ORPH Orphazyme AS

Orphan Medical Sees Lead Product Growing to $20 Million This Year MINNEAPOLIS, Feb. 23 /PRNewswire-FirstCall/ -- Orphan Medical, Inc.'s (NASDAQ:ORPH) chief executive officer John Bullion believes his company's lead product, Xyrem(R), will double its sales in 2005, becoming a $20 million product this year with even greater potential in 2006 and beyond. In an interview with The Wall Street Reporter, Mr. Bullion said Xyrem was prescribed by over 2,100 physicians last year, up from 1,200 in 2003 and that the average number of prescriptions per physician has grown from 3.4 to 4.9, "... indicating that the adoption of Xyrem by sleep physicians and other doctors has grown very well." He indicated that a much larger potential market awaits Xyrem in 2006 upon the FDA's approval of a broad narcolepsy label for the drug, expanding the addressable market to $250 million. Xyrem's current label is for cataplexy, a debilitating symptom of narcolepsy involving the loss of muscle tone that's treated in less than 25 percent of narcoleptics, putting the addressable cataplexy market at $50 million. The new label will expand the product's use to include narcoleptics who suffer from the disease's two other debilitating symptoms, excessive daytime sleepiness and fragmented nighttime sleep. "In effect, the new label will expand the market for Xyrem from 20,000 patients to more than 100,000," Mr. Bullion said. Two Phase III(b) trials to support the application for an expanded label were completed last year and submitted to the FDA last month. One showed that Xyrem used in combination with commonly used stimulants decreased fragmented sleep, or nighttime awakenings, and increased slow-wave sleep, an important component of sleep. The other study assessed how Xyrem performs alone and in combination with Provigil(R) in treating excessive daytime sleepiness. The results showed Xyrem was as effective as prior dosing of Provigil in controlling daytime sleepiness in narcolepsy patients, and the two drugs together were more effective in reducing daytime sleepiness than either alone. Meantime, the company is conducting studies to evaluate Xyrem for fibromyalgia, yet another disorder characterized by disrupted sleep. The roughly four million sufferers of fibromyalgia represents a significant market opportunity, the company said. There is building scientific rationale as well as published studies underlying the company's assessment of Xyrem as a treatment for fibromyalgia. Subsequent to the interview the company released 2004 financial results. Revenue from marketed products grew 37 percent to $21.3 million for the year ended December 31, 2004, compared to $15.5 million in the year-ago period, which included $3.5 million from products divested in 2003. Same- product sales grew 78 percent in 2004. Total revenue was a record $23.8 million. 2004's net loss attributable to common shareholders was $14.0 million, or $1.26 per diluted share, compared to the net loss in 2003 of $19.7 million, or $1.51 per diluted share, excluding the $29.8 million net gain from the divestment of products in 2003. In 2003 the company reported net income attributable to common shareholders of $10.1 million, or $0.85 per diluted share. Gross margins on product revenue increased to 86 percent in 2004, up from 84 percent a year ago. To access the interview, go to: http://www.wallstreetreporter.com/linked/OrphanMedical.html. 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 http://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. Contact: Tim McGrath Thomas Redington VP & CFO Redington, Inc. 952-513-6900 203/222-7399 212/926-1733 http://www.redingtoninc.com/ DATASOURCE: Orphan Medical, Inc. CONTACT: Tim McGrath, VP & CFO of Orphan Medical, Inc., +1-952-513-6900; or Thomas Redington of Redington, Inc., +1-203-222-7399, +1-212-926-1733, for Orphan Medical, Inc. Web site: http://www.orphan.com/

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