Orexo´s partner Endo announces positive results from interim analysis of Rapinyl ™ phase III clinical trial

Orexo´s partner Endo announces positive results from interim analysis of Rapinyl
™ phase III clinical trial 

Orexo´s licensing partner for Rapinyl ™ in North America announced today
positive results from the previously announced, planned interim statistical
analysis of a Phase III, placebo-controlled, double-blind trial of its
development product, Rapinyl ™.  The data from the analysis of 61 patients
demonstrated that Rapinyl ™ met its primary endpoint, the Sum of Pain Intensity
Difference from baseline to 30 minutes (SPID 0-30), and the results were highly
statistically significant (p=0.0004). In addition, all the secondary endpoints
were met. Statistically significant separation from placebo on mean pain
intensity difference was seen as early as 10 minutes. 

On the basis of these results and in accordance with the predetermined criteria
of the interim analysis, Endo is terminating enrollment in the double-blind
crossover portion of this clinical study. Enrollment is continuing in the safety
portion of this trial and a second Phase III trial to meet the requirements for
additional safety data. Rapinyl ™ is an oral, fast-dissolving tablet of fentanyl
intended for the treatment of breakthrough cancer pain. Rapinyl ™ is in
registration phase in Europe with Orexo's partner ProStrakan. Kyowa Hakko, a
licensee in Japan, is preparing for a phase III study.

“We are extremely pleased by the outcome of this analysis, which we believe
demonstrates that Rapinyl ™ can be an effective treatment for breakthrough pain
in cancer patients,” said David A. Lee, M.D., Ph.D., Chief Scientific Officer. 
“We remain confident that Rapinyl´s quick dissolution and rapid absorption
profile make it a potentially attractive treatment for breakthrough cancer
pain.”

Endo will conduct a thorough analysis of the data to determine the next course
of action, including the possibility of filing a New Drug Application (NDA)
based on these results. 

Endo further noted that although this planned interim analysis was only intended
to determine efficacy and not tolerability, those adverse events that were
reported were consistent with what is usually observed with other opioids.

“The results from Endo Pharmaceuticals support that Rapinyl ™ can be an
effective treatment for breakthrough pain in cancer patients,” said Torbjorn
Bjerke, M.D., President and CEO.  “It is also a confirmation of our sublingual
tablet form and how well it works when immediate onset of effect is desirable”.

For more information, please contact: 

Torbjörn Bjerke, President and CEO, Orexo AB 
Tel: +46 (0)708-66 19 90 
E-mail: torbjorn.bjerke@orexo.com 

Claes Wenthzel, Executive Vice President & CFO, Orexo AB 
Tel: +46 (0)18-780 88 44, +46 (0)708-62 01 22 
Email: claes.wenthzel@orexo.com 

TO THE EDITORS 

About Orexo 

Orexo is a pharmaceutical company which focuses on identifying suboptimal
therapeutic characteristics of existing products and developing more efficient
and effective delivery methods for them. By combining approved active substances
with Orexo´s drug delivery technologies it is possible to significantly enhance
their therapeutic value, such as providing quicker onset of action or ease of
administration. This business model is aimed at bringing products to market
faster with lower development risk and costs. 

Orexo, which has its global headquarters and development laboratories in Sweden,
currently operates across the world through development, licensing and
distribution agreements in all major markets. 

Orexo has a balanced portfolio with two products on the market, three in
registration and/or late stage clinical phase, one in clinical phase I, one in
formulation phase and two in early development phase. 

Orexo is listed on the Nordic List at the OMX Nordic Exchange Stockholm, Mid Cap
(ticker: ORX). 

www.orexo.com 
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo
Pharmaceuticals is a fully integrated specialty pharmaceutical company with
market leadership in pain management products. The company researches, develops,
produces and markets a broad product offering of branded and generic
pharmaceuticals, meeting the needs of healthcare professionals and consumers
alike. More information, including this and past press releases of Endo
Pharmaceuticals Holdings Inc., is available online at www.endo.com.