MALVERN, Pa., Jan. 7, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium"), a specialty biopharmaceutical company, today announced that it has exercised its exclusive option under the Second Amended and Restated Development and License Agreement ("CCH License Agreement"), dated as of August 31, 2011, with BioSpecifics Technologies Corp., Inc. ("BioSpecifics") to expand the field of its license for collagenase clostridium histolyticum ("CCH") to include the potential treatment of adult patients with edematous fibrosclerotic panniculopathy ("EFP"), commonly known as cellulite. The Company exercised its option to include cellulite as an additional indication by making a one-time license fee payment of $500,000 to BioSpecifics. As a result of this exercise, the Company's exclusive, world-wide license has now been expanded, subject to the terms of the CCH License Agreement, to include all research, development, use, commercialization, marketing, sales and distribution rights for CCH for the potential treatment of cellulite.
"We are encouraged by the initial safety profile and potential efficacy of CCH in our recently completed phase Ib cellulite trial," said Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe cellulite represents a significantly undertreated condition and that innovative approaches such as CCH may, if approved, one day be a viable solution for treatment."About AuxiliumAuxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism and XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult DC patients with a palpable cord in the U.S. GSK co-promotes Testim with Auxilium in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia through April 24, 2013; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. The sBLA for XIAFLEX for the treatment of PD was submitted to the FDA on November 6, 2012 and has been accepted for Standard review with a PDUFA date of September 6, 2013. Additionally, collagenase clostridium histolyticum (CCH) is in phase IIa of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for CCH. For additional information, visit http://www.auxilium.com.
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