GENZYME FILES FOR EUROPEAN APPROVAL OF SYNVISC.Genzyme Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :GENZ), Cambridge, Mass., has filed with the European authority to expand the CE mark for Synvisc(R) (hylan G-F 20) to include treatment of pain due to osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. (OA) of the ankle and shoulder. Approval of a new label will provide opportunity to broaden the use of Synvisc beyond its current European-approved use in the knee and hip to the two additional joints. "Our filing in Europe for approval of Synvisc in the ankle and shoulder reaffirms our commitment to the field of osteoarthritis and to pursuing new medical indications to help patients manage pain from OA," stated Ann Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme Corp. that manufactures and markets Synvisc. "With approval in the ankle and shoulder, Synvisc will be one of the few viscosupplements available in Europe for treating OA pain in four major joints that is supported by strong clinical data." Genzyme's filing for label expansion of Synvisc contains data from two clinical trials in the ankle and shoulder. The studies were prospective, multi-center, open investigations that took place in several countries throughout Europe. Both studies found treatment with Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder and that the decreased pain effect is maintained for up to six months. Data from the ankle study have been accepted for presentation at the American College of Rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. meeting this fall in Washington, D.C. Genzyme expects the European regulatory review of the Synvisc label expansion to be complete by the end of the year. 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 rheumatism (r `mətĭzəm), general term for a number of disorders that cause inflammation and pain in muscles, bones, joints, or nerves. (EULAR) meeting in Amsterdam, The Netherlands. Genzyme is utilizing evidence-based medicine evidence-based medicine Decision-making 'The use of scientific data to confirm that proposed diagnostic or therapeutic procedures are appropriate in light of their high probability of producing the best and most favorable outcome'. See Meta-analysis. 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 the side effects Side effects Effects of a proposed project on other parts of the firm. associated with some non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis 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 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 Analgesics Definition Analgesics are medicines that relieve pain. Purpose Analgesics are those drugs that mainly provide pain relief. , for example, acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. . Synvisc is currently approved in Europe and Canada to treat pain due to osteroarthritis in both the knee and hip. In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion effusion /ef·fu·sion/ (e-fu´zhun) 1. escape of a fluid into a part; exudation or transudation. 2. effused material; an exudate or transudate. 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. 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 lymphatic /lym·phat·ic/ (lim-fat´ik) 1. pertaining to lymph or to a lymphatic vessel. 2. a lymphatic vessel. lym·phat·ic adj. 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 aseptic /asep·tic/ (-tik) free from infection or septic material. a·sep·tic adj. Of, relating to, or characterized by asepsis. technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc in children and in pregnant or lactating lac·tate 1 intr.v. lac·tat·ed, lac·tat·ing, lac·tates To secrete or produce milk. [Latin lact women have not been established. It is unknown whether Synvisc is excreted in human milk. About Genzyme Corporation 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. For more information, visit http://www.genzyme.com or call 800/905-4369 or 617/768-6690. |
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