Orexo announces that Abstral is ready for launch in France
Uppsala, Sweden, 30th June, 2009 – Orexo (STO: ORX) announces that ProStrakan Group plc (LSE: PSK) Orexo’s partner for Abstral in Europe and North America, today confirms that it has completed the reimbursement pricing process with the French authorities for its pan-European breakthrough cancer pain product, Abstral, earlier than expected and, as a result, plans to launch this product in the important French market next month. Abstral is a new formulation of fentanyl, a long-established opioid, used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for their chronic pain. In June 2008 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of Abstral across the European Union. Abstral will be marketed in France through ProStrakan’s 17-strong sales force. France is viewed as an important market for Abstral as it is one of the largest existing fentanyl markets in Europe. The French launch of Abstral follows on from the product’s introduction in the UK and Germany where it has displayed strong growth since its launch in January 2009. In May 2009 ProStrakan reported that sales of Abstral in the UK and Germany had reached 7,200 tablets per week. Torbjörn Bjerke, President and CEO of Orexo, comments: "Abstral's early launch in France will provide improved treatment options for many sufferers of breakthrough cancer pain. This marks another important step in the international launch of Abstral and Orexo’s development of becoming a profitable pharmaceutical company." For further information, contact: Torbjörn Bjerke, President and CEO Tel: +46 (0)708-66 19 90 E-mail: email@example.com Johan Andersson, Investor Relations Manager Tel: +46 (0)702-100 451 E-mail: firstname.lastname@example.org About Abstral Abstral 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. It is based on Orexo’s unique and patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral is sold in Sweden, UK and Germany. In Sweden, Abstral is sold through Orexo’s and ProStrakan’s joint venture, ProStrakan AB. The product is in clinical Phase III in Japan and in the US the clinical phase III is finalized. Distribution agreements regarding Abstral for Russia and the CIS, Bulgaria and Rumania have been signed with Gedeon Richter. A distribution agreement has been signed with Hospira for the Southeast Asian market. For the Chinese market, Orexo has signed a distribution agreement with NovaMed, and for the Israeli market Orexo has signed a distribution agreement with Neopharm. About Orexo Orexo is a pharmaceutical company focusing on developing treatments for pain and inflammation. The company has four commercialized products as well as a broad project portfolio in late stages of development. Sales and product development are mainly carried out through worldwide partnership agreements with larger pharmaceutical companies. Orexo has 122 employees, and has its head office located in Uppsala, Sweden. More information can be found at www.orexo.com. About ProStrakan ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. ProStrakan’s head office is situated in Galashiels in Scotland. The company’s development capabilities are centred on Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan’s portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain and other EU countries. More information can be found at www.prostrakan.com. Note: Orexo AB (publ) is required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on June 30, 2009 at 08:00 CET.