Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. have announced that they 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.
Under the terms of the agreement, 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.
Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in these countries.
XIAFLEX has been approved by the U.S. Food and Drug Administration and the European Medicines Agency as a treatment for Dupuytren's contracture, and is also in development in Japan.
In addition, XIAFLEX has been accepted for review by Health Canada for the treatment of Dupuytren's contracture in Canada and regulatory action is expected in the second half of 2012.
Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico over the next 12 months.
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.
"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.
Adams continued, "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."
Philippe de Lavenne, VP Actelion Pharmaceuticals, Head of Europe, Canada, Latin America, Middle East & Africa commented: "This tailored partnership has been designed to leverage Actelion's regulatory and marketing expertise, as well as our established local operating companies in these markets. Auxilium has done an outstanding job in the development of this innovative product, and we look forward to contributing to making XIAFLEX a global success."
Under the terms of the agreement, 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.
Auxilium will also receive increasing tiered double-digit royalties based on sales of XIAFLEX in Actelion's territories and will supply product to Actelion at a predetermined cost.
Auxilium will remain primarily 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 activities and associated costs corresponding to any additional trials required for specific territories.