STOCKHOLM, Sweden--(BUSINESS WIRE)-- Orexo (STO:ORX) today announces that the US Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Orexo’s partner Meda (NASDAQ-OMX: MEDA A) acquired the exclusive worldwide commercialization license for Edluar last year and they expect to launch the product in the US market during the 2nd half of 2009. Orexo will receive royalties on Meda’s sales of Edluar.
This approval triggers a milestone payment to Orexo from Meda. The amount of the milestone is USD 5 million and is based upon the product labelling.
Commenting on the news Torbjörn Bjerke, CEO of Orexo, said “I am delighted that the FDA has approved Edluar for the treatment of short-term insomnia. This is a great achievement by Orexo. Edluar provides a convenient sublingual administration and we believe that this offers insomnia sufferers an effective alternative. This is the second product approved in a major market within 12 months and is an excellent achievement. The milestone payment and the anticipated product launch during 2nd half of 2009 will continue Orexo’s progress towards profitability.”
About Orexo Orexo is a pharmaceutical company focused on developing drugs for the treatment of pain and inflammation. The company has three products on the market as well as a competitive product portfolio in late stages of development. Sales and product development are mainly carried out through worldwide partnership agreements with larger pharmaceutical companies. Orexo has 128 employees, and has its head office located in Uppsala, Sweden.
Note: This is information that Orexo AB (publ) is required to disclose pursuant to the Swedish Securities Markets Act. The information was provided for public release on March 16, 2009 at 08:30 CET.
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Contact:
Orexo Torbjörn Bjerke, President and CEO Tel: +46 (0)708-66 19 90 E-mail: torbjorn.bjerke@orexo.com or Johan Andersson, Investor Relations Manager Tel: +46 (o) 702-10 04 51 E-mail: johan.andersson@orexo.com
