Allergy Thera. Regulatory News (AGY)

1 Nov 2007 07:02

Allergy Therapeutics PLC01 November 2007 1 November 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Update on FDA Clinical Hold Allergy Therapeutics today provides an update on the clinical hold that has beenplaced by the United States Food and Drug Administration ('FDA') on theCompany's product development programmes. On 11 July 2007 the Company announcedthat activity on its clinical studies had been placed on hold by the FDA whilstthe Agency fully assessed the report of a rare adverse event classified at thattime by the physician involved as 'possibly related' to the study drug. The Company has now had a 'Type A' meeting with the FDA. Prior to the meetingAllergy Therapeutics submitted a comprehensive package of information to theAgency. The meeting was constructive and resulted in a better mutualunderstanding of the position regarding the Company's development programmes.The FDA has indicated that it is in the process of conducting a thorough review.The Company will make further submissions in the coming weeks and will continueto work with the FDA to lift the clinical hold. A further announcement will be made as and when appropriate. For further information Allergy Therapeutics +44 (0) 1903 845 820Keith Carter, Chief ExecutiveTom Holdich, R&D Director Landsbanki +44 (0) 207 003 3131Shaun Dobson Financial Dynamics +44 (0) 207 831 3113Ben Brewerton This information is provided by RNS The company news service from the London Stock Exchange