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Re: surf1944 post# 5

Monday, 01/07/2013 11:56:52 AM

Monday, January 07, 2013 11:56:52 AM

Post# of 12
8:04AM BioSpecifics Tech announces XIAFLEX progress in two pipeline indications; FDA accepts supplemental biologics license application filing for treatment of Peyronie's Disease (BSTC) 14.53 : Co announced progress for XIAFLEX in two pipeline indications. BioSpecifics' strategic partner Auxilium Pharmaceuticals has exercised its exclusive option under the Second Amended and Restated Development and License Agreement, dated as of August 31, 2011, to expand the field of its license for injectable collagenase to include the potential treatment of adult patients with edematous fibrosclerotic panniculopathy, commonly known as cellulite. As a result, BioSpecifics will receive a license fee payment of $500,000 from Auxilium. In addition, on December 27, 2012, the U.S. Food and Drug Administration (FDA) accepted for filing Auxilium's supplemental Biologics License Application (sBLA) for XIAFLEX for the potential treatment of Peyronie's disease. As a result, BioSpecifics will also receive a modest milestone payment from Auxilium. The filing was granted standard review status and, under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.