2015 to support the Company's clinical and other development plans, and has growing revenues from products on sale in Europe. Ian leaves the Company in the strongest position it has ever been in, in terms of sales, cash balance and growth potential. We are very positive about the future of Allergy Therapeutics and wish Ian the best for his ongoing career."


http://www.moneyam.com/action/news/showArticle?id=5241719

banjomick - 23 Mar 2016 09:11 - 10 of 159

23 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Issue of equity in respect of the exercise of options


Allergy Therapeutics announces the issue and allotment of 2,305,089 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 2,305,089 share options by certain employees.

Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8:00 a.m. on 29 March 2016. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.

Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 589,158,508 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 589,158,508. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.


http://www.moneyam.com/InvestorsRoom/posts.php?tid=19493#lastread

banjomick - 30 Mar 2016 21:50 - 11 of 159

Allergy Therapeutics-Edison Report

Fresh finance, fresh product lines

30 March 2016 | Allergy Therapeutics, Pharma & biotech

http://www.edisoninvestmentresearch.com/research/report/allergy-therapeutics21/full

banjomick - 13 Apr 2016 13:08 - 12 of 159

***You need to Register for FREE to finish reading this article"***


Interview - Allergy Therapeutics Sniffs Out Second Chance
Apr. 12, 2016 8:51 AM ET
About: Allergan plc (AGN)

After nearly a decade of delays Allergy Therapeutics (NYSE:AGN) is getting back on track with its short-course allergy vaccines. The company expects results from two phase II studies at the end of June: one in the US with Pollinex Quattro Grass, the other in Europe with Pollinex Quattro Birch.

The UK group hopes that the grass vaccine will be the first seasonal subcutaneous immunotherapy to reach the US, with phase III trials to start later this year and launch in 2020 if all goes well. In Europe, Allergy already sells its Pollinex Quattro products on a named-patient basis, with revenues of £43m ($60m) in 2015, but is also seeking its first formal approval.

The US opportunity is “potentially transformational”, say Edison analysts, who put peak US sales for the Pollinex Quattro range – including the grass vaccine, the tree vaccine and a third product, Pollinex Quattro Ragweed – at $1.1bn.

This would be quite a turnaround from 2007, when Allergy was forced to delay its research program after an adverse event. Although this turned out to be unrelated to the vaccine, the FDA did not lift its clinical hold until 2012 after it had conducted a review of novel vaccine adjuvants.

Subcutaneous vs sublingual

Allergy did not resume US clinical development until last year. In the meantime, the company’s vaccines have been overtaken by sublingual allergy treatments developed by Stallergenes and ALK Abello.

But these oral treatments have not taken off, perhaps owing to a preference for subcutaneous vaccines in the US. Allergy's chief executive, Manuel Llobet, tells EP Vantage that, being subcutaneous, Pollinex Quattro “will have a really fast penetration”.

Somewhat counterintuitively, he believes that compliance with Allergy’s vaccines, which require four to six injections, is better than with sublingual treatments. “You might have to go to the doctor six times, but then that’s it. With the tablet you have to take one every day for at least a year, and patients don’t really follow the treatment.”

page 1 / 3 | Next »

http://seekingalpha.com/article/3964658-interview-allergy-therapeutics-sniffs-second-chance

banjomick - 09 May 2016 09:23 - 13 of 159

9 May 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces positive top-line results from the PQBirch204 Phase II study for birch-induced seasonal allergic rhinitis


· Primary endpoint met

· Statistically significant dose-response relationship (p<0.01)

· All dosing regimens were safe and well tolerated

· Adherence was greater than 90%

Allergy Therapeutics, (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive top-line results from the Company's PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis.

The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.


Results summary of the PQBirch 204 Phase II study programme


· The primary endpoint, to demonstrate a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development

· The study demonstrated a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied

· The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU

· PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid

· Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis. Approximately 6% of the population in Europe alone is allergic to birch pollen and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue. Pollinex is the only ultra-short course aluminium-free treatment in the market and its convenience for patients is driving our market penetration in all our European markets.

"This study is a significant milestone in our route to Marketing Authorisation and keeps us on track to commence the Phase III study in early 2017."

http://www.moneyam.com/action/news/showArticle?id=5337115


banjomick - 09 May 2016 10:18 - 14 of 159

I missed this video from 8th March 2016..........

08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable

banjomick - 09 May 2016 13:23 - 15 of 159

Allergy Therapeutics results not to be sniffed at
12:33 09 May 2016

The phase II trial assessed the response from 371 patients, which revealed a statistically significant dose-response relationship from the groups receiving the medication.

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Allergy Therapeutics plc (LON:AGY) described as “very encouraging” the results from the latest clinical study of its PQBirch204 treatment for hay fever caused by birch pollen.

The phase II trial assessed the response from 371 patients, which revealed a statistically significant dose-response relationship from the groups receiving the medication.

Allergy said the latest clinical data “reaffirmed the potential” of the company’s Pollinex platform to treat the different variants of allergic rhinitis.

Researchers also found that PQBirch204 was safe and well tolerated, while 94% of patients stuck to the dosing guidelines.

It is expected a phase III study will get underway early next year.

"The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis,” said chief executive Manuel Llobet.

Is Allergy undervalued?

The shares, up 28% in the last year, were ahead a further 3% in early afternoon trade at 26.37p.

There is further for the stock to go, according to Panmure Gordon’s Dr Mike Mitchell.

He says the market is applying an “unduly onerous” discount to the Allergy shares, which he values at 53p.

“In itself the outcome for the Birch programme paves the way for late-stage development of that programme on track and, on a qualitative basis, the news potentially reflects an important de-risking factor for Allergy Therapeutics’ wider platform,” Mitchell said in a note to clients.

Profitable and growing strongly

Allergy Therapeutics has a profitable core business and, as the name suggests, a number of ground-breaking allergy vaccines that trade under various brand names. Its most commonly prescribed vaccines are used to treat pollen-related allergies, particularly allergies to grasses and trees.

It has has a strong presence in Europe with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets it often makes its products available through distribution partners.

Its Pollinex Quattro vaccine for the treatment of seasonal allergic rhinitis from grass, tree or ragweed pollen allergy is already established in Europe, and the board is confident the success can be replicated in the US, where it will enjoy first mover advantage in a market potentially worth $2bn.

----ADDS BROKER COMMENT, SHARE PRICE AND BAKCGROUND---

Ian Lyall

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banjomick - 09 May 2016 18:21 - 16 of 159

Allergy Therapeutics boss excited by PQBirch204 Phase II data
14:25 09 May 2016

Manuel Llobet, chief executive of Allergy Therapeutics plc (LON:AGY) says the latest data from its Phase II trial of its PQBirch204 treatment for hay fever caused by birch pollen is “exciting for our company”.

Allergy released the results from the latest clinical study, which assessed the response from 371 patients.

The phase II trial revealed a statistically significant dose-response relationship from the groups receiving the medication, with Llobet noting the company has received “very strong top –line data”.

It means the company is still on track to start the Phase III study in early 2017, and Llobet says the data is “another step towards our clinical goal to get Polinex Quattro Birch registered in Europe as soon as possible”.


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banjomick - 09 May 2016 18:34 - 17 of 159

Hardman & CoAllergy Therapeutics Plc Progress towards EU reg approval
Allergy Therapeutics Plc (LON:AGY) is a long-established specialist in the prevention, diagnosis and treatment of allergies. It’s lead product, Pollinex Quattro is available in Europe only on a ‘Named Patient’ basis. However, protocols have been agreed with EU and US regulators for a programme of clinical trials to get full regulatory approval of Pollinex Quattro as a biological. AGY has reported positive outcomes from one of the trials required for EU approval. There remains a considerable valuation mis-match between AGY and its peers, which provides scope for considerable upside towards our risk-adjusted DCF valuation of 89p per share.

***Link below for full report***

http://www.directorstalkinterviews.com/wp-content/uploads/2016/05/09-05-16-progress-towards-eu-reg-approval.pdf

banjomick - 10 May 2016 11:04 - 18 of 159

PQBirch204 Phase II Study (May 2016)- Video


http://fmp-tv.co.uk/company/allergy-therapeutics-investors-video-and-news/

banjomick - 14 May 2016 11:56 - 19 of 159

Proactive Investors One2One Investor Forum - London

Clinigen Group PLC | Allergy Therapeutics plc | Sareum Holdings Plc | Abzena plc

May 19th 2016, 6.00 pm - Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair

The presentations will start at 6:00pm and finish at approx 8:00pm. After the presentations are complete the directors will also be available to take questions during a free canapé and wine reception.

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banjomick - 23 May 2016 16:30 - 20 of 159

The presentation from last Friday can be viewed from link below:

http://www.proactiveinvestors.co.uk/archives/documents

banjomick - 26 May 2016 13:57 - 21 of 159

Allergies%20468x60.jpg

Conference Overview

SMi proudly announces the return of 3rd annual Allergies conference to London in July 2016!

Aimed at an audience of senior scientists and allergy specialists involved in immunology and drug research, Allergies 2016 will provide the perfect platform to discuss pioneering clinical developments and the next generation of allergy therapeutics.

Created with a top panel of industry thought leaders, this year's event will look to capture expert insight by honing in on new pathways with novel vaccines and adjuvants, immunoassays for molecular diagnostic’s, paediatric allergies, personalised treatment, allergen specific immunotherapies, plus much more.

Through strategic direction and regulatory guidance, the programme will look to strengthen knowledge in topics such as biomarker validation, and arm attendees with the key requirements and tools for successful trials and study outcomes.

************************************************************

Day1

16:00 Defining the most effective dose


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Tim Higenbottam, Research & Development Director, Allergy Therapeutics Ltd

•Development of new allergen subcutaneous specific immunotherapies
•Limiting factors on injection intervals optimal dose of allergen (allergoid)
•Use of provocation testing

Conference programme

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banjomick - 06 Jun 2016 11:37 - 22 of 159

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banjomick - 07 Jun 2016 14:11 - 23 of 159

Major Shareholders

Shareholder Name--------------------------------Amount-----------------% Holding

CFR International SPA & Associated Holding-- 240,584,571---------------40.84
Southern Fox Investments----------------------125,158,783---------------21.59
Odey Asset Management-------------------------42,959,498-----------------7.29
Invesco Asset Management----------------------34,110,209-----------------5.79
Black Rock Investment Management------------19,000,000-----------------3.22

Director Shareholdings (*- Executive Director)

Director Name-------------------------------Amount--------------% Holding

Manuel Llobet*-----------------------------3,175,000---------------0.54
Ian Postlethwaite*-------------------------1,360,000---------------0.23
Stephen Smith-------------------------------776,513----------------0.13
Peter Jensen---------------------------------120,000----------------0.02

Help using this page

As at 23 March 2016

http://www.allergytherapeutics.com/investor-relations/shareholder-information/major-shareholders/

banjomick - 10 Jun 2016 09:05 - 24 of 159

10 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Appointment of Finance Director

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Nick Wykeman to the Board as Finance Director with immediate effect.

Mr Wykeman was most recently at Skyepharma PLC until August 2015 where he was the Group Financial Controller for six years. Prior to that, Mr Wykeman had also worked at Quest International (a part of ICI PLC) as the Group Financial Controller (Special Projects), following six years at Deloitte & Touche. Mr Wykeman has a BSc (Hons) in Economics and is a qualified accountant, being a member of the Institute of Chartered Accountants of England and Wales.

Mr Wykeman replaces Ian Postlethwaite, who, further to the announcement made on 17 March 2016, has now resigned from the Company and the Board with immediate effect.

Peter Jensen, Chairman of Allergy Therapeutics, said: "We welcome Nick to his role as Finance Director and look forward to his contribution to the Company as we continue to grow the business internationally on all fronts. His international experience in life sciences is well suited to the role and we're pleased to have attracted him to Allergy Therapeutics.

"We also thank Ian Postlethwaite for his fourteen, successful years with Allergy Therapeutics and wish him well for his future."

Nicolas Alexander Ulrich Wykeman, age 51, is currently a director of the following company:

Current Directorships

Wykeman Consulting BV

Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies.

http://www.moneyam.com/action/news/showArticle?id=5357969

banjomick - 13 Jun 2016 07:49 - 25 of 159

13 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics hosts Satellite Symposium at EAACI

~ World-leading allergists present technological advances and immunotherapy innovations ~

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces today that data was presented in a Satellite Symposium entitled: "Adjuvants in Allergy: elevating efficacy" at the 35th Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, Austria on 12 June 2016, relating to a number of the Company's products and technologies.

Three world-leading experts in the field of allergen immunotherapy and vaccine delivery, Ralph Mösges, Randolph Brehler and Thomas Kündig, presented information on innovation in immunotherapy including Allergy Therapeutics' key product Pollinex Quattro®. Pollinex Quattro®'s specialist technology was discussed, highlighting the marketed product's ability to reduce irritation and systemic reactions. Furthermore, Dr Brehler discussed how the potent depot adjuvant MCT (Micro Crystalline Tyrosine), initiated by the Company as an alternative to aluminium in subcutaneous immunotherapy and used in Pollinex Quattro® as well as certain other of the Company's subcutaneous injected therapies, has an immunomodulating action that augments a shift in the immune reactions responsible for the symptoms of allergic rhinitis.

Data on the future role of Virus-Like-Particles (VLP) in immunotherapy was also presented as a potential new injectable vaccine immunotherapy technology. Allergy Therapeutics recently acquired an exclusive VLP technology licence and is conducting a research project on VLP-based allergy vaccines. The worldwide food allergy market is worth a potential $8bn and, currently, there is no established and safe immunotherapy treatments available for peanut allergy, the first indication the Company intends to address.


Manuel Llobet, Chief Executive Officer, commented: "As a fully integrated specialty pharmaceutical company, we are delighted to be breaking new ground in allergen immunotherapy. Allergy Therapeutics has the potential to transform allergy treatment with an established range of diagnostics and specific short-course aluminium-free immunotherapy vaccines and we are well-placed to deliver the relief from symptoms of allergy that millions of patients need."

Satellite Symposium: Adjuvants in Allergy: elevating efficacy

1) Ultra-short course immunotherapy, Ralph Mösges MD, PhD, MSEE, University of Cologne (Pulmonology, Allergology and Clinical Immunology)

2) Adjuvants in immunotherapy, Randolf Brehler MD, University of Münster (Allergology)

3) Future immunotherapy: virus like particles, Thomas Kündig, University Hospital Zurich (Immunology, Cell Biology and Pharmacology)

http://www.moneyam.com/action/news/showArticle?id=5358789

banjomick - 13 Jun 2016 12:00 - 26 of 159

Shares Spotlight - Manuel Llobet CEO of Allergy Therapeutics (AGY)
Published on Jun 13, 2016

Mark Dunne interviews Manuel Llobet who discusses his companies allergy products.

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banjomick - 27 Jun 2016 08:03 - 27 of 159

27 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces findings from mEEC dose range finding study G204

~ Further dose range finding required and US plans progress with goal of being first to market ~

~ Group's European sales accelerate at 19% growth rate ~

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces findings from its exploratory Phase II dose-ranging study (G204) for the US GrassMATAMPL clinical development program and informs that the results did not determine a recommended dose for the Phase III trial. A further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy ("SCIT") administered prior to the grass pollen season.

Based on the successful dose response data identified in the Phase II G203 study for the same US GrassMATAMPL programme, the G204 trial was designed to explore higher dose regimens using the novel technology of the mEEC (mobile environmental exposure chamber) and optimise the recommended dose before starting the pivotal Phase III trial (G306) to be performed in the US.

In contrast to the G203 study, the dose range finding data with the mEEC did not allow the Company to recommend an optimised dose regime to take into Phase III studies for the US. Consequently, Allergy Therapeutics will undertake a further dose-ranging study employing the same successful European dose-finding trial design with a fixed Conjunctival Provocation Test (CPT) which provided robust results for the optimisation of the Company's marketed subcutaneous birch pollen product, Pollinex® Quattro Birch (PQBirch).

The next dose range finding study is planned to start in 2017. Allergy Therapeutics will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III.

Commenting on the announcement, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Defining the optimal dose is part of late-stage product development and we will revisit dose evaluation as we recently successfully did with our PQ Birch product, using two separate and complimentary dose-ranging studies. Additionally, the new findings of our Phase II EEC study will need to be discussed with FDA before deciding on the recommended dose for the following Phase III registration trial. While still being determined to become the first company to introduce SCIT to the US, a deferred entry time into the market is now anticipated.

"In Europe, our market penetration continues to accelerate, outperforming the market with 19% year-to-date revenue growth*, an increase from the 12% revenue growth* we had achieved in December 2015.

"Elsewhere in the pipeline, we successfully completed a Phase IIb dose finding study for Pollinex Quattro Birch in Germany and Austria earlier this year; we've completed the exploratory dose finding study in the US; set up the protocols for the Acarovac Quattro programme in Spain; and we have initiated the proof-of-concept plan for the VLP Peanut allergy vaccine in Switzerland.

"We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets."

*revenue growth is at constant currency and is supported by the Immunal acquisition.

http://www.moneyam.com/action/news/showArticle?id=5366973

banjomick - 08 Jul 2016 08:22 - 28 of 159

8 July 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces publication of 1-year follow up results of its mite allergoid immunotherapy Acarovac Plus™

~ Significant decreases in symptom scores reported with Acarovac Plus ~

~ Product treatment was proven to be well tolerated and safe ~

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the publication of a 1-year follow-up study of patients using Acarovac Plus™, its unique, microcrystalline tyrosine-adsorbed, house dust mite-allergoid subcutaneous immunotherapy in the peer-review journal Immunotherapy.

A previous study in 2014, led by Dr Albert Roger, Director of the Allergy Unit at Universitari Hospital Trias I Pujol, Badalona, Spain, assessed the tolerability and safety of Acarovac Plus™ in patients with respiratory allergy to Dermatophagoides pteronyssinus under conditions of normal clinical practice. This 1-year follow-up investigation, with the existing patient pool and testing regimen, assessed effectiveness using a nasal provocation test and measurement of immunological markers that are indicative of immunotherapy success.

A statistically significant reduction in symptom scores was observed at both follow-up visits (four weeks and one year), with >50% reduction in symptom scores recorded after one year. Moreover, significant improvements in immunological markers were noted at the follow-up visits. Patients reported statistically significant improvements in satisfaction scores after one year in relation to overall effectiveness and convenience of the treatment.

2016 has seen a significant increase in sales of Acarovac Plus™ to over EUR 1 million in key markets Spain and Portugal, compared to 2015. Sales of house dust mite immunotherapy are expected to increase rapidly over the coming years with over 20% of the population in Europe experiencing an allergic reaction to house dust mites. Therefore, Allergy Therapeutics is continuing to develop Acarovac Quattro™, an ultra-short course therapy utilising the adjuvant monophosphoryl lipid A (MPL), which is used in the Company's successful Pollinex Quattro product range currently in late stage development in Europe and the US to complement Acarovac Plus™.

Commenting on the publication, Dr Albert Roger, principal investigator for the study, said: "The successful clinical results in the 1-year follow-up study clearly demonstrate the effective treatment of house dust mite allergy by Acarovac Plus™. We also observed significant decreases in symptom scores and improvement in nasal sensitivity immediately after the up dosing phase of one month and a high rate of patient satisfaction early in treatment."

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "This data further reinforces the benefits of Acarovac Plus™ in the perennial allergy vaccine market. Using maintenance injections six weeks apart, Acarovac Plus™ has been shown to decrease the symptoms of house dust mite allergy one year after treatment. This dosing regime has the potential to improve the adherence and compliance that is essential for a successful treatment. Acarovac Plus™ bolsters our portfolio of allergy immunotherapy products on the market in Europe and we look forward to continued good growth."

http://www.moneyam.com/action/news/showArticle?id=5376022

banjomick - 08 Jul 2016 10:30 - 29 of 159

Allergy Therapeutics sees "statistically significant" improvement one year on
07:40 08 Jul 2016

“Acarovac Plus bolsters our portfolio of allergy immunotherapy products on the market in Europe and we look forward to continued good growth.”

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Allergy Therapeutics plc (LON:AGY) reported statistically significant reduction in symptoms in patient studies to test the efficacy of its dust mite allergy immunotherapy treatment.

The allergy vaccines group published its one-year follow-up study of patients using Acarovac Plus, its flagship dust mite allergy vaccine.

A statistically significant reduction in symptom scores was observed at both follow-up visits (four weeks and one year), with a reduction of up to 50% in symptom scores recorded after one year.

Significant improvements in immunological markers were noted at the follow-up visits, said the group.

With over 20% of Europeans allergic to dust mites, sales of house dust mite immunotherapy are expected to increase rapidly over the coming years.

“Acarovac Plus bolsters our portfolio of allergy immunotherapy products on the market in Europe and we look forward to continued good growth,” said chief executive Manuel Llobet.

Josh Allsopp

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banjomick - 13 Jul 2016 08:31 - 30 of 159

13 July 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Trading Update


Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2016 ahead of its Preliminary Results to be announced in September 2016.

Financials

Reported revenues are expected to be £48.5m (2015: £43.2m), slightly ahead of current market expectations. This represents a growth of 12%* despite the negative impact from the weakening Euro during most of the year. At constant currency, this represents a growth of 19%* for the year. This solid growth has been against a flat market backdrop and has allowed the Company to increase its market share two percentage points from 10% to 12% on average across its key European markets. The main contributions in terms of market share gains for the Company have come from Germany, Austria, Spain and the UK.

Product

Allergy Therapeutics' market penetration is consistent across the product portfolio, particularly from Pollinex Quattro, Oralvac (which has benefited from a competitor situation) and our newer products entering the market including Acarovac and Synbiotics.

The Company expects strong revenue growth to continue for several years and aims to achieve a leading European market position in the allergoid subcutaneous immunotherapy product (SCIT) market before 2020.

Pipeline


In Europe, the development program for PQ Birch is on track and the Pivotal Phase III study is planned to start in H1 2017. For the US, the Company will perform another dose ranging study for PQ Grass in order to ensure that the best dose is chosen for the final Phase III study. Acarovac Quattro development is on track and initiation of Phase I studies is expected to start in H2 2016. Finally, the proof of concept study for the novel vaccine, Polyvac Peanut, is progressing according to plan.

Commenting on the positive trading update, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said:

Our strong sales growth of 19%* at constant rates and further gain in market share of two points to 12% shows that our ambition to build a world-leading portfolio of aluminium-free, patient-friendly vaccines is gaining increased traction. We continue to invest in our business and remain on course to become the leading company in the subcutaneous segment. We are also very excited about the commercial opportunities in our current broad portfolio."

*The growth figures include 3% which relates to the acquisition of the Alerpharma business in June 2015.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

http://www.moneyam.com/action/news/showArticle?id=5378575

banjomick - 13 Jul 2016 12:05 - 31 of 159

Allergy Therapeutics' revenues top forecasts
11:25 13 Jul 2016

Updating investors, the company said turnover will be around £48.5mln, representing a rise of 12%, or 19% once the figure is adjusted for currency movements.

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Allergy Therapeutics plc (LON:AGY) said revenues for the year ended June were slightly ahead of market expectations.

Updating investors, the company said turnover will be around £48.5mln, representing a rise of 12%, or 19% once the figure is adjusted for currency movements.

Against a “flat backdrop”, the business, which specialises in allergy vaccines, has grown its market share by two percentage points to 12%.

Gains were made in Germany, Austria, Spain and the UK where demand for products such as Pollinex Quattro, Oralvac and newer lines, such as Acarovac and Synbiotics, remains buoyant.

IN DEPTH: Getting under the skin of Allergy Therapeutics

AT A GLANCE: All facts and figures


“The company expects strong revenue growth to continue for several years,” Allergy added.

Turning to the pipeline, it said a phase III study for its PQ Birch product should get underway in the first half of next year, while in the US the company is in the process of deciding the optimum dose for its phase III trial of PQ Grass.

“We continue to invest in our business and remain on course to become the leading company in the subcutaneous segment,” said chief executive Manuel Llobet.

“We are also very excited about the commercial opportunities in our current broad portfolio."

Broker reckons the stock could more than double in value

The shares rose 4% to 19.77p, valuing the business at £122mln. The broker Panmure Gordon reckons the stock is worth 53p.

“With our investment thesis fundamentally unchanged despite the speed bump of the US dose ranging study we view the share price reaction offers investors an excellent opportunity,” said analyst Dr Mike Mitchell.

About the company

Allergy Therapeutics has an 80-year history and is no “jam tomorrow” drug development company.

It has a profitable core business and, as the name suggests, a number of ground-breaking allergy vaccines that trade under various brand names. Its most commonly prescribed vaccines are used to treat pollen-related allergies, particularly allergies to grasses and trees.

It has has a strong presence in Europe with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets it often makes its products available through distribution partners.

Its Pollinex Quattro vaccine for the treatment of seasonal allergic rhinitis (hay fever) from grass, tree or ragweed pollen allergy is already established in Europe, and the company wants to replicate that in the US, where it will enjoy first mover advantage in a market potentially worth $2bn.

---ADDS BROKER COMMENT & SHARE PRICE---

Ian Lyall

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banjomick - 22 Jul 2016 13:49 - 32 of 159

Profit from the market's Allergy reaction
By Megan Boxall,
21 July 2016

Using immunotherapy - stimulating the immune system - to treat allergies is rapidly gaining traction. As a scientific discipline it's not particularly new, but for a long time it has been difficult to safely and effectively revamp the body's immune system by injecting a small dose of an allergen. However, recent improvements in science, alongside increased investor interest, has carved a path for a multibillion-dollar global market and Aim-traded Allergy Therapeutics (AGY) is in an excellent position to take a slice of this.

***The content of this section is only available to Investors Chronicle online subscribers.***

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banjomick - 03 Aug 2016 12:22 - 33 of 159

This symposium was highlighted in Post 25 and is now featured on the European Medical Journal website for download:

Disclosure: Prof Matthias Kramer is an employee of Allergy Therapeutics UK Ltd


Adjuvants in Allergy: Elevating Efficacy
August 2, 2016

Meeting Summary

This symposium provided an overview of the current and future technologies and treatments used in the field of allergen immunotherapy (AIT). Prof Ralph Mösges explored the concept of pre-seasonal immunotherapy in overcoming the problem of recurrent allergy, focussing on the use of Pollinex® Quattro versus the use of symptomatic treatment according to current guidelines. The use and mechanisms of adjuvants was explored by Prof Randolf Brehler, who discussed the use of adjuvants in AIT including delivery systems, immunopotentiators, and targeted delivery systems to facilitate optimum immune responses with the potential of a lower injection burden and increased efficacy of treatment. Prof Thomas Kündig concluded the symposium with an overview of the future of AIT and the use of virus-like particles (VLP) in harnessing the innate immune system response to protect against allergens.

xemj-logo1.png.pagespeed.ic.-2zHZUqqN1.p

and link to the actual download:

http://emjreviews.com/wp-content/uploads/Adjuvants-in-Allergy-Elevating-Efficacy.pdf

Bullshare - 23 Aug 2016 14:45 - 34 of 159

Shares Investor Evenings showcase presentations from leading companies bringing them together in one room.

 - Directors present their latest plans regarding development and growth

 - An opportunity to talk directly to the companies and personally put forward your questions

 - The chance to network with other attendees over drinks and canapés - private investors, wealth managers, fund managers and financial institutions

Who Should Attend?

The evening exposes investors to companies across various sectors. Perfect for existing investors as well as those looking for new investment opportunities.

Date:

Tuesday 27th September 2016

Venue:

Novotel Tower Bridge, London EC3N, 10 Pepys Street, London, EC3N 2NR

Event Timings:
18.00 
Registration and coffee
+ More to be announced
18.30 
Presentations
• Manuel Llobet, CEO - Allergy Therapeutics (AGY)
• Nick Wykeman, FD - Allergy Therapeutics (AGY)
• Alex Borrelli, Chairman & CEO - BMR (BMR)
• Jeremy Hawke, Mining & Operations Director - BMR (BMR)
• Nick Clarke, Executive Chairman - Central Asia Metals (CAML)
• Neil Sinclair, Chief Executive - Palace Capital (PCA)
20.30 
Drinks reception and canapés
21.30 
Close
Attendance is free, but spaces are limited. Register now to secure your place!
Allergy Therapeutics (AGY)
Allergy Therapeutics (AGY) 

We provide information to healthcare professionals about the prevention, diagnosis and treatment of allergic conditions with a special focus on allergy vaccination (also known as specific immunotherapy or desensitisation therapy). Allergy vaccination is a successful treatment that deals with the underlying cause of allergies and not just the symptoms! Allergy Therapeutics has a long-term commitment to the development of innovative therapies for allergy treatment and allergy prevention.

BMR (BMR)
BMR (BMR) 

BMR has successfully developed a proprietary acid/brine leach process that enables it to achieve high metal recoveries from the different tailings deposits.

BMR Group PLC is listed on AIM under the ticker BMR.

The Company is focused on the recovery of lead and zinc from the tailings deposits of Zambia’s oldest mine at Kabwe.

Central Asia Metals (CAML)
Central Asia Metals (CAML) 

Central Asia Metals plc (“CAML” or the “Company”) is an AIM-listed company incorporated in England & Wales, with operational headquarters in London. Its countries of operation are Kazakhstan, Chile and Mongolia. CAML produces copper in Kazakhstan and has a strategic interest in the Copper Bay project in Chile.

Palace Capital (PCA)
Palace Capital (PCA) 

Palace Capital is a UK property investment company listed on the Alternative Investment Market (AIM) of The London Stock Exchange. The company is not sector specific and looks for opportunities where we can enhance the long-term income and capital value through asset management and strategic capital development.

Real Good Food (RGD)
Real Good Food (RGD) 

RGF is a diversified food business and, following the sale of the Napier Brown sugar business, is focused on three pillar markets; cake decorating, food ingredients and premium bakery. All these markets have the benefit of being spread across a broad spectrum of trade channels: mainstream retail, specialist retail, manufacturing, wholesale, foodservice and export. All are also showing growth. It is proposed that all investment funds, either for capital projects or acquisition, will be focused on building RGF’s scale and presence and in these market sectors.

Sponsored by:
AJ Bell Youinvest

banjomick - 23 Aug 2016 15:09 - 35 of 159

Was just copying that over, cheers Bullshare

Bullshare - 23 Aug 2016 16:01 - 36 of 159

saved you :-0)

banjomick - 31 Aug 2016 15:39 - 37 of 159

Allergy Therapeutics Plc to present at the Shares Investor Evening in London on 27th September 2016

31 August 2016 | 15:29pm

StockMarketWire.com - Manuel Llobet, CEO and Nick Wykeman, FD of Allergy Therapeutics (AGY) (LSE:AGY) will be giving a briefing at the Shares Investor Evening on 27th September 2016. It will take place in London at an investor evening being organised by Shares magazine; the event is supported by AJ Bell Youinvest.

Allergy Therapeutics provides information to healthcare professionals about the prevention, diagnosis and treatment of allergic conditions with a special focus on allergy vaccination (also known as specific immunotherapy or desensitisation therapy). Allergy vaccination is a successful treatment that deals with the underlying cause of allergies and not just the symptoms! Allergy Therapeutics has a long-term commitment to the development of innovative therapies for allergy treatment and allergy prevention.

The Shares event offers a unique opportunity to hear about the latest plans and strategy from the Directors of UK listed companies and Fund Managers, attendees can personally put forward questions to the presenters. The event will take place at the Novotel Tower Bridge, 10 Pepys Street, London EC3N 2NR. Registration begins at 17:15 and presentations at 17.45, followed by a drinks reception where attendees can mingle with the speakers and fellow investors.

http://www.stockmarketwire.com/article/5406664/Allergy-Therapeutics-Plc-to-present-at-the-Shares-Investor-Evening-in-London-on-27th-September-2016.html

banjomick - 05 Sep 2016 08:29 - 38 of 159

Allergy Therapeutics schedules FY results

Allergy Therapeutics will issue its preliminary results for the 12-month period ended 30 June on 26 September

http://www.moneyam.com/action/news/showArticle?id=5408944


banjomick - 05 Sep 2016 11:08 - 39 of 159

Prelim.Results 26th September then on 27th September AGY will be giving a briefing at the Shares Investor Evening.......

banjomick - 26 Sep 2016 11:03 - 40 of 159

26 September 2016
Allergy Therapeutics plc

Preliminary report for the year ended 30 June 2016


- Significant progress made towards becoming a global provider of allergy solutions -

Allergy Therapeutics plc, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces preliminary results for the year ended 30 June 2016.

Highlights

· 19% increase in revenue at constant currency to £51.5m (2015: £43.2m)*

· 12% increase in revenue to £48.5m (2015: £43.2m)

· Increased market share in our main European markets to 12% (2015: 10%)

· Core business (excluding R&D) shows 11% increase in Operating Profit to £4.3m (2015: £3.8m)

· Ramp up on R&D investment with £16.2m (2015: £3.1m) spent, reflecting investment in PQ registration and pipeline

· Achieved primary endpoint for PQ Birch Phase II Study in Europe and selected dose to be used in Phase III, starting in 2017

· Inconclusive results of Phase II dosing study in the US for Pollinex Quattro Grass

· Successfully raised £11.5m (gross) to fund new product development and organic and inorganic growth opportunities

· Acarovac PlusTM one-year study showed statistically significant improvement for patients

· Acquisition of Virus Like Particle technology licence for the development of a potential new injectable vaccine immunotherapy treatment for allergy sufferers with peanut as lead project

· Strong cash balance of £23.4m at year end (2015: £21.2m)

Manuel Llobet, Chief Executive Officer, commented: "This year has seen many events in the allergy market. I would like to highlight Allergy Therapeutics' revenue growth, now accounting for 12% of the share in our competitive market, and progressing well towards our long-term strategic plans with developments across all areas of the business.

Our excellent products and outstanding team have delivered success in product development and marketing and, despite the requirement for our additional range-finding study, we look forward to capitalising on opportunities to continue growing into new markets and delivering patient-friendly, market-leading treatments, to help patients across the allergy spectrum.

We are a thriving, visionary company, led by a self-driven team, totally committed to transforming allergy treatments. We are passionate about what we do and we are convinced that the best is yet to come."

http://otp.investis.com/clients/uk/allergy_therapeutics/rns/regulatory-story.aspx?cid=1045&newsid=789353

banjomick - 26 Sep 2016 16:12 - 42 of 159

MAM managing to report another news item :-)

26 September 2016
 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
 
Director/PDMR Shareholding
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that on 26 September 2016, the Board of Allergy Therapeutics was informed that today Manuel Llobet, Chief Executive Officer, purchased 100,000 ordinary shares of 0.10p in the Company ("Ordinary Shares") at a price of 18.0 pence per Ordinary Share.  Mr Llobet's beneficial holding now stands at 3,275,000 Ordinary Shares, which represents 0.56% of the issued share capital of the Company to which voting rights are attached.
 
- ENDS -

http://www.moneyam.com/action/news/showArticle?id=5421000

banjomick - 27 Sep 2016 16:02 - 43 of 159

Reminder of tonight's event:

Allergy Therapeutics Plc to present at the Shares Investor Evening in London on 27th September 2016

31 August 2016 | 15:29pm

StockMarketWire.com - Manuel Llobet, CEO and Nick Wykeman, FD of Allergy Therapeutics (AGY) (LSE:AGY) will be giving a briefing at the Shares Investor Evening on 27th September 2016. It will take place in London at an investor evening being organised by Shares magazine; the event is supported by AJ Bell Youinvest.

Allergy Therapeutics provides information to healthcare professionals about the prevention, diagnosis and treatment of allergic conditions with a special focus on allergy vaccination (also known as specific immunotherapy or desensitisation therapy). Allergy vaccination is a successful treatment that deals with the underlying cause of allergies and not just the symptoms! Allergy Therapeutics has a long-term commitment to the development of innovative therapies for allergy treatment and allergy prevention.

The Shares event offers a unique opportunity to hear about the latest plans and strategy from the Directors of UK listed companies and Fund Managers, attendees can personally put forward questions to the presenters. The event will take place at the Novotel Tower Bridge, 10 Pepys Street, London EC3N 2NR. Registration begins at 17:15 and presentations at 17.45, followed by a drinks reception where attendees can mingle with the speakers and fellow investors.

http://www.stockmarketwire.com/article/5406664/Allergy-Therapeutics-Plc-to-present-at-the-Shares-Investor-Evening-in-London-on-27th-September-2016.html

banjomick - 28 Sep 2016 09:01 - 44 of 159

28 September 2016
Allergy Therapeutics plc

Director/PDMR Shareholding

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that the Board of Allergy Therapeutics was informed that on 27 September 2016 Nicolas Wykeman, Finance Director, purchased 150,000 ordinary shares of 0.10p in the Company ("Ordinary Shares") at a price of 17.75 pence per Ordinary Share. Mr Wykeman's total beneficial holding amounts to 150,000 Ordinary Shares, which represents 0.04% of the issued share capital of the Company to which voting rights are attached.

http://uk.advfn.com/stock-market/london/allergy-therapeutics-AGY/share-news/Allergy-Therapeutics-PLC-Director-PDMR-Shareholdin/72538369

banjomick - 28 Sep 2016 09:12 - 45 of 159

Zeus Capital Q&A: Allergy Therapeutics Plc Preliminary Results (LON:AGY)
Posted by: Amilia Stone 28th September 2016

Zeus Capital Healthcare Research Director Dr Gary Waanders caught up with DirectorsTalk to discuss Allergy Therapeutics Plc (LON:AGY)

http://www.directorstalkinterviews.com/zeus-capital-qa-allergy-therapeutics-plc-preliminary-results-lonagy/412711300


Also

INTERVIEW: Allergy Therapeutics Plc Impress Zeus Capital with Growth Figures
Posted by: giles.arbor 27th September 2016


Allergy Therapeutics Plc (LON:AGY) is the topic of conversation with Dr Gary Waanders the Director of Healthcare Research at Zeus Capital. Gary talks through the preliminary results for the year ended 30th June, tells us if this changes his view of the company and what investors should look for news wise over the next year.

http://www.directorstalkinterviews.com/interview-allergy-therapeutics-plc-impress-zeus-capital-growth-figures/412711151

banjomick - 28 Sep 2016 10:00 - 46 of 159

Financial Presentations

2016 Financial Presentations

Click here to download the preliminary results for the year ending 30 June 2016

Click here to listen to the audio file of the preliminary results for the year ending 30 June 2016

http://www.allergytherapeutics.com/investor-relations/financial-presentations/

banjomick - 28 Sep 2016 11:17 - 47 of 159

Focus remains US, says expanding Allergy Therapeutics
10:02 28 Sep 2016

Allergy Therapeutics (LON:AGY) chief executive Manuel Llobet said: “It’s been quite a good year, we have progressed on all of our strategic goals, namely progressing on our businesses in Europe.”

Allergy Therapeutics said the global allergy treatment market had seen some “turmoil” affecting the competitive market environment in Europe and the US, but the group said it would likely see mid to long-term benefits in terms of its US market share.

“We are building a nice, thriving, sound company in the European market,” says Llobet, but focus remains the US.

“The biggest opportunity we want to tap is the US, that’s our focus,” he says.

The group plans to add two or three new markets a year to expand its portfolio franchise.



Meet Allergy Therapeutics plc, Cello Group plc, Sphere Medical Holding PLC and ValiRx Plc at our event, London, 06 October 2016. Register here »

http://www.proactiveinvestors.co.uk/companies/stocktube/6058/focus-remains-us-says-expanding-allergy-therapeutics-6058.html

banjomick - 30 Sep 2016 10:59 - 48 of 159

29 September 2016
Allergy Therapeutics plc

Director/PDMR Shareholding

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that the Board of Allergy Therapeutics was informed that on 29 September 2016 Peter Jensen, Non-Executive Chairman, purchased 30,000 ordinary shares of 0.10p in the Company ("Ordinary Shares") at a price of 19.25 pence per Ordinary Share. Mr Jensen's total beneficial holding now amounts to 150,000 Ordinary Shares, which represents 0.03% of the issued share capital of the Company to which voting rights are attached.

http://otp.investis.com/clients/uk/allergy_therapeutics/rns/regulatory-story.aspx?cid=1045&newsid=794731

banjomick - 06 Oct 2016 10:44 - 49 of 159

Tonight's event:

One2One Investor Forum 6th October 2016-UK

banjomick - 10 Oct 2016 09:05 - 50 of 159

10 October 2016 
Allergy Therapeutics plc

 
Allergy Therapeutics presents enhanced efficacy data in a malaria vaccine model
with its novel adjuvant system

 
Data to be presented today at the World Vaccine Congress demonstrates significant improvements in effective infectious disease applications using Bencard Adjuvant Systems technology
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, together with its wholly-owned division, Bencard Adjuvant Systems (BAS), which specialises in developing and optimising adjuvants for prophylactic vaccination and allergen immunotherapy, announces new data using a novel adjuvant system that shows enhancement of efficacy in a malaria vaccine model. These results will be presented today at the World Vaccine Congress in Barcelona, Spain at 16:00 CET.
 
In an oral session entitled: "Platform technologies to emerging pathogens", Allergy Therapeutics' principal scientist, Dr Matthew Heath, PhD, in conjunction with the Jenner Institute, University of Oxford, will present new information on adjuvant activity and enhanced efficacy in a candidate vaccine formulation against Plasmodium vivax (malaria). Microcrystalline tyrosine (MCT), the aluminium-free depot adjuvant used in Allergy Therapeutics' successfully marketed and rapidly growing Pollinex Quattro® immunotherapy product, was shown to elicit high, sustained antibody titres in a preclinical model and demonstrated increased protective efficacy compared to existing adjuvants.
 
Furthermore, Dr Heath will discuss how MCT has synergistic effects when coupled with Virus Like Particles (VLP) to create a combined and unique Adjuvant System, AdSys-VcT. The data indicated a significant increase in specific antibodies and other immune parameters indicative of protective efficacy compared to aluminium salts. The potential for this novel adjuvant system in infectious disease applications was concluded to be highly significant.
 
Allergy Therapeutics has been pioneering the development of novel adjuvant systems with the combination of MCT and monophosphoryl lipid A (MPL) in allergy immunotherapy, allowing for the successful introduction of the concept of ultra-short course immunotherapy in the allergy vaccines market.
 
BAS, the fully owned Allergy Therapeutics division specialising in adjuvant systems, has signed a Memorandum of Understanding with Saiba GmbH, the Swiss-based vaccines company, to develop new applications of its novel adjuvant system, AdSys-VcT, for use in prophylactic vaccination and food allergy immunotherapy. BAS has a portfolio of adjuvants with certain exclusive rights.
 
Dr Murray Skinner, Chief Scientific Officer of Allergy Therapeutics, said: "Our positive data on adjuvant development is great news in an environment where organisations such as the US National Institutes of Health describe a significant unmet need for adjuvants suitable for use in combination with the growing number of emerging and evolving infectious disease targets1. These data support our belief that Bencard Adjuvant Systems has a potentially wide range of applications and we look forward to further results and collaborations, such as this one, in infectious diseases."

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "It is exciting to announce that our portfolio of adjuvants can be combined to create adjuvant systems that deliver optimised immunotherapy in both allergy indications and infectious disease applications. Our strategy for growth with Bencard Adjuvant Systems focuses on extending the use of MCT with novel adjuvants to create novel adjuvant systems capable of increasing the effectiveness of new and existing vaccines with unmet needs, and or new and emerging infectious diseases that require an effective adjuvant system like AdSys-VcT."

References
1 Mullard, A. NIAID amps up vaccine adjuvant work. Nature Reviews Drug Discovery. 2014. 13:803.
 
ENDS

http://www.moneyam.com/action/news/showArticle?id=5429449

banjomick - 10 Oct 2016 10:46 - 51 of 159

Presentation for the Proactive event last week:
One2One Investor Forum 6th October 2016-UK

Presentation-Proactive Investors 6th Oct 2016



Video from the Shares Investor Evening:
Shares Investor Evening 27th September 2016-UK

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banjomick - 10 Oct 2016 10:52 - 52 of 159

Allergy Therapeutics' malaria boost
07:53 10 Oct 2016

The firm's scientists used what’s called an adjuvant, which enhances the body’s immune response to an illness or disease.

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Allergy Therapeutics plc (LON:AGY) said that a subsidiary company has found a way of potentially improving the efficacy of the malaria vaccine.

It uses what’s called an adjuvant, which enhances the body’s immune response to an illness or disease.

In fact Bencard Adjuvant Systems’ technology identical to that found in the company’s highly successful jab for hay fever, Pollinex Quattro.

The latest data will be presented by Allergy Therapeutics' principal scientist, Dr Matthew Heath, at the World Vaccine Congress in Barcelona later Monday.

"Our positive data on adjuvant development is great news in an environment where organisations such as the US National Institutes of Health describe a significant unmet need for adjuvants suitable for use in combination with the growing number of emerging and evolving infectious disease targets,” said the company’s chief scientific officer, Dr Murray Skinner.

“These data support our belief that Bencard Adjuvant Systems has a potentially wide range of applications and we look forward to further results and collaborations, such as this one, in infectious diseases."

Ian Lyall

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banjomick - 24 Oct 2016 13:38 - 53 of 159

24 October 2016
 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
 
Annual Report and Accounts
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, announces that the Annual Report and Accounts for the year ended 30 June 2016 are available on the Company's website in the Investor Relations section. They can be located at:
 
www.allergytherapeutics.com/media/1241/allergytherapeutics_ra_15-16.pdf

Annual Report and Accounts

Printed copies of the Annual Report and Accounts for the year end 30 June 2016 were posted to shareholders on 22 October 2016, together with the Notice of the Annual General Meeting.

http://www.moneyam.com/action/news/showArticle?id=5436752

banjomick - 27 Oct 2016 17:06 - 54 of 159

27 October 2016 
Allergy Therapeutics plc
 
Issue of equity in respect of the exercise of options
 
Allergy Therapeutics announces the issue and allotment of 80,000 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 80,000 share options by certain employees.
 
Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8:00 a.m. on 3 November 2016. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.
 
Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 593,444,020 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 593,444,020. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.

http://www.moneyam.com/action/news/showArticle?id=5438949

banjomick - 02 Nov 2016 08:33 - 55 of 159

2 November 2016
 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
 
European Patent Office grants new and expanded patent underpinning Allergy Therapeutics' core Microcrystalline Tyrosine technology
 
Patent already granted in the United Kingdom and New Zealand
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, today announces that the European Patent Office has granted a broad technology patent relating to the Company's unique Microcrystalline Tyrosine (MCT) depot adjuvant manufacturing process. This patent covers the novel manufacture and physiochemical characteristics of MCT in combination with one or more antigens, further strengthening the Company's core intellectual property.
 
The granting of this patent further strengthens Bencard Adjuvant Systems, the wholly-owned division of Allergy Therapeutics which specialises in developing and optimising aluminium-free adjuvants for infectious diseases. Recent data generated have shown how MCT has a synergistic effect when coupled with another adjuvant from BAS's portfolio, Virus Like Particles (VLP), to create the adjuvant system AdSys-VcT. As recently announced, this adjuvant system demonstrated protective efficacy in a malaria model in a study performed in collaboration with the University of Oxford, UK.
 
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "We are pleased to expand this key patent and are excited by the potential for MCT as a core technology within our adjuvant portfolio to create novel and efficacious vaccines, both in allergies and also in infectious disease areas such as malaria and influenza. This further underpins the future pipeline for products, and the long term success of Allergy Therapeutics to continue innovating and producing novel medicines."

http://www.moneyam.com/action/news/showArticle?id=5441981

banjomick - 02 Nov 2016 09:11 - 56 of 159

From todays news "The granting of this patent further strengthens Bencard Adjuvant Systems, the wholly-owned division of Allergy Therapeutics which specialises in developing and optimising aluminium-free adjuvants for infectious diseases".

More info:

Bencard Adjuvant Systems
Bencard Adjuvant Systems is a division of Allergy Therapeutics UK; based in Worthing, on England’s south coast.

Bencard Adjuvant Systems specialise in developing and optimising adjuvants for infectious diseases, cancer immunotherapy and allergen immunotherapy and are committed to engaging in long-term partnerships with those who require our patented platform of adjuvant technologies.

Please click on the link below to download a copy of our brochure to find out more.

http://www.allergytherapeutics.com/media/1238/bencard-adjuvant-systems.pdf

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http://www.bencard-as.com/

banjomick - 30 Dec 2016 15:53 - 57 of 159

30 December 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the 'Company")
 
Grant of Awards under Long Term Incentive Plan
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, announces that, pursuant to the Company's Long Term Incentive Plan ("LTIP") the following conditional awards of shares of 0.1 pence each were made to Executive Directors at nominal cost of 0.1 pence each on 30 December 2016.

The issuance and distribution of ordinary shares of 0.1 pence each under the LTIP is conditional on the satisfaction of performance conditions which include an earnings growth test over a three year testing period to 30 June 2019 and share price growth over the 3 year plan cycle.

http://www.moneyam.com/action/news/showArticle?id=5473207

banjomick - 06 Jan 2017 13:35 - 58 of 159

Broker 'nuts' about Allergy Therapeutics; reckons stock could double in value
08:34 06 Jan 2017

Initiating coverage of the vaccines business, finnCap set a price target of 40p a share based on its analysis of the company’s peer group.

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A leading small-cap broker said it is ‘nuts’ about Allergy Therapeutics plc (LON:AGY), which it reckons has the potential to double in value.

Initiating coverage of the vaccines business, finnCap set a price target of 40p a share based on its analysis of the company’s peer group. Currently, the stock is changing hands for just over 20p.

Analyst Mark Brewer reckons the allergy immunotherapy market is worth around US$800mln here in Europe and US$1.7bn in the US.

“The potential addressable market, however, is estimated to be much larger at nine billion dollars,” he added.

The company’s lead product is Pollinex Quattro (PQ), a short-course hay fever treatment administered by injection.

On sale here in Europe, it is undergoing trials ahead of regulator sign-off in the US. In fact Brewer reckons there is “substantial further upside” when PQ gets the green light Stateside.

“A development programme that should result in an approved product in Europe and the US in 2021 provides significant upside to the current valuation,” said the finnCap number cruncher in his investment conclusion.

“We consider the current share price to be out of line with its nearest peers.”

The 33-page report gives a comprehensive overview of Allergy and also provides some financial grist.

finnCap reckons Allergy will turnover £59.4mln this year, rising to £65.4mln and then £71.4mln.

Ian Lyall

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banjomick - 06 Jan 2017 16:26 - 59 of 159

Financial Calendar

16 01 2017 Trading update

01 03 2017 Interim Results 2017

banjomick - 07 Jan 2017 10:39 - 60 of 159

finnCap - Allergy Therapeutics, Initiation of coverage (Video)
Fri, 06 Jan 2017, 03:30pm GMT

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banjomick - 10 Jan 2017 10:47 - 61 of 159

By Harriet Mann | Mon, 9th January 2017 - 14:09

Allergy Therapeutics

With a quarter of the UK suffering from hayfever at some point in their lives and 10-30% of the global population afflicted, the European allergy immunotherapy market (AIT) is worth $0.8 billion (£0.66 billion). In the US it is worth more than double that, at $1.7 billion.

Look at the potential addressable market and its value surges to around $9 billion. This backdrop is perfect for pharmaceuticals business Allergy Therapeutics (AGY).

The allergy vaccination group's profitable European operation is busy gobbling up market share as it gathers financial momentum. Revenue is expected to grow 23% in 2017 thanks to foreign exchange tailwinds, and gross margin should climb 260 basis points to 73.6% as volumes grow on a fixed cost base.

Before crucial research and development costs and general operational spend, profit should jump by a third to £19 million, finnCap analysts reckon.

Outside the flagship European business, Allergy also houses a US division that is trialling the Pollinex Quattro treatment. While the group continues these studies finnCap thinks it will remain loss-making.

Trading at a chunky 45% discount to its peers, with a profitable business and healthy pipeline, the valuation looks unjustified. finnCap believes the shares are worth nearly double at 40p, which would give them a market value of £235 million.

http://www.iii.co.uk/articles/381415/top-10-small-cap-share-tips-2017

banjomick - 11 Jan 2017 12:09 - 62 of 159

The dates (previously posted 6th January) have changed slightly on the AGY website so I've updated the header accordingly:

EVENTS

19 01 2017 Trading update (tentative)
29 03 2017 Interim Results 2017 Announcement (tentative)

banjomick - 19 Jan 2017 08:27 - 63 of 159

19 January 2017 
Allergy Therapeutics plc
 
Trading Update
 
-      H1 reported revenues ahead of expectations
-      Regulatory update: Pollinex Quattro clinical development programs to proceed as planned
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today provides an update on trading for the six months ended 31 December 2016 ahead of its unaudited interim results to be announced on 29 March 2017.
 
Financials

Reported revenues for the six months ended 31 December 2016 are expected to be £40.4m (2015: £29.0m), representing 17.9% organic growth at constant currency* (39.3% growth on a reported basis, aided by the impact on euro revenues of the weak pound). This growth reflects continued strong momentum across the majority of the Company's key markets. In a flat European market, the Company is fuelling its growth by increasing market share in most of its key markets. The main contributions in terms of net sales growth were generated in Germany, Austria, Spain and The Netherlands. In terms of products, growth is being provided across the whole portfolio, with the Company's ultra-short course aluminium-free therapies being the main contributor. The Board expects continuing growth in the second half of the year.
 
The strength of the euro against sterling has also led to higher overheads and R&D costs as most of these costs are incurred in continental Europe in euros but are reported in sterling.
 
The cash balance at 31 December 2016 was £27.8m (£33.2m at 31 December 2015).
 
Regulatory

Further to the Company's announcement on 27 June 2016, the Company has held discussions with the US regulatory authorities in relation to its US Grass MATA MPL programme and is proceeding as planned with the safety trial (G104) in the USA and the Phase II conjunctival provocation test dose selection study (G205) in Europe in 2017, ahead of the planned pivotal Phase III trial (G306).
 
Commenting on the positive trading update, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The Company's progress continues according to our long-term plans both in gaining market share in our main territories and with our clinical development. Our 18% top line organic growth in real terms reflects the quality of our products, technology and team, and the underlying convenience of our ultra-short course vaccines. We are excited by the prospects of the Company as we continue expanding our operations in Europe, progressing our development pipeline and moving forward with a world-class portfolio of allergy vaccines.  We are confident about the full year and look forward to updating shareholders on further progress throughout 2017."
 
*Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements.

http://www.moneyam.com/action/news/showArticle?id=5482133

banjomick - 19 Jan 2017 08:51 - 64 of 159

Not to be sneezed at - Allergy Therapeutics revenues up 18%
07:42 19 Jan 2017

The company, which has developed short course inoculations against hay fever, said turnover was £40.4mln in the six months ended December 31.

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Allergy Therapeutics plc (LON:AGY) said it had gained share in a “flat” European market as it said sales had grown strongly in the first half of its financial year.

The company, which has developed short course inoculations against hay fever, said turnover was £40.4mln in the six months ended December 31.

That represents an increase of 18% at constant currencies or 39% when the translational currency effect of the weak pound is brought into play.

“We are excited by the prospects of the company as we continue expanding our operations in Europe, progressing our development pipeline and moving forward with a world-class portfolio of allergy vaccines,” said chief executive Manuel Llobet.

“We are confident about the full year and look forward to updating shareholders on further progress throughout 2017."

The drug development programme in the US and Europe is proceeding to plan, Allergy said.

Ian Lyall

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banjomick - 20 Jan 2017 07:54 - 65 of 159

20 January 2017
 
Hardman Research: Investment driving market share gains

Investment driving market share gains: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies.

Pollinex Quattro continues to gain market share despite being available in Europe only on a 'Named Patient' basis.

Trials to obtain full regulatory approval as a biological have progressed well in the EU, and are back on-track in the US with a planned new safety trial.

AGY remains on course to have the first short-course allergy vaccine approved in both Europe and the US. Meanwhile, an excellent trading performance in 1H'17 shows that AGY is continuing to gain market share from its international peers.

Please click here for the full report:
http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/20.01.17-investment-driving-market-share-gains.pdf


http://www.moneyam.com/action/news/showArticle?id=5482889

banjomick - 23 Jan 2017 10:09 - 66 of 159

INTERVIEW: Zeus Capital Upgrade forecast for Allergy Therapeutics Plc
Uploaded by DirectorsTalk
Friday, January 20, 2017 at 9:45 AM EST

Allergy Therapeutics Plc (LON:AGY) is the topic of conversation when DirectorsTalk caught up with Dr Gary Waanders the Director of Healthcare Research at Zeus Capital. Gary explains whats driven growth in the 6 months to Dec 31st, affects on the full year and what other things should we be focusing on for Allergy Therapeutics.

http://www.directorstalk.com/interview-zeus-capital-upgrade-forecast-allergy-therapeutics-plc/

banjomick - 01 Feb 2017 08:01 - 67 of 159

01 February 2017 
Allergy Therapeutics plc
 
Positive Efficacy and Safety Data Shown in Peanut Allergy Vaccine
 
1 February 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive results from preclinical research into its unique therapeutic peanut allergy vaccine, Polyvac® Peanut. Having delivered these positive preclinical Proof of Concept results, Allergy Therapeutics will now progress the vaccine in accordance with its stated strategic plan when funding the programme and will proceed to Phase I development following completion of a first in man safety data trial.
 
The findings demonstrate that a single dose of the Company's virus-like-particles (VLP) adjuvant combined with recombinant peanut allergen successfully protected against anaphylaxis when challenged with peanut. Additionally, when examining symptom scores in the investigational model, those vaccinated with the candidate vaccine exhibited no symptoms compared to placebo. Furthermore, the safety profile of the product was evaluated via an intravenous challenge and found that the vaccine itself did not induce anaphylaxis in peanut sensitised subjects (a hypoallergenic vaccine).
 
Allergy Therapeutics' innovative peanut vaccine is focussed on a subcutaneous application of recombinant peanut allergen coupled with its state-of-the-art VLP adjuvant to increase the safety and efficacy profile. This approach aims to induce protective immunity, enabling shorter therapy duration and an enhanced safety profile and thus has significant implications for peanut allergy therapy with the potential to redefine the market for food allergy products. Alternative peanut vaccines in development often require repeated and long-lasting exposure transdermally or orally which may limit patient adherence.
 
Food allergy represents a significant and strategically important area for the Company, with peanut allergy treatments alone being an $8 billion p.a. addressable market globally. Allergy Therapeutics has the exclusive rights to develop VLP technology, a carrier system to present allergens to the immune system, for allergy vaccines.
 
Allergy Therapeutics intends to publish full data from this study in a peer-reviewed journal.
 
Commenting on the data, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Part of our international growth strategy has been to expand our immunotherapy platforms into other indications to widen our total addressable market. Consequently, whilst recognising the early stage nature of this project, we are extremely encouraged by these results. The data clearly demonstrate that when our unique adjuvant is coupled with recombinant peanut allergen it provides protection against anaphylaxis and also indicated no safety concerns often associated with traditional injected peanut vaccines. Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives. This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience."
 
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

http://www.moneyam.com/action/news/showArticle?id=5488908

banjomick - 01 Feb 2017 08:22 - 68 of 159

Allergy Therapeutics peanut allergy vaccine to move into phase I trials after pre-clinical success
07:44 01 Feb 2017

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

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Allergy Therapeutics (LON:AGY) will take its Polyvac vaccine for peanut allergy into a phase I clinical trial after it delivered positive pre-clinical results.

The findings showed a single dose of the company's unique adjuvant when combined with recombinant peanut allergen successfully protected against the serious allergic reaction anaphylaxis.

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

“Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives,” said Allergy Therapeutics chief executive Manuel Llobet.

“This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience."

Ian Lyall

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banjomick - 01 Feb 2017 12:56 - 69 of 159

Allergy Therapeutics hails progression of peanut allergy vaccine (Video interview)
12:40 01 Feb 2017

Allergy Therapeutics (LON:AGY) international medical director Dr Matthias Kramer talks to Proactive about the company taking its Polyvac vaccine for peanut allergy into a phase I clinical trial after it delivered positive pre-clinical results.

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

http://www.proactiveinvestors.co.uk/companies/stocktube/6831/allergy-therapeutics-hails-progression-of-peanut-allergy-vaccine

banjomick - 08 Feb 2017 07:54 - 70 of 159

8 February 2017 
Allergy Therapeutics plc
 
Directorate Change 
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Mr Jeff Barton to the Company's Board as a Non-Executive Director, nominated by Abbott Laboratories, Inc. ("Abbot", NYSE: ABT) in replacement of Mr Jean-Yves Pavee who retires from the Board, both effective after close of business 7 February 2017.
 
Jeff Barton currently serves as Vice President, Licensing and Acquisitions, at Abbott. During his time in this role, Abbott has executed several strategically important transactions including the acquisition of St. Jude Medical, CFR Pharmaceuticals and Veropharm.  He has served Abbott since joining in 1990 in the Financial Development Training program, and during his career has held a variety of financial management positions across Abbott's businesses, including in Diagnostics, Nutrition and Pharmaceuticals. He previously served as Divisional Vice President and Controller for Abbott's North American Nutrition Business and as Area Finance Director for its Asian, African, and Middle Eastern Pharmaceutical unit. Mr Barton holds a degree in accounting from Indiana University, and a Masters of Management from the Northwestern University Kellogg Graduate School of Management. 
 
Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Jeff to the Board.  He brings extensive commercial experience, particularly in the United States, which will be valuable to our Company as we continue to execute our global strategy. We also wish to take this opportunity to thank Jean-Yves for his contribution and support to Allergy Therapeutics since 2014."
 
Jeffery Glen Barton, age 48, has no current or prior directorships in the past five years. Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies.

http://www.moneyam.com/action/news/showArticle?id=5493038

banjomick - 10 Feb 2017 22:41 - 71 of 159

Germany gains Strength in Allergy Immunotherapeutics

Clara Rodríguez Fernández Clara Rodríguez Fernández on 10/02/2017

Bencard Allergie is developing ultra-short course allergy immunotherapies, backed by a strong growth in its German market.

Bencard Allergie is the German subsidiary of Allergy Therapeutics in the UK, which develops allergy vaccines. The German company was the first to market allergoids for allergen-specific immunotherapies. These are proteins modified to be recognized by immune cells while inducing a less intense response mediated by IgE antibodies. Over time, the patient’s immune system is exposed to larger doses to develop tolerance to the original allergen.

Now, the company is about to start Phase III trials with its product Pollinex Quattro birch against birch tree pollen allergy. The treatment is an ultra-short course subcutaneous immunotherapy that reduces a whole year of therapy to a period ranging from 3 to 8 weeks. With it, the company uses the aluminium-free adjuvant MCT as well as MPL, unique to Bencard, which binds to the TLR-4 receptor of immune cells and specifically induces a TH1-type immune response.

On top of that, Allergy Therapeutics and its subsidiaries are working on a new approach for allergen immunotherapy using virus-like particles. Backed by promising preclinical data, the group is now planning to enter clinical trials with the technology to treat peanut allergy.

In the market, Bencard will face competitors like the Swiss Anergis, also working in ultra-fast immunotherapies, and the French DBV Technologies, developing a non-invasive skin patch for children with peanut allergy. For its part, the British Circassia recently faced failure from a Phase III trial in cat allergy that has halted the development of its whole allergy pipeline.

Despite having strong competitors, Bencard seems well positioned. Allergy Therapeutics recently reported that Germany is its biggest source of sales growth, where 60% of its revenues are contributed by Bencard. This is great news for the company and its subsidiaries, which are seeking approval for their products according to the new Therapy Allergens Ordinance (TAO).

These regulations, implemented in Europe back in 2008, are expected to translate into fewer approved products by fewer suppliers, but the team seems confident in its products and is also planning for launch in the US soon.

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banjomick - 14 Feb 2017 08:40 - 72 of 159

14 February 2017 
Allergy Therapeutics plc
 
Novel House Dust Mite Allergy Vaccine Gains Clinical Trial Application Approval
 
CTA approval in Spain for Phase I AM101 clinical study evaluating safety of adjuvanted, modified house dust mite allergy vaccine
 
14 February 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that the Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A) has received Clinical Trial Application (CTA) approval in Spain.
 
House dust mites are a major cause of perennial allergic rhinitis and allergic asthma1. Acarovac MPL builds on the strong foundation of technologies employed in the successful Pollinex® Quattro range of subcutaneous allergy immunotherapies, and builds on the demonstrated efficacy2 of the existing successful product platform of Acarovac PlusTM, the fastest growing "named-patient product" in Allergy Therapeutics' Spanish subsidiary. Acarovac MPL is the only house-dust mite immunotherapy in development utilising MCT® (microcrystalline tyrosine), a natural, biodegradable depot, and the adjuvant MPL for the treatment of perennial allergic rhinitis making this vaccine unique in a $1.5 billion per annum market3.
 
CTA approval has been granted and the Company now expects this formulation to begin Phase I studies immediately, to assess the safety and tolerability of two different dose regimens. Both treatment regimens include a two-to-four week initial up-dosing phase but differ in the duration of the later maintenance phase. The Phase I trial of 32 patients is expected to last one year, and to be delivered on-time in-line with the Company's stated strategic plan when funding the programme in November 2015. If the Phase I trial is successful, the Company expects to launch Acarovac MPL in Spain on a named-patient basis. 
 
Commenting on the CTA approval, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "By using the successful biodegradable adjuvant system of MCT® and MPL, integral in our seasonal marketed vaccines, in a perennial house dust mite vaccine, we aim to improve both safety and efficacy for the thousands of patients who suffer year-round due to house dust mite allergy. Acarovac Quattro will provide convenience to our patients and doctors and more efficient pharmacoeconomics. Effectively, the dosing regime in Acarovac Quattro has the potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform."

http://www.moneyam.com/action/news/showArticle?id=5495889

banjomick - 14 Feb 2017 09:24 - 73 of 159

Allergy Therapeutics launches phase I trial of dust mite inoculation
08:05 14 Feb 2017

A total of 32 patients will receive Acarovac MPL. The trial is expected to take 12 months from start to finish.

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Allergy Therapeutics plc (LON:AGY) said the phase I clinical study of Acarovac MPL has received official sign-off in Spain.

The trial will assess the safety and how well tolerated the new dust mite treatment is.
A total of 32 patients will receive Acarovac, which will be administered at two different doses. The trial is expected to take 12 months from start to finish.

If the phase I assessment is successful, Allergy Therapeutics will launch the inoculation in Spain on a named-patient basis. This is where doctors can prescribe a drug without it having received regulatory sign-off.

Acarovac MPL is the only house-dust mite immunotherapy in development utilising microcrystalline tyrosine, which is natural and biodegradable.

It also uses monophosphoryl lipid A, or MPL for short, as an adjuvant which enhances the body’s immune response.

Harnessing the two in tandem should improve both safety and efficacy for the thousands suffers, according to Allergy Therapeutics’ boss Manuel Llobet.

The new formulation has the “potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform”, he added.

Microscopic in size, the problems house dust mites create are significant and include perennial allergic rhinitis (non-seasonal hay fever) and allergic asthma.

The market is worth an estimated US$1.5bn annually.

Ian Lyall

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banjomick - 14 Feb 2017 22:46 - 74 of 159

Allergy Therapeutics' Murray Skinner talks up 'huge market opportunities' for dust mite treatment
14:19 14 Feb 2017

Allergy Therapeutics plc (LON:AGY) chief scientific officer Murray Skinner speaks to Proactive about their phase I clinical study of Acarovac MPL receiving official sign-off in Spain.
A total of 32 patients will receive Acarovac, which will be administered at two different doses. The trial is expected to take 12 months from start to finish.
 
Andrew Scott

http://www.proactiveinvestors.co.uk/companies/stocktube/6911/allergy-therapeutics-murray-skinner-talks-up-huge-market-opportunities-for-dust-mite-treatment-6911.html

Big picture - Why invest in Allergy Therapeutics plc

banjomick - 09 Mar 2017 08:00 - 75 of 159

Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
 
Notice of Interim Results
 
9 March 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, will issue its interim results for the six months ended 31 December 2016 on Wednesday 29 March 2017.
 
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will hold a presentation and conference call for analysts on the day of results at 9:00am at Panmure Gordon, One New Change, London, EC4M 9AF.
 
Please contact Consilium Strategic Communications for further details.
 
- ENDS -

http://www.moneyam.com/action/news/showArticle?id=5509442

banjomick - 16 Mar 2017 08:02 - 76 of 159

16 March 2017 
Allergy Therapeutics plc

First Patient Recruited in Pivotal Phase III Birch Immunotherapy B301 Study 
 
16 March 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the recruitment of the first patient in its Phase III study designed to evaluate the efficacy and safety of its ultra-short course, aluminium-free Pollinex® Quattro Birch immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.
 
The first patient in the B301 Phase III study was recruited in Austria on 15 March. The study is anticipated to run for one year and involve more than 550 patients over 50 sites across Germany, Sweden, Austria and Poland. The primary objective of this study is to evaluate the efficacy of Pollinex® Quattro Birch in birch pollen-induced rhinoconjunctivitis and to enable registration of the product in Germany via the Therapieallergene-Verordnung (TAV) process of the Paul Ehrlich Institut, before anticipated marketing authorisation in 2019.
 
The adopted cumulative dose has been demonstrated to be efficacious in two recent dose range finding studies with respect to reduction of symptoms induced by a conjunctival provocation test (CPT) with no prior safety concerns.
 
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The start of our Phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens. If approved, Pollinex Quattro Birch will be the first MPL adjuvanted ultra-short course aluminium-free vaccine ever approved. Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT® and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance."

http://www.moneyam.com/action/news/showArticle?id=5513615

banjomick - 16 Mar 2017 09:47 - 77 of 159

Allergy Therapeutics recruits first patients to its phase III birch trial
07:43 16 Mar 2017

The year-long study over 50 sites in Germany, Sweden, Austria and Poland

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Allergy Therapeutics plc (LON:AGY) has recruited the first patients to its phase III trial of people with a sensitivity to birch pollen.

The year-long study over 50 sites in Germany, Sweden, Austria and Poland will recruit 550 patients and assess the efficacy and safety of its ultra-short course treatment Pollinex Quattro.

A successful outcome will pave the way to marketing authorisation in 2019.

"The start of our phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens,” said chief executive Manuel Llobet.

If approved, Pollinex Quattro Birch will be the first MPL enhanced ultra-short course aluminium-free vaccine ever approved.

MPL, or monophosphoryl lipid A, is what’s called an adjuvant that enhances the body’s immune response.

“Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance," said Llobet.

Ian Lyall

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banjomick - 29 Mar 2017 08:04 - 78 of 159

29 March 2017 
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 0900 BST today. Dial-in details are: +44 (0) 1452 555566. Conference ID: 75062637. 
 
Allergy Therapeutics plc

 
Interim Results for the six months ended 31 December 2016
 
29 March 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces its unaudited interim results for the six months ended 31 December 2016.
 
Highlights (including post period end highlights)
 
Financial highlights

·      Revenue increased by 18% at constant currency to £34.2m (H1 2016: £29.0m)* while reported revenue increased by 39% to £40.4m (H1 2016: £29.0m)

·      R&D expenditure of £3.8m (H1 2016: £6.5m) following a higher level of investment in Phase II trials in H1 2016

·      Strong growth in operating profit pre R&D of 40% as a result of broad investment in the business to £11.1m (H1 2016: £7.9m) and the strength of the euro against sterling

·      Cash balance of £27.8m (H1 2016: £33.2m)
 

Products and pipeline highlights

·      Increased market share in the Group's main European markets to 13% (2016: 12%) against a low to flat market

·      Pollinex franchise continues to expand and shape the market as a more convenient treatment

·      First patient recruited in pivotal Pollinex Quattro Birch Phase III study in Europe

·      US Grass MATA MPL programme proceeding as planned with the safety trial (G104) advancing to a dosing trial in H2 2017

·     CTA approval in Spain for Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A)

·      Positive proof of concept preclinical trial results announced with Polyvac® Peanut, the Group's peanut allergy vaccine
 
Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said: "In the first half of this year, we delivered an increase of 18% in revenue at constant currency, despite flat or low growth in European markets, driven by the quality of the Group's highly convenient, ultra-short course, aluminium-free therapy enabling us to continue to gain market share. This, linked to the recent announcements on progress with our pipeline projects, illustrates that the approach of investing both in the current business as well as the pipeline is working, paving the way for our long-term strategic international plans for a world-class allergy vaccines portfolio."
 
*Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.
 

Conference call
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a conference call for analysts at 0900 BST today.

http://www.moneyam.com/action/news/showArticle?id=5521411

banjomick - 29 Mar 2017 09:21 - 79 of 159

Allergy Therapeutics confident of further growth
08:17 29 Mar 2017

Its European markets were largely flat but the company still managed to achieve top-line growth of 18% on a constant currency basis

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Allergy vaccines specialist Allergy Therapeutics plc (LON:AGY) continued to gain market share in the second half of 2016.

The group issued half-year results that largely confirmed the numbers in its January trading update.

• Read Allergy Therapeutics' revenues rising across hay fever portfoliot

Revenue rose 39% to £40.4mln from £29.0mln in the second half of 2015, helped by favourable exchange rate movements. Stripping out currency fluctuations, the increase was still an impressive 18%.

The revenue uplift was achieved despite European markets as a whole showing no or very little growth.

Germany, Austria, Spain and The Netherlands contributed the most to top-line growth, Allergy revealed, although all markets saw sales head higher.

In the 12 months to 31 December 2016, market share grew to 13% compared to 12% in the year ended 30 June 2016 in the markets in which the group competes.

The flagship pollen allergy Pollinex franchise continues to expand, while Acarovac Plus, its dust mite allergy treatment, continues to grow well in Spain and has been launched in Austria.

Sales of synbiotics products – products that are a synthesis of prebiotics (substances that encourage the growth of microorganisms) and probiotics (health-giving microorganisms) - have performed well in Italy and Spain.

Profit before tax shot up to £7.2mln from £1.3mln as research & development (R&D) costs declined to £3.82mln from £6.54mln the previous year.

“The board and management team expect that growth in net sales will continue in the second half of the year and have great confidence in the future of the business,” the company said.

“As planned, research and development costs are expected to rise significantly in the second half of the year compared to the first half, reflecting the exciting preparation for the expected start of two major trials (US Grass MATA MPL Phase II and PQ Birch Phase III) as well as investment in infrastructure to progress the important TAV process. Other costs are expected to be similar to H1 2017,” Allergy Therapeutics confirmed.

Broker finnCap, which rates the shares a 'buy' said that apart from a slightly lower than expected first half R&D charge, “which is likely to be timing related”, it will make no change to its full-year forecasts.

“We retain a near term target price of 43p and point to the further upside that Pollinex Quattro (PQ) Grass programme in the US offers investors,” the broker said.



John Harrington

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banjomick - 05 Apr 2017 07:54 - 80 of 159

05 April 2017
 
Hardman Research: Progressive development across portfolio

Progressive development across portfolio - AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies.

Pollinex Quattro continues to gain market share despite being available in EU only on a 'Named Patient' basis.

Trials to obtain full approval as a biological have progressed well in EU with the first patient recruited in the pivotal birch pollen allergy vaccine Phase III trial.

US trials are back on-track with a new safety trial underway.

A Phase I study of Acarovac MPL, a 'dust mite allergy' vaccine, has been approved in Spain for 32 patients.

Finally, Polyvac Peanut has completed pre-clinical testing and has potential to significantly disrupt the peanut allergy market.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/agy-interim-results-update-5th-april.pdf

http://www.moneyam.com/action/news/showArticle?id=5526728

banjomick - 13 Apr 2017 09:13 - 81 of 159

Issue of equity in respect of the exercise of warrants and options
 
13 April 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces the issue and allotment of a total number of 673,748 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 353,748 share warrants issued to JSB Partners, LP in 2012 and pursuant to the exercise of 320,000 share options by certain employees.
 
Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8.00 a.m. on 18 April 2017. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.
 
Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 594,117,768 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 594,117,768. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.
 
- ENDS -

http://www.moneyam.com/action/news/showArticle?id=5531505

banjomick - 18 Apr 2017 09:19 - 82 of 159

General interest:

Month of misery in store for hay fever sufferers, say scientists
By Henry Bodkin
15 April 2017

Hay fever sufferers face another month of misery from tree pollen with scientists also predicting an early start to the grass pollen season.

The birch pollen season, which began around 10 days sooner than last year, has left millions experiencing symptoms and now allergy scientists expect the grass pollen season will begin earlier in May than normal.

The late date of the Easter weekend means holidaymakers keen to get outdoors are facing higher levels of pollen in the atmosphere than in previous years, with more trees in leaf.

Birch pollen is currently at peak levels in the South of England and the Midlands, with high readings expected in northern parts of the UK later in the month.

The early onset of the season is thought to have been brought about by the comparatively warm winter and early spring.

The sustained warm temperatures also mean 2017 is likely to be a year when the grass pollen season builds up steadily, rather than beginning suddenly in the final week of May. (More from link below)

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banjomick - 17 May 2017 09:37 - 83 of 159

Interesting study (Note-AGY sponsored the research):

Virus-Like Particle (VLP) Plus Microcrystalline
Tyrosine (MCT) Adjuvants Enhance Vaccine Efficacy
Improving T and B Cell Immunogenicity and
Protection against Plasmodium berghei/vivax


Published 2nd May 2017

Vaccination is the most effective prophylactic tool against infectious diseases.
Despite continued efforts to control malaria, the disease still generally represents a significant unmet medical need.

Microcrystalline tyrosine (MCT) is a well described depot used in licensed allergy
immunotherapy products and in clinical development. However, its proof of concept in prophylactic vaccines has only recently been explored. MCT has never been used in combination with virus-like particles (VLPs), which are considered to be one of the most potent inducers of cellular and humoral immune responses in mice and humans.

In the current study we assessed the potential ofMCT to serve as an adjuvant in the development of a vaccine againstmalaria either alone or combinedwith VLP using
Plasmodium vivax thrombospondin-related adhesive protein (TRAP) as a target antigen. We chemically coupled PvTRAP to VLPs derived from the cucumber mosaic virus fused to a universal T-cell epitope of the tetanus toxin (CMVtt), formulated with MCT and compared the induced immune responses to PvTRAP formulated in PBS or Alum.

The protective capacity of the various formulations was assessed using Plasmodium berghei expressing PvTRAP. All vaccine formulations using adjuvants and/or VLP
increased humoral immunogenicity for PvTRAP compared to the antigen alone. The most proficient responder was the group of mice immunized with the vaccine formulated with PvTRAP-VLP + MCT.

The VLP-based vaccine formulated in MCT also induced the strongest T cell response and conferred best protection against challenge with recombinant Plasmodium berghei. Thus, the combination of VLP with MCT may take advantage of the properties of each component and appears to be an alternative biodegradable depot adjuvant for development of novel prophylactic vaccines.

http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjG47f0v_bTAhUhBcAKHZGrBLAQFggiMAA&url=http%3A%2F%2Fwww.mdpi.com%2F2076-393X%2F5%2F2%2F10%2Fpdf&usg=AFQjCNF9PyTKNj05k19umwAMjX4DdB4Lpw

banjomick - 17 May 2017 09:49 - 84 of 159

Information on Micro Crystalline Tyrosine (MCT) can be found from page 7 from the Bencard Adjuvant Systems (a division of Allergy Therapeutics UK) brochure:

http://www.allergytherapeutics.com/media/1238/bencard-adjuvant-systems.pdf

banjomick - 02 Jun 2017 14:04 - 85 of 159

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

BlackRock, Inc. have gone above 5% to 30,368,413 (5.11%)

http://www.moneyam.com/action/news/showArticle?id=5560882

banjomick - 06 Jun 2017 08:48 - 86 of 159

06 June 2017
 Allergy Therapeutics plc
 
Directorate changes
 
6 June 2017 Allergy Therapeutics (AIM:AGY), the fully integrated speciality pharmaceutical company specialising in allergy vaccines, announces the appointment of Dr Tunde Otulana to its Board of Directors as a Non-Executive Director with effect from 6 June 2017.
 
Additionally, Dr Thomas Lander has indicated that he wishes to retire from his position as a Non-Executive Director of the Group with effect from 30 June 2017.
 
Dr Babatunde 'Tunde' Adekunle Otulana, aged 60, brings over 20 years' pharmaceutical industry knowledge and significant executive level experience in clinical development and medical affairs roles. He currently serves as Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals where he has responsibility for all global medical functions, and has previously worked for Boehringer Ingelheim Pharmaceutical Inc. as Senior Vice President, Clinical Development and Medical Affairs. He has previously spent over six years working at the US Food and Drug Administration (FDA) as a Medical Officer and Medical Team Leader in the Division of Pulmonary-Allergy Drug Products.
 
Dr Otulana received his medical degree in Nigeria where he also completed hospital residency training. He then moved to Cambridge, UK to complete his Clinical Research Fellowship in Pulmonary Medicine at the Papworth and Addenbrooke's hospitals, University of Cambridge.
 
Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Tunde to the Board. He brings a wealth of global experience in clinical and regulatory work, particularly with the FDA in the United States, which will be especially valuable as we continue to execute our global strategy.
 
"I also want to take this opportunity to thank Thomas for his significant contribution and support to the Group during the past five years. Thomas has always given the Board very clear advice on R&D matters and his experience has been hugely valuable. We all wish him well for the future in his retirement."
 
Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies in respect of Dr Otulana's appointment.

http://www.moneyam.com/action/news/showArticle?id=5562090

banjomick - 19 Jun 2017 08:59 - 87 of 159

19 June 2017 
Allergy Therapeutics plc
 
Allergy Therapeutics hosts satellite symposium at EAACI 2017
 
~ World-leading experts discuss allergy immunotherapies ~
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces today that a satellite symposium entitled: "The Best Therapies by Design"  was held at the 36th Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Helsinki, Finland on 18 June 2017, providing an overview of the technologies and strategies involved in designing the best immunotherapies.
 
Chaired by Professor Stephen Durham, four world-leading experts in the field of allergy, pollen, and immunotherapy vaccine delivery, Jörg Kleine-Tebbe, Erika Jensen-Jarolim, Uwe Berger & Tim Higenbottam presented on the strategy, design and considerations involved in creating immunotherapies such as Allergy Therapeutics' flagship product, Pollinex Quattro®.  Uwe Berger and Erika Jensen-Jarolim discussed the importance of highlighting relevant allergens and characterising them sufficiently.  Jörg Kleine-Tebbe discussed why successful immunotherapy requires identification of the optimal dose before Phase III studies are begun, before Tim Higenbottam finished the session describing the results recently gained from the Group's clinical studies.
 
Manuel Llobet, Chief Executive Officer, commented: "We are delighted with our progress in developing the next generation of allergen immunotherapy products. Our latest clinical data on dose-ranging confirms that our unique allergen-specific immunotherapies are formulated to the optimal strength and we believe Allergy Therapeutics has the potential to transform allergy treatment with optimised-dose, well-characterised, aluminium-free products."


Satellite Symposium: "The Best Therapies by Design"

1.   The importance of defining the optimal dose - Jörg Kleine-Tebbe, Allergie und Asthma - Zentrum Westend, Berlin.
2.   Molecular fingerprinting of complex allergoids - Erika Jensen-Jarolim, Institute of Pathophysiology and Allergy Research, Medical University Vienna.
3.   Rationale for broad spectrum grass immunotherapy - Uwe Berger, Medical University of Vienna. Head of Aerobiology & Pollen Information Research Unit.
4.   Defining the plateau of the efficacy for Allergen Specific Immunotherapy - Tim Higenbottam, R&D Director, Allergy Therapeutics.

http://www.moneyam.com/action/news/showArticle?id=5569444

banjomick - 19 Jun 2017 22:51 - 88 of 159

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banjomick - 27 Jun 2017 09:27 - 89 of 159

27 June 2017 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
 
Investor and analyst site visits
 
27 June 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, is hosting a site visit at its corporate headquarters for sell-side analysts today and institutional investors tomorrow.
 
The site visits will be hosted by Manuel Llobet, Chief Executive Officer, Nick Wykeman, Finance Director, and Murray Skinner, Chief Scientific Officer and will include presentations by the Group's key opinion leaders who are world-leading in their fields of expertise, including Professor Lawrence DeBuske, Clinical Professor of Medicine at the George Washington University School of Medicine, and Professor Dr Matthias Kramer, International Medical Director of Allergy Therapeutics.
 
During the visits, attendees will be provided with an update on the Group's market-leading businesses, markets, strategy and pipeline.
 
No inside information will be disclosed. The presentations will be available on the Group's website from 28 June 2017.

http://www.moneyam.com/action/news/showArticle?id=5573994

banjomick - 05 Jul 2017 09:52 - 90 of 159

Link to the presentation mentioned above:

http://www.allergytherapeutics.com/media/1251/investors_slides_jul_2017.pdf

banjomick - 06 Jul 2017 08:21 - 91 of 159

06 July 2017 
Allergy Therapeutics plc
 
Two studies of adjuvants in malaria and influenza vaccines published in peer-reviewed journals
 
~ Publications demonstrate the potential of Allergy Therapeutics' novel adjuvant systems in infectious diseases, further broadening the product pipeline ~

 
6 July 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that two preclinical studies carried out through its Bencard Adjuvant Systems division have been published in peer-review journals.
 
The two papers report that the novel depot adjuvant behind Allergy Therapeutics' successful allergy immunotherapy Pollinex® platform, microcrystalline tyrosine (MCT), both alone and in an adjuvant system, have broad applications and elicit high, sustained antibody titres demonstrating enhanced protective efficacy compared to conventional adjuvants including aluminium.
 
Commenting on the recent publications, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "These publications underpin the strategy for our Bencard Adjuvant Systems division, which focuses on extending the use of MCT® and VLP in further developing vaccines against unmet needs, and new and emerging infectious diseases that require an effective depot adjuvant."
 
The two publications are:
 
Comparison of a novel microcrystalline tyrosine adjuvant with aluminium hydroxide for enhancing vaccination against seasonal influenza:
Heath et al., BMC Infectious Diseases (2017) 17:232
The paper authored by principal scientist Dr Matthew D. Heath & collaborators from Public Health England discusses the use of MCT® in a seasonal influenza vaccine model. The use of MCT® displayed higher binding affinity compared to the conventional depot adjuvant, aluminium, demonstrating the suitability of MCT® as a depot adjuvant in applications outside of allergy immunotherapy. MCT® elicited an immune response (HAI titre) indicative of protection in a pre-clinical model. The data provide evidence of the suitability of using the MCT® platform in an influenza model and address some of the issues associated with weakly stimulating vaccine targets/antigens.
 
Virus-like particle (VLP) plus microcrystalline tyrosine (MCT) adjuvants enhance vaccine efficacy improving T and B cell immunogenicity and protection against plasmodium berghei/vivax: Cabral-Miranda et al., Vaccines (2017) 5;10.
 
This publication authored with The Jenner Institute at the University of Oxford has been published investigating the use of adjuvants MCT and adjuvant system MCT+VLP (AdSys-VCT) in malaria. In a pre-clinical model, malaria antigens conjugated to VLP and formulated in MCT induced highest antibody responses, highest T-cell responses, and offered the best protection against malaria compared with antigens formulated with aluminium. Moreover, the study demonstrated that MCT® alone is able to elicit high and sustained IgG antibody responses that are specific and protective against P.vivax (malaria).

http://www.moneyam.com/action/news/showArticle?id=5580828

banjomick - 06 Jul 2017 09:14 - 92 of 159

Allergy Therapeutics publishes pre-clinical data on malaria and flu vaccines
08:47 06 Jul 2017

The studies were carried out through Allergy’s Bencard Adjuvant Systems division.

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Allergy Therapeutics (LON:AGY) has published data in peer-reviewed journals from two preclinical studies analysing its immuno-therapy platform as a potential vaccine against malaria and the flu.

The two papers reported that Allergy’s immunotherapy Pollinex platform, microcrystalline tyrosine (MCT), both alone and in an adjuvant (immune system booster) system, had broad applications and boosted protection compared to conventional adjuvants.

The studies were carried out through Allergy’s Bencard Adjuvant Systems division. 
Manuel Llobet, chief executive, said
: "These publications underpin the strategy for our Bencard Adjuvant Systems division, which focuses on extending the use of MCT and VLP (virus-like particle) in further developing vaccines against unmet needs, and new and emerging infectious diseases that require an effective depot adjuvant."

http://www.proactiveinvestors.co.uk/companies/news/180447/allergy-therapeutics-publishes-pre-clinical-data-on-malaria-and-flu-vaccines-180447.html

banjomick - 11 Jul 2017 10:50 - 93 of 159

General interest but still AGY specific:

Filling and capping machine boosts output by 300%
10th July 2017

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A Flexicon FMB210L fully automatic vial filling and screw capping machine from Watson-Marlow Fluid Technology Group (WMFTG) has boosted output by 300% at a major pharmaceutical company, dedicated to reducing the impact of allergies on sufferers. The new machine has been set to work producing a sublingual immunotherapy (SLIT) product at a rate of 2,400 vials an hour.

UK-headquartered Allergy Therapeutics produces a wide range of aluminium-free allergy vaccines and diagnostics for customers across Europe and further afield in markets such as Canada, South Korea and Hong Kong. Sales currently stand at circa £50 million a year. The company has a special focus on allergy vaccination – also known as specific immunotherapy or desensitisation therapy – which is a treatment that deals with the underlying cause of allergies and not just the symptoms.

Central to manufacturing operations at Allergy Therapeutics is the ability to fill and cap product vials at throughput rates that match market demand. With this in mind, the company recently sought to enhance its operations in two areas.

“Firstly, we researched the market for robust components (vial and cap) to help progress the filling of our sublingual products,” explains the company’s head of Manufacturing and Technology, Rick Poland. “Secondly, we wanted to invest in an automatic filling and capping machine with faster throughput capacity.”

Having identified suitably robust 10cc vial and screw-cap components, Allergy Therapeutics set about reviewing various filling and capping machine manufacturers against a comprehensive user-requirement specification.

“We specified Flexicon for a number of reasons, but principally because the FMB210L proved to be extremely fit-for-purpose with regard to our particular application,” states Poland. “Furthermore, we’ve had a number of Flexicon machines over the years, so their proven track record was a prime consideration.”

Set up as a dedicated solution, the Flexicon FMB210L is being used to fill 10cc threaded-neck amber diluent vials with a raspberry flavouring, to which an allergen concentrate is added at a second stage before capping. Throughput rates of 2400 vials an hour are being achieved.

Allergy Therapeutics’ sublingual immunotherapy (SLIT) product is used to address the causes of allergic rhinitis (hay fever) against different allergens. It consists of a liquid that sufferers place under the tongue, and is more convenient than a traditional injected therapy in that patients can administer doses themselves at home. The raspberry flavouring is designed to increase the likelihood of sufferers using the therapy.

Automatic filling and capping

The FMB210L is a fully automatic filling and screw-capping system designed for the biopharm, diagnostic and pharmaceutical industries. It can fill volumes from less than 0.2ml to more than 250ml with ±0.5% accuracy to prevent costly overfilling. It also caps to a consistent torque that prevents leaks and over-tightening. The system is modular and easily customisable, and can work with many different liquids, containers and caps.

Only the liquid contacts a single-use fluid path, so changeover from one product to another can be completed in less than 20 minutes without the risk of cross-contamination. Flexicon offers IQ/OQ for the equipment and provides a free validation pack for the fluid path, reducing the time and resources needed.

In this case the FMB210L was equipped with an integrated Laminar Airflow System to maintain a near particle-free environment in the critical zones.

Installed at Allergy Therapeutics in October 2016, the Flexicon machine (and new vial and cap products) have since been validated, successfully passing final regulatory approval. Validation has also been achieved for processing empty vials to which a threaded cap is added. The system is now in full production.

“We worked hand-in-hand with WMFTG against a rigorous user specification, to develop a fit-for-purpose process that would withstand regulatory requirements,” says Poland. “Today, we have a filling and capping machine that offers 300% more output than our previous capability. As we operate in a highly-competitive market, investments of this nature are key to our business.”

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banjomick - 18 Jul 2017 08:52 - 94 of 159

18 July 2017
Allergy Therapeutics plc

Trading Update

15% constant currency revenue growth

Double-digit compound annual revenue growth over the past 18 years

18 July 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2017 ahead of its Preliminary Results to be announced in September 2017.

Financials

Revenues for the year are expected to be ahead of market expectations at £64.1m (2016: £48.5m). This strong performance represents 15% annual growth on a constant currency basis and 32% on a reported basis which reflects the favourable euro exchange rate.

The Company is continuing to gain market share within its core markets in Europe. Revenues have grown over the past 18 years at a double-digit compound annual growth rate. Research and development expenditure for the 2017 financial year is anticipated to be lower than market expectations due to the phasing of activities across the year end and these costs will now be incurred in financial year 2018. The ongoing pipeline trials continue to progress well and timing remains in line with Board expectations.


The cash balance at the end of June 2017 was £22.1m (30 June 2016: £23.4m).


Products

Allergy Therapeutics' market penetration has continued with strong growth in Pollinex Quattro and Pollinex. Venomil sales have also performed well due to the pre-stocking of raw materials compared to elsewhere in the market where there have been shortages of stock. Sales of the newer products in the Group's portfolio (Synbiotics and Acarovac) continue to develop well.

Pipeline

In Europe, recruitment of patients for the pivotal Phase III PQ Birch trial is on track with the trial still expected to start in the autumn of 2017. Likewise for the US, the Phase II Grass MATA MPL trial is also still planned to start this autumn. Patients for the Acarovac Quattro Phase I trial are being recruited and results continue to be expected in the autumn of 2018.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "Revenue growth of 15% at constant currency reflects the continued strong performance of the product portfolio and its growing market share. Our successful strategy focuses on our patient-convenient products and controlled investment in our development pipeline to expand our addressable market. Our double digit CAGR of revenue over the past 18 years demonstrates that we have a robust, reliable and successful business model."

https://www.investegate.co.uk/allergy-therapeutics--agy-/rns/trading-update/201707180700083133L/

banjomick - 18 Jul 2017 09:29 - 95 of 159

Allergy Therapeutics sales soar as market share in Europe rises
08:20 18 Jul 2017

Allergy continued to gain market share in Europe with its hay fever vaccines Pollinex Quattro and Pollinex.

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Allergy Therapeutics plc (LON:AGY) will report sales well ahead of market forecasts after strong organic growth combined with a hefty currency boost.

Revenues for the year to June will be £64.1mln (2016:£48.5mln), comprising 15% annual growth stripping out the foreign exchange effect and 32% on an actual basis.

Over the past year, Allergy continued to gain market share in Europe with its hay fever vaccines Pollinex Quattro and Pollinex.

Allergy also said research and development expenditure has also come below market expectations due to the phasing of activity, though these will now be incurred in the current year.


Cash at end June was £22.1mln (£23.4mln).

The company has just recruited the first patients to its phase III trial of core product Pollinex Quattro in people with a sensitivity to birch pollen.

The year-long study will take place over 50 sites in Germany, Sweden, Austria and Poland will recruit 550 patients and assess the efficacy and safety of its ultra-short course treatment Pollinex Quattro. The trial is scheduled to start in the autumn.

In the US, a Phase II Grass MATA MPL trial is also still planned to start this autumn while patients for the Acarovac Quattro dust mite allergy Phase I trial are being recruited and results continue to be expected in the autumn of 2018.

Manuel Llobet, Allergy's chief executive, said: "Revenue growth of 15% at constant currency reflects the continued strong performance of the product portfolio and its growing market share.

“Our double digit CAGR of revenue over the past 18 years demonstrates that we have a robust, reliable and successful business model."

Philip Whiterow

http://www.proactiveinvestors.co.uk/companies/news/181043/allergy-therapeutics-sales-soar-as-market-share-in-europe-rises-181043.html

banjomick - 15 Aug 2017 08:34 - 96 of 159

15 August 2017
Allergy Therapeutics plc

Notice of Preliminary Results

15 August 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, will issue its preliminary results for the year ended 30 June 2017 on Thursday 28 September 2017.

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will hold a presentation and conference call for analysts on the day of results at 9:30am BST at The Dome Room, 1 Cornhill, London, EC3V 3ND.

Please contact Consilium Strategic Communications for further details.

http://www.moneyam.com/action/news/showArticle?id=5626860

banjomick - 11 Sep 2017 08:28 - 97 of 159

11 September 2017
Allergy Therapeutics plc

Expansion of Clinical Development and R&D teams

- Key appointments reflect Group's commitment to EU and US strategy for product development -

11 September 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces new senior appointments and expansion of the R&D and clinical team in line with the Group's growth plans at the Group's UK headquarters in Worthing. These appointments are aimed at broadening the clinical development team in order to facilitate continued progress of the pipeline and clinical development programmes, in addition to continuing to prepare for US market entry.

The Group has underlined its commitment to clinical excellence by appointing Pieter-Jan de Kam as Clinical Director effective immediately. Pieter-Jan de Kam joins the Group from HAL Allergy in The Netherlands where he was responsible for clinical development, with recent successes including European and US studies for pollen and house dust mites. Prior to that, Pieter-Jan worked across Europe, in the US and in Singapore in various roles including Director of Clinical Research at Merck Sharp & Dohme.

In addition to the appointment of Pieter-Jan, the Group has recruited Simon Piggott as Head of Clinical Science. Simon will be responsible for the delivery of Allergy Therapeutics' robust clinical strategy to facilitate progression of the Group's broad pipeline and innovative technologies, working with both the established product development teams and clinical operations departments. Simon has significant experience including successful respiratory development programs through Phase I to IV having previously worked as Global Scientific Director at GSK and Associate Director at Quintiles and Vertex.

As part of the Group's continued investment in its R&D function, Tim Higenbottam has been appointed to the position of Senior Pharmaceutical Physician and will focus on the US regulatory process, a key part of the Group's three-pillar growth strategy. The R&D team which is led by Murray Skinner, Chief Scientific Officer, has doubled the size of its headcount since 2016.

Murray Skinner, Chief Scientific Officer of Allergy Therapeutics, commented: "We are delighted to welcome Pieter-Jan and Simon to the Allergy Therapeutics team. Their vast experience and expert knowledge is ideally focussed to promote continued innovation and help us bring new and convenient products for patients into the allergy immunotherapy market."

Pieter-Jan de Kam, new Clinical Director at Allergy Therapeutics, stated: "This is a company with a long history in allergen immunotherapy, an excellent pipeline of innovative allergy products and a focus on addressing the causes of allergy to help patients with their allergy. I am very excited to be able to join the Company at such a crucial time in its development and look forward to leading the clinical team to continued successes."

http://www.moneyam.com/action/news/showArticle?id=5658616

banjomick - 11 Sep 2017 10:14 - 98 of 159

Allergy Therapeutics finalises senior appointments
Iain Gilbert 11 Sep, 2017

pharma_biotech_gsk_glaxo_research_trials

Specialised pharmaceutical group Allergy Therapeutics announced it had finalised the appointment of two new senior staff as it looks to step up its research and development in line with the firms UK growth plans.

Allergy Therapeutics announced it had appointed Pieter-Jan de Kam, formerly of HAL Allergy in the Netherlands, to the vacant clinical director's position, citing his recent success on the study of pollen and house dust mites, two key areas of product development for the firm.

In addition to the appointment of Pieter-Jan, Allergy Therapeutics also recruited Simon Piggott as head of clinical science.

Piggott previously held the role of global scientific director at GSK where he gained "significant experience" on respiratory development programs through phase one to four clinical trials.

Murray Skinner, chief scientific officer, said "We are delighted to welcome Pieter-Jan and Simon to the Allergy Therapeutics team. Their vast experience and expert knowledge is ideally focussed to promote continued innovation and help us bring new and convenient products for patients into the allergy immunotherapy market."

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Also

Allergy Therapeutics strengthens clinical research team with senior appointments

banjomick - 18 Sep 2017 08:35 - 99 of 159

18 September 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")

Approval of clinical trial application for PQ Grass Phase II trial

- Trial aimed at determining optimal dose of an MPL-adjuvanted,
modified grass allergy vaccine -

18 September 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that the fully-funded Phase II clinical trial investigating the dosing of PQ Grass has received clinical trial application (CTA) approval.

PQ Grass is a unique, ultra-short course, aluminium free subcutaneously injected product with the potential to cure grass pollen-induced allergic rhinitis.

The US market, which is anticipated to be the main market for this product if successful, is estimated by the Group to be worth $2bn with potential peak sales of $300m per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the USA.

The Group expects the Phase II trial to begin imminently. The trial will take place in Europe in Germany, Poland and Austria and will involve approximately 440 patients. The results of the trial are expected in H2 2018. The trial is part of a continuing clinical trial programme aimed at developing the PQ Grass platform worldwide. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary before it progresses to a Phase III trial.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "This revised Phase II trial will prepare the ground for entry in to the high value US market in which PQ Grass has the potential to become a convenient, best in class, ultra-short course subcutaneous immunotherapy. We look forward to reporting headline data next year as we advance this product."

http://www.moneyam.com/action/news/showArticle?id=5667706

banjomick - 24 Sep 2017 09:47 - 100 of 159

Trials by Allergy Therapeutics loom for nut allergy vaccine
Sabah Meddings
September 24 2017, 12:01am,
The Sunday Times

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Children allergic to peanuts could soon be offered a short course of injections to cure them of the condition.

AIM-listed Allergy Therapeutics has already tested the vaccine in the laboratory, and is poised to scale up production before applying for approval from regulators. It will then begin human trials.

If successful, the series of inoculations could prevent hundreds of deaths a year. “It’s estimated there could be in the region of 3m people in the US who would come forward for this type of treatment,” said Nick Wykeman, finance director of Allergy Therapeutics.

An estimated 0.6% to 1% of the global population have a peanut allergy. For some, just touching peanuts can spark reactions such as breathing difficulties, a racing pulse and loss of consciousness.

Allergy Therapeutics hopes its vaccine will be fast-tracked through the approval process due to the absence of any similar treatment.

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109064949_RA_3for3_Banner_920x385_v13-1.

banjomick - 24 Sep 2017 10:50 - 101 of 159

This article from Investors Chronicle (published by the Financial Times Group) tipping AGY relates to the announcement 18 September 2017 on Approval of clinical trial application for PQ Grass Phase II trial:

Allergy Therapeutics: sniffing out the potential
September 21, 2017
By Megan Boxall

The US allergy pharmaceuticals market has the potential to be very lucrative. Roughly 18m Americans sniff and itch their way through the hay fever season each year and, at present, treatment options are limited. But it is also a notoriously tricky sector to navigate. Allergy Therapeutics (AGY) is proof of that, gaining the go-ahead for the phase II clinical trial of its new grass allergy medicine – Pollinex Quattro (PQ) – after 10 years.

In 2007, Allergy’s final trial into the efficacy of PQ was put on hold after a participant reported numbness and weakening, which regulators couldn’t be sure had nothing to do with the treatment. That hold was only lifted in 2011, and since then the group has failed to show US regulators an acceptable dosage of the drug.

But with demand for PQ so strong, Allergy has been given the go-ahead to try again. The newest dosing study will begin imminently, according to management, and is expected to release results by the second half of 2018. If approved, PQ will be the first injectable allergy treatment available in the US.

But as well as sidestepping tight regulation, Allergy Therapeutics must hurdle another demon of the allergy drugs market: the placebo effect. In 1999 a food allergy vaccine made by Peptide Therapeutics successfully helped 75 per cent of patients on a clinical trial tolerate more of the food they were allergic to. Unfortunately, a similar number of patients on the placebo treatment responded the same way, meaning the trial was deemed a failure. It was a similar story at Circassia (CIR) last year when its cat allergy treatment failed to show any significant benefits above the placebo drug, which had improved symptoms by 59 per cent. Many academic studies have found this high placebo effect to be common in allergy drugs trials, but no-one can fully explain why.

Allergy Therapeutics should be more immune to placebo effect than its peers. PQ has already successfully improved the symptoms of more than 250,000 patients and is marketed in seven countries. Moreover, the trial has not been designed using the self-report measures that have caused problems for many allergy studies; instead patients’ eyes will be observed for signs of improvement before and after treatment.


IC View

Investors have been slow to forgive Allergy Therapeutics for its US misfortunes. The share price has gained good momentum in the past few months, but at 32p it is still far from its 2006 highs. There are factors to be wary of that are outside of the company’s control, such as tight US allergy regulation, but demand for PQ is clearly high. If Allergy can crack the tough US regulatory environment, the financial rewards could be big. Buy.

Last IC View: Buy, 25p, 03 Apr 2017

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banjomick - 26 Sep 2017 23:50 - 102 of 159

One2One Investor Forum

Amryt Pharmaceuticals | Allergy Therapeutics plc | Faron Pharmaceuticals Oy | Avacta Group Plc | Genedrive PLC

Oct 5th 2017, 6.00 pm - Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair

The presentations will start at 6:00pm and finish at approx 8:00pm. After the presentations are complete the directors will also be available to take questions during a free canapé and wine reception. Details on the presenting companies can be found below.
 
This event is suitable for the following:
Sophisticated & private investors, private client brokers, fund managers, financial institutions, hedge funds, buy & sell side analysts and journalists.

http://www.proactiveinvestors.co.uk/register/event_details/110

banjomick - 28 Sep 2017 07:54 - 103 of 159

28 September 2017

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 0930 BST today. Dial-in details are: +44 (0) 1452 555566. Conference ID: 86318311.

Allergy Therapeutics plc

Preliminary Results


28 September 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces preliminary results for the year ended 30 June 2017.

Financial highlights

· 72% increase in operating profit (pre-R&D) to £7.4m (2016: £4.3m)
· 32% revenue growth increase in actual terms to £64.1m (2016: £48.5m)
· 15%* revenue growth at constant currency to £55.5m (2016: £48.5m)
· 10% compound annual growth in net sales over 18 years
· Market share in the Group's main European markets increased to 13% (2016: 12%)
· Cash at 30 June £22.1m (2016: £23.4m)


Operational highlights

· Commencement of recruitment for pivotal Phase III Pollinex Quattro Birch trial
· US Grass MATA programme proceeding well; safety study successfully completed
· First patient recruited for Acarovac MPL Phase I trial in Spain
· Positive pre-clinical proof of concept trial data announced for Polyvac Peanut

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "This has been another strong year of growth with constant currency growth of 15%* increasing our market share and, together with a favourable sterling/euro exchange rate, boosting operating profit pre R&D by £3.1m. Our continuing growth and progress on our pipeline reflects the quality of the products and the committed team that works at Allergy Therapeutics. We expect further good progress in the coming year."

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

* percentage based on figures in thousands (2017: £55.545m, 2016: £48.509m)

http://www.moneyam.com/action/news/showArticle?id=5682414

banjomick - 28 Sep 2017 08:51 - 104 of 159

Allergy Therapeutics preparing the ground for big opportunities in the US (Video)
08:28 28 Sep 2017


Allergy Therapeutics plc’s (LON:AGY) finance director Nick Wykeman and chief executive Manuel Llobet tell Proactive it's been another year of strong growth for the company.

Operating profits (pre-research and development expenditure) rose 72% in the 12 months to June 30 on revenues of £64.1mln, up 32%.

Allergy, which saw its market share grow by a percentage point to 13%, is in a strong financial position, with £22.1mln in the bank.

http://www.proactiveinvestors.co.uk/companies/stocktube/8152/allergy-therapeutics-preparing-the-ground-for-big-opportunities-in-the-us-8152.html

banjomick - 09 Oct 2017 17:34 - 105 of 159

Firstly FMP/TV had (28th September) AGY's Manuel Llobet and Nick Wykeman on:

http://fmp-tv.co.uk/company/allergy-therapeutics-investors-video-and-news/

And the presentation slides from last weeks event:

http://www.proactiveinvestors.co.uk/upload/SponsorFile/File/2017_10/1507280090_Allergy-Therapeutics---Corporate-Presentation-2017.pdf

banjomick - 10 Oct 2017 09:34 - 106 of 159

10 October 2017

Hardman Research: Continuing to gain market share

Continuing to gain market share - AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro continues to gain market share despite being available in the EU only on a 'Named Patient' basis. Investment in marketing over the last three years has been reflected in exceptional growth, with +10% CAGR in sales over the last five years compared to overall allergy vaccine market growth of +1%. In fiscal 2017, AGY gained another one-point market share to 13%. R&D investment in clinical trials for full approval as a biological in both Europe and the US are progressing with results due to be released in the second half of calendar 2018.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/10.10.17-continuing-to-gain-market-share.pdf

banjomick - 12 Oct 2017 16:11 - 107 of 159

12 October 2017
Allergy Therapeutics plc

Director/PDMR Shareholding

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that, on 11 October 2017, Tunde Otulana, Non-Executive Director of the Company, purchased 25,000 ordinary shares of 0.10p in the Company ("Ordinary Shares") at a price of $0.5066 per Ordinary Share (equivalent to 38.41p per Ordinary Share)*. Mr Otulana's total beneficial holding now amounts to 25,000 Ordinary Shares, which represents 0.004% of the issued share capital of the Company to which voting rights are attached.

http://www.moneyam.com/action/news/showArticle?id=5702117

banjomick - 19 Oct 2017 09:00 - 108 of 159

19 October 2017
Allergy Therapeutics plc

Commencement of dosing in PQ Grass Phase II Trial

19 October 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that dosing has commenced in its G205 Phase II study designed to evaluate the dose-response and safety of its ultra-short course, aluminium free PQ Grass immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.

The study is anticipated to run for one year and involve approximately 440 patients in more than 50 sites across Germany, Austria and Poland. The trial is designed to identify the optimal efficacious cumulative dose using conjunctival provocation testing. This type of challenge testing has recently been used in studies for a similar subcutaneous birch pollen product resulting in selection and approval of dose for use in a current phase III study. The results of the G205 trial are expected in H2 2018. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary to enable Phase III trial design.

The US allergy immunotherapy market, which is anticipated to be the main market for this product, is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the US for allergy.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The start of treatment in this important Phase II trial marks an exciting and critical period of trials for the Group's research and development pipeline. This trial aims to strengthen the Group's portfolio in Europe and the US and takes us another step closer to treating patients in the major US market."

http://www.moneyam.com/action/news/showArticle?id=5709529

banjomick - 20 Oct 2017 13:49 - 109 of 159

Missed yesterdays 16:14 announcement:

19 October 2017


Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")


ANNUAL FINANCIAL REPORT 2017 AND NOTICE OF 2017 ANNUAL GENERAL MEETING


Allergy Therapeutics Plc has today published the following documents:

· Annual Report for the year ended 30 June 2017 ("Annual Report"); and

· Notice of 2017 Annual General Meeting ("Notice of Meeting");

Each of these documents is available electronically on the Company's website at www.allergytherapeutics.com

A hard copy of the Annual Report and Notice of Meeting is anticipated to be posted to shareholders on 19 October 2017.

http://www.moneyam.com/action/news/showArticle?id=5711023


Annual Report for the year ended 30 June 2017

banjomick - 20 Oct 2017 14:29 - 110 of 159

Allergy Therapeutics - strong financial showing, solid cash position, progress in the clinic
10:08 20 Oct 2017

Allergy, which saw its market share grow by a percentage point to 13%, is in a strong financial position, with £22.1mln in the bank

757z468_1506582950_shutterstock_24653838

Allergy Therapeutics PLC’s (LON:AGY) preliminary results charted a period of strong financial and operational progress with the company predicting further progress on all fronts this year.

Operating profits (pre-research and development expenditure) rose 72% in the 12 months to June 30 on revenues of £64.1mln, up 32%. The latter figure did benefit from a boost from the weak pound. Even so, at constant currencies, top-line growth was a solid 15%.

WATCH: Allergy preparing the ground for big opportunities in the US

Allergy, which saw its market share grow by a percentage point to 13%, is in a strong financial position, with £22.1mln in the bank.

Strong cash position

That cash will be important when it comes to funding its research programmes.

It has started the recruitment for a Phase III clinical trial of Pollinex Quattro for those with an allergy to birch pollen.

The programme for the Grass MATA MPL product is “proceeding well”, Allergy said. A US safety study has been completed and a Phase II programme is expected to get underway soon.

The first patient has been recruited for a Phase I assessment of Acarovac, for dust mite allergy, which is underway in Spain.

Further progress expected

The allergy treatment specialist has also received positive pre-clinical proof of concept data announced for Polyvac for a reaction to peanuts.

“Our continuing growth and progress on our pipeline reflects the quality of the products and the committed team that works at Allergy Therapeutics,” said chief executive Manuel Llobet.

“We expect further good progress in the coming year."

Minor tweaks

The broker FinnCap said it had made only minor tweaks to its forecasts following the results.

It expects revenues to rise to £72.5mln. Its price target is 47p a share (current price 32.8p).

Market share gains

Finncap sees Allergy with a market share of about 16% in 2020, which equates to revenues of €97mln in a market that the broker estimates will be worth €605mln, assuming market growth over 2017-2020 of 3% per annum.

This is set against the company's aspirational target of “20% in 2020".

An additional 4% share in 2020/21 would imply revenues some €20m higher than currently forecast, which would add a further 10p to the target valuation.

Market share in the yar to Juen just ended grew by 100bps (1%) to about 13% making a gain of 300bps since 2015 in a market that is broadly flat.

Growth was strong in Spain (+13%), Holland (+29%), Austria (+27%) and Germany (+13%).

An 80-year history

Allergy Therapeutics has an 80-year history and so is no “jam tomorrow” drug development company.

It has a profitable core business and, a number of ground-breaking allergy vaccines that trade under various brand names.

READ: Allergy Therapeutics strengthens clinical research team with senior appointments

Its most commonly prescribed vaccines are used to treat pollen-related allergies, particularly allergies to grasses and trees.

It has a strong presence in Europe with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets it often makes its products available through distribution partners.

Its Pollinex Quattro vaccine for the treatment of seasonal allergic rhinitis (hay fever) from grass, tree or ragweed pollen allergy is already established in Europe, and the company wants to replicate that in the US, where it will enjoy first mover advantage in a market potentially worth £1.5bn ($2bn).

- -updated October for new finncap comment--


http://www.proactiveinvestors.co.uk/companies/news/184731/allergy-therapeutics-strong-financial-showing-solid-cash-position-progress-in-the-clinic-184731.html

banjomick - 13 Nov 2017 09:35 - 111 of 159

13 November 2017
Allergy Therapeutics plc

Allergy Therapeutics to Present at Jefferies 2017 London Healthcare Conference

13 November 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces that Manuel Llobet, Chief Executive Officer, will be presenting at the Jefferies 2017 Healthcare Conference in London, on Wednesday 15 November at 13:20 GMT.

http://www.moneyam.com/action/news/showArticle?id=5739958

banjomick - 13 Nov 2017 10:31 - 112 of 159

Jefferies 2017 London Healthcare Conference

November 15-16, 2017
London, UK

The Jefferies 2017 London Healthcare Conference will be taking place November 15-16 in London, UK.

Now in its eighth year, the Jefferies Conference is the largest healthcare-dedicated conference in Europe. This year, we hosted 350 participating companies, 1,400 attendees and 3,400 investor and business-to-business meetings. The event featured leading public and private companies from the pharmaceuticals, biotechnology, generics, consumer health, animal health, medical technology and healthcare services sectors from the United States, Europe, Africa, Middle East, Latin America, Russia, India, Israel, China and Japan.

You must be pre-registered to attend this conference. Please reach out to your Jefferies representative in order to register.

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banjomick - 21 Nov 2017 07:58 - 113 of 159

21 November 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Block Listing Application

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that an application has been made to the London Stock Exchange for admission to AIM for a block listing of 10,000,000 ordinary shares of 0.1p each in the Company ("Ordinary Shares").

The new Ordinary Shares will not be allotted immediately but rather will be issued and allotted from time to time pursuant to the exercise of employee options under the Allergy Therapeutics 2013 Long Term Incentive Plan. On exercise, these new Ordinary Shares will be issued as fully paid and will rank pari passu in all respects with the existing Ordinary Shares of the Company.

The expected effective date of admission of these securities to AIM is on or around 24 November 2017.

http://www.moneyam.com/action/news/showArticle?id=5750700

banjomick - 12 Dec 2017 08:40 - 114 of 159

12 December 2017
Allergy Therapeutics plc

Allergy Therapeutics enters co-development agreement with Ergomed plc

12 December 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces it has entered into a co-development collaboration agreement with Ergomed plc ("Ergomed") (AIM:ERGO) for the clinical development of three OralVac immunotherapy products. Allergy Therapeutics' core focus remains the convenient short course subcutaneous immunotherapy (SCIT) products, with the OralVac sublingual products providing an alternative option for patients who prefer oral products.

To capitalise on the changing regulatory requirements in Germany, the OralVac products, which are currently sold in Europe on a named patient basis, are being registered under the new TAV (Therapieallergene-Verordnung) regulation programme managed by the Paul Ehrlich Institute in Germany. The pharmaceutical development and pre-clinical evaluation for these products has already been completed by Allergy Therapeutics.

This planned OralVac clinical development expands Allergy Therapeutics' current broad SCIT clinical programme. To manage this expansion, Simon Piggott, Head of Clinical Sciences and Denise Lee, Head of Clinical Operations will lead early and late phase EU clinical development respectively, with Pieter-Jan de Kam, Clinical Director, to lead the US clinical development programme, which is focused on SCIT products and is a key part of the Group's three-pillar growth strategy.

Under the terms of the agreement, Ergomed will progress the clinical development of OralVac products for the treatment of grass pollen, tree pollen, and house dust mite allergies. The collaboration includes a future revenue share and reduced service fee.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are pleased to announce this co-development programme with Ergomed, which is aimed at strengthening our product portfolio across Europe in a risk-sharing fashion. Ergomed has over 20 years of experience in clinical development and significant expertise in the allergy field, and are thus ideally placed to support us in the progression of our OralVac products."

http://www.moneyam.com/action/news/showArticle?id=5777145

banjomick - 09 Jan 2018 08:52 - 115 of 159

09 January 2018
Allergy Therapeutics plc

PQ Birch Phase III clinical trial completes recruitment

9 January 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that recruitment of the Group's Phase III clinical trial with PQ Birch (PQBirch301) has been completed as expected. The PQBirch301 study is a pivotal Phase III study designed to evaluate the safety and efficacy of the Group's ultra-short course, convenient for patients, aluminium free PQ Birch subcutaneous immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.

The PQBirch301 study has randomised over 560 patients from 59 centres in four European countries: Germany, Austria, Poland and Sweden. The primary efficacy data will be assessed during the birch pollen season of 2018 and the results of the trial are expected during H2 2018. The successful completion of this pivotal Phase III study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institut before anticipated marketing authorisation.

PQ Birch is one of a number of ultra-short course, subcutaneous immunotherapy products in clinical development for various allergies, and these form a key component of the Group's three-pillar growth strategy. This includes: developing a strong pipeline facilitated by investment from the growing, profitable European revenue stream; expanding the existing European business; and preparing for product entry into the US market. The PQ family of products complement the Group's existing European marketed portfolio of convenient short course subcutaneous immunotherapy products and are particularly suited to the changing regulatory environment for allergy products in the US


Approximately 6% of the population of Europe alone is allergic to birch pollen1 and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The completion of recruitment in our pivotal Phase III clinical study with PQ Birch is an important milestone for the Group. Marketing authorisation of the first MPL-adjuvanted, ultra-short course aluminium free vaccine available to patients will strengthen the Group's portfolio and help address the current unmet needs in allergy."

1 DataMonitor Epidemiology Report. 2011

http://www.moneyam.com/action/news/showArticle?id=5807728

banjomick - 31 Jan 2018 10:29 - 116 of 159

31 January 2018
Allergy Therapeutics plc

Trading Update

Market share gains driving top line growth

Strong cash position sustained by good performance.


31 January 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today provides a trading update for the six months ended 31 December 2017, ahead of its unaudited interim results to be announced on 7 March 2018.


Financials

The Group reports that it is trading in line with the Board's expectations. Reported revenues for the six months ended 31 December 2017 are expected to be £42.2m (2016: £40.4m), representing 4.4% growth on a reported basis and 1.3% growth at constant currency. The Group has continued to grow in the past six months of 2017, notwithstanding an abnormally weak pollen season in Central Europe1, outperforming the market by an average of 4 percentage points2 thanks to focused sales and marketing strategy and its exclusive technology platform. In Germany, the Group's market share has risen by one percentage point to 14% over the past twelve months on a moving annual average basis. The fastest growing operations for the Group in the six months ended 31 December 2017 were the Spanish subsidiary as well as the Emerging Markets segment.

By leveraging additional revenues on current infrastructure, the Group continues to improve its operational margins pre-R&D. This, along with careful planning of working capital and capex investments, has allowed the Group to maintain a strong cash position of £25.8m (31 December 2016: £27.8m).


Products

There continues to be increasing uptake of the Group's portfolio of convenient and patient-friendly treatments. Pre-seasonal ultrashort course aluminium free vaccine Pollinex Quattro, designed to address the cause of symptoms of patients sensitised to seasonal allergens (grass, trees, ragweed), remains a key growth driver for Allergy Therapeutics based on the benefits of the Group's treatment programs.

Venomil, the Group's product that treats the life threatening condition of venom allergy, grew strongly as well as Acarovac Plus3 which continued to outperform the rest of the portfolio in Spain.


Pipeline

The Group's Phase III PQ Birch trial has recently completed recruitment, with results expected in H2 2018. The successful completion of this pivotal Phase III study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institute before anticipated marketing authorisation.

The PQ Grass Phase II trial continues to recruit on schedule with results also expected in H2 2018. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary to enable Phase III trial design.

Additionally, all the German TAV plans are on track with the recent incorporation of the clinical development programmes for the oral vaccine Oralvac, under a co- development agreement with Ergomed announced in December 2017.


Outlook

Post the period end current trading remains positive and the Board remains confident in the outlook for the business for the remainder of the year. Allergy Therapeutics' competitive position continues to improve with increased market share, in the countries in which it operates, increasing in line with its long term plans to achieve 20% market share. Market share gains are consistent across its key European markets, notably in highly competitive markets like Spain, Germany, Austria and Holland.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "Our strategy to prioritise patient friendly vaccines with focus on patient compliance and improving adherence rates is demonstrating success. Our portfolio of ultra-short course vaccines is driving our market penetration in Europe and preparing the ground for a successful US entry. All our key development programmes are being executed according to plan and our long-term strategic objectives, are on track. We feel privileged to keep developing Allergy Therapeutics as we satisfy the significant unmet needs of our patients."

http://www.moneyam.com/action/news/showArticle?id=5836625

banjomick - 02 Feb 2018 08:53 - 117 of 159

02 February 2018

Hardman Research: Growth in a tough market

Growth in a tough market: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a 'Named Patient' basis. Trials designed to obtain regulatory approval for PQ approved as a biologic in both Europe and the US are well advanced. Meanwhile, although underlying sales growth was weaker than expected in 1H'18, this was on the back of an unusually shorter and lower pollen season in central Europe, suggesting that AGY has continued to make further market share gains.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/02.02.18-growth-in-a-tough-market.pdf

http://www.moneyam.com/action/news/showArticle?id=5840974

banjomick - 12 Feb 2018 10:21 - 118 of 159

Allergy Therapeutics plc

Completion of recruitment in PQ Grass Phase II trial

Trial running ahead of schedule with data now due in early H2 2018


12 February 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that recruitment has been completed in its grass allergy Phase II study (G205), with results due ahead of expectations in early H2 2018. The trial is designed to evaluate the dose-response and safety of its ultra-short course, aluminium free PQ Grass immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.


The study protocol involves more than 440 patients in over 50 sites across Germany, Austria and Poland. The trial is designed to identify the optimal efficacious cumulative dose using conjunctival provocation testing. This type of challenge testing has recently been used in studies for a similar subcutaneous allergoid MPL product resulting in selection and approval of dose for use in a phase III study.


One of the key markets for this global product is expected to be the US. The US allergy immunotherapy market is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the US for allergy.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The completion of recruitment for all patients in our Phase II trial is an important step in our journey towards access to the US market in which PQ Grass has the potential to become a convenient, best in class, ultra-short course subcutaneous immunotherapy. We are pleased that the study is running ahead of schedule and look forward to seeing the results later this year."

http://www.moneyam.com/action/news/showArticle?id=5851299

banjomick - 15 Feb 2018 15:50 - 119 of 159

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies

http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

banjomick - 28 Feb 2018 09:28 - 120 of 159

28 February 2018
Allergy Therapeutics plc

Allergy Therapeutics prepares for manufacturing and clinical development of Polyvac® Peanut allergy product


- Specialist CMO AGC Biologics engaged -


28 February 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces it has signed a contract with AGC Biologics (Heidelberg, Germany) to scale up the manufacturing of its Polyvac® Peanut product for use in clinical studies.

Pre-clinical findings using Polyvac® Peanut demonstrated protection against anaphylaxis and induction of protective immunity. It is planned that further development of this product will enable the Group to address the current unmet need. Allergy Therapeutics will now scale-up and validate the manufacturing processes for Polyvac® Peanut as part of the clinical development programme.

Food allergy, and in particular peanut allergy, is a significant and strategically important area for Allergy Therapeutics due to the serious and destabilising effects on the lives of both patients and their families. The global addressable market for therapies to help mitigate these effects is estimated at $8 billion per annum1.

AGC Biologics is a contract manufacturing organisation (CMO) specialising in expression and purification of recombinant therapies. The company has produced batches of cGMP-compliant material for a variety of pharmaceutical and biotech companies with proven operational expertise in the transfer, development, scale-up and validation of cGMP processes and has prior experience in expression of virus like particle constructs.


Manuel Llobet, CEO at Allergy Therapeutics, stated: "The disruption to patients' social and family life as a result of food allergies is significant, and we are committed to addressing these current unmet needs. The Group's peanut vaccine programme complements our current marketed range of ultra-short course vaccines in terms of safety, efficacy and improved patient convenience. We are pleased to start working with AGC Biologics in order to further progress the clinical programme."

http://www.moneyam.com/action/news/showArticle?id=5872398

banjomick - 02 Mar 2018 12:45 - 121 of 159

Unless I made a mistake AGY have changed their tentative Interim Results date from the 8th to the 7th:

07 03 2018 Interim Results 2018 Announcement (tentative)

http://www.allergytherapeutics.com/investor-relations/financial-calendar/


Hmmm, which now ties in with

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies
http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

and te start of the European Drug Safety Summit 2018
http://www.wplgroup.com/aci/event/european-drug-safety-summit/

banjomick - 02 Mar 2018 14:09 - 122 of 159

Just had a quick check on AGY global sites and the Italy one has changed address and has a new look:

C_Allergy_logo.png

The Germany/Austria site has same address but new look:

logo.gif


There is now a Swiss site:

On 1.11.2017 we renamed the company Teomed AG to Bencard AG.

https://bencard.ch/

banjomick - 07 Mar 2018 07:50 - 123 of 159

07 March 2018

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 0930 GMT today. Dial-in details are: +44 (0) 1452 580733. Conference ID: 2485568.

Allergy Therapeutics plc

Interim Results for the six months ended 31 December 2017


- Consistent performance driven by market share gains

- Pivotal year with Grass MATA MPL readout due in H2 2018

7 March 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces its unaudited interim results for the six months ended 31 December 2017.

Highlights (including post period end highlights)



Financial highlights

· Reported revenue increased by 4.4% to £42.2m (H1 2017: £40.4m) and to £40.9m at constant currency*, representing 1.3%** growth despite an abnormally weak pollen season

· R&D expenditure increased to £5.9m (H1 2017: £3.8m) due to investment in the Grass MATA MPL Phase II and PQ Birch Phase III trials

· 12% growth in pre-R&D operating profit to £12.3m (H1 2017: £11.1m) as a result of broad investment in the business and the strength of the euro against sterling

· Strong cash balance of £25.8m (H1 2017: £27.8m)



Operational highlights

· Increased market share in the German market to 14% (2017: 13%)

· Breadth of portfolio demonstrated by strong performance from Venomil and Acarovac Plus

· Completion of recruitment in the pivotal Pollinex Quattro Birch Phase III study for Europe

· Completion of recruitment ahead of schedule for the Grass MATA MPL Phase II dosing trial for the US

· Contract for scaling up the Polyvac® Peanut product signed with AGC Biologics, aiming for first in human trials in 2019

· Acarovac Phase I trial continues with readout expected in H1 2019

· Contract for joint development of Oralvac products in the TAV process signed with Ergomed

· Bencard Adjuvant Systems continues to build its IP assets with microcrystalline tyrosine manufacturing process patented in key worldwide markets



Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said: "2018 is set to be a pivotal year for Allergy Therapeutics with the key Grass MATA MPL Phase II trial on course for readout in the second half of the calendar year. This could provide us the platform to expand into the lucrative US market. In the first half of this year, we continued to outperform the wider market and delivered an increase in revenue at constant currency despite an abnormally weak pollen season, demonstrating the strength of our differentiated products. This reflects the quality of the Group's highly convenient, ultra-short course, aluminium-free therapy, enabling us to continue to gain market share."

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

* Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.

** Percentage based on figures in thousands (2017: £40.956m, 2016: £40.427m)

http://www.moneyam.com/action/news/showArticle?id=5882305

banjomick - 07 Mar 2018 07:51 - 124 of 159

A reminder:

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies

http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

banjomick - 07 Mar 2018 12:04 - 125 of 159

'Pivotal' year ahead for Allergy Therapeutics with key trial readouts (Video)
08:56 07 Mar 2018

Nick Wykeman and Manuel Llobet from Allergy Therapeutics plc (LON:AGY) caught up with Proactive Investors following the release of their interim results.

Allergy's continued to gain market share as it heads into a ‘pivotal’ twelve months.
Interim revenues rose by 4% to £42.2mln despite the pollen season being described as ‘abnormally weak’.

Headline or first glance data from the Phase III Pollinex Quattro Birch study in Europe is expected in the second half of the year along with first results from a Grass MATA MPL Phase II trial.

http://www.proactiveinvestors.co.uk/companies/stocktube/8851/-pivotal-year-ahead-for-allergy-therapeutics-with-key-trial-readouts-8851.html

https://www.youtube.com/watch?time_continue=201&v=ly_tv57J0XI

banjomick - 07 Mar 2018 16:08 - 126 of 159

Allergy Therapeutics Results Video & investor meeting details
7th March 2018 | Allergy Therapeutics plc

Allergy Thereapeutics plc (LON:AGY) this morning released their Interim Results for the 6 months ended 31st December 2017. A short video is available below, with further explainer videos available on their company wall.

They reported a 4.4% increase in revenues, and this was against a backdrop of an unusually weak market: the pollen season was abnormally weak this year, leading to less demand for remedies & vaccinations. Their products Venomil and Acarovac Plus performed very well, and there have been a number of developments in AGY’s clinical trial pipeline.

Allergy Thereapeutics increased their R&D expenditure to £5.9m from £3.8m in the previous half. This was due to investment in their grass and Birch vaccine trials ( Grass MATA MPL Phase II and PQ Birch Phase III trials.

Professional Investors, UK wide meeting details
We are organising UK wide investor meetings with Allergy over the coming year, visiting London, Birmingham, Bristol, Manchester, Leeds, Edinburgh and Glasgow. The meetings are strictly for professional investors, and please contact us if you would like to meet them. We will be releasing dates shortly.

http://fmp-tv.co.uk/2018/03/07/allergy-therapeutics-results-video-investor-meeting-details/

banjomick - 07 Mar 2018 16:19 - 127 of 159

07 March 2018

Hardman Research: Clinical development towards submission

Clinical development towards submission: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) Grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a 'Named Patient' basis. The Phase III trial, designed to obtain approval for PQ Birch as a biologic in Europe, is well advanced, and the Phase II PQ Grass trial will report data shortly. As explained in the February trading update, underlying 1H'18 sales growth, although weaker than expected due to a low pollen season in central Europe, suggests that AGY has continued to make market share gains.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/agy---interims---7th-march-2018.pdf

http://www.moneyam.com/action/news/showArticle?id=5882943

banjomick - 10 Mar 2018 10:02 - 128 of 159

Slides from the Investor Evening - 7 March:


http://s1.moneyam.com/pdfs/20180307-investor-evening/nick-wykeman-allergy-therapeutics.pdf

banjomick - 15 Mar 2018 13:55 - 129 of 159

Video from the Investor Evening - 7 March:

Nick Wykeman, FD - Allergy Therapeutics (AGY)

Shares Magazine
Published on Mar 12, 2018

Allergy Therapeutics (AGY) - Allergy Therapeutics is a Europe-based specialty pharmaceutical company focused upon the diagnosis and treatment of allergy. Allergy Therapeutics has an existing sales base of approximately £40 million per year, an MHRA-approved manufacturing capability as well as an established sales and marketing infrastructure in several major European markets.

https://www.sharesmagazine.co.uk/video/nick-wykeman-fd-allergy-therapeutics-agy

banjomick - 16 Mar 2018 13:31 - 130 of 159

16 March 2018
Allergy Therapeutics plc

Director/PDMR Shareholding

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that, on 15 March 2018, Tunde Otulana, Non-Executive Director of the Company, purchased 25,000 ordinary shares of 0.1p in the Company ("Ordinary Shares") at a price of $0.388 per Ordinary Share (equivalent to 27.8p per Ordinary Share)*. Mr Otulana's total beneficial holding now amounts to 50,000 Ordinary Shares, which represents 0.01% of the issued share capital of the Company to which voting rights are attached.

http://www.moneyam.com/action/news/showArticle?id=5896523

banjomick - 14 May 2018 08:06 - 131 of 159

14 May 2018
Allergy Therapeutics plc

Allergy Therapeutics Publishes New Data Validating Mode of Action and Unique Adjuvant Properties of its Patented Adjuvant, Microcrystalline Tyrosine (MCT®), in The Journal of Immunology

Novel Findings Further Highlight the Effectiveness of MCT as Alternative to Alum and its Potential Advantage in Allergy-Specific Immunotherapy

WORTHING, United Kingdom, 14 May 2018 - Allergy Therapeutics (AIM:AGY), a leading, fully-integrated commercial biotechnology company specialising in allergy vaccines, today announces that new data from a study investigating immune responses produced by microcrystalline tyrosine (MCT®)-based vaccines as compared with conventional aluminium hydroxide has been published online in The Journal of Immunology. The findings demonstrate that, based on its comparable strength and mechanism of Ag-specific IgG induction and induction of T cell responses, MCT® is a suitable and flexible alternative to aluminium hydroxide as an adjuvant in both allergen-specific immunotherapy and infectious disease applications. The study also demonstrated that MCT®-adjuvanted allergens caused fewer anaphylactic reactions compared with alum-adjuvanted allergens.

"These findings provide evidence of the effectiveness of MCT as an adjuvant, confirming the mechanism of action underlying its ability to induce a robust and sustained immunological response. Additionally, the findings indicated a potentially favourable profile for the use of MCT over alum in allergy-specific vaccines," said Matthias Kramer, M.D., Allergy Therapeutics' International Medical Director and co-author of the paper. "We believe these data highlight the significance of our differentiated proprietary platform technology in the development of our growing suite of cutting-edge, globally marketed ultra-short course allergy vaccines."


This is the first study to report the mechanism of action by which MCT governs the immunologic response after exposure to an antigen and protection against anaphylaxis in an allergic model. The results illustrate upregulation of IgG antibody responses and a higher IgE:IgG ratio in MCT-based immunotherapy compared with Alum-based immunotherapy. A high IgE:IgG ratio has been reported to be a positive predictive marker for allergen immunotherapy in humans.

Further evaluation in this study indicated that MCT facilitates robust adaptive T cell responses with associated IFN-γ (interferon gamma) and TNF-α (tumour necrosis factor alpha), which is in line with previous studies illustrating protective efficacy in influenza and malaria applications1, 2. Meanwhile, studies in a cancer (melanoma) model are underway.


A link to publication is here: www.jimmunol.org/content/200/9/3151

http://www.moneyam.com/action/news/showArticle?id=5968725

banjomick - 21 May 2018 09:23 - 132 of 159

21 May 2018
Allergy Therapeutics plc

Allergy Therapeutics announces positive top-line results from its Grass MATA MPL
Phase II dose ranging study


- Primary endpoint met with highly statistically significant dose-response relationship established -

- Optimal Phase III dose identified -

- Phase III study due to commence in 2019 -



21 May 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces highly positive top-line results from its Grass Modified Allergen Tyrosine Absorbed (MATA) MPL Phase II dose ranging study (G205). The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose. Approximately 30% of the population in Europe and 25% of the population of the US are allergic to grass pollen1, one of the most prevalent global aeroallergens.



The key results announced today:

· Primary endpoint of the trial met with highly statistically significant dose-response relationship (p<0.0001)

· All dosing regimens were safe and well tolerated

· The currently marketed product showed a significant improvement compared to placebo (p<0.01)

· Significant increase in immunoglobulin results, highly consistent with the dose response observed for the primary endpoint

· Adherence to the short treatment course was excellent. More than 95% of patients received the target cumulative dose during six weekly subcutaneous injections


The G205 trial is a multi-centre, double-blind, placebo controlled study designed to explore the safety and response of different cumulative doses of Grass MATA and MPL for grass-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland and Austria and 447 patients were randomised into four active arms plus a placebo, evaluating the change in allergic symptoms as determined by the total symptom score (TSS) following conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.



Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are thrilled with these extremely positive results demonstrating dose dependent efficacy of the product including the current marketed dose. This study represents a major milestone in our path forward to a registered grass allergy product in Europe. Additionally, this brings us closer towards marketing authorisation in the estimated $2bn US allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy. With an optimal dose identified, we look forward to sharing this new, exciting data with the health authorities and plan to commence a Phase III study in 2019.


"Allergy Therapeutics provides the only ultra-short course, aluminium-free treatment containing our MPL adjuvant in the European market, and its convenience for patients is driving market penetration in all our markets."

http://www.moneyam.com/action/news/showArticle?id=5978006

banjomick - 21 May 2018 09:54 - 133 of 159

Allergy Therapeutics on track for phase III grass pollen trial in 2019
08:59 21 May 2018

Manuel Llobet, chief executive of Allergy Therapeutics plc (LON:AGY), spoke to Proactive Investors after reporting “extremely positive results” from the phase II trial of their grass pollen-induced hay fever immunotherapy.
Llobet says PQ Grass met its primary endpoint, with those taking the drug showing “a highly statistically significant” reduction in symptoms compared to patients in the placebo arm of the study.

http://www.proactiveinvestors.co.uk/companies/stocktube/9336/allergy-therapeutics-on-track-for-phase-iii-grass-pollen-trial-in-2019-9336.html

banjomick - 21 May 2018 18:17 - 134 of 159

Allergy Therapeutics

Opening the door to registration

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/21.05.18-opening-the-door-to-registration.pdf

banjomick - 29 May 2018 08:47 - 135 of 159

29 May 2018
Allergy Therapeutics plc

Positive new clinical data with house-dust mite immunotherapy

~ House-dust mite immunotherapy shown to be well-tolerated and demonstrates highly significant symptom improvement ~

~ Allergy experts present an overview of adjuvants at satellite symposium during EAACI 2018 ~


29 May 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces positive new data on its wholly-owned modified house-dust mite subcutaneous immunotherapy1. This data will be presented today at the 37th Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Munich, Germany.

The Group's modified house-dust mite product sold as through a Named Patient Program in Spain, is the precursor to the modified house-dust mite + MPL product currently in Phase I, as announced in February 2017.


In this observational study conducted in 10 sites across Spain, 141 patients were evaluated and demonstrated a 43% decrease in combined symptom medication score compared with baseline after one year (p = <0.0001). In addition, in a subgroup of asthmatic subjects, 16.7% of patients were observed with moderate persistent asthma at one year compared with 50.9% at baseline (p = <0.01). No patients presented with serious adverse events and no patients had to stop treatment due to any adverse event.

Allergy Therapeutics also presented a series of poster presentations at EAACI with key highlights including an overview of the early-phase pre-clinical developments for the Group's planned recombinant peanut vaccine3 and a discussion of the results of a non-interventional study investigating rapid up-dosing of tree sublingual immunotherapy4.


Other events held by the Group at EAACI included a satellite symposium entitled: "Adjuvants through the ages"2 which provided a summary of how adjuvant technologies have evolved and how Allergy Therapeutics is spearheading the design and testing of state of the art allergen-specific immunotherapies.



Manuel Llobet, Chief Executive Officer, commented: "We are excited to be sharing our latest research at EAACI, demonstrating the breadth of our unique allergen immunotherapy company. The positive new data on our modified house-dust mite immunotherapy and our recent announcement on the success of our Grass G205 dose-finding clinical study confirms that our novel allergen-specific immunotherapies are formulated to the optimal strength, and we believe Allergy Therapeutics has the potential to transform allergy treatment with optimised-dose, well-characterised, aluminium-free, convenient products."

http://www.moneyam.com/action/news/showArticle?id=5987568

banjomick - 30 May 2018 16:03 - 136 of 159

Allergy Therapeutics appear to have a new UK website using a different logo:

logo.png

banjomick - 30 May 2018 16:18 - 137 of 159

and in the highly unlikely event of them reading this post, the "Financial calendar" page isn't working as yet!

https://www.allergytherapeutics.com/investor-relations/financial-calendar/

banjomick - 25 Jun 2018 09:14 - 138 of 159

25 June 2018
Allergy Therapeutics plc

Allergy Therapeutics announces publication of data demonstrating long-lasting efficacy of Pollinex Quattro Grass vaccine in Immunotherapy

25 June 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces the publication of positive data in the journal Immunotherapy, demonstrating long-lasting efficacy of Pollinex Quattro Grass in patients with grass pollen allergy. Zielen et al., Long-term effect of monophosphoryl lipid A adjuvanted specific immunotherapy in patients with grass pollen allergy. doi; 10.2217/imt-2018-0004 (ePub ahead of print).

The observational study, led by Professor Stefan Zielen of the Goethe University, Germany, focused on the long-term efficacy of Pollinex Quattro Grass. Each of the clinical symptoms (runny nose, sneezing and conjunctivitis) were statistically significantly reduced in treated patients compared with controls without allergen-specific immunotherapy. The study concluded that patients treated with Pollinex Quattro Grass vaccine exhibited significant and long-lasting symptom improvements 3-6 years after cessation of treatment.


Professor Stefan Zielen, author of the paper commented; "We are delighted with the publication of our observational study that demonstrates the long-term effects of Pollinex Quattro Grass immunotherapy. Our paper highlights the benefits that this allergen-specific immunotherapy can offer allergy sufferers, in terms of patient convenience, as well as the potential for positive and long-lasting effects."

Manuel Llobet, CEO at Allergy Therapeutics, said: "This paper validates earlier studies indicating Pollinex Quattro is disease modifying for the many patients affected by grass allergy. Together with the recently announced positive data from our Phase Grass G205 clinical study, we believe that we have a robust data set for our suite of novel allergy product candidates. We look forward to commencing further studies with the goal of developing a strong allergy portfolio to patients globally, including in the significant US market."


The data presented supports earlier studies investigating Pollinex Quattro, Zielen et al., 20071 and Rabe et al 20172. Sustained efficacy according to European Medicine Agency criteria in 3114 patients was shown in the 2007 Zielen paper1, where after 3 years, improvement of symptoms was reported in more than 93% of patients and the consumption of anti-allergic medication decreased in more than 75% of patients.

http://www.moneyam.com/action/news/showArticle?id=6024872

banjomick - 12 Jul 2018 10:55 - 139 of 159

12 July 2018
Allergy Therapeutics plc

Trading update


Group's market share continues to grow


12 July 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2018 ahead of its Preliminary Results to be announced in September.

Financials


Revenues for the year are expected to be in line with market expectations at £68.3m (2017: £64.1m). This performance represents 6.6% annual growth on a reported basis and 3.5% on a constant currency basis which reflects a strong performance during an unusually weak pollen season in 2017. The Group is continuing to gain market share within its core markets in Europe and data for the key markets for the 9 months ending 31 March 2018 showed an increase of 0.7 of a market share point1. Expenses are expected to be in line with market expectations due to continuing cost control.

The cash balance at the end of June 2018 was £15.5m (30 June 2017: £22.1m).


Pipeline

Following the positive Grass Phase II trial, the ongoing pipeline trials continue to progress well and timing remains in line with the Group's strategy. The results of the pivotal Birch Phase III trial for Europe continue to be expected in Q3 2018.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "Our convenient, flexible and varied product portfolio has enabled us over the past 19 years to grow revenues at 10% compound annual growth rate. We are pleased that we have continued to make headway in market share this year, despite a poor pollen season, and have maintained a tight control on costs in the period. Our pipeline continues to progress well, with the announcement of excellent Grass Phase II results, the publication of significant papers on the long-term effect of our product and the positive Birch Phase II Trials. We are looking forward to the results of the Birch Phase III trial, expected in Q3 2018."

1Market data and internal estimates for 9 months to 31 March 2018, for the core European markets in which Allergy Therapeutics operates excluding Switzerland (competitor data not available)

http://www.moneyam.com/action/news/showArticle?id=6049128

banjomick - 13 Jul 2018 13:09 - 140 of 159

Hardman & Co Research: Steady performance in a tough market

AGY is a long-established specialist in the prevention, diagnosis, and treatment of allergies. Pollinex Quattro (PQ) Grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a 'Named Patient' basis. The Phase III trial, designed to obtain approval for PQ Birch as a biologic in Europe, is well advanced and will report data shortly. As explained at the interim stage, underlying 1H'18 sales growth was affected by a low pollen season in central Europe. A trading statement indicates that this has remained a difficult market, but one in which AGY has continued to make market share gains.

http://www.hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/13.07.18-steady-performance-in-a-tough-market.pdf

http://www.moneyam.com/action/news/showArticle?id=6051535

banjomick - 19 Jul 2018 08:31 - 141 of 159

19 July 2018
Allergy Therapeutics plc

Proposed placing and subscription to raise up to £10.6 million


Allergy Therapeutics plc (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces a placing and subscription of up to 40,000,000 new ordinary shares of 0.1 pence each in the capital of the Company ("New Shares"), representing up to approximately 6.7% of the Company's existing ordinary share capital, to raise up to £10.6 million.

Highlights

· Placing and subscription of up to 40,000,000 New Shares in the Company ("Placing and Subscription"), representing up to approximately 6.7% of the Company's existing ordinary share capital, at a price of 26.5 pence per New Share ("Issue Price") to raise up to approximately £10.6 million before expenses.

· The Company intends to use the Placing and Subscription proceeds to expand the planned Phase III PQ Grass Trial, part fund the Acarovac Phase II Trial and continue to progress its diversified pipeline.

· Revenue for the financial year ended 30 June 2018 is expected to be £68.3 million (2017: £64.1 million). This represents a 6.6% annual growth on a reported basis and 3.5% on a constant currency basis despite the unusually weak pollen season in 2017. The Company is also continuing to gain market share within its core markets in Europe and data for the key markets for the 9 months ended 31 March 2018 showed an increase of 0.7 of a market share point[1].

The Placing is being conducted through an accelerated bookbuilding process (the "Bookbuild") which will commence immediately in accordance with the terms and conditions set out in Appendix I to this Announcement.

Panmure Gordon (UK) Limited ("Panmure Gordon") is acting as Financial Adviser, Nominated Adviser and Corporate Broker in respect of the Placing.

Manuel Llobet, Chief Executive Officer, stated:

"Allergy Therapeutics is poised for a transformational period of growth both with our marketed products and our R&D pipeline. With this planned funding, we hope to expand our planned Phase III PQ Grass trial, scheduled to start in H2 2019, including a project to analyse pollen trends in the US to maximise the exposure of patients to grass pollen. We also intend to support the Acarovac Phase II trial and, looking further out, further progress our diversified pipeline of patient friendly, convenient to use products including Polyvac Peanut."

Background to the Placing and Subscription

Allergy Therapeutics is an international commercial biotechnology company focused on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third-party products from its subsidiaries in eight major European countries and via distribution agreements in an additional fourteen countries. Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.

In a trading update for the year ended 30 June 2018, the Company reported that revenues for the year are expected to be in line with market expectations at £68.3 million (2017: £64.1 million). This performance represents 6.6% annual growth on a reported basis and 3.5% on a constant currency basis which reflects a strong performance during an unusually weak pollen season in 2017. The Group is continuing to gain market share within its core markets in Europe and data for the key markets for the nine months ended 31 March 2018 showed an increase of 0.7 of a market share point[2].

The Company is making continual advances across all three of its major strategic objectives; profitably expanding the existing European business; preparing for product entry into the US market; and developing a strong product pipeline.

The European business of Allergy Therapeutics has grown at a CAGR of 10% over the last 19 years from its flexible and varied product portfolio. Recently, the Company reported annual growth of 3.5% and increased its market share by 0.7 of a market share point[3] which is the result of:

· Innovative, convenient and patient-friendly (short-course) products;

· Increased regulatory requirements which has resulted in 40% of all the products that were on the market and submitted for the TAV process dropping out and no longer being allowed to be sold in Germany[4];

· Focused investment across the business;

· Strength of a broad portfolio with modified house dust mite and venom SCIT; and

· Scaling-up to drive technological and geographical expansion.



The Directors believe that the US allergy immunotherapy market is estimated to be valued at $2 billion and, of that market, estimated peak grass sales could be $300-400 million. There are no registered injected products and adherence levels to treatments are as low as 15%[5]. The changing US regulatory landscape provides an opportunity for Allergy Therapeutics. New United States Pharmacopeia ("USP") and US Food and Drug Administration ("FDA") regulations are moving to pharmaceutical grade, centrally manufactured, single allergen treatments. Existing products in the market are long courses of treatment with between 50-100 injections with efficacy in 6-12 months. Allergy Therapeutics can offer a short course treatment of 4-6 injections with efficacy in three weeks for a four shot treatment plan.

Allergy Therapeutics is progressing its Birch Phase III trial for Europe, the results of which are expected in Q3 2018. The Phase III field trial in Europe recruited 582 patients from 59 centres in Germany, Austria, Poland and Sweden. The trial is a double blind placebo controlled trial and is pivotal for approval in Germany. If the trial is successful and approved, the next step is expected to lead to a market authorisation.

On 21 May 2018, the Company announced positive top-line results from its grass modified allergen tyrosine absorbed MPL Phase II dose ranging study. The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose. The trial, conducted on 447 patients in 50 sites in Germany, Austria and Poland, measured four aspects of eye symptoms to generate a total symptom score.

Acarovac, the Company's Mite MPL house dust mite product, is currently undergoing its Phase I trial with the results expected in H1 2019. Acarovac is a short-course product that can be used to address the potential market of $3 billion[6] worldwide with only Europe partially covered already. In the Company's preclinical pipeline, its Polyvac peanut product offers a potential solution to the $8 billion[7] worldwide food allergy market. The single dose of VLP combined with recombinant peanut allergen successfully protects against anaphylaxsis when challenged with peanut. Polyvac Peanut received positive results from its pre-clinical research and pre-clinical development has been progressing according to plan with important product differentiation demonstrated. The Company signed a manufacturing contract for scale-up of the Polyvac product with the aim of having the first trial in humans in 2019.


Reasons for the Placing and Subscription and Use of Proceeds


The Directors believe that Allergy Therapeutics has the opportunity to accelerate growth across its three pillars of growth outlined above. Allergy Therapeutics is seeking to raise up to £10.6 million via the Placing and Subscription, earmarked for investment by the Company in:

· expanding the planned Phase III PQ Grass trial, scheduled to start in H2 2019. The Phase III trial will entail an increase in the number of patients recruited to the study, the introduction of a vaccinated placebo arm (following the completion of the trial, to reduce the overall cost of the potential safety database), and an additional project to analyse pollen trends in the US to maximise the exposure of patients to grass pollen;

· part funding of the Acarovac Phase II trial (balance of funding for trial from CDTI to start, subject to contract, in 2019); and

· ensuring continued progress on a diversified pipeline, including developing the Polyvac Peanut product.


Details of the Placing and Subscription ***More details via link below***

http://www.moneyam.com/action/news/showArticle?id=6058111

banjomick - 26 Jul 2018 12:40 - 142 of 159

TR-1: Standard form for notification of major holdings

http://www.moneyam.com/action/news/showArticle?id=6067980

banjomick - 26 Jul 2018 12:56 - 143 of 159

Their 'Financial Calendar' wasn't working for some time but all okay now:

31 07 2018 Trading update (tentative)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)
27 11 2018 AGM (tentative)

https://www.allergytherapeutics.com/investor-relations/financial-calendar/

banjomick - 27 Jul 2018 23:38 - 144 of 159

17:26----TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

http://www.moneyam.com/action/news/showArticle?id=6070179

banjomick - 04 Aug 2018 11:37 - 145 of 159

The Placing Roadshow slides from July 2018

https://www.allergytherapeutics.com/media/1319/placing-slides-july-2018.pdf

banjomick - 08 Aug 2018 08:47 - 146 of 159

08 August 2018
Allergy Therapeutics plc

Notice of Preliminary Results

8 August 2018 Allergy Therapeutics (AIM:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, will issue its preliminary results for the year ended 30 June 2018 on Wednesday 26 September 2018.

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Chief Financial Officer, will hold a presentation and conference call for analysts on the day of results at 10:30am BST at the offices of Panmure Gordon & Co, One New Change, London, EC4M 9AF.

Please contact Consilium Strategic Communications for further details.

http://www.moneyam.com/action/news/showArticle?id=6082995

banjomick - 05 Sep 2018 14:20 - 147 of 159

One week after the Preliminary Results are released AGY are taking part in this event:

03 10 2018 Shares Investor Evening (London)

banjomick - 26 Sep 2018 09:51 - 148 of 159

Allergy Therapeutics plc

Preliminary Results

26 September 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces preliminary results for the year ended 30 June 2018.

Financial highlights

· 6.6% revenue growth increase in actual terms to £68.3m (2017: £64.1m)

· 3.5%1 revenue growth at constant currency2 to £66.4m (2017: £64.1m)

· One point increase to 14%3 in market share in European business (2017: 13%)

· 10% compound annual growth in net sales over 19 years since the company formed

· 26% increase in operating profit4 (pre-R&D) to £9.3m (2017: £7.4m)

· Cash at 30 June £15.5m (2017: £22.1m) prior to the July 2018 fundraising of £10.2m net of expenses


Operational highlights

· Successful completion of the Phase II PQ Grass (G205) in May, allowing progression to a pivotal trial for US registration. The Phase III PQ Birch (B301) study has completed and top line data are now expected by the end of the year

· Good pipeline progress, including initiation of Acarovac Phase I trial (data readout expected H1 2019) and positive pre-clinical Polyvac peanut work, with first in-human trials expected in 2019

· Completion of £10.6m (gross) oversubscribed placing in July 2018



Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "2018 was a solid year for Allergy Therapeutics as we made important progress in key areas across the Company. We generated continued growth despite a low pollen season in our core business, with constant currency revenue growth of 3.5%1, driving additional gains in market share and a 26% increase in pre-R&D operating profit4. We also achieved significant clinical success in the year, with the positive Phase II PQ Grass in May and we now expect headline data from the Phase III PQ Birch study by the end of the year. With progress towards the US market, a pipeline of exciting clinical and pre-clinical assets, and a robust balance sheet, we look to the future with confidence in our growth prospects."


1 Percentage based on figures in thousands (2018: £66.369m, 2017:£ 64.139m)

2 Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements.

3 Market data and internal estimates for 12 months to 30 June 2018 for Allergy Therapeutics' direct sales competitive markets excluding UK and Switzerland due to lack of competitor information.

4 Operating profit (pre R&D) is calculated by adding back R&D expenditure for the year to the operating loss of the year to arrive at an operating profit (pre R&D) of £9.3m (2017: £7.4m)

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

- ENDS -

Analyst briefing today

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Chief Financial Officer, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 10.30 BST today at the offices of Panmure Gordon & Co, One New Change, London, EC4M 9AF. Dial-in details are: +44 (0) 207 192 8000. Conference ID: 9583215.

http://www.moneyam.com/action/news/showArticle?id=6142192

banjomick - 26 Sep 2018 10:57 - 149 of 159

Increased Market Share and Revenues at Allergy Therapeutics
26th September 2018

Allergy Therapeutics plc (LON:AGY) today released Preliminary Results for the year ended 30th June 2018. European market share for their products has increased by 1% to 14%, whilst revenues have grown by 6.6% to £68.3m (2017:£64.1m).

Below is a video interview with Manuel Llobet and Nick Wykeman, who discuss the results in detail and explore the drivers behind the company’s growth.

Video Interview: Allergy Therapeutics Preliminary Results:

http://www.fmp-tv.co.uk/2018/09/26/increased-market-share-and-revenues-at-allergy-therapeutics/

banjomick - 26 Sep 2018 11:02 - 150 of 159

Allergy Therapeutics outperforming the market "significantly" in latest financial year-Video interview (another one!)
10:08 26 Sep 2018


Allergy Therapeutics plc's (LON:AGY) Nick Wykeman and Manuel Llobet tell Proactive the company has continued to take market share and is "outperforming the market significantly" as the firm releases its figures for the latest financial year.

The group said the year to the end of June was one of strong progress made against its strategic objectives of expanding in Europe, preparing for entry into the US market, and making clinical progress with the group's lead assets.

Despite a low pollen season, revenue rose 6.6% to £68.3mln from £64.1mln the year before, albeit helped by currency movements; on a constant currency (CC) basis, revenue growth was 3.5%.

http://www.proactiveinvestors.co.uk/companies/stocktube/10614/allergy-therapeutics-outperforming-the-market-significantly-in-latest-financial-year-10614.html

banjomick - 27 Sep 2018 08:47 - 151 of 159

Hardman & Co: 2018 full-year results: solid growth

http://www.moneyam.com/action/news/showArticle?id=6144455

banjomick - 16 Oct 2018 22:58 - 152 of 159

Video from the Shares Investor Evening earlier this month:

https://www.sharesmagazine.co.uk/video/nick-wykeman-fd-allergy-therapeutics-agy-2

banjomick - 24 Oct 2018 00:18 - 153 of 159

23 October 2018
Allergy Therapeutics plc

ANNUAL FINANCIAL REPORT 2018 AND NOTICE OF 2018 ANNUAL GENERAL MEETING

Allergy Therapeutics plc has today published the following documents:

· Annual Report for the year ended 30 June 2018 ("Annual Report"); and


· Notice of 2018 Annual General Meeting ("Notice of Meeting");



Each of these documents is available electronically on the Company's website at
www.allergytherapeutics.com


A hard copy of the Annual Report and Notice of Meeting is anticipated to be posted to shareholders on 23 October 2018.

https://www.moneyam.com/action/news/showArticle?id=6178705

banjomick - 24 Oct 2018 09:04 - 154 of 159

Director/PDMR Shareholding

24 October 2018 - Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Manuel Llobet, Chief Executive Officer and Nick Wykeman, Chief Financial Officer, have today purchased 50,000 and 150,000 ordinary shares, respectively, of 0.1 pence each in the Company ("Ordinary Shares"), at a price of 17.5 pence per Ordinary Share.

Furthermore, Peter Jensen, Non-Executive Chairman, has today purchased 20,000 Ordinary Shares at a price of 18 pence per Ordinary Share. Following the dealings, the interests of Manuel Llobet, Nick Wykeman and Peter Jensen in the issued share capital of the Company are set out below:

https://www.moneyam.com/action/news/showArticle?id=6178890

banjomick - 08 Nov 2018 08:55 - 155 of 159

08 November 2018
Allergy Therapeutics plc


Directorate Change

8 November 2018 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Mr Scott Leinenweber to the Company's Board as a Non-Executive Director, nominated by Abbott Laboratories, Inc. ("Abbott", NYSE: ABT) in replacement of Mr Jeff Barton who retires from the Board, both effective after close of business 7 November 2018.


Scott Leinenweber currently serves as Vice President of Investor Relations and Licensing & Acquisitions at Abbott. During his time in this role, he has been the lead spokesman with investors and served as lead for Abbott's M&A activities in the Medical Devices, Diagnostics, Pharmaceuticals and Nutritionals business segments. Scott started his career at Abbott as a financial analyst in 1997, before moving into product management, sales and marketing roles across Abbott's businesses. Mr Leinenweber holds a degree in finance from the University of Wisconsin-Oshkosh and a Masters of Business Administration from the Marquette University, Graduate School of Business.



Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Scott to the Board. He brings extensive investor relations and marketing experience, particularly in the United States, which will be valuable to our Company as we continue to execute our global strategy. We also wish to take this opportunity to thank Jeff for his contribution and support to Allergy Therapeutics since February 2017."


Scott Michael Leinenweber, aged 47, is, or has been, a director or partner of the following companies or partnerships during the past five years:

Current Directorships and Partnerships
Abbott Healthcare Private Limited (an Indian subsidiary of Abbott Laboratories)

Past Directorships and Partnerships in the previous five years
None

https://www.moneyam.com/action/news/showArticle?id=6199006

banjomick - 12 Nov 2018 12:13 - 156 of 159

Allergy Therapeutics to present at Jefferies 2018 London Healthcare Conference

12 November 2018 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Manuel Llobet, CEO, and Nick Wykeman, CFO, will attend the Jefferies Healthcare Conference in London on Wednesday 14 November 2018.

Nick Wykeman, CFO, will lead an investor presentation at 15.20 GMT on Wednesday 14 November.

https://www.moneyam.com/action/news/showArticle?id=6203440


Conference website:

http://www.jefferies.com/OurFirm/Conferences/325/433

banjomick - 27 Nov 2018 09:45 - 157 of 159

AGM Trading Update


Sales continue to grow strongly with market share gains


27 November 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides an AGM trading and regulatory update ahead of its Half Year Results to be announced in March 2019.

Financials


The Group continues to perform well with revenues up strongly from the prior year in most markets and sales in line with market expectations for the year. The Group continues to gain market share in Europe, particularly in Germany.1

Regulatory update

The Group continues to prepare for the upcoming PQ Grass pivotal Phase III trial that can allow for US registration. An end of Phase II meeting with the FDA has now been confirmed for January 2019 and good progress is being made regarding the Phase III trial protocol. Further to previous updates, top line results from the PQ Birch (B301) Phase III trial for Europe are now expected in Q1 2019. Allergy Therapeutics remains blinded to the data package and looks forward to the disclosure of the data.

The Worthing site recently completed a successful MHRA audit with no critical findings illustrating the quality of the Group's supply chain.


AGM voting results

The company will announce the results of the AGM voting later today.



Manuel Llobet, CEO at Allergy Therapeutics, stated: "Our revenue growth reflects the quality of our products, the strength of our supply chain and our sales and marketing team. We are pleased that we have continued to make headway this year both in market share and in the progress of our pipeline."


1Insight Health Data

https://www.moneyam.com/action/news/showArticle?id=6221475

banjomick - 16 Jan 2019 09:51 - 158 of 159

16 January 2019
Allergy Therapeutics plc

Trading Update & Notice of Results

Sales continue to grow strongly

Strong cash position sustained by good performance


16 January 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunology vaccines, today provides a trading update for the six months ended 31 December 2018 ahead of its Half Year Results to be announced on 6 March 2019.

Financials

The Group is trading in line with Board expectations. Reported revenues for the six months ended 31 December 2018 are expected to be £46.7m (2017: £42.2m) representing 10.6% growth on both a reported and constant currency basis. In terms of geography, the main contributors to this strong sales growth are Germany, Austria, Switzerland and Netherlands. Spain has continued to grow well despite the withdrawal of all bacterial products across the market. In terms of product mix, this growth is being driven primarily by the Group's ultra-short course, aluminium-free treatments (Pollinex and Pollinex Quattro) as well as Acarovac and Venomil. The Group continues to gain market share in Germany1 and again achieved number one position in this market for the month of October 2018 (the Group's busiest month of the year) for the second year running2.

The cash balance at the end of December 2018 was £31.6m (31 December 2017: £25.8m).

Regulatory

The Group continues to make good progress with the peanut allergy vaccine outsourced manufacturing scale up and the Acarovac Phase I trial for dust mite allergies. The first in-human trials for the Polyvac peanut product are expected to start in 2019, and data from the Acarovac Phase I trial is expected in H1 2019. As announced in December 2018, the top line results of the PQ Birch Phase III trial will be announced in Q1 2019. Meetings with the FDA and the German regulator, the Paul-Ehrlich-Institut (PEI), in relation to the PQ Grass trials are scheduled for Q1 2019.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "This is another period of revenue growth and continued gain in market share for Allergy Therapeutics, in line with our mid and long-term strategy. The Group is also making good progress across its clinical pipeline, with a number of key developments anticipated for the first half of this year. We see momentum in the business and look forward to updating the market at our interim results."

1Insight Health Data November 2018

2 Insight Health Data October 2018


https://www.moneyam.com/action/news/showArticle?id=6278405

banjomick - 17 Jan 2019 10:28 - 159 of 159

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