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| |  Genzyme Biosurgery Gains European Approval for Synvisc in the Hip EU Approves Claim of 12-Month Effectiveness in the Knee CAMBRIDGE, MA -- July 2, 2002 -- Genzyme Biosurgery, a division of Genzyme Corp., announced today that it has gained approval in the European Union to market Synvisc® (Hylan G-F 20) for the treatment of osteoarthritis pain in the hip. Synvisc has been approved for use in the knee since 1995 in Europe and 1997 in the United States. In addition, European regulatory officials have approved changing the product's label to indicate that Synvisc can provide up to one full year of relief from the pain and immobility associated with osteoarthritis (OA) in the knee, making it the longest-acting product of its kind in Europe. The expanded efficacy claim was approved in light of strong clinical evidence supportive of Synvisc's effectiveness beyond its previous six-month indication. "The European approvals announced today are important accomplishments as we fully develop the Synvisc franchise," said Ann Merrifield, executive vice president of Genzyme Biosurgery in charge of orthopaedics. "The 15 countries of the European Union accounted for one-quarter of our total Synvisc sales last year, and they make up one of our fastest-growing markets. By expanding Synvisc's uses in Europe and promoting its longer-lasting benefits we can continue this strong growth well into the future." Synvisc is currently approved in more than 60 countries to treat OA knee pain, and has been used to treat more than 2.5 million patients worldwide. It is Genzyme Biosurgery's largest product, with worldwide sales of more than $250 million in 2001. Genzyme Biosurgery sells Synvisc in Europe through a network of country- specific marketing partnerships, and through its own extensive sales and marketing organization. It expects to begin selling Synvisc for the treatment of hip OA in Europe during the second half of this year. It is estimated that there are approximately four million patients with symptomatic OA of the hip in Europe. Genzyme Biosurgery also intends to pursue approval for the use of Synvisc to treat OA in the hip in the United States. It is currently in discussions with the U.S. Food and Drug Administration regarding the design of a pivotal clinical trial of this use. Synvisc is currently approved in the U.S. for treating pain from OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapies and simple analgesics, such as acetaminophen. Synvisc is the largest selling viscosupplementation product on the market for the treatment of OA of the knee. Viscosupplementation is endorsed by the American College of Rheumatology as a standard of care in the treatment of OA of the knee. Synvisc supplements the shock-absorbing and lubricating properties of synovial fluid. For treatment of osteoarthritis of the knee, the product is administered in three injections over a 15-day period and can provide up to six months of OA pain relief, according to the label approved in the United States. In medical studies, the most pain relief and the greatest amount of treatment success occurred 8-12 weeks after Synvisc treatment began. Synvisc is generally well tolerated; however, it may not work for everyone. The most commonly reported side effects are temporary pain, swelling, and/or fluid accumulation in the injected knee (about 2 percent of injections). If fluid accumulation becomes large or painful, patients should consult their doctor. Other side effects, such as rash, have been reported rarely. Before beginning treatment with Synvisc, patients should advise their doctor if they are allergic to products from birds, such as feathers, eggs and poultry, or if their leg is swollen or infected. The results of repeat use have not been established. Genzyme Biosurgery is a leader in the emerging market for implantable therapeutics. Its products and pipeline are concentrated in the rapidly growing markets of orthopaedics and heart disease and in broader surgical applications. Genzyme Biosurgery is a division of Genzyme Corporation. This press release contains forward-looking statements, including the statements regarding the achievement of development objectives for Synvisc, the size, growth and rate of growth of Synvisc in the European market, the commencement date for the sale of Synvisc for the treatment of pain associated with OA in the hip in Europe, and the pursuit of regulatory approval for Synvisc as a treatment of pain associated with OA in the hip in the United States. 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 medical, clinical, regulatory and financial feasibility of Genzyme Biosurgery continuing to expand the Synvisc franchise to other treatment indications; the commercial acceptance of Synvisc in the European marketplace; the commercialization of competitive viscosupplementation products and other methods and products for the treatment of pain related to OA in the knee and hip, and the availability of financial and other resources to maintain the growth of Synvisc in Europe; the ability of Genzyme Biosurgery and its partners to complete all of the regulatory, operational, logistical and marketing requirements necessary to launch the sale of Synvisc for the hip in Europe; the ability for Genzyme Biosurgery to reach agreement with the FDA on the design of a clinical trial for Synvisc for the hip, to complete a clinical trial for this indication, and thereafter to receive FDA approval for such indication based on the outcomes of such trial; and factors contained under the caption "Factors Affecting Future Operating Results" in Exhibit 99.2 to Genzyme Corporation's 2001 Annual Report on Form 10-K. Genzyme Biosurgery is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme Biosurgery common stock are subject to all of the risks and uncertainties described in those reports. 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.
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