MINNEAPOLIS -- 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 May 15, 2005, was 5,268, up from both 2,962 for the same prior-year period and 5,010 for the six-week period ended March 31, 2005. In addition, the number of prescribers increased to nearly 2,450 from approximately 1,150 a year ago.
Xyrem is currently marketed as the first and only approved treatment for cataplexy, a sudden loss of muscle tone, a debilitating symptom of narcolepsy. An sNDA for Xyrem is under review by the FDA and, if approved, is expected to expand the Xyrem label to encompass the other primary symptoms of narcolepsy, specifically the reduction of excessive daytime sleepiness (EDS) and improvement in fragmented nighttime sleep.
The Company reiterated that the data from the clinical trial designed to evaluate Xyrem in the treatment of fibromyalgia syndrome is expected to be available in the second half of 2005.
Narcolepsy is a chronic, debilitating neurological disease. Cataplexy, a sudden loss of muscle tone, is usually triggered by strong emotions such as laughter, anger or surprise. As such, patients often selectively isolate themselves from interaction with others resulting in a worsening effect on a patient's quality of life. Narcolepsy afflicts approximately 100,000 to 140,000 Americans with about 50,000 to 75,000 patients receiving some form of treatment for their symptoms. An estimated 60 to 90 percent of those with narcolepsy suffer from cataplexy. All patients with narcolepsy suffer from EDS.
Fibromyalgia is a chronic condition that is estimated to affect over four million individuals in the United States and represents a market opportunity in excess of $1 billion 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.
About Orphan Medical
Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon central nervous system diseases treated by specialist physicians. The Company's lead product is Xyrem, which is the first and only approved treatment for cataplexy associated with narcolepsy. Xyrem is being 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
Notice to Investors
The pending merger with Jazz Pharmaceuticals has not been consummated. Orphan Medical has filed a proxy statement with the Securities and Exchange Commission (SEC). The proxy statement contains important information that should be read carefully before any decision is made with respect to the merger. Investors may obtain a free copy of the proxy statement (and all other offer documents filed with the SEC) on the SEC's Web site (www.sec.gov) and on Orphan Medical's Web site (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. The following factors, among others, could cause actual results to differ materially from these assumptions and expectations: the ability to obtain Orphan Medical stockholders' approval of the transaction; the ability of Jazz Pharmaceuticals to obtain senior debt financing; the ability to satisfy other closing conditions; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; and the risk of new and changing regulation in the U.S. and internationally. Additional factors that could cause Orphan Medical's results to differ materially from those described in the forward-looking statements can be found in Orphan Medical's most recent Form 10-Q or Form 10-K filed with the SEC. (These documents can be accessed through the Orphan Medical Web site at (www.orphan.com). All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements.
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