Orexo announces Kyowa Hakko Kirin's submission of KW-2246 (Abstral) for approval in Japan

Orexo announces Kyowa Hakko Kirin's submission of KW-2246 (Abstral) for approval
in Japan

Uppsala, February 25, 2010 — Orexo AB (STO: ORX) today announces that its
partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA)
in Japan for the cancer pain drug KW-2246 (Abstral). 

Kyowa Hakko Kirin has confirmed KW-2246's safety and efficacy in clinical trials
conducted in Japan. 

The drug will be marketed by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical Co.,
Inc. Kyowa Hakko Kirin and Hisamitsu will also market HFT-290 (Fentanyl
transdermal patch) under development by Hisamitsu. 

Commenting on the announcement, Torbjörn Bjerke, Orexo's President and CEO,
said: “The submission of KW-2246 in Japan is an important step in the
international development of Orexo's sublingual fentanyl product, in Europe
launched under the brand AbstralTM.  The success of Abstral is confirmed by its
strong sales growth in Europe. 

This submission further strengthens that Orexos sublingual fentanyl product has
the potential to be an important product for the treatment of severe pain
episodes in cancer patients globally. The submission is a result of the
continued strong commitment we see from our partner Kyowa Hakko Kirin in the
Japanese market.”


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

Claes Wenthzel, Executive Vice President and CFO
Tel: +46 (0)708-620 122
E-mail: claes.wenthzel@orexo.com


About AbstralTM(KW-2246)
AbstralTM is a fast-disintegrating tablet for sublingual 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 disintegrating tablet
is placed under the tongue and the active substance is absorbed by the mucous
membrane. Currently AbstralTM is sold in Sweden, UK, Germany, Spain, Greece and
France. An NDA for AbstralTM has been filed in the US by the partner ProStrakan.
 In Japan  a registration application has been submitted by the partner Kyowa
Hakko Kirin.

About Orexo
Orexo is a pharmaceutical company focusing on developing treatments for pain and
inflammation. The company has four products on the market 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 108 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:
This is information that Orexo AB (publ) is required to disclose pursuant to the
Swedish Financial Instruments Trading Act and/or the Swedish Securities Markets
Act. The information was provided for public release on 25th February, 2010 at
08:00 CET.