Investigational New Drug Application Under Review by FDA: Xyrem for Fibromyalgia
April 21, 2004Investigational New Drug Application Under Review by FDA MINNEAPOLIS--(BUSINESS WIRE)--April 21, 2004--Orphan Medical, Inc. (Nasdaq:ORPH) today announced results for the first quarter ended March 31, 2004. Revenue for the quarter was $5.4 million, which includes $1 million of licensing revenue. The $4.4 million in product revenue was highlighted by growth in Xyrem(R) (sodium oxybate) oral solution and strong Antizol(R) (fomepizole) Injection sales. Xyrem revenue for the quarter was $1.7 million compared to $0.6 million in the prior year. Orphan Medical reported a net loss to common shareholders of $4.3 million, or $0.40 per share, compared to a net loss of $4.1 million, or $0.39 per share, in the first quarter of 2003. The Company also announced that it has filed an Investigational New Drug (IND) Application to begin a clinical trial to assess Xyrem in the treatment of fibromyalgia syndrome. The Food and Drug Administration (FDA) has received the application and has begun its statutory review of the IND. The Company expects to initiate the trial during the second quarter of 2004. "Xyrem continues to make steady progress on both the commercial and development fronts," said John Bullion, Orphan Medical Chief Executive Officer. "Xyrem prescribing grew well during the first quarter, especially in the second half of the quarter and sales of our antidote product Antizol were very strong. We are reaffirming guidance of $18-$20 million in total 2004 revenues with Xyrem revenues contributing $12 to $14 million. The balance of the year is going to be very exciting as the Xyrem EDS trial results are analyzed, the fibromyalgia trial is advanced, and we submit our supplemental NDA." Xyrem Update As of March 31, 2004 more than 1,400 physicians had written Xyrem prescriptions. In the most recent six-week period, a record 744 new prescriptions were written for Xyrem. As previously announced, there were a total of 2,738 prescriptions filled in the last six-weeks bringing the total to 5,087 in the first-quarter of 2004. As previously mentioned, two Phase III(b) trials are underway to evaluate Xyrem in the treatment of EDS in narcolepsy. The clinical portions of the first of these trials, SXB-15, is complete. The Company expects to receive initial data from this trial in late May and will present summary results at the upcoming Associated Professional Sleep Societies (APSS) meeting in June. Patient enrollment in the second EDS trial, the EXCEEDS trial, is nearing completion and expected to be complete in the third-quarter. Orphan Medical plans to include results from both EDS trials in a supplemental NDA to be submitted to the FDA in late 2004. Narcolepsy is a chronic, debilitating neurological disease. Cataplexy associated with narcolepsy, 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 dramatic 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 sixty to ninety percent of those with narcolepsy suffer from 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 a 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. Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon CNS diseases treated by specialist physicians. The lead product for the company is Xyrem, which is the first and only approved treatment for cataplexy associated with narcolepsy. Xyrem is also being assessed as a treatment for the full range of narcolepsy symptoms including excessive daytime sleepiness. Orphan Medical's pipeline includes development stage products for fibromyalgia and pain. 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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