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
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 Lumizymein the US and as Myozymein 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
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
Genzyme® and Myozyme® are registered trademarks,
and Lumizyme? is a trademark, of Genzyme Corporation or its
subsidiaries. All rights reserved.
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.