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news.Orexo has confirmed the announcement made by ProStrakan Group, the company's partner for Abstral in Europe and North America, that the UK Medicines and Healthcare products Regulatory Agency has issued a marketing authorization for Abstral.
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As a result of the approval, Orexo will receive a milestone payment of $1 million. This authorization will enable ProStrakan to complete UK pricing negotiations and launch planning by the end of 2008, enabling UK sales of Abstral to make a full contribution in 2009.
Abstral (formerly branded as Rapinyl) is a fast-dissolving tablet for sub-lingual administration of fentanyl intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. Orexo has a license agreement with ProStrakan regarding the exclusive rights to this product in Europe and North America.
Torbjorn Bjerke, president and CEO of Orexo, said: “This is a major achievement for the partnership between Orexo and ProStrakan and the royalty stream from Abstral will be important for Orexo in becoming a profitable pharmaceutical company. We look forward to expanding our successful working partnership in Europe and in the US in the near future.”