Genzyme Announces Regulatory Approvals of Expanded Waterford, Ireland Manufacturing Plant
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 3, 2012 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant.
With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme® and Lumizyme® (alglucosidase alfa) produced at the 4000 liter bioreactor scale. Genzyme will also begin the process to secure FDA and EMA approvals to fill and finish additional products in the second suite, with the long-term goal to use the Waterford site as a filling and finishing platform across its portfolio of products.
“The approval of the second filling and finishing suite in Waterford is another important milestone on our journey to build a robust manufacturing network capable of ensuring reliable and consistent supply of our products to patients,” said Genzyme's Head of Global Manufacturing Operations, Bill Aitchison.
Genzyme's Waterford facility has been in operation for over ten years, and a $150 million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme's center of excellence for aseptic manufacturing.
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®, Myozyme® and Lumizyme® are registered trademarks of Genzyme Corporation. All rights reserved.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Lori Gorski, 617-768-9344
Posted: May 2012