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Allergy Therapeutics plc Release: Submissions of Complete Response to PEI in Germany and Clinical Study Protocol to US FDA


11/28/2011 12:16:01 PM

November 28, 2011 -- 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.”

For further information

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Ian Postlethwaite, Finance Director

Tom Holdich, R&D Director

+44(0) 7771 663 619

www.allergytherapeutics.com

Nomura Code Securities

+44 (0) 207 776 1200

Juliet Thompson/ Clare Terlouw

FTI Consulting

+44 (0) 207 831 3113

Ben Brewerton/ Susan Quigley


Read at BioSpace.com

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