Auxilium Pharmaceuticals and Pfizer have entered into a strategic alliance for the development, commercialization and supply of Xiaflex, a novel, first-in-class, biologic for the treatment of Dupuytren's contracture and Peyronie's disease. Pfizer will receive exclusive rights to commercialize Xiaflex in the 27 member countries of the EU and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for Xiaflex in these countries.
Pfizer will make an up-front payment of $75 million to Auxilium and as much as $410 million in 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.
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 has completed Phase III trials for Xiaflex in Dupuytren's contracture and expects to file a biologics license application (BLA) in the U.S. for the treatment of Dupuytren's contracture 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."