Finding Has Potential to Reduce Burden and Cost of Treatment
CAMBRIDGE, Mass., Nov. 30 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today that preliminary results from a new study
indicate that patients using Synvisc (hylan G-F 20) through a single-dose
regimen achieved a statistically significant improvement in pain from
osteoarthritis of the knee over 26 weeks compared with those using placebo.
Currently Synvisc is delivered through three intra-articular
administrations given at one-week intervals. Genzyme undertook the current
trial in an attempt to improve patient care by reducing the burden of
treatment and the overall cost of therapy.
The prospective double-blind placebo-controlled study involved 253
patients at 21 sites in Europe. Patients were randomized to receive one
six-milliliter dose of Synvisc or one six-milliliter dose of placebo
(saline). In the primary endpoint, patients were evaluated over 26 weeks
according to the WOMAC A scale, a validated and commonly used measurement
of osteoarthritis pain.
The statistically significant findings of the primary endpoint were
supported by a number of secondary outcomes, most notably a statistically
significant treatment effect in favor of Synvisc in assessments completed
by patients and their physicians of the severity of osteoarthritis
symptoms. Both patients and physicians completing this assessment were
blinded, meaning that they were unaware of whether the patient had received
Synvisc or placebo. Analysis of the full set of secondary endpoints is
ongoing.
In addition to the treatment advantage seen in the Synvisc group,
preliminary data showed comparable safety information between the treatment
and placebo arms.
"We are very encouraged by these results, which add to the growing body
of evidence in support of Synvisc and reflect our commitment to continued
innovation on behalf of patients and physicians," said Ann Merrifield,
president of the Genzyme Biosurgery division. "We believe that delivering
the benefits of Synvisc through one administration rather than three will
provide additional options for physicians and patients that will reduce the
cost and burden of multiple injections."
Genzyme will prepare the full set of data for publication in 2007 and
presentation at upcoming orthopaedics and rheumatology conferences. Based
on the results, Genzyme plans in the first half of 2007 to submit this new
information to regulatory agencies and request an amendment to the Synvisc
product label in the United States and Europe to include this type of
administration.
Supporting Data
These new data add to the growing clinical evidence that further
supports Synvisc's use in treating the pain from osteoarthritis. Recently
announced results 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, at the British Orthopaedic
Association congress held last month in Glasgow, and at the American
College of Rheumatology (ACR) meeting this month in Washington.
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.
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 has recently received
approval in Europe for the ankle and shoulder indications.
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. 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 the extent to which a one-injection regime of Synvisc
could impact its market position and whether and when Genzyme will present
the full data set from the study. 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, whether and when the appropriate
regulators approve a one-injection regimen for Synvisc, whether and when
Genzyme ultimately commercializes a one-injection regimen for Synvisc, the
extent to which doctors and patients would find one-injection Synvisc a
preferable alternative for the treatment of osteoarthritis of the knee, the
timing of compilation and submission of the full data set from the study
for presentation, 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 September 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 Kristen Galfetti
(617) 768-6849 (617) 768-6563
SOURCE Genzyme Corporation
 back to top
Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/104284.htm /
CONTACT:
Media: Dan Quinn, +1-617-768-6849, or
Investors: Kristen Galfetti, +1-617-768-6563, both of Genzyme
|
