FDA-approved drug will be developed for treating Dupuytren contracture and Peyronie disease.
Actelion Pharmaceuticals is paying Auxilium Pharmaceuticals $10 million up front as part of a long-term partnership centered on development and commercialization of the latter’s Xiaflex™ (collagenase clostridium histolyticum) biologic for the treatment of Dupuytren contracture and Peyronie disease, in Canada, Australia, Brazil, and Mexico. Auxilium could receive up to another $16 million related to regulatory and commercialization milestones, $42.5 million in sales milestones, and double digit sales royalties.
Xiaflex® has already been approved in the U.S. and EU for the treatment of Dupuytre contracture and is under regulatory review in Canada. Development for the same indication is separately in progress in Japan. Under terms of its deal with Auxilium, Actelion has exclusive rights to commercialize Xiaflex for the treatment of both the Dupuytren contracture and Peyronie disease indications in its four territories and will have primary responsibility for regulatory and commercialization activities. The firm says it expects to file for approval of the drug for the Dupuytren contracture indication in Australia, Brazil, and Mexico during the next 12 months.
Auxilium will be responsible for global development of Xiaflex against Peyronie disease as well as all clinical and commercial drug manufacturing and supply activities. A global Phase III trial program for the Peyronie disease indication is under way, and topline data is expected before the second half of this year. Actelion will shoulder any costs and clinical development activities that may be required to develop the drug for the Peyronie disease indication in its designated territories.
Auxilium is separately developing Xiaflex injections for the potential treatment of frozen shoulder syndrome (idiopathic adhesive capsulitis of the shoulder) and for reducing cellulite (edematous fibrosclerotic panniculopathy). Patient dosing for the Phase I cellulite study was initiated in January, and in December 2011, the first patients received treatment in an open-label Phase II study evaluating Xiaflex in the treatment of frozen shoulder.