CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the
Food and Drug Administration (FDA) has approved its manufacturing plant
in Framingham, Mass., for the production of Fabrazyme® (agalsidase
beta). This follows the previously announced approval by the European
Medicines Agency (EMA) last week.
“With
this approval, we continue upon our 2012 plan to restore unconstrained
supply for all patients globally throughout the course of the year.”
“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
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.
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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.