Genzyme to Invest $80 Million in Framingham, Mass. Site to Expand Manufacturing Capacity for Fabrazyme®

  Genzyme to Invest $80 Million in Framingham, Mass. Site to Expand
  Manufacturing Capacity for Fabrazyme®

Business Wire

CAMBRIDGE, Mass. -- October 15, 2013

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that
it is investing $80 million to build a new downstream processing facility for
Fabrazyme® (agalsidase beta). The new plant, which will be located adjacent to
the new Fabrazyme cell culture manufacturing site in Framingham,
Massachusetts, will significantly expand purification capacity to support
anticipated growth in global demand over the coming years.

“As we continue to meet the global demands for Fabrazyme and build inventory,
our focus also remains on the future needs of the global Fabry community,”
said Genzyme President and CEO, David Meeker, M.D. “Following last year’s
regulatory approvals of our manufacturing facility in Framingham and a new
vial filling line at our plant in Waterford, Ireland, we continue to execute
on our global manufacturing strategy, enhancing our capabilities across the
entire manufacturing process for Fabrazyme.”

Downstream processing, a vital step in biologic production, involves the
purification of material harvested from the cell culture manufacturing
process. The final product, which is administered as an intravenous (IV)
infusion, is formulated and fill-finished in a separate facility in Waterford,
Ireland and shipped to multiple distribution centers for labeling, packaging
and shipping around the world.

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® and Fabrazyme® are registered trademarks of Genzyme Corporation. All
rights reserved.

About Sanofi

Sanofi, an integrated global 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).

Sanofi 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, 2012. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

Contact:

Genzyme  Media Contact:
David Murdoch, 508-661-1127
David.Murdoch@genzyme.com
 
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