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Allergy Therapeutics plc Release: FDA Confirms Clinical Hold Will be Lifted on all Three INDs for Pollinex Quattro Products


4/26/2011 10:20:54 AM

26 April 2011 -- Allergy Therapeutics plc (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, is pleased to announce that following its meeting with the US Food and Drug Administration (FDA) on March 17, 2011, it has received official communication from the FDA stating that the clinical hold on the Investigational New Drug applications (INDs) for the three MATA-MPL© products will be lifted once the protocols have been agreed. As a part of the normal process, the FDA has asked the Company to submit its study protocols to the INDs for further discussions in order to provide review and feedback on the proposed studies.

Manuel Llobet, Chief Executive of Allergy Therapeutics, said:

“We are very pleased to report that a clear path forward has been agreed. We are encouraged that the clinical hold on all three INDs will be lifted, allowing the development programmes for these important products for treatment of allergic rhinoconjunctivitis due to grass, trees and ragweed pollen to restart. It is also encouraging that we will receive comments and feedback on our proposed study protocols from the FDA prior to restarting the development programmes. The Company is now moving ahead to identify a development and commercial partner in the US.”

Peter Jensen, Chairman of Allergy Therapeutics, said:

“We expect the commercialisation of Pollinex Quattro in the US and further afield to be transformational for the Company. Allergic rhinoconjunctivitis affects millions of people in the US, with an estimated 2.7 million receiving allergy vaccines annually. According to independent reports, the US market has the potential to be worth $1.5-$2.0 billion a year and the company is well placed to develop products for this exciting new market.”

Lawrence DuBuske MD, Clinical Professor of Medicine at George Washington University School of Medicine, Washington, DC, who was the principal investigator for the phase III study of the Company’s Grass MATAMPL product, the largest ever allergy immunotherapy study undertaken, said:

“The lifting of the clinical hold on all three INDs is good news and will allow specific injectable short course immunotherapy products to be developed using modern clinical trial methodology. With a course of just four injections administered ahead of the peak allergy season, compared to the current practice of up to 100 injections administered over 52 to 104 weeks, this new approach promises to transform the way allergy immunotherapy is practiced in the US. The very short course of therapy will increase patient compliance and provide important savings in healthcare costs.”

For further information

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Ian Postlethwaite, Finance Director

www.allergytherapeutics.com

Nomura Code Securities

+44 (0) 207 776 1200

Juliet Thompson/ Clare Terlouw

Financial Dynamics +44 (0) 207 831 3113

Ben Brewerton/ Susan Quigley

About Pollinex® Quattro (MATAMPL)

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.

Juliet Edwards

Assistant

Financial Dynamics

Holborn Gate, 26 Southampton Buildings

London, WC2A 1PB

D +44 (0)20 7269 7125

www.fd.com


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