Celltech Group plc Submits Xyrem for Approval in Europe
Thursday April 1, 1:02 am ET
SLOUGH, U.K., April 1, 2004 (PRIMEZONE) -- Celltech Group plc (London:CCH.L - News) (NYSE:CLL - News) today announces that the European Medicines Evaluation Agency (EMEA) has accepted for review its marketing authorisation application for Xyrem (sodium oxybate) oral solution, a treatment for symptoms of narcolepsy. Xyrem has been filed through the EU centralised 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 in-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.
Ingelise Saunders, Celltech's Global Commercial Director, commented: ``We are pleased at having rapidly submitted our marketing authorisation application for Xyrem in narcolepsy, in line with our expectations. Xyrem will be an important product within our European specialist-focused commercial organisation. We are looking forward to progressing our European submission and working with sleep centres and physicians in order help fulfil the unmet medical need in patients with this serious disorder.''
Celltech Group plc (LSE: CCH; NYSE: CLL) is one of Europe's largest biotechnology companies, with an innovative development pipeline funded by its profitable, cash-generative pharmaceutical business. Celltech also possesses drug discovery capabilities of exceptional strength, including a leading position in antibody engineering. More details can be found at celltechgroup.com |
