Genzyme Receives Approval To Market Elaprase(R) In Japan

Main Category: Genetics
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 05 Oct 2007 - 0:00 PDT

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Genzyme Corp. (Nasdaq: GENZ) announced 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 Corp.
http://www.genzyme.com

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