CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced that it
has begun shipping Fabrazyme® (agalsidase beta) produced at
its newly approved plant in Framingham, Massachusetts. As previously
communicated, patients in the U.S. are now able to return to full dosing
in March. In addition, all new patients in the U.S. are eligible to
begin Fabrazyme treatment, at full dosing levels.
“The ability to meet the needs of patients in the U.S. is an important
first step in restoring unconstrained supply for all patients globally
throughout the course of 2012”
“The ability to meet the needs of patients in the U.S. is an important
first step in restoring unconstrained supply for all patients globally
throughout the course of 2012,” said Genzyme’s President and CEO David
Meeker.
In Europe the process of moving the most severely affected patients to
full dose of Fabrazyme will begin in March 2012. 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.
The Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) approved the manufacturing plant in Framingham, Mass., for the
production of Fabrazyme in January 2012.
About Fabry Disease
Fabrazyme is approved for treatment of Fabry disease, an
inherited condition that is characterized by excessive accumulation of
the lipid GL-3 in various organs and tissues, which over time can cause
renal, cardiac and cerebrovascular events. As a result, patients with
Fabry disease typically have a shortened life span, and children must
often cope with significant pain and disability. Fabry disease is an
inherited and life threatening disease linked to the X chromosome which
affects approximately 5,000 patients in the world.
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® is a registered trademark 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,
consumer healthcare, emerging markets, animal health and the new
Genzyme. 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
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“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.