Auxilium Pharmaceuticals, Inc has entered into a strategic alliance with Pfizer, Inc for the development, commercialization and supply of Xiaflex (clostridial collagenase for injection), a novel, first-in-class, late-stage biologic, for the treatment of Dupuytren's contracture and Peyronie's disease. Under the terms of the agreement, Pfizer will receive exclusive rights to commercialize Xiaflex in the 27 member countries of the European Union (EU) and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for Xiaflex in these countries.

Auxilium has completed phase-III trials for Xiaflex in Dupuytren's contracture and expects to file a US biologics license application (BLA) for the treatment of Dupuytren's contracture with the US Food and Drug Administration in early 2009. Pfizer expects to file Xiaflex for approval for the treatment of Dupuytren's contracture in Europe in 2010. Xiaflex is also being evaluated in a phase-IIb trial for Peyronie's disease with top line data expected in late 2009.

"Today, Pfizer and Auxilium have forged a compelling partnership and together we believe we have the opportunity to offer the first, effective non-surgical treatment for two diseases," said Armando Anido, chief executive officer and president of Auxilium. "With the strength of Pfizer's commercialization and development organization, this relationship greatly enhances our ability to effectively introduce this potentially groundbreaking technology for the treatment of Dupuytren's contracture and Peyronie's disease in Europe."

Under the agreement, Pfizer will make an up-front payment of $75 million to Auxilium and up to $410 million in potential milestone payments, with $150 million tied to regulatory milestones and $260 million based on sales milestones. Auxilium will receive increasing tiered royalties based on sales of Xiaflex in Pfizer's territories.

"Our partnership with Auxilium is a testament to Pfizer's commitment to draw on the best external science for innovative products that complement our existing portfolio and fill unmet medical needs," said Olivier Brandicourt, president and general manager of Pfizer's Specialty Care Business Unit. "We look forward to combining our strengths to further the potential for Xiaflex as an advanced new treatment for patients suffering from Dupuytren's contracture and Peyronie's disease."

Auxilium will remain primarily responsible for the global development of Xiaflex and will be responsible for all clinical and commercial drug manufacturing and supply. Pfizer will share clinical development costs for certain trials required for the EU and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex. Pfizer will have a right of negotiation to obtain exclusive rights to commercialize Xiaflex pipeline indications in its territories.

Auxilium Pharma is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopaedists and select primary care physicians.