Expanded Label to Broaden Use of Product
CAMBRIDGE, Mass., Oct. 2 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has received European approval to
expand the CE mark labeling for Synvisc(R) (hylan G-F 20) to include
treatment of pain due to osteoarthritis (OA) of the ankle and shoulder.
Approval of this new label will broaden the use of Synvisc beyond its
established use in knee and hip OA patients. Synvisc has been shown in
European clinical trials to provide up to twelve months of pain relief in
knee OA.
"We are very pleased with this approval to expand the Synvisc label in
Europe to now include the ankle and shoulder joints," stated Ann
Merrifield, president of Genzyme Biosurgery, the business unit that
manufactures and markets Synvisc. "We are eager to begin our marketing and
sales effort and will continue to emphasize the strong clinical data that
Synvisc has now generated in four major joints."
The approval of Synvisc in the ankle and shoulder follows clinical
studies that were conducted in Europe in these two joints, and the filing
of data from these trials. The studies were prospective, multi-center, open
investigations that took place in several countries throughout Europe. Both
studies found treatment with 1 or 2 injections of Synvisc to be
well-tolerated, and data show that Synvisc significantly decreases pain due
to OA in the ankle and shoulder.
Data from the ankle study have been accepted for presentation at the
American College of Rheumatology (ACR) meeting this fall in Washington,
D.C. and data from the shoulder study at the American Academy of
Orthopaedic Surgeons (AAOS) meeting in San Diego, February 2007. Both
abstracts also will be presented at the Osteoarthritis Research Society
International (OARSI) congress in Prague in December. Genzyme expects to
immediately begin marketing Synvisc in the European Union with its new
label.
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These new data on ankle and shoulder add to the vast clinical evidence
that further supports Synvisc's use in treating major joints affected by
OA.
Recently announced data from an independent investigator's clinical
study found Synvisc to be superior in magnitude and duration of pain
relief, functional improvement and patient satisfaction to another
viscosupplementation product in treating patients with OA of the knee.
These independent data were presented last June at the European League
Against Rheumatism (EULAR) meeting in Amsterdam, The Netherlands, and also
at the British Orthopaedic Association congress held this month in Glasgow.
Genzyme is utilizing evidence-based medicine in broadening Synvisc
label claims that further establish its efficacy and safety. In addition,
two meta-analyses in 2004 and 2006 also affirmed the clinical benefit of
Synvisc and its class of viscosupplements. These studies were conducted
using research methodologies that provide physicians and payers with tools
to evaluate new treatments using an evidence-based approach. In addition to
its efficacy in relieving OA knee pain, Synvisc, as a non-systemic
treatment, has the advantage of avoiding some of the side effects
associated with some non-steroidal anti-inflammatory drugs including the
COX-2 inhibitors.
Synvisc is marketed in more than 60 countries and has been used to
treat more than 3 million people. Synvisc is currently approved in the
United States for treatment of pain due to osteoarthritis of the knee.
Genzyme is pursuing a label expansion in the U.S. that would include the
hip indication.
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 osteroarthritis in both the knee and hip.
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 Corporation
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 8,500 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 the
statements regarding whether the expanded label indication for Synvisc will
broaden its use beyond its established use in the knee and hip, whether we
are ultimately able to obtain approval for the hip indication in the United
States and the timing of commencement of our efforts to market the ankle
and shoulder indications 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, our ability to effectively market the
ankle and shoulder indications in Europe, the market's acceptance of the
therapeutic benefits of Synvisc for the treatment of pain associated with
osteoarthritis of the ankle and shoulder, our ability to launch a marketing
campaign for the new shoulder and ankle indications while continuing to
market Synvisc for the treatment of pain associated with osteoarthritis of
the knee and hip, our ability to obtain marketing approval for the hip
indication from the U.S. Food and Drug Administration, 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.
Please see the discussion under the heading "Factors Affecting Future
Operating Results" 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, 2006 for a more complete
discussion of these and other risks. 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 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 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Dan Quinn Sally Curley
617-768-6849 617-768-6140
SOURCE Genzyme Corporation
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CONTACT:
Dan Quinn, +1-617-768-6849, or Sally Curley,
+1-617-768-6140, both of Genzyme
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