Healthcare Industry News: kidney disease
News Release - December 19, 2007
Genzyme Receives European CE Mark for Single-Treatment Synvisc-One(TM)Only Product of its Kind in Europe to Offer up to Six Months of Pain Relief in OA Knee Pain
CAMBRIDGE, Mass., Dec. 19 (HSMN NewsFeed) -- Genzyme Corp. (Nasdaq: GENZ ) announced today that it has been granted European approval through a CE mark for Synvisc-One(TM), the single treatment of Synvisc® (hylan G-F 20) that has been shown in the European Union to provide up to six months of proven pain relief from osteoarthritis (OA) of the knee. Synvisc-One is now the only viscosupplementation product available in Europe that is labeled to provide this long-term duration of pain relief from a single injection.
Genzyme believes that Synvisc-One will simplify osteoarthritis pain management and provide added patient convenience, while reducing the overall cost of therapy associated with multiple injections and offering a treatment option that will expand the benefits of viscosupplementation to a broader number of patients.
"The European approval of Synvisc-One is based on positive clinical 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. "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."
Genzyme will also pursue marketing approvals for Synvisc-One in wider geographies in Canada, Asia and Latin America based on the European CE mark approval.
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 just one single six milliliter administration. Competitive injection regimens call for up to five injections.
Safety and efficacy
Genzyme's regulatory filing for CE mark of Synvisc-One was based on final data from a prospective, randomized, double-blind, placebo-controlled study that involved 253 patients at 21 sites across Europe. In this study, a statistically significant improvement in pain from osteoarthritis of the knee was observed over 26 weeks when compared to pain relief for patients receiving placebo treatment.
Statistically significant differences in favor of Synvisc-One were also observed in several secondary outcome measures of efficacy, including patient and clinician global assessments. The safety profile of Synvisc-One was no different from that of placebo; also, there was no increased risk of post- injection adverse reactions in the patients receiving a second injection of Synvisc-One six months after the first injection.
Data from the study were presented earlier this year at the European League Against Rheumatism annual meeting in Barcelona, Spain and have been accepted for a podium presentation at the American Association of Orthopaedic Surgeons annual meeting in March, 2008.
"Synvisc-One provides long-term pain relief for patients without the systemic safety risks associated with traditional OA therapies such as NSAIDs and COX2 inhibitors," stated Xavier Chevalier M.D., Head of Rheumatology, Hopital Henri Mondor, Creteil France. "This is a unique opportunity for physicians to treat patients with a single injection viscosupplement that offers a very good risk-benefit profile."
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, covering the major joints.
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.
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 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was 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 Genzyme's belief that a single-injection regimen of Synvisc will simplify pain management, provide additional patient convenience, reduce costs and expand the viscosupplementation market, and Genzyme's plans to pursue marketing approvals in additional jurisdictions. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, 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, whether doctor's recognize the benefits of Synvisc-One and adopt it as a preferred treatment option 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 quarter ended September 30, 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® and Synvisc® are registered trademarks and Synvisc-One(TM) is a trademark of Genzyme Corporation. All rights reserved.
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