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Positive Synvisc Data Published by Cochrane Collaboration

Date: 9th December 2008, Source: Hyaluronic News

Results Reaffirm Efficacy of Viscosupplementation and Synvisc


CAMBRIDGE, Mass., May 5 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ - News) announced today that a lengthy review examining the clinical benefits of Synvisc® (hylan G-F 20) and the class of viscosupplements to which it belongs has been published by the Cochrane Collaboration, an independent, international organization that disseminates systematic reviews of healthcare interventions and clinical trials data. Synvisc is the leading viscosupplementation product for the treatment of pain due to osteoarthritis of the knee in the U.S. and Canada, and one of the top products in this category in Europe. Since it is delivered locally, Synvisc avoids many of the associated side-effects of traditional non-steroidal anti-inflammatory drugs and COX-2 agents.
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Using rigorous, objective methodology, the Cochrane Collaboration review concluded that the class of viscosupplements is superior to placebo and that several of the products have greater efficacy than steroid injections in treating pain associated with osteoarthritis of the knee. Viscosupplements are injectable products delivered locally that are comprised of hyaluronan (HA) and hyaluronan derivatives. The review also showed that considerable, positive differences were reported for Synvisc versus placebo in a number of clinical trials, including statistically significant and clinically meaningful robust improvements in pain, stiffness, and physical functioning for patients with osteoarthritis of the knee. Moreover, the review found that the overall treatment effect of each key Synvisc clinical trial studied was more robust than for the class of viscosupplementation products as a whole.

Richard Polisson, M.D., senior vice president of clinical research at Genzyme, states that the study findings are significant because the Cochrane review is the pre-eminent clinical research meta-analysis tool, a mainstay of the new evidence-based medicine approach to assessing new drugs and technologies. This type of analysis is essential for clinicians and managed care plans as they continue to utilize new treatments.

"The Cochrane uses high-quality statistical techniques and unbiased analysis, and we are thrilled that this independent review shows that Synvisc is highly effective in treating the symptoms of osteoarthritis of the knee," said Polisson. "The analysis also showed that the treatment effect sizes for the Synvisc trials were somewhat larger than that for the entire class of viscosupplements in treating this disease. Clearly, these data show that Synvisc provides physicians with another treatment option, other than the traditional non-steroidal anti-inflammatory drugs including the COX-2 inhibitors, that offers significant pain relief for patients with osteoarthritis of the knee."

Study Findings

The review describes a meta-analysis of numerous clinical trials to determine the weighted mean difference between viscosupplementation and placebo. These studies were conducted in the United States, Europe and Canada. All patients enrolled had a radiologically confirmed diagnosis of osteoarthritis of the knee.

Eighteen randomized controlled clinical trials of Synvisc were included in the analyses. These trials enrolled several hundred patients. The Cochrane study found that Synvisc-treated patients achieved outcomes superior to placebo for multiple variables at several time periods, including weight- bearing pain, pain at night, function as measured by improvement in most painful knee movement, and patient overall evaluation of efficacy due to treatment.

In an analysis of all randomized controlled trials of Synvisc compared to placebo, the weighted mean difference (WMD) from control in weight-bearing pain from 13-26 weeks after treatment was statistically significant vs. placebo at p=0.006. Measurement of effect on function via improvement in the most painful knee movement from 5-13 weeks post-therapy was also statistically significant vs. placebo at p<0.00001, as well as the weighted mean difference in the patient's global evaluation of treatment efficacy at p<0.00001. These differences were clinically meaningful in addition to being highly statistically significant.

"The Cochrane review has shown that hyaluronic acid has a significant effect on controlling knee arthritis symptoms when compared to placebo, and that Synvisc and other HA products have a clinically proven, solid position as a treatment option for pain associated with knee osteoarthritis," said Vijay Vad, MD., assistant professor in rehabilitation at the Hospital for Special Surgery in New York City and a physician with the PGA Tour. "Synvisc is an appealing treatment option for moderate knee arthritis sufferers when combined with a proper exercise program."

Synvisc is approved in more than 60 countries worldwide for the treatment of pain associated with osteoarthritis of the knee, and is also approved in the European Union and Canada to treat pain from osteoarthritis of the hip. Synvisc has become the top-selling viscosupplement in the United States and Canada because of the benefits that it provides patients who experience pain due to osteoarthritis of the knee. Additionally, Synvisc is the only viscosupplement on the U.S. market that can provide up to six months of osteoarthritis knee pain relief with just three injections per treatment regimen. For these reasons, Synvisc has been used to treat more than three million patients worldwide.

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.

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. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with annual revenues exceeding $2 billion and more than 7,000 employees in locations spanning the globe. 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, orthopedics, 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. 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, the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission. Please see the disclosure under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of Genzyme's Annual Report on Form 10-K for the year ended December 31, 2004 for a more complete discussion of these and other risks. We caution investors not to place undue reliance on the forward-looking statements contained in this document. These statements speak only as of the date of this document and we undertake no obligation to update or revise the statements.