CAMBRIDGE, Mass., Nov. 30 /PRNewswire-FirstCall/ -- Genzyme Corporation announced today that preliminary results from a new study indicate that patients using Synvisc (hylan G-F 20) through a single-dose regimen achieved a statistically significant improvement in pain from osteoarthritis of the knee over 26 weeks compared with those using placebo. Currently Synvisc is delivered through three intra-articular administrations given at one-week intervals. Genzyme undertook the current trial in an attempt to improve patient care by reducing the burden of treatment and the overall cost of therapy.
The prospective double-blind placebo-controlled study involved 253 patients at 21 sites in Europe. Patients were randomized to receive one six-milliliter dose of Synvisc or one six-milliliter dose of placebo (saline). In the primary endpoint, patients were evaluated over 26 weeks according to the WOMAC A scale, a validated and commonly used measurement of osteoarthritis pain.
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 in assessments completed by patients and their physicians of the severity of osteoarthritis symptoms. Both patients and physicians completing this assessment were blinded, meaning that they were unaware of whether the patient had received Synvisc or placebo. Analysis of the full set of secondary endpoints is ongoing.
In addition to the treatment advantage seen in the Synvisc group, preliminary data showed comparable safety information between the treatment and placebo arms.
“We are very encouraged by these results, which add to the growing body of evidence in support of Synvisc and reflect our commitment to continued innovation on behalf of patients and physicians,” said Ann Merrifield, president of the Genzyme Biosurgery division. “We believe that delivering the benefits of Synvisc through one administration rather than three will provide additional options for physicians and patients that will reduce the cost and burden of multiple injections.”
Genzyme will prepare the full set of data for publication in 2007 and presentation at upcoming orthopaedics and rheumatology conferences. Based on the results, Genzyme plans in the first half of 2007 to submit this new information to regulatory agencies and request an amendment to the Synvisc product label in the United States and Europe to include this type of administration.
Supporting Data
These new data add to the growing clinical evidence that further supports Synvisc’s use in treating the pain from osteoarthritis. Recently announced results 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, at the British Orthopaedic Association congress held last month in Glasgow, and at the American College of Rheumatology (ACR) meeting this month in Washington.
In addition to its efficacy in relieving OA 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.
Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people.
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 has recently received approval 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. 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 extent to which a one-injection regime of Synvisc could impact its market position and whether and when Genzyme will present the full data set from the study. 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, whether and when the appropriate regulators approve a one-injection regimen for Synvisc, whether and when Genzyme ultimately commercializes a one-injection regimen for Synvisc, the extent to which doctors and patients would find one-injection Synvisc a preferable alternative for the treatment of osteoarthritis of the knee, the timing of compilation and submission of the full data set from the study for presentation, 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. Please see the discussion 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 September 30, 2006 for a more complete discussion of these and other risks. 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.
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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: Investor Contact: Dan Quinn Kristen Galfetti (617) 768-6849 (617) 768-6563
Genzyme Corporation
CONTACT: Media: Dan Quinn, +1-617-768-6849, or Investors: KristenGalfetti, +1-617-768-6563, both of Genzyme
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