CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today 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.
Important Safety Information
Synvisc is contraindicated in patients with known hypersensitivity to hyaluronan products and in patients with infections in or around the target knee. Do not inject Synvisc extra-articularly, into the synovial tissues, into the fat pad or joint capsule, or intravascularly. The safety and efficacy of Synvisc in locations other than the knee, or for conditions other than osteoarthritis, or in combination with other intraarticular injectables have not been established. Use caution when using Synvisc in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphatic or venous stasis in the leg to be injected; or who have severe inflammation in the knee to be treated. Strict adherence to aseptic technique must be followed. Remove any synovial fluid or effusion before each Synvisc injection. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. 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.
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. The most commonly reported systemic side effects were rash, fever, nausea, and headache.
Viscosupplementation is a treatment for patients with osteoarthritis (OA) in which hyaluronic acid is injected into the knee joint to replace degraded joint fluid. Normal joint fluid can act as a lubricant and a shock absorber. Viscosupplementation is an accepted therapy for OA pain that is both comparable to oral therapies, yet avoids toxicity and the associated risks of systemic therapy. This procedure is performed on an out-patient basis and requires little recovery time.
About Teijin Pharma Limited
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. Teijin Pharma has strong marketing positions, particularly in the respiratory and bone/joint areas, with pharmaceutical products as well as a home healthcare business, including home oxygen therapy. Teijin Pharma continues to enhance its presence worldwide through in-house R&D as well as in-licensing and out-licensing activities. For more information, visit www.teijin-pharma.co.jp/english/index.html
About the Teijin Group
Based in Tokyo and Osaka, Japan, Teijin is a global technology-driven group operating in six main fields: high-performance fibers (aramid fibers and carbon fibers); polyester fibers; films and plastics; pharmaceuticals and home health care; trading and retail; and IT and new products. Teijin Limited, the holding company for the Teijin Group, is listed on the Tokyo and Osaka stock exchanges. The group had consolidated sales of USD 8.5 billion (JPY 765.8 billion, USD 1=JPY 90) in fiscal 2009 and employs 18,778 people worldwide, with 156 companies around the world. Please visit www.teijin.co.jp/english
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 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in approximately 100 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 disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
This press release contains forward-looking statements, including Genzyme’s plans to launch Synvisc in Japan by year end and its expectation that the product will gain market share. 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 patients and doctors recognize the benefits of Synvisc 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 June 30, 2010. 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.
Lori Gorski, 617-768-9344
Jennifer Murphy, 617-768-6301