CAMBRIDGE, Mass., July 5 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced top-line results from a pivotal study
investigating the safety and efficacy of hylastan in treating pain in
patients with osteoarthritis (OA) of the knee. Hylastan is being developed
within Genzyme's program to introduce a viscosupplementation product that
can be delivered through a single knee injection. The goal of this effort
is to simplify OA pain management, reduce the overall cost of therapy and
advance a treatment option that may expand the benefits of
viscosupplementation to a broader number of patients.
Genzyme's development program also includes Synvisc-One(TM), an
investigational combined-dose regimen of Synvisc(R) (hylan G-F 20) provided
in a single injection, which the company is currently seeking to market in
the United States and Europe. Genzyme has submitted an application to the
FDA for Synvisc-One, and later this month will apply for a CE Mark to
introduce Synvisc-One in Europe. Regulatory action on both applications is
expected this year. Results from the successful pivotal study of
Synvisc-One were presented last month at the Annual European Congress of
Rheumatology.
The pivotal trial of hylastan was a double-blind, active-control study
involving nearly 400 patients with osteoarthritis of the knee enrolled at
27 sites in North America and Europe. Patients were randomized to receive
two intra-articular injections of hylastan delivered two weeks apart, a
single injection of hylastan, or an injection of a corticosteroid. Patients
were evaluated for 26 weeks following treatment. Results showed a
statistically significant and clinically meaningful reduction in knee pain
compared to baseline for each of the three treatment arms. However, the
difference in pain reduction between patients treated with hylastan and
patients treated with a steroid was not significant, and the trial did not
meet its primary endpoint of demonstrating that hylastan provides superior
pain relief to steroids. The safety profile of the three treatment arms
appeared to be comparable in the preliminary analysis of the study results.
"We structured our development program in a way that provided us with
several chances to reach our goal of introducing a single-injection
product," said Ann Merrifield, president of Genzyme Biosurgery, the
business unit that manufactures and markets Synvisc. "It is now clear that
we will focus our efforts on bringing Synvisc-One to the market. We are
confident that simplifying the treatment process will encourage a greater
number of physicians and patients to seek the benefits of
viscosupplementation to help manage OA knee pain. We will continue to
analyze the findings from the hylastan study to determine how this product
fits into our longer-range strategy, as we continue to invest in bringing
innovation to this field."
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 more than 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 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 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 the
statements regarding whether and when Synvisc-One obtains marketing
approval in the US and the timing of a regulatory filing for Synvisc-One in
Europe. 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 extent to which the US Food and Drug Administration determines
that Synvisc- One can appropriately be approved for marketing in the US,
our ability to prepare the necessary regulatory filing for Europe in a
timely fashion 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 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 March 31,
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) and Synvisc(R) are registered trademarks and Synvisc-One(TM)
is a trademark of Genzyme Corporation. 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 1-678-999-4572 outside the
United States.
Media Contact: Investor Contact:
Bo Piela Sally Curley
(617) 768-6579 (617) 768-6140
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, Sally Curley, +1-617-768-6140, both of Genzyme Corp.
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