Business
FDA Update
FDA Update.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 4113F Allergy Therapeutics PLC 26 April 2011 \n \n\n26 April 2011\n \nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or \"the Company\")\n \nFDA confirms Clinical Hold will be lifted on all three INDs for Pollinex Quattro products \n \n \nAllergy 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.\n \nManuel Llobet, Chief Executive of Allergy Therapeutics, said:\n \n\"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.\"\n \nPeter Jensen, Chairman of Allergy Therapeutics, said:\n \n\"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.\"\n \nLawrence 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 ...