Allergy Thera. Regulatory News (AGY)

20 November 2013

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company")

Business and R&D Update

Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, will this morning hold its Annual General Meeting at which the Company's Chairman will update shareholders with regard to certain business and R&D details covering the period from 1 July 2013 to 31 October 2013.

Trading update

The Company reports that, in the first four months of the current financial year, net revenues were up 16% against the same period for the prior year while gross sales, on a constant currency basis, increased 7% over the same period. It will be recalled that the Company initiated a three year process to streamline its portfolio in Germany to comply with the new TAV regulatory framework, resulting in a significant number of products being taken out of the market. This process completed in 2011. For the first full financial year following the completion of this project - and as noted in the last Company Report and Accounts - the Company's products have been gaining market share in the allergy immunotherapy market; it is pleasing to note that this trend is being maintained in all of the Company's main markets.

R&D update

The Company reports that it has recently had an informal meeting with the Paul-Ehrlich Institute (PEI) in Germany, at which Grass Mata MPL 0.5 ml (the smaller volume version of the current Grass Mata MPL 1 ml marketed under the TAV regulation) was discussed. At the meeting it was agreed that some further investment would be required before a Marketing Authorisation for Grass Mata MPL 0.5 ml could be granted. Following a strategic analysis of its product portfolio, the Company will now proceed with the registration of the 1 ml Grass MATA MPL product, and as a consequence, at this point in time, will withdraw its application for the 0.5 ml version. The registration process for 1 ml product provides the most cost and time efficient option for the Company in registering Grass Mata MPL in Germany given it has already submitted the Chemistry and Manufacturing Controls section of its dossier for the 1 ml product in 2010 under the TAV process. Unlike the 1ml version, the 0.5ml version is not in the market and consequently this decision has no impact on forecasted sales.

Appointment of R&D Director

Furthermore, Allergy Therapeutics is pleased to announce the appointment of Professor Tim Higenbottam as the Company's new R&D Director. He will lead the registration process of the Pollinex Quattro range of subcutaneous immunotherapy products in both Europe and the US. Tim is a recognised expert in Respiratory Medicine including asthma and has extensive experience in clinical development and regulatory affairs from within the pharmaceutical industry and academia. Tim was Professor of Medicine at Sheffield University between 1995 and 2001 and from 2001, he held senior positions with AstraZeneca before moving onto Chiesi Farmaceutici as a Corporate Director. He joins Allergy Therapeutics from TranScrip Partners where he was a Senior Partner.

Peter Jensen, Chairman of Allergy Therapeutics, commented:

"We very much appreciate the guidance from the PEI. We are confident that our decision to withdraw the application for the 0.5 ml version and to progress with the 1 ml product will benefit the regulatory submission of the already marketed version of PQ grass 1ml for the benefit of our patients in the most time efficient manner. I am also pleased to welcome Tim who will lead this process and I am sure that his extensive scientific and regulatory experience will add significant value to our products and to our Company.

Finally, I am glad to report an increase in our market share across all our key European operations as a result of the executive management team's actions taken in the previous years to adapt our portfolio to the changing TAV regulation."

-Ends-

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