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

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

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

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

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

Link to the presentation mentioned above:

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

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

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.



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

General interest but still AGY specific:

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



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.”

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/

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.



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

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

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