CAMBRIDGE, Mass., Oct. 4 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has received approval to market
Elaprase(R) (idursulfase) in Japan for the treatment of Hunter syndrome.
Elaprase is an enzyme replacement therapy developed by Shire Human Genetic
Therapies Inc., and Genzyme is commercializing the product in Japan and
other Asia Pacific countries under an agreement with Shire. Genzyme intends
to launch Elaprase this quarter, following reimbursement approval.
Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a
rare, life-threatening genetic condition mainly affecting males that
results from the absence or insufficient levels of the lysosomal enzyme
iduronate-2-sulfatase. Without this enzyme, cellular waste products
accumulate in tissues and organs which then begin to malfunction, leading
to severe clinical complications and early mortality.
Elaprase is the fifth enzyme replacement therapy that Genzyme has
introduced in Japan. The company also markets Cerezyme(R) (imiglucerase for
injection) for Type 1 Gaucher disease; Fabrazyme(R) (agalsidase beta) for
Fabry disease; Aldurazyme(R) (laronidase) for MPS I; and Myozyme(R)
(alglucosidase alfa) for Pompe disease.
"Our deep experience in Japan in the area of lysosomal storage
disorders will enable us to make Elaprase available to all patients who
need treatment as quickly as possible," said David Meeker, M.D., president
of Genzyme's Lysosomal Storage Disorders business unit. "We anticipate that
Elaprase will become an increasingly significant contributor for us as we
introduce the product across the region."
Genzyme is currently working to obtain marketing approval for Elaprase
in several additional countries. The company anticipates approval in
Australia by the end of this year and in Taiwan and South Korea next year.
Under its agreement with Shire, Genzyme will record product sales in
the region and allocate approximately one-third of net sales to Shire.
Genzyme will make a $3 million milestone payment to Shire in recognition of
Japanese marketing approval, and it will make a $4 million milestone
payment upon reimbursement approval.
Genzyme established commercial operations in Japan twenty years ago and
currently employs more than 100 people in the country. Genzyme was the
first non-Japanese biotechnology company to introduce therapeutic products
in Japan without Japanese partners. The company today also markets
Seprafilm(R) adhesion barrier and offers genetic testing services.
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 nearly 10,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was 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 nearly
90 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 diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
This press release contains forward-looking statements, including
statements about the expected launch date for Elaprase, the timing of
receipt of reimbursement approvals, our ability to make Elaprase available
to all patients who need treatment, the potential impact of Elaprase sales
on Genzyme's revenue, actions by regulatory and governmental agencies as
well as anticipated regulatory approval dates, and the number of potential
patients in Genzyme's territories. 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: Genzyme's ability to secure sufficient
product supply and to distribute the product in a timely and effective
manner, Genzyme's ability to obtain reimbursement approvals and the level
of such approvals, the ability to obtain marketing approval within the
territory, the size of the market in Genzyme's jurisdictions for the
therapy, actions by governmental authorities related to Elaprase, and the
other 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 without limitation the information under the
heading "Risk Factors" in the Management's Discussion and Analysis of
Financial Condition and Results of Operations section of the Genzyme
Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. 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 the statements.
Genzyme(R), Cerezyme(R), Fabrazyme(R), Aldurazyme(R), Myozyme(R), and
Seprafilm(R) are registered trademarks of Genzyme Corporation. All rights
reserved. Elaprase is a trademark of Shire Human Genetic Therapies Inc.
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:
Bo Piela
617-768-6579
Investor Contact:
Patrick Flanigan
617-768-6563
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Media, Bo Piela, +1-617-768-6579, or
Investor, Patrick Flanigan, +1-617-768-6563, both of Genzyme
Corp.
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