As a result, the scientific/technical review procedure commenced on 21 January 2010. Xiaflex is a biologic for the treatment of dupuytren’s contracture.
Based on the completion of the validation phase and confirmation from the European Medicines Agency of the start of the regulatory review procedure, Auxilium is expected to receive a $15m milestone payment from Pfizer.
As per the terms of the strategic alliance agreement between Pfizer and Auxilium, Pfizer will receive exclusive rights to commercialise 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.
Armando Anido, president and CEO 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.”