CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the
Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) have approved a second suite for filling and finishing product at
its Waterford, Ireland manufacturing plant.
“The approval of the second filling and finishing suite in Waterford is
another important milestone on our journey to build a robust
manufacturing network capable of ensuring reliable and consistent supply
of our products to patients”
With this approval, Genzyme has nearly doubled its ability to fill and
finish Myozyme® and Lumizyme® (alglucosidase alfa) produced at the 4000
liter bioreactor scale. Genzyme will also begin the process to secure
FDA and EMA approvals to fill and finish additional products in the
second suite, with the long-term goal to use the Waterford site as a
filling and finishing platform across its portfolio of products.
“The approval of the second filling and finishing suite in Waterford is
another important milestone on our journey to build a robust
manufacturing network capable of ensuring reliable and consistent supply
of our products to patients,” said Genzyme’s Head of Global
Manufacturing Operations, Bill Aitchison.
Genzyme’s Waterford facility has been in operation for over ten years,
and a $150 million expansion was completed earlier this year. The
Waterford manufacturing site employs over 500 people and is considered
Genzyme’s center of excellence for aseptic manufacturing.
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®, Myozyme® and Lumizyme® 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.
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, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.