Genzyme to Build Additional Plant to Support Growth of Myozyme® and Lumizyme®
January 20 2011 - 7:00AM
Business Wire
Genzyme Corp. (NASDAQ: GENZ) today announced that it will build
an additional manufacturing plant in Geel, Belgium, to support the
long-term growth of Myozyme® and Lumizyme® for Pompe disease. The
company held a ceremony today in Geel to mark the start of
construction of the new €250 million plant, which will include
8,000 liters of production capacity, a complete purification
installation, and ample room for additional future capacity
expansions. Commercial approvals for the new site are expected to
start late 2014.
Genzyme currently produces Myozyme and Lumizyme at an adjacent
plant in Geel, where it is increasing production capacity to 12,000
liters with the addition of a third bioreactor scheduled for
approval by the end of this year. Genzyme is also continuing its
160 L production in the U.S. for patients with infantile-onset
Pompe disease. The investment in Geel is part the company’s program
to increase its overall biologics manufacturing capacity four fold.
About 150 new jobs will be created as part of the expansion,
bringing the total workforce at the site to nearly 600 people.
“The expansion of our Geel facility is a critical element of our
manufacturing strategy and is fundamental to our mission,” said
Scott Canute, Genzyme’s President, Global Manufacturing and
Corporate Operations. “We are committed to delivering a reliable
supply of high quality medicines to our patients. This investment
ensures continued supply to our patients in the Pompe community for
the long term.”
Genzyme believes that its Pompe disease treatments represent a
commercial opportunity that is comparable to that of Cerezyme for
Gaucher disease. The company estimates that there are about 10,000
Pompe patients worldwide; approximately 1,400 Pompe patients are
currently treated with either Myozyme or Lumizyme, which are the
only treatments approved for the disease. Myozyme is currently
available in 48 markets worldwide and Genzyme expects to increase
this to 60 markets by the end of this year.
"Our strong track record of results, the expertise and
dedication of our workforce along with the partnership with
the authorities in Belgium, have been instrumental in bringing this
exciting new investment to our site," said Piet Houwen, General
Manager of Genzyme’s Geel manufacturing site.
About Pompe Disease
Pompe disease is a progressive, debilitating and often fatal
neuromuscular disease caused by a genetic deficiency or dysfunction
of the lysosomal enzyme acid alpha-glucosidase (GAA). This
enzymatic defect results in the accumulation of glycogen primarily
in muscle tissues that leads to muscle weakness, loss of
respiratory function, and often premature death. When symptoms
occur in infancy, babies typically die within the first year of
life. When symptoms occur in childhood or adulthood, patients
typically lose their ability to walk and require wheelchairs to
assist with mobility and experience difficulty breathing as well as
mechanical ventilation to breathe.
About Myozyme and Lumizyme
Alglucosidase alfa, known as Lumizyme in the US and as Myozyme
in the rest of the world, targets the underlying cause of Pompe
disease by replacing the enzyme that is deficient. In the US,
Lumizyme is indicated for patients 8 years and older with late
(non-infantile) onset Pompe disease (GAA deficiency) who do not
have evidence of cardiac hypertrophy. In the US, Myozyme
(alglucosidase alfa) is indicated for use in patients with Pompe
disease (GAA deficiency). Myozyme has been shown to improve
ventilator-free survival in patients with infantile-onset Pompe
disease as compared to an untreated historical control, whereas use
of Myozyme in patients with other forms of Pompe disease has not
been adequately studied to assure safety and efficacy. In Europe,
Myozyme is indicated for infants, children and adults with Pompe
disease.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a
small start-up to a diversified enterprise with approximately
10,000 employees in locations spanning the globe.
With many established products and services helping patients in
approximately 100 countries, Genzyme is a leader in the effort to
develop and apply the most advanced technologies in the life
sciences. The company's products and services are focused on rare
inherited disorders, kidney disease, orthopaedics, cancer,
transplant and immune disease. Genzyme's commitment to innovation
continues today with a substantial development program focused on
these fields, as well as cardiovascular disease, neurodegenerative
diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding
Genzyme’s business plans including, without limitation, statements
about the expansion of manufacturing capacity for Myozyme and
Lumizyme in Geel, Belgium, the timing of regulatory approvals and
expectations relating to the production of Lumizyme and Myozyme.
These statements are subject to risks and uncertainties that could
cause actual results to differ materially from those forecasted.
These risks and uncertainties include, among others: whether
Genzyme has forecasted the size of the commercial opportunity and
potential product demand accurately; whether Genzyme is able to
manufacture product in sufficient quantities to meet demand;
whether the FDA and other regulatory authorities approve the
manufacturing facilities in Geel and the timing thereof; whether
regulatory approval for Myozyme is received from regulatory
authorities in the expected timeframe; whether the new facility
allows for additional expansion as expected; and the risks and
uncertainties described in Genzyme's SEC reports filed under the
Securities Exchange Act of 1934, including the factors discussed
under the caption "Risk Factors" in Genzyme's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2010. Genzyme
cautions investors not to place substantial reliance on the
forward-looking statements contained in this press release. These
statements speak only as of the date of this press release and
Genzyme undertakes no obligation to update or revise these
statements.
Genzyme® and Myozyme® are registered trademarks, and Lumizyme™
is a trademark, of Genzyme Corporation or its subsidiaries. All
rights reserved.
Important Information
Genzyme has filed with the Securities and Exchange Commission a
Solicitation/Recommendation Statement on Schedule 14D-9 relating to
the tender offer by Sanofi-Aventis. Genzyme shareholders are
advised to read the company's Solicitation/Recommendation Statement
on Schedule 14D-9 because it contains important information.
Shareholders may obtain a free copy of the
Solicitation/Recommendation Statement on Schedule 14D-9, as well as
any other documents filed by Genzyme in connection with the tender
offer, free of charge at the SEC's website at http://www.sec.gov.
In addition, investors can obtain free copies of these documents
from Genzyme by directing a request to Genzyme at 500 Kendall
Street, Cambridge, MA 02142, Attention: Shareholder Relations
Department, or by calling 617-252-7500 and asking for the
Shareholder Relations Department.
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