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| |  Genzyme Receives European Approval for Hylan G-F 20 in Ankle and Shoulder Osteoarthritis Indications Expanded Label to Broaden Use of Product CAMBRIDGE, MA -- October 2, 2006 -- Genzyme Corp. announced today that it has received European approval to expand the CE mark labeling for Synvisc(R) (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Approval of this new label will broaden the use of Synvisc beyond its established use in knee and hip OA patients. Synvisc has been shown in European clinical trials to provide up to twelve months of pain relief in knee OA. "We are very pleased with this approval to expand the Synvisc label in Europe to now include the ankle and shoulder joints," stated Ann Merrifield, president of Genzyme Biosurgery, the business unit that manufactures and markets Synvisc. "We are eager to begin our marketing and sales effort and will continue to emphasize the strong clinical data that Synvisc has now generated in four major joints." The approval of Synvisc in the ankle and shoulder follows clinical studies that were conducted in Europe in these two joints, and the filing of data from these trials. The studies were prospective, multi-center, open investigations that took place in several countries throughout Europe. Both studies found treatment with 1 or 2 injections of Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder. Data from the ankle study have been accepted for presentation at the American College of Rheumatology (ACR) meeting this fall in Washington, D.C. and data from the shoulder study at the American Academy of Orthopaedic Surgeons (AAOS) meeting in San Diego, February 2007. Both abstracts also will be presented at the Osteoarthritis Research Society International (OARSI) congress in Prague in December. Genzyme expects to immediately begin marketing Synvisc in the European Union with its new label. 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, and also at the British Orthopaedic Association congress held this month in Glasgow. 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 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. 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 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. Genzyme(R) and Synvisc(R) are registered trademarks of Genzyme Corporation. All rights reserved.
SOURCE: Genzyme Corporation
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