Regulatory update PEI FDA

RNS Number : 8414S

Allergy Therapeutics PLC

28 November 2011

 



28 November 2011

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Submissions of complete response to PEI in Germany and clinical study protocol to US FDA

Allergy Therapeutics plc (AIM: "AGY" or the "Company"), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that it has submitted its complete response to  the Paul Ehrlich Institute ("PEI") on its Marketing Authorization Application ("MAA") for Pollinex® Quattro Complete Grass in Germany. Separately, the company has also submitted a detailed study protocol to the US Food and Drug Administration ("FDA") to enable the formal lifting of the clinical hold, allowing the MATA MPL development programmes in the US to progress.

The Company submitted its MAA for Pollinex Quattro Complete Grass to PEI, the Regulatory Authority for biological products in Germany, in March 2009. In June 2011 the company received the complete report on its application from the PEI which, in line with the normal review process, raised a number of questions on the submission. The Company has now formally updated its MAA and responded to the PEI and believes that it has now addressed all their questions.

In the US, at a meeting in March 2011, the FDA stated its intention to lift the clinical hold on the Investigational New Drug applications ("INDs") for the three MATA MPL development programmes pending agreement of future study protocols. The Company has now submitted a detailed study protocol to the FDA for its review and feedback.

The search for potential partners in the US is continuing and the agreement of the clinical studies and the formal lifting of the clinical hold will support this process.

Manuel Llobet, Chief Executive of Allergy Therapeutics, said:

"This is another significant step forward in the key regulatory activities in Germany and the United States which we have been progressing in parallel over the last few months. With our initiatives in Latin America, Allergy Therapeutics is now active on three continents, and we are making good progress towards achieving our ambition to be one of the top three companies in the global allergy immunotherapy field."

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For further information

Allergy Therapeutics	[phone]
Manuel Llobet, Chief Executive Officer
Ian Postlethwaite, Finance Director
Tom Holdich, R&D Director	[phone]
www.allergytherapeutics.com
Nomura Code Securities	[phone]
Juliet Thompson / Clare Terlouw
FTI Consulting	[phone]
Ben Brewerton / Susan Quigley

About Pollinex® Quattro Complete (MATA MPL)

Pollinex® Quattro is a four injection therapeutic vaccine which is being developed for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis.

 

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