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Orphan Medical announced notification that the Committee for Orphan Medicinal Products (COMP) has recommended Orphan Designation in Europe for Xyrem® (sodium oxybate) oral solution for the treatment of narcolepsy.
The positive recommendation from the COMP has to be endorsed by the European Agency for the Evaluation of Medicinal Products (EMEA), which is expected to occur within 45 days. The Orphan Designation in Europe provides a 10-year period of market exclusivity in the current 15-Member States of the European Community once a medication is approved for marketing. John Bullion, Orphan Medical Chief Executive Officer commented, "Orphan Designation for Xyrem is an important milestone that will be a factor in our search for a partner to commercialize Xyrem outside of the United States. We are in active discussions with several potential partners and I would expect to have a licensing agreement for Xyrem complete in the first half of 2003."
The United States Food and Drug Administration (FDA) approved Xyrem in July of 2002. Orphan Medical launched the product through its own specialty sales force in October of 2002. Narcolepsy affects an estimated 0.034 percent of the population in Europe according to a recently compiled META analysis on its prevalence in Europe. Narcolepsy is a chronic, currently incurable disease which affects daytime functioning of those afflicted. The primary symptoms of narcolepsy include
excessive daytime sleepiness and cataplexy. Cataplexy, a sudden loss of muscle tone, is usually triggered by strong emotions such as laughter, anger, or surprise and, in its most severe form, can cause a person to collapse.
Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases treated by specialist physicians. Orphan Medical's Internet Web site address is www.orphan.com.
The information in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. A number of factors could cause actual results to differ materially from the Company's assumptions and expectations. These are set forth in the cautionary statements included in Orphan Medical's most recent Form 10-Q or Form 10-K filed with the Securities and Exchange Commission. (These documents can be accessed through the Orphan Medical Web site at http://www.orphan.com). All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements.
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