Genzyme Corp.
(Nasdaq: GENZ) announced today that it has filed with the European
authority to expand the CE mark for Synvisc(R) (hylan G-F 20) to include
treatment of pain due to osteoarthritis (OA) of the ankle and shoulder.
Approval of a new label will provide opportunity to broaden the use of
Synvisc beyond its current European-approved use in the knee and hip to the
two additional joints.
"Our filing in Europe for approval of Synvisc in the ankle and shoulder
reaffirms our commitment to the field of osteoarthritis and to pursuing new
medical indications to help patients manage pain from OA," stated Ann
Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme
Corp. that manufactures and markets Synvisc. "With approval in the ankle
and shoulder, Synvisc will be one of the few viscosupplements available in
Europe for treating OA pain in four major joints that is supported by
strong clinical data."
Genzyme's filing for label expansion of Synvisc contains data from two
clinical trials in the ankle and shoulder. The studies were prospective,
multi-center, open investigations that took place in several countries
throughout Europe. Both studies found treatment with Synvisc to be
well-tolerated, and data show that Synvisc significantly decreases pain due
to OA in the ankle and shoulder and that the decreased pain effect is
maintained for up to six months. Data from the ankle study have been
accepted for presentation at the American College of Rheumatology meeting
this fall in Washington, D.C.
Genzyme expects the European regulatory review of the Synvisc label
expansion to be complete by the end of the year.
A Market Leader Powered by Clinical Benefit
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.
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 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 the European regulatory review of the Synvisc label
expansion. 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, that the European regulatory review will not be completed by
the end of the year 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, including without limitation
the information 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. 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 Corp.
genzyme/
View drug information on Synvisc, Synvisc-One.
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