Orexo AB (STO: ORX) announces that its sales partner in the EU and USA for Abstral™, ProStrakan Group plc ("ProStrakan") yesterday issued its interim report, which gave further information on progress with Abstral™, Orexo's leading sublingual fentanyl product for treatment of breakthrough cancer pain. Abstral™ recorded sales of £14.1m (156 MSEK) in the first 10 months of the year, representing growth of 345% over the corresponding period in 2009. In September 2010, ProStrakan launched Abstral™ in Italy which completes the roll-out of the product across the 5 major European markets.
ProStrakan also reported that Abstral™ is completing its registration in the US. The FDA has confirmed to ProStrakan that the Risk Evaluation and Mitigation Strategy ("REMS") is close to finalisation - final REMS comments have been provided to the FDA and labelling comments are expected imminently. Consequently, ProStrakan anticipate approval of Abstral™ by the FDA by the end of the year. Preparatory work for the US marketing launch of Abstral™, planned by ProStrakan for early in the first quarter of 2011, is also at an advanced stage.