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Allergy Therapeutics plc Release: Health Canada Approves Submission Of CTA To Progress Ultra-Short Course Pollinex Quattro Grass Efficacy Study


2/19/2014 9:27:59 AM

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February 19, 2014 -- Allergy Therapeutics, the fully integrated specialty pharmaceutical company, announces that the Canadian Health Authority, Health Canada, has approved the Company’s proposal to submit a full Clinical Trial Application (CTA) for a new clinical efficacy study (G304) for Pollinex Quattro Grass MATA MPL (0.5ml). Health Canada reviewed the proposal and all supporting data at a meeting with the Company on 18th February 2014.

The meeting builds on the successful discussions held with the FDA, which resulted in the lifting of the clinical hold on the Company’s clinical studies using vaccines containing the adjuvant monophosphoryl lipid A (MPL) in August 2012. Health Canada similarly had a hold on CTAs involving MPL. These decisions enable the Company to plan the start of the G304 study, which will involve two clinical sites in the USA as well as one in Canada.

The study, involving over 600 patients, will use multiple Environmental Exposure Chambers (EECs), allowing for controlled allergen exposure, to study the response to treatment with the new Pollinex Quattro Grass MATA MPL (0.5ml) compared to Grass MATA (0.5 ml) and placebo.

Patients will be exposed to grass pollen in the EECs before treatment and then after treatment, with the ultra-short course of four subcutaneous injections. An evaluation of long term efficacy, 12 months post treatment, in patients enrolled for the G304 study will also be made in the EECs.

The safety and efficacy advantages of the addition of MPL to the MATA products, previously seen in Allergy Therapeutics’ Pollinex Quattro Ragweed MATA MPL (0.5 ml), will be further determined during the G304 study. The full results of the ragweed clinical trial were recently published in the January print edition of The Journal of Allergy and Clinical Immunology1 (JACI) and summarised in the Company press release dated 27th January 2014.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:

“I am pleased with the progress we have made with the regulatory authorities in the US and Canada. The planned Environmental Exposure Chamber study for grass has been designed to build on the success of the Ragweed study, published in The Journal of Allergy and Clinical Immunology in January this year. The recent positive developments in the US allergy regulatory environment further underscore our confidence that North America will emerge as a valuable market for registered allergy vaccines. We continue to explore our strategic options for the development and commercialisation of Pollinex Quattro in this territory.”

“In Europe we continue to grow the market share of our allergy products and I look forward to reporting fully on our market developments in the forthcoming Interim announcement.”

1 Piyush Patel, MD, Tom Holdich, MBBS, Karl J. Fischer von Weikersthal-Drachenberg, MD, and Birgit Huber, PhD. J Allergy Clin Immunol. 2014 133(1):121-129.e2.

For further information

Allergy Therapeutics +44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Ian Postlethwaite, Finance Director

Peel Hunt LLP +44 (0) 20 7418 8900
James Steel
Claire Terlouw

FTI Consulting +44 (0) 20 7831 3113
Simon Conway
Victoria Foster Mitchell

About Allergy Therapeutics

Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving sales in the prior financial year of £39.3 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors. The Company is expanding its infrastructure into the Emerging Markets.

About Pollinex Quattro Grass MATA MPL (0.5ml) and Grass MATA (0.5 ml)

The Pollinex Quattro Grass MATA MPL (0.5ml) offers the full advantages of the Pollinex Quattro product range, including the MPL adjuvant, enabling an ultra-short course of just 4 injections in as little as 3 weeks. The Grass MATA (0.5ml) will allow a determination of the size of the benefit of including the MPL in the Grass vaccines.

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