Orphan Medical Issues Xyrem Prescriptions Update
MINNEAPOLIS–(BUSINESS WIRE)–Feb. 23, 2005–Orphan Medical, Inc. (Nasdaq:ORPH) announced that the total number of Xyrem(R) (sodium oxybate) oral solution prescriptions filled in the six-week period ended February 15, 2005, was 4,790. This represents an 8 percent sequential increase from the six-week period ended December 31, 2004, and a 104 percent increase over the 2,349 prescriptions filled during the six-week prior-year period ended February 15, 2004.
Narcolepsy is a chronic, debilitating neurological disease whose primary symptoms are excessive daytime sleepiness (EDS), fragmented nighttime sleep and cataplexy. Cataplexy, a sudden loss of muscle tone, is usually triggered by strong emotions such as laughter, anger or surprise. All patients with narcolepsy suffer from EDS and an estimated 60 to 90 percent suffer from cataplexy. Patients often selectively isolate themselves from social interaction with others resulting in a worsening effect on a patient’s quality of life. Narcolepsy afflicts 100,000 to 140,000 Americans of which an estimated 50,000 receive some form of treatment for their symptoms. Orphan Medical submitted a Supplemental New Drug Application (sNDA) for Xyrem to the Food and Drug Administration (FDA) on January 18, 2005. The sNDA is expected to expand the Xyrem label to encompass the other primary symptoms of narcolepsy, specifically the reduction of EDS and the improvement in fragmented nighttime sleep, in addition to the established efficacy of Xyrem in treating cataplexy.
Fibromyalgia is a chronic condition that is estimated to affect as many as four million individuals in the United States and represents a market opportunity in excess of $1 billion dollars per year. The disease is characterized by widespread muscle pain and stiffness and affects women three times more often than men. Other symptoms include persistent fatigue, headaches, cognitive or memory impairment, morning stiffness and non-restorative sleep. The Company’s trial evaluating Xyrem as a treatment for symptoms of fibromyalgia syndrome is fully enrolled with data expected to be available in mid-2005.
About Orphan Medical, Inc.
Orphan Medical acquires, develops and markets pharmaceuticals of high medical value for inadequately treated and uncommon central nervous system (CNS) diseases treated by specialist physicians. Xyrem has now been assessed as a treatment for the full range of narcolepsy symptoms including excessive daytime sleepiness. The Company is also conducting a trial to evaluate Xyrem as a treatment for symptoms of fibromyalgia syndrome. Orphan Medical’s Internet Web site address is www.orphan.com
The information in this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “expects,” “anticipates,” “intends,” “may,” “should,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would” or the negative of such terms or other comparable terminology. Such forward-looking statements are based upon current expectations and beliefs and involve numerous risks and uncertainties, both known and unknown, that could cause actual events or results to differ materially from these forward-looking statements. 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.