Orexo and ProStrakan advance date for taking over rights for Rapinyl in North America
As announced earlier, Orexo is changing partner for Rapinyl in North America to ProStrakan. Orexo and the former partner Endo Pharmaceuticals have now set the date for the takeover at October 31, 2008. In conjunction with the takeover, Orexo will receive USD 0.75m from Endo in accordance with an earlier agreement. Orexo will also receive compensation in the amount of USD 1.5m corresponding to Endo’s earlier undertaking for the ongoing Phase III studies.
In conjunction with the current contractual transfer of Rapinyl in North America to ProStrakan Ltd, Orexo will receive USD 2m from ProStrakan.
“We are very satisfied with advancing the takeover of rights for Rapinyl in North America,” says Torbjörn Bjerke, President and CEO of Orexo. “With our partner ProStrakan, we will now complete the Phase III studies, which are expected to be concluded in December. Concurrently, we will be preparing submission of a registration application and for the marketing of Rapinyl in North America.”
Rapinyl (Abstral in Europe) is a fast-dissolving tablet for sublingual (under the tongue) administration intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics for pain treatment. Orexo and partner ProStrakan plan to submit a registration application for Rapinyl in the US during 2009. In Europe, the EMEA has recommended approval of Abstral and the product was recently approved for sale in the UK. Since August, Abstral is also sold in Sweden.
About breakthrough pain
Each year, approximately 1.4 million patients are diagnosed with cancer. Between 30-30% of this group suffer acute pain, of which 64% have breakthrough pain. The American market for treatment of breakthrough pain is estimated to exceed USD 500m annually.
For more information, please contact:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708-66 19 90
Claes Wenthzel, Executive Vice President and CFO, Orexo AB
Tel: +46 (0)708-62 01 22
Orexo AB (publ) may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on October 31, 2008 at 08:00 a.m. CET.