Thymoglobulin Fill/Finishing to Begin Immediately; Other Products Expected
to Soon Follow
CAMBRIDGE, Mass., July 24 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today that the U.S. Food and Drug Administration
has approved the fill/finishing, packaging and labeling of Thymoglobulin(R)
(anti-thymocyte globulin, rabbit) at its state-of-the-art Waterford,
Ireland facility. The approval allows Genzyme to begin manufacturing and
distribution of Thymoglobulin, a product for the treatment of acute
rejection in patients with a kidney transplant, from this single location
and further enhances Genzyme's manufacturing efficiencies.
"We are very pleased with this approval, as it continues the
development of our supply strategy with Waterford serving as our major
European production and distribution center for large volume runs of a
broad range of products," stated Mark R. Bamforth, Genzyme's senior vice
president for corporate operations and pharmaceuticals. "We look forward to
also receiving similar fill/finish approvals for two of our enzyme
replacement therapies at Waterford in the coming months."
Genzyme is currently conducting approval-qualifying manufacturing runs
of Cerezyme(R) (imiglucerase for injection) and Myozyme(R) (alglucosidase
alfa) at the facility. Myozyme was approved this year in Europe and the
U.S. for treatment of Pompe disease -- a debilitating, progressive and
often fatal disorder affecting fewer than 10,000 people worldwide. Genzyme
currently manufactures Myozyme in the United States. The company expects to
also scale-up bulk production of Myozyme at its new protein manufacturing
facility in Geel, Belgium, and then fill and package the product in
Waterford to ensure that it is able to meet the anticipated demand for
Myozyme throughout the world. Genzyme currently produces Cerezyme at its
flagship manufacturing facility in Allston, MA. The company plans to use
the Waterford facility for additional capacity and security for Cerezyme's
fill/finish.
When Genzyme completed a major expansion at Waterford last year, it
added high-quality biological filling and packaging capabilities to support
the growth of protein products such as Myozyme and Cerezyme, along with
products like Thymoglobulin that are manufactured at other Genzyme
facilities. The facility uses a state-of-the-art isolator system that
provides the reliability of a sterile environment and the assurance of
producing quality products.
Waterford is already the primary tableting and bottling center for
Renagel(R) (sevelamer hydrochloride). In 2005, the plant produced
approximately 3 million bottles of Renagel for patients with chronic kidney
disease who are on dialysis.
A Strong Global Infrastructure
Genzyme has substantially strengthened its global infrastructure for
manufacturing and product development through four major recent expansion
projects in Belgium, Ireland, and the United Kingdom. The expanded
facilities officially opened last year and are supporting Genzyme's
continued growth and innovation, particularly in the areas of antibody and
protein-based medicines.
In addition to Waterford and Geel, the facilities include expansion of
a manufacturing center in Haverhill, UK and the creation of an antibody
discovery research facility in Cambridge, UK.
Genzyme has a total of seven manufacturing sites in Europe, including a
small molecule production site in Liestal, Switzerland, a polyclonal
bio-manufacturing site in Lyon, France, and diagnostic manufacturing
facilities in Kent, UK and Russelsheim, Germany.
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. This year marks the 25th anniversary of Genzyme's
founding. Since 1981, the company has grown from a small start-up to a
diversified enterprise with more than 8,000 employees in locations spanning
the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by
FORTUNE as one of the "100 Best Companies to Work for" in the United
States.
With many established products and services helping patients in more
than 80 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 diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as heart
disease and other areas of unmet medical need.
This press release contains forward-looking statements, including
without limitation statements about: intended manufacturing and other uses
for Genzyme's manufacturing facilities and the anticipated timing thereof,
including the use of the Waterford, Ireland facility for Cerezyme and
Myozyme and the production of Myozyme at Genzyme's facility in Geel,
Belgium; the estimated Pompe disease patient population; the expected
receipt of regulatory approvals to manufacture and/or fill/finish Myozyme
and Cerezyme in the Waterford facility and the expected timing thereof; the
anticipated ability to meet demand for Myozyme; and the anticipated growth
of antibody and protein- based products. These statements are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected in these forward-looking statements. These
risks and uncertainties include, among others: the timing and results of
manufacturing runs at the Waterford facility that are intended to be used
to receive regulatory approvals; the ability to obtain regulatory and other
approvals, including any and all regulatory approvals required for the
planned uses of the Waterford and Geel facilities, and the actual timing
thereof; the accuracy of the company's information about the Pompe disease
patient population; Genzyme's ability to manufacture products in a timely
and cost effective manner; and the risks and uncertainties described in
reports filed by Genzyme with the Securities and Exchange Commission under
the Securities Exchange Act of 1934, as amended, including the factors
discussed under the caption "Factors Affecting Future Operating Results" in
Genzyme's Quarterly Report on Form 10-Q for the quarter ended March 31,
2006. 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(R), Thymoglobulin(R), Cerezyme(R), Myozyme(R) and Renagel(R)
are trademarks of Genzyme Corporation or its subsidiaries. All rights
reserved.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line
at 1-800-905-4369 within the United States or 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Maria Cantor Sally Curley
(617) 768-6690 (617) 768-6140
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com/
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media Contact: Maria Cantor, +1-617-768-6690,
or Investor Contact: Sally Curley, +1-617-768-6140, both of
Genzyme Corporation
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