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news.Auxilium Pharmaceuticals, a specialty biopharmaceutical company, and Pfizer have entered into a strategic alliance for the development, commercialization and supply of Xiaflex, a novel, late-stage biologic, for the treatment of Dupuytren's contracture and Peyronie's disease.
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Under the terms of the agreement, 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 is expected to be primarily responsible for regulatory activities for Xiaflex in these countries.
Under the agreement, Pfizer will make an up-front payment of $75m to Auxilium and up to $410m in potential milestone payments, with $150m tied to regulatory milestones and $260m 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 is expected to 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 US biologics license application for the treatment of Dupuytren’s contracture with the FDA 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.