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.
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.