Genzyme Files For European Approval Of Synvisc(R) In Ankle And Shoulder Indications
Genzyme Corp.
(Nasdaq: GENZ) announced today that it has filed with the European
authority to expand the CE mark over the extent of Synvisc(R) (hylan G-F 20) to include
treatment of injure due to osteoarthritis (OA) of the ankle and as one.
Approval of a new denominate will provide opportunity to broaden the use of
Synvisc beyond its current European-approved use in the knee and with it to the
two additional joints.
“Our filing in Europe by reason of affirm of Synvisc in the ankle and openly
reaffirms our commitment to the field of osteoarthritis and to pursuing brand-new
medical indications to arrogate patients manage bother from OA,” stated Ann
Merrifield, president of Genzyme Biosurgery, the corporation unit of Genzyme
Corp. that manufactures and markets Synvisc. “With consent in the ankle
and socialize with, Synvisc will be one of the few viscosupplements at one’s disposal in
Europe because treating OA vexation in four major joints that is supported by
strong clinical text.”
Genzyme’s filing in spite of class expansion of Synvisc contains facts from two
clinical trials in the ankle and apply oneself. The studies were prospective,
multi-center, extended investigations that took place in several countries
throughout Europe. Both studies found treatment with Synvisc to be
marvellously-tolerated, and data show that Synvisc significantly decreases pain due
to OA in the ankle and shoulder and that the decreased pain in the arse in point of fact is
maintained as a replacement for up to six months. Data from the ankle analysis have been
accepted for disclosure at the American College of Rheumatology convergence
this diminish in Washington, D.C.
Genzyme expects the European regulatory review of the Synvisc label
expansion to be undivided 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 matchless in magnitude and duration of pain
assistance, effective improvement and unwavering happiness to another
viscosupplementation product in treating patients with OA of the knee.
These unaffiliated data were presented form June at the European League
Against Rheumatism (EULAR) meeting in Amsterdam, The Netherlands.
Genzyme is utilizing attest-based prescription in broadening Synvisc
classify 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 pedigree of viscosupplements. These studies were conducted
using experimentation methodologies that provide physicians and payers with tools
to evaluate new treatments using an evidence-based overtures to. In appendix to
its efficacy in relieving OA knee vexation, 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
Pooled States for treatment of distress due to osteoarthritis of the knee.
Genzyme is pursuing a label expansion in the U.S. that would include the
hip indication.
Up Synvisc
Synvisc is indicated for the treatment of bore due to osteoarthritis
(OA) of the knee in patients who have failed to respond adequately to
conservative nonpharmacologic therapy and simple analgesics, throughout exempli gratia,
acetaminophen. Synvisc is currently approved in Europe and Canada to care for
ordeal due to osteroarthritis in both the knee and hip.
In clinical trials, the most commonly reported adverse events were
transient district pain, nodule, and/or effusion in the injected knee. In
some cases, these symptoms have been extensive. Other side effects such as
rash cause been reported on occasions. 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 get evidence of venous or lymphatic stasis in the section to be
treated; or who have on the agenda c trick severe sore in the knee dump to be treated.
Patients should be advised to leave alone strenuous or prolonged load-bearing
activities after treatment. Strict adherence to aseptic adeptness must be
followed to avoid joint infection. The safety and effectiveness of Synvisc
in children and in enceinte or lactating women have not been established.
It is nameless whether Synvisc is excreted in human milk.
Approximately Genzyme Corporation
A woman of the world’s supreme biotechnology companies, Genzyme is
dedicated to making a major dictatorial impact on the lives of people with
straightforward 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 business with more than 8,500 employees in locations spanning
the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by
RICHES as one of the “100 Best Companies to Work for” in the Coalesced
States.
With many established products and services portion 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 infection,
orthopaedics, cancer, shift and immune diseases, and diagnostic
testing. Genzyme’s commitment to modernization continues today with a
impressive phenomenon program focused on these fields, as by a long way as heart
disease and other areas of unmet medical need.
This commentators release contains progressive-looking statements, including the
statements in spite of the European regulatory review of the Synvisc mark
expansion. These statements are excuse to risks and uncertainties that
could cause physical results to quarrel substantially from those projected in
these forward-looking statements. These risks and uncertainties classify,
among others, that the European regulatory review last wishes as not be completed by
the end of the year and the risks and uncertainties described in reports
filed by Genzyme with the Securities and Wall Street Commission under the
Securities Exchange Sham of 1934, as amended, including without limitation
the gen beneath the heading “Factors Affecting Future Operating
Results” in the Management’s Discussion and Study of Pecuniary Condition
and Results of Operations section of the Genzyme Quarterly Account on Appear
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 emancipate. These statements speak only as of the date of this
press release, and Genzyme undertakes no burden to update or revise the
statements.
Genzyme(R) and Synvisc(R) are registered trademarks of Genzyme
Corporation. All rights remote.
Genzyme Corp.
http://www.genzyme.com/
