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Genzyme Announces FDA Approval of Framingham Manufacturing Plant

8 February 2012

Genzyme, a Sanofi company, announced today that the US Food and Drug Administration (FDA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta).  Please click here to view the press release.  This  announcement follows last week’s press release that the EMA also approved the Framingham manufacturing plant for the production of Fabrazyme.
 
Today’s announcement further supports our ability to return Fabry patients globally to regular dosing in accordance with our previously communicated goal of returning all patients to unconstrained full supply throughout 2012.  Product from Framingham can now support the return of US patients to full doses as planned.  Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year
as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.
 
We will continue to update the Fabry community at a regional/local level about specific Fabrazyme availability.  As a reminder, despite this positive step towards resuming a stable supply of treatment, we continue to operate with limited inventory, so any change to our manufacturing plans could affect the availability of product to patients.  Please contact your local Genzyme representative or your treating physician with additional questions.
 
This posting 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.

 

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