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Express Scripts (ESRX) and Orphan Medical, Inc. today announced that Express Scripts will be the sole distributor of Orphan Medical's Xyrem® (sodium oxybate) oral solution through its Specialty Distribution Services (SDS) subsidiary. The U.S. Food and Drug Administration (FDA) approved Xyrem® on July 17, 2002 for the treatment of cataplexy, a debilitating symptom associated with narcolepsy. It is the first and only medication approved to treat the disorder. Xyrem is expected to be available to patients through Express Scripts early in the fourth quarter of 2002.
Narcolepsy is a chronic, neurological sleep disorder affecting approximately 140,000 Americans. Between 60 and 90 percent of narcolepsy patients experience cataplexy, a sudden loss of muscle tone triggered by strong emotions such as laughter, anger, fright or surprise. In severe attacks, the patient may collapse and be unable to move for up to several minutes.
Clinical trials have shown Xyrem®, a formulation of the chemical compound gamma hydroxybutyrate, to be highly effective, reducing cataplexy attacks by approximately 70 percent and maintaining its effect long-term. Since the medicine is a Schedule III controlled substance approved under the FDA's Subpart H regulations governing distribution, Orphan Medical has developed a system that makes Xyrem available to patients exclusively from a single source -- the SDS specialty pharmacy. The system includes an educational program that physicians will receive before they can prescribe Xyrem and that patients will receive before first use.
SDS will provide pharmacy services to patients, collect patient-registry information, provide reimbursement support, distribute informational materials, and serve as a resource for product and educational program information. For more information, physicians and patients can call 1-866-997-3688 (1-866-XYREM88).
"Express Scripts is extremely pleased to work with Orphan Medical to bring this important medication to cataplexy patients, who previously have had no approved therapy available," said Barrett Toan, Express Scripts chairman and CEO.
Jean-Marc Quach, SDS vice president and general manager, added, "The administrative safeguards and distribution controls for Xyrem will be exceptionally rigorous; however, SDS has years of experience managing specialty products for unique markets and patient groups. We have the knowledge, the systems, and the patient-education and counseling capability required to distribute this medicine effectively within the safeguards defined by the Orphan Medical distribution system."
John Bullion, chairman and CEO of Orphan Medical, said, "SDS will be the only source through which Xyrem can be obtained. Distribution will comply fully with the risk-management controls jointly developed by Orphan Medical, the FDA, the Drug Enforcement Agency and law enforcement agencies. Express Scripts is the right choice to serve the physicians and patients we serve. Together, we will bring Xyrem - and new hope - to cataplexy patients in the United States."
Express Scripts (NASDAQ:ESRX), a Fortune 500, Forbes Platinum 400 and Nasdaq-100 company, is one of the largest pharmacy benefit management (PBM) companies in North America. Through facilities in eight states and Canada, the company provides pharmacy services and pharmacy benefit plan-design consultation for clients, including managed-care organizations, insurance carriers, third-party administrators, employers and union-sponsored benefit plans. Core services include pharmacy network management, mail and Internet pharmacies, formulary management, targeted clinical programs, integrated drug and medical data analysis, market research programs, medical information management, workers' compensation programs and informed-decision counseling. The company also provides non-PBM services, including distribution services for specialty pharmaceuticals through its Specialty Distribution Services subsidiary. Express Scripts is headquartered in St. Louis, Missouri. More information can be found at www.express-scripts.com.
Orphan Medical acquires, develops and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases treated by specialist physicians. Orphan Medical's Internet Web site address is www.orphan.com.
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