Full Press Release Details
Genzyme Announces European Approval of
Framingham Manufacturing Plant
Paris, France - January 18, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the European Medicines Agency (EMA) has approved its manufacturing plant in
Framingham, Mass., for the production of Fabrazyme (agalsidase beta).
This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained
supply for all patients, said Genzyme s President and CEO David Meeker. Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme and working toward all regulatory approvals of our Framingham plant are our highest priorities, and we remain on
track to achieve all of these crucial goals.
The complete return to normal supply levels of Fabrazyme globally will not be immediate, as it will take time to obtain all global regulatory approvals throughout the year
and due to production lead times.
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.
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).
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 labeling and other matters that could
affect the availability or commercial potential of such products candidates, the absence of guarantee that the products 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 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, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
| Contacts: | ||
| Genzyme Media Relations | ||
| Lori Gorski | ||
| +1 (617) 768-9344 | ||
| Lori.gorski@genzyme.com | ||
| Sanofi Media Relations | Sanofi Investor Relations | |
| Marisol P ron | S bastien Martel | |
| Tel: +33 (0) 1 53 77 45 02 | Tel: +33 (0) 1 53 77 45 45 | |
| E-mail: mr@sanofi.com | E-mail: ir@sanofi.com |