Genzyme Corporation announced that Japan's Ministry of Health, Labour and Welfare has approved Synvisc (hylan G-F 20; 3 x 2 mL), indicated for the treatment of osteoarthritis of the knee. Reimbursement has been obtained and publicized by Japan's Central Social Insurance Medical Council.

According to a recent Japanese epidemiological study (ROAD), nearly 30 million people in Japan have osteoarthritis (OA) of the knee. The existing viscosupplements on the market in Japan require a greater number of injections than Synvisc, and may offer a much shorter duration of pain relief. Synvisc, the first non-Japanese viscosupplement to be approved in the country, will be the only product to offer six months of OA knee pain relief with three injections. Genzyme plans to launch Synvisc in Japan by the end of this year.

Genzyme has entered into an agreement with Teijin Pharma Limited to commercialize Synvisc in Japan. Under the terms of the agreement, Teijin Pharma has exclusive commercialization rights for Synvisc in Japan, and will pay certain milestone payments and a predetermined supply price for the product. Teijin Pharma, a division of the multinational Teijin Group, has extensive commercial experience in the orthopaedic market in Japan through its active promotion of products for bone and joint health.

"Launching Synvisc in Japan supports the growth of the franchise globally," said Alison Lawton, senior vice president and general manager of Genzyme Biosurgery, the business unit of Genzyme that manufactures and markets Synvisc. "Teijin Pharma's expertise in the Japanese orthopaedic arena gives us confidence that they will successfully launch Synvisc and gain market share."

"The viscosupplement market in Japan is valued at more than $500 million and there is increasing demand for new treatment options," said Osamu Nishikawa, president of Teijin Pharma Limited. "Doctors and patients will be pleased to have a new product available that provides OA knee pain relief with just three injections rather than multiple injection products which are currently on the market. We look forward to utilizing our extensive marketing and sales experience in the orthopaedics space to offer physicians and patients this therapeutic option."

Synvisc (hylan G-F 20) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

Teijin Pharma Limited, the core company of Teijin Group's medical and pharmaceuticals business, focuses on three key therapeutic areas: respiratory, bone/joint, and cardiovascular/metabolic diseases.

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