Orexo’s licensing partner submits registration file for the pain product Rapinyl™

Orexo’s European licensing partner ProStrakan Group plc. has announced submission of the registration file to obtain marketing approval on the European market for the pain product Rapinyl™ – Orexo’s patented product for the treatment of breakthrough cancer pain. The Swedish Regulatory authority will be the rapporteur and coordinator for the registration process in Europe. ”ProStrakan’s submission of the Rapinyl™ registration file is a big step towards the launch of our product in the European market place”, says Zsolt Lavotha, President and CEO Orexo AB. ”The fact that a registration file can be submitted for a product that we have developed in a few years, is another proof of the strength of Orexo’s business model – to develop new, patented products in shorter time, with lower development costs and with low development risk. Furthermore, ProStrakan has a sales organisation covering key European markets which, in combination with recent market research study indicating a significant medical need for new pain products, are favourable conditions promising for a successful launch of Rapinyl™ in Europe” Lavotha said. In addition to the up-front license fee payment of 5 M EURO (approximately 47 MSEK) received in January this year, and a milestone payment of 2 M EURO (approximately 19 MSEK) Orexo receives in connection with the Regulatory Filing indicated above, Orexo may receive other license fees and payments based on regulatory approvals and sales milestones, which total up to 15 M EURO (approximately 140 MSEK). When ProStrakan introduces Rapinyl™ on the European market, the agreement also provides for double-digit royalties upon commercial sales. Furthermore, the licensing agreement provides Orexo with the right to - in parallel with ProStrakan - market Rapinyl™ on the Nordic market. Rapinyl™ is a product for the treatment of acute pain. The first indication is breakthrough pain in cancer. Rapinyl™ is based on Orexo´s unique proprietary technology for sublingual administration, where a tablet is placed under the tongue and rapidly disintegrates into ordered mucoadhesive units of the active substance. This novel pharmaceutical preparation combines the properties of fast dissolution, quicker onset of action and predictable effect. The marketing rights for Rapinyl™ are licensed to Kyowa Hakko Kogyo Co. Ltd for the Japanese market, to Endo Pharmaceuticals for the North American market and to ProStrakan Group plc for the European market. For more information, please contact; Zsolt Lavotha, President & CEO, Orexo AB +46 (0)18 780 88 12, e-mail: zsolt.lavotha@orexo.se Claes Wenthzel, Executive Vice President and CFO, Orexo AB +46 (0)18 780 88 44, +46 (0)708-62 01 22 e-mail: claes.wenthzel@orexo.se