Development milestone payment to Orexo after completed clinical study

03 October 2005 · Pressrelease · Regulatory
Orexo AB has met the requirements for its first $6.5 million development milestone payment from Endo Pharmaceuticals Inc., following the completion of a clinical trial of Rapinyl™ (OX 20) with positive outcome. In this trial, the dose range to be used in the next stage of development was established. Orexo’s patented product Rapinyl™ (OX 20) is being studied for the management of breakthrough cancer pain . The two companies entered into a licensing agreement August 2004, which gives Endo Pharmaceuticals exclusive rights to develop and market Rapinyl™ (OX 20) for the North American market.

“With the completion of this study, we now look forward to Endo, a market leader in pain management, conducting a Phase III trial programme supporting approval in the US for breakthrough pain in opioid tolerant cancer patients. This programme is planned to start later this year”, said Zsolt Lavotha, president and CEO of Orexo AB. “This accomplishment demonstrates the strength of our business.” Rapinyl™ (OX 20) is an oral fast-dissolving sublingual tablet for the treatment of breakthrough cancer pain. It is based on Orexo’s unique proprietary technology for sublingual administration where a fast-dissolving tablet is placed under the tongue and the active substance is absorbed over the sublingual mucosa. It is believed this novel pharmaceutical preparation could provide fast onset of action, predictable, consistent drug delivery and added convenience for patients suffering from breakthrough pain. In return for the developing and marketing rights on the North American market, Orexo received an up-front payment of $10 million. In addition to the above indicated milestone payment, Orexo may receive up to $54.8 million, comprised of $15.6 million in license fees and $39.2 million in sales milestone payments. The agreement also provides for double-digit royalties upon commercial sales. The Japanese marketing rights for Rapinyl™ (OX 20) were licensed to Kyowa Hakko Kogyo Co. Ltd in January 2003. For further information, please contact: Zsolt Lavotha, President and CEO, Orexo AB +46 (0)18 780 88 00, e-mail: zsolt.lavotha@orexo.se Claes Wenthzel, CFO, Orexo AB +46 (0)18 780 88 00, e-mail: claes.wenthzel@orexo.se