Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Jan 21 2010

Pfizer Inc. (NYSE: PFE) and Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

“XIAFLEX, if approved, will be an important addition to the Specialty Care Business Unit’s portfolio of medicines in Europe designed to offer true clinical value to patients and healthcare providers who need them.”

“We are pleased to partner with Auxilium to bring forward what potentially could be the first approved pharmaceutical treatment option for patients suffering with Dupuytren’s contracture, a condition which can significantly impact patients’ ability to perform everyday tasks with their hands and therefore impacts quality of life,” said Michael Berelowitz, M.D., senior vice president, Clinical Development and Medical Affairs, Pfizer Specialty Care Business Unit. “XIAFLEX, if approved, will be an important addition to the Specialty Care Business Unit’s portfolio of medicines in Europe designed to offer true clinical value to patients and healthcare providers who need them.”

Armando Anido, Chief Executive Officer and President of Auxilium said, “We believe that commencement of the regulatory review procedure is a notable milestone in our effort to bring the first approved minimally-invasive, nonsurgical treatment option to Dupuytren’s contracture patients in Europe. We look forward to working with our partner Pfizer as the EU regulatory review process for the product moves forward.”

Based on the completion of the validation phase and today’s confirmation from the European Medicines Agency of the start of the regulatory review procedure, Auxilium will receive a $15 million milestone payment from Pfizer.

Under the terms of the strategic alliance agreement between Pfizer and Auxilium, 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.