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.

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

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

Allergy Therapeutics finalises senior appointments
Iain Gilbert 11 Sep, 2017



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."



Also

Allergy Therapeutics strengthens clinical research team with senior appointments

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

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

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.

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

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

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

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

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

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

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

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

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

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



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

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

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.

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

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

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

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