Auxilium Pharmaceuticals and Actelion Pharmaceuticals have entered into a long-term partnership for the development, supply and commercialization of Xiaflex, a novel, first-in-class biologic for the potential treatment of Dupuytren’s contracture and Peyronie’s disease. Upon approval, Actelion will have exclusive rights to commercialize Xiaflex in Canada, Australia, Brazil and Mexico, and will be responsible for regulatory and commercialization activities in these countries.

Xiaflex is approved by the FDA and the EMA as a treatment for Dupuytren’s contracture, and is also in development in Japan. It has been accepted for review by Health Canada, with regulatory action expected in 1H12. Actelion expects to file for approval in Australia, Brazil and Mexico during the next 12 months. The drug is also being evaluated in a global Phase III program for Peyronie’s disease.

Auxilium will receive $10 million upfront and as much as $58.5 million in potential milestone payments, as well as royalties on sales in Actelion’s territories. Auxilium will supply product to Actelion at a predetermined cost. Auxilium will remain responsible for the global development of Xiaflex in Peyronie’s disease and will be responsible for all clinical and commercial drug manufacturing and supply. Actelion will be responsible for clinical development and associated costs for any additional trials required for specific territories.

“Today, Actelion and Auxilium have forged a partnership, which we believe has the opportunity to offer, subject to regulatory approval, the first, effective nonsurgical treatment for two diseases in multiple new geographies,” said Adrian Adams, chief executive officer and president of Auxilium. “With the strength of Actelion’s commercialization and development organization in these diverse and far-ranging markets, this relationship should further enhance our ability to bring this potentially groundbreaking product to a global audience.”