Auxilium Pharmaceuticals, a specialty biopharmaceutical company, and Actelion Pharmaceuticals have entered into a long-term partnership for the development, supply and commercialization of Xiaflex(collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's disease.
Actelion will pay Auxilium $10 million upfront and will also make up to $16 million in potential regulatory, pricing and reimbursement milestone payments and $42.5 million in potential sales milestone payments. In turn, Actelion will receive exclusive rights to commercialize Xiaflex for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals, which it plans to file for over the next 12 months.
In addition, Auxilium will be responsible for all clinical and commercial drug manufacturing and supply, while Actelion will be responsible for clinical development activities and associated costs corresponding to 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, CEO and president of Auxilium.
Xiaflex, which has been approved by the FDA and the European Medicines Agency, is currently in development in Japan and has been accepted for review by Health Canada. Xiaflex is also being evaluated in a global phase III development program for Peyronie's disease with top-line data expected in late second quarter 2012.