Pfizer Inc. and Auxilium Pharmaceuticals, Inc. 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.
“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 XIAF Xiaflex se countries.
Dupuytren’s contracture is a condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient’s fingers contract and the function of the hand is impaired. Currently, surgery is the only effective treatment. The incidence of Dupuytren's disease, inclusive of pits, nodules and cords, is highest in Caucasians, historically those of Northern European descent, with a global prevalence of three to six percent of the Caucasian population. Most cases of Dupuytren's contracture occur in patients older than 50 years and a hereditary component exists in approximately 40% of patients.
The most frequently affected parts of the hand associated with Dupuytren's contracture are the joints called the Metacarpal-Phalangeal Joint, or MP joint, which is the joint closest to the palm of the hand and the Proximal Intra-Phalangeal Joint, or the PIP joint, which is the middle joint in the finger. The little finger and ring finger are most frequently involved and about half of patients have bilateral disease. There are currently no drugs approved by the US Food and Drug Administration or in the European Union for the treatment of Dupuytren's contracture, which is treated primarily by an open surgical procedure.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians.