Only Product of its Kind in Europe to Offer up to Six Months of Pain Relief
in OA Knee Pain
CAMBRIDGE, Mass., Dec. 19 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has been granted European approval
through a CE mark for Synvisc-One(TM), the single treatment of Synvisc(R)
(hylan G-F 20) that has been shown in the European Union to provide up to
six months of proven pain relief from osteoarthritis (OA) of the knee.
Synvisc-One is now the only viscosupplementation product available in
Europe that is labeled to provide this long-term duration of pain relief
from a single injection.
Genzyme believes that Synvisc-One will simplify osteoarthritis pain
management and provide added patient convenience, while reducing the
overall cost of therapy associated with multiple injections and offering a
treatment option that will expand the benefits of viscosupplementation to a
broader number of patients.
"The European approval of Synvisc-One is based on positive clinical
data which demonstrated that combining three doses of Synvisc in a single
treatment is safe and effective in providing pain relief for up to six
months in patients with knee osteoarthritis," stated Ann Merrifield,
president of Genzyme Biosurgery, the business unit of Genzyme Corp. that
manufactures and markets Synvisc. "Delivering the benefits of Synvisc
through one treatment rather than three will provide additional options for
physicians and their patients to reduce the cost and burden of multiple
injections."
Genzyme will also pursue marketing approvals for Synvisc-One in wider
geographies in Canada, Asia and Latin America based on the European CE mark
approval.
Synvisc is currently delivered through three intra-articular
administrations of two milliliters each given at one-week intervals.
Synvisc-One is delivered as three combined doses in just one single six
milliliter administration. Competitive injection regimens call for up to
five injections.
Safety and efficacy
Genzyme's regulatory filing for CE mark of Synvisc-One was based on
final data from a prospective, randomized, double-blind, placebo-controlled
study that involved 253 patients at 21 sites across Europe. In this study,
a statistically significant improvement in pain from osteoarthritis of the
knee was observed over 26 weeks when compared to pain relief for patients
receiving placebo treatment.
Statistically significant differences in favor of Synvisc-One were also
observed in several secondary outcome measures of efficacy, including
patient and clinician global assessments. The safety profile of Synvisc-One
was no different from that of placebo; also, there was no increased risk of
post- injection adverse reactions in the patients receiving a second
injection of Synvisc-One six months after the first injection.
Data from the study were presented earlier this year at the European
League Against Rheumatism annual meeting in Barcelona, Spain and have been
accepted for a podium presentation at the American Association of
Orthopaedic Surgeons annual meeting in March, 2008.
"Synvisc-One provides long-term pain relief for patients without the
systemic safety risks associated with traditional OA therapies such as
NSAIDs and COX2 inhibitors," stated Xavier Chevalier M.D., Head of
Rheumatology, Hopital Henri Mondor, Creteil France. "This is a unique
opportunity for physicians to treat patients with a single injection
viscosupplement that offers a very good risk-benefit profile."
About Synvisc
Synvisc is indicated for the treatment of pain due to osteoarthritis
(OA) of the knee in patients who have failed to respond adequately to
conservative nonpharmacologic therapy and simple analgesics, for example,
acetaminophen. Synvisc is currently approved in Europe and Canada to treat
pain due to osteoarthritis in the knee and hip, and also approved in Europe
for the ankle and shoulder indications, covering the major joints.
In clinical trials, the most commonly reported adverse events were
transient local pain, swelling, and/or effusion in the injected knee. In
some cases, these symptoms have been extensive. Other side effects such as
rash have been reported rarely. Synvisc is contraindicated in patients with
known hypersensitivity to hyaluronan products or patients with infections
in or around the knee. Healthcare practitioners should exercise caution
when using Synvisc in patients allergic to avian proteins, feathers, or egg
products; who have evidence of venous or lymphatic stasis in the leg to be
treated; or who have severe inflammation in the knee joint to be treated.
Patients should be advised to avoid strenuous or prolonged weight-bearing
activities after treatment. Strict adherence to aseptic technique must be
followed to avoid joint infection. The safety and effectiveness of Synvisc
in children and in pregnant or lactating women have not been established.
It is unknown whether Synvisc is excreted in human milk.
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 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
Genzyme's belief that a single-injection regimen of Synvisc will simplify
pain management, provide additional patient convenience, reduce costs and
expand the viscosupplementation market, and Genzyme's plans to pursue
marketing approvals in additional jurisdictions. These statements are
subject to risks and uncertainties that could cause actual results to
differ materially from those projected. These risks and uncertainties
include, among others, the extent to which the government and private
insurers recognize the benefits of Synvisc-One and maintain or otherwise
implement reimbursement policies that reflect these benefits, whether
doctor's recognize the benefits of Synvisc-One and adopt it as a preferred
treatment option and the risks and uncertainties described in reports filed
by Genzyme with the U.S. Securities and Exchange Commission, including
without limitation the factors discussed under the caption "Risk Factors"
in Genzyme's Quarterly Report on Form 10-Q for the quarter ended September
30, 2007. We caution investors not to place undue reliance on the
forward-looking statements contained in this press release. These
statements speak only as of the date of this press release, and we
undertake 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:
Maria Cantor Sally Curley
(617) 768-6690 (617) 768-6140
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
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CONTACT:
Media, Maria Cantor, +1-617-768-6690, or
Investors, Sally Curley, +1-617-768-6140, both of Genzyme Corp.
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