Results Show Superiority of Synvisc in Pain Relief and Patient Satisfaction
CAMBRIDGE, Mass., June 23 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced that data were presented from an independent
clinical study examining the effectiveness, functional outcome and patient
satisfaction following injections with Synvisc(R) (hylan G-F 20) and
Hyalgan(R) (sodium hyaluronate) in patients with osteoarthritis (OA) of the
knee. The investigator-initiated study was conducted in a leading
university teaching hospital in the United Kingdom and finds that Synvisc
is superior to Hyalgan in magnitude and duration of pain relief, functional
improvement and patient satisfaction. These data were presented this
afternoon at the annual congress of the European League Against Rheumatism
(EULAR) meeting in Amsterdam, The Netherlands.
Study Results
In this controlled, prospective study, 348 patients with osteoarthritis
of the knee were randomized to receive intra-articular injections of either
Synvisc or Hyalgan. All patients were given the recommended doses (3 weekly
injections of Synvisc or 5 weekly injections of Hyalgan) which were
administered by the same physician. All patients were reviewed by
independent assessors who were blinded for the treatment at pre-injection,
six weeks, three and six months, and yearly thereafter.
As reported at the conference, both treatment groups experienced pain
reduction. However, patients receiving Synvisc experienced a greater
magnitude of pain relief which occurred earlier and lasted longer.
Similarly, the functional outcome and physical activity scores were
significantly better in the Synvisc group throughout the study.
"Our study demonstrated that the pain relief obtained in patients
treated with Synvisc was superior to that of Hyalgan," stated Raghu Raman,
M.D., orthopaedic surgeon at the Hull Royal Infirmary in Hull, United
Kingdom, and the principal investigator of the study. "Patients treated
with Synvisc also demonstrated an early increase in activity levels and,
from these data, it appears both the clinical effectiveness and general
patient satisfaction are better among patients who received Synvisc."
Richard Polisson, M.D., senior vice president of clinical research at
Genzyme, stated that these findings are significant not only because of the
noted differences in outcomes between the two products, but also because of
the well designed nature of the study and the completely independent status
of the investigator.
"We are very pleased that this clinical study clearly shows that
Synvisc is highly effective in treating the symptoms of osteoarthritis of
the knee," said Polisson. "These data now provide an answer to the
questions that the clinical community has asked about products in this
class and confirms what we have always believed -- that Synvisc delivers a
greater magnitude and duration of pain relief and greater improvement in
function than Hyalgan, and should be viewed differently from other
viscosupplements."
Additional Study Findings
Both treatments were well tolerated, however, a local inflammatory
reaction was observed in one patient treated with Synvisc. Data from the
study also show that there was a local increase in knee pain in one patient
who received Synvisc, which settled by four weeks.
A Market Leader Powered by Clinical Benefit
Synvisc is marketed in more than 60 countries and has been used to
treat more than 3 million people. Because market penetration is still in
the early stages, there is much room for future growth. In 2004 and 2005,
two meta-analyses affirmed the clinical benefit of Synvisc and its class of
viscosupplements. The 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
pain, Synvisc, as a non-systemic treatment, has the advantage of avoiding
the side effects associated with some non-steroidal anti-inflammatory drugs
including the COX-2 inhibitors.
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 8,000 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.
Genzyme(R) and Synvisc(R) are registered trademarks of Genzyme
Corporation. Hyalgan(R) is a registered trademark of Sanofi Aventis. 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:
Maria Cantor Kristen Galfetti
(617) 768-6690 (617) 768-6563
SOURCE Genzyme Corp.
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http://www.genzyme.com/
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media Contact: Maria Cantor, +1-617-768-6690,
or Investor Contact: Kristen Galfetti, +1-617-768-6563, both of
Genzyme
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