C. histolyticum-derived collagenase preparation will be developed for Dupuytren contracture and Peyronie disease.
Asahi Kasei Pharma is paying Auxilium Pharmaceuticals $15 million up front for rights to develop and commercialize the latter’s Xiaflex® (collagenase Clostridium histolyticum) in Japan for the treatment of Dupuytren contracture and Peyronie disease. Xiaflex is already approved in the U.S. and Europe for the treatment of Dupuytren contracture, and a global Phase III development program for Peyronie disease is ongoing. Phase II studies evaluating the product as a treatment for frozen shoulder syndrome (adhesive capsulitis) are also ongoing.
Under terms of the Japanese deal, Asahi Kasei will be primarily responsible for clinical development, regulatory activities, and commercialization of the drug in its territory. The firm expects to start clinical trials for the Dupuytren contracture indication in 2012. Auxilium could potentially receive another $37 million in development and regulatory milestones, $210 in sales-related milestones, and tiered double-digit royalties on Xiaflex sales in Japan. Asahi in addition retains a right of first negotiation to obtain an exclusive license to commercialize Xiaflex pipeline indications in Japan.
Xiaflex comprises a combination of several subtypes of collagenase derived from Clostridium histolyticum and is the only FDA-approved nonsurgical treatment for adults with Dupuytren contracture with a palpable cord, Auxillium points out.
