“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” said Genzyme’s President and CEO David Meeker. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”
Approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in Q1 2012. Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the U.S. onto Fabrazyme, at full dosing levels. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory
approvals throughout the year and to build inventory.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® and Fabrazyme® are registered trademarks of Genzyme Corporation. All rights reserved.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer
healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme
Gooimeer 10, 1411 DD, Naarden
Phone: + () www.genzyme.com
Sector: Pharma
Description: Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing.