November 29, 2004
Orphan Medical Issues Xyrem Prescriptions and sNDA Update; Company Reaffirms Total 2004 Revenue Guidance of $23 to $24 Million
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 November 15, 2004 was 4,374. The Company reaffirmed its 2004 guidance of $23 to $24 million in total revenue including $10.5 to $11.0 million in revenue from Xyrem, the first and only approved treatment for cataplexy associated with narcolepsy. The Company also announced that its supplemental New Drug Application (sNDA) filing to expand the Xyrem label to encompass improvement in the other primary symptoms of narcolepsy is expected to be submitted to the Food and Drug Administration in late December or January.
Narcolepsy is a chronic, debilitating neurological disease whose primary symptoms are excessive daytime sleepiness, fragmented nighttime sleep and cataplexy, a sudden loss of muscle tone, usually triggered by strong emotions such as laughter, anger, or surprise. 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 sixty to ninety percent of those with narcolepsy suffer from cataplexy. All patients with narcolepsy suffer from excessive daytime sleepiness and most from fragmented nighttime sleep.
The Company also indicated that patient enrollment continues on schedule in the clinical trial designed to evaluate Xyrem in the treatment of Fibromyalgia Syndrome. The Company expects initial data from this trial to be available in the second half of 2005.
Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon 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.