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Endo International plc

Drug Names(s): clostridial collagenase for injection, AA4500, PF-5076985, Xiapex (EU), AK160, AK-160, EN3835, CCH

Description: AA4500 is a injectable version of collagenase ABC, an enzyme which has been used in the treatment of excess collagen deposits, debriding chronic dermal ulcers, and severely burned areas.

Deal Structure: Auxilium and BioSpecifics
Auxilium licensed AA4500 from BioSpecifics Technologies, which owns the rights to Collagenase ABC; BioSpecifics will receive low double-digit royalties on worldwide net sales. In addition to the marketing exclusivity which comes with its orphan drug status, the enzyme underlying this product candidate is covered by two use patents in the U.S., one for the treatment of Peyronie's Disease and one for the treatment of Dupuytren's Disease. The Peyronie's patent expires in 2019 and the Dupuytren's patent expires in 2014.

In August 2011, Auxilium and BioSpecifics announced that they will collaborate on identifying further indications for treatment with Xiaflex. Based on the terms of the amended agreement, Auxilium will pay BioSpecifics an opt-in fee at the time of completion by Auxilium of Stage I development of cellulite and will be responsible for all development costs associated with cellulite. Auxiliums opt-in rights remain unchanged with respect...See full deal structure in Biomedtracker

Partners: BioSpecifics Technologies Corp. Asahi Kasei Corporation Actelion Pharmaceuticals Ltd. Swedish Orphan Biovitrum

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