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Orphan Medical, Inc. announced today that Celltech Pharmaceuticals, a division of Celltech Group plc received notice that the European Medicines Evaluation Agency (EMEA) has accepted for review its marketing authorization application for Xyrem® (sodium oxybate) oral solution, a treatment for symptoms of narcolepsy.
Xyrem has been filed through the EU centralized procedure, and has been granted Orphan Drug designation status in Europe, which provides a 10-year period of marketing exclusivity upon approval. Celltech will use its specialist sales forces to market the product to neurologists and sleep specialists across Europe following approval, anticipated during 2005.
Celltech licensed the European rights to Xyrem from Orphan Medical in October 2003. Under the terms of the agreement, Celltech will be responsible for the registration, sales and marketing of Xyrem in Europe. Celltech made a milestone payment to Orphan Medical related to the European regulatory filing and will make further payments tied to future product development milestones and sales related milestones. Celltech will also pay Orphan a royalty on sales of the product. The licensing agreement also provides Celltech with rights to negotiate in regard to other potential future indications including fibromyalgia syndrome.
"The filing of this application for approval, which came about very quickly thanks to the efforts of those at Celltech and our internal staff, is the first important step in establishing a worldwide brand for Xyrem," said John Bullion, Orphan Medical CEO.
Ingelise Saunders, Celltech's Global Commercial Director, commented: "We are pleased at having rapidly submitted our marketing authorization application for Xyrem in narcolepsy, in line with our expectations. Xyrem will be an important product within our European specialist-focused commercial organization. We are looking forward to progressing our European submission and working with sleep centres and physicians in order help fulfill the unmet medical need in patients with this serious disorder."
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. Xyrem is the first and only approved medication for the treatment of cataplexy. 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.
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