Orexo announces positive Phase III results for KW-2246 in Japan

Orexo announces positive Phase III results for KW-2246 in Japan

Orexo's partner in Japan, Kyowa Hakko Kirin, has obtained positive phase III
results in Japan for KW-2246, which is approved for the treatment of
breakthrough pain in cancer patients and marketed under the brand AbstralTM in
Europe. Kyowa Hakko Kirin will now proceed with preparations for a new-drug
application for KW-2246 in Japan for use in continuous pain management of acute
cancer pain (breakthrough pain). 

Uppsala, Sweden, 24 July, 2009 - Orexo (STO: ORX) announces that Kyowa Hakko
Kirin, Orexo's partner in Japan, today confirms that it has obtained positive
clinical phase III results for KW-2246 in Japan. The clinical study results
revealed a statistically significant difference between KW-2246 and the placebo,
and clinical effectiveness was confirmed. In addition, with regard to safety, no
unacceptable side effects were found during the clinical study period.

Kyowa Hakko Kirin will now proceed with the preparations for a new-drug
application for KW-2246 in Japan. According to the market research institute
Datamonitor, the Japanese market for opioids is one of the largest markets in
the world (Datamonitor 2008, Commercial and Pipeline Insight: Opioids). 

Torbjörn Bjerke, President and CEO of Orexo, comments: "The positive phase III
results in Japan are an important milestone for our successful collaboration
with Kyowa Hakko Kirin. This marks another important step in the international
development of AbstralTM and strengthening Orexo in the process of becoming a
profitable pharmaceutical company".

Trial design
The clinical study was conducted using a crossover design involving a
double-blind placebo-controlled trial, targeting patients to whom an opioid
analgesic was administered at fixed intervals for intermediate to severe cancer
pain and who use a morphine preparation for breakthrough pain, and a non-blind
controlled trial with a morphine preparation. 

For further information, contact:
Torbjörn Bjerke, President and CEO
Tel: +46 (0)708-66 19 90
E-mail: torbjorn.bjerke@orexo.com 
 
Johan Andersson, Investor Relations Manager
Tel: +46 (0)702-100 451
E-mail: johan.andersson@orexo.com


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 and is ready for launch in
France. In Sweden, Abstral is sold through Orexo's and ProStrakan's joint
venture, ProStrakan AB. The product is being prepared for registration in Japan
and in the US the clinical phase III is finalized.

License agreements have been signed with Kyowa Hakko Kirin for Japan and with
ProStrakan for EU and the US. 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 128 employees, and has its head office
located in Uppsala, Sweden. More information can be found at www.orexo.com.  

About Kyowa Hakko Kirin 	
Kyowa Hakko Kirin Co., Ltd. is engaged in the manufacturing and marketing of
medical products and pharmaceuticals. As the parent company of the Kyowa Hakko
Kirin Group, it manages the business activities in the Bio-Chemicals and
Chemicals segments with the Pharmaceuticals segment as its core business. More
information can be found at http://www.kyowa-kirin.co.jp/english/index.html.

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 July 24, 2009 at 08:00 CET.