CAMBRIDGE, Mass., June 20 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has filed with the U.S. Food and
Drug Administration (FDA) for approval of Synvisc-One(TM), the single
treatment of Synvisc(R) (hylan G-F 20) that provides up to six months of
pain relief from osteoarthritis (OA) of the knee. If approved, Synvisc-One
would be the only viscosupplementation product available worldwide proven
to provide this duration of pain relief from a single injection. Genzyme
believes this product line extension of Synvisc can simplify OA knee pain
management and reduce the overall cost of therapy. The company expects the
FDA to take action on this submission by the end of the year.
"The submission for approval of Synvisc-One is based on positive 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. "We strongly believe that 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."
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 one single six
milliliter administration.
Genzyme's product marketing authorization (PMA) for Synvisc-One is
based on final data from a prospective, randomized, double-blind,
placebo-controlled study that involved 253 patients at 21 sites across
Europe. Data from the study were presented last week at the European League
Against Rheumatism annual meeting in Barcelona, Spain. Submission of these
data to obtain a CE mark for Synvisc-One in Europe is expected to occur
next month.
"Synvisc-One has been shown to be effective in providing long-term pain
relief with the convenience of a single treatment without the systemic
safety risks associated with traditional OA therapies such as NSAIDs and
COX2 inhibitors." stated Xavier Chevalier, M.D., professor of rheumatology,
Hopital Henri Mondor, Creteil, France. "The data show that Synvisc-One
demonstrated a sustained response rate up to six months and an excellent
safety profile in first and repeat courses. This is a unique opportunity
for physicians to treat patients with a single injection viscosupplement
which offers a very good risk-benefit profile."
The only other single treatment viscosupplement available in Europe
offers only six weeks of pain relief.
Synvisc-One Study Findings
Patients in the study were randomized to receive one six-milliliter
treatment of Synvisc or one six-milliliter injection of placebo (saline).
In the primary endpoint, patients were evaluated over six months according
to the WOMAC A scale, a validated and commonly used measurement of
osteoarthritis pain. These data resulted in statistically significant
improvement in pain from osteoarthritis of the knee over 26 weeks when
compared to pain relief for patients receiving placebo treatment. Data from
the study also show that Synvisc-One demonstrated a 36 percent reduction in
pain over 26 weeks as compared to baseline.
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-One in assessments
completed by patients and their physicians of the severity of knee
osteoarthritis symptoms. Both patients and physicians completing these
assessments were blinded, meaning that they were unaware of whether the
patient had received Synvisc-One or placebo.
In addition to the treatment advantage seen in the Synvisc-One group,
data showed comparable safety information between the treatment and placebo
arms. Eight patients (6.5%) in the Synvisc-One group and six patients
(4.6%) in the placebo group experienced procedure or study treatment
related AEs following initial treatment. Four patients (3.3%) in the
Synvisc-One group and two patients (1.5%) in the placebo group experienced
mild to moderate adverse events determined to be related to the study
treatment in the first course, and one patient (1.3%) experienced target
knee adverse events determined to be related to the study treatment in the
repeat course.
Supporting Data
Synvisc continues to be the market-leading viscosupplementation product
in the U.S. It is marketed in more than 60 countries and has been used to
treat more than 3 million people worldwide.
These new Synvisc-One data add to the growing clinical evidence that
further supports the use of Synvisc in treating OA knee pain. Results
announced last year 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 at several meetings throughout Europe and the U.S., and are
expected to be submitted for publication.
In addition to its efficacy in relieving osteoarthritis 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, and may be beneficial in wider patient
care.
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.
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 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
statements about: whether and when Synvisc-One obtains marketing approval
in the US, whether a single-injection regimen of Synvisc will reduce costs
and burden, and provide additional options for physicians, 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: extent to which the US
Food and Drug Administration determines that Synvisc-One can appropriately
be approved for marketing in the US, 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, 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 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 fiscal quarter ended March
31, 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 1-703-797-1866 outside the
United States.
Media Contact:
Maria Cantor
(617) 768-6690
Investor Contact:
Carol Miceli
(617) 768-6602
SOURCE Genzyme Corp.
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CONTACT:
Media, Maria Cantor, +1-617-768-6690, or
Investors, Carol Miceli, +1-617-768-6602, both of Genzyme Corp.
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