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| |  MedImmune's Synagis (palivizumab) Approved in Canada GAITHERSBURG, MD -- May 28, 2002 -- MedImmune, Inc. announced today that Synagis(R) (palivizumab) was approved on May 15, 2002 by Health Canada, the Canadian regulatory agency responsible for health policy, regulation, and the promotion of disease prevention in Canada. "With the important approval of Synagis in Canada, MedImmune and our partners at Abbott International have brought Synagis to fundamentally all of the major worldwide markets," commented Armando Anido, MedImmune's senior vice president of sales and marketing. "RSV infection creates a significant healthcare burden throughout the world, and we remain focused on making the drug available to infants at high risk of the disease." The New Drug Submission (NDS) for Synagis was originally submitted to Health Canada on February 26, 1999. The drug has been available in Canada since 1998 under their special access program. RSV is the most common respiratory infection in infancy or childhood, resulting in over 125,000 hospitalizations in the U.S. annually in children less than one year of age. Approximately two-thirds of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely or with chronic lung disease are at highest risk of severe disease and hospitalization due to RSV. Synagis is a humanized monoclonal antibody approved and available for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease (see full prescribing information at http://www.medimmune.com/products/synagis/index.asp). It is administered by intramuscular injection at 15 mg/kg and is given once per month during anticipated periods of increased RSV prevalence in a given community. In the Northern Hemisphere, the RSV season typically commences in September an lasts through April or May. MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets three products, Synagis(R) (palivizumab), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune globulin intravenous (human)), and has 11 products in clinical testing. MedImmune employs approximately 1,500 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on MedImmune, visit the company's website at http://www.medimmune.com. This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. SOURCE: MedImmune, Inc.
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