Abstral™ file submitted to the FDA for approval in the USA

Abstral™ file submitted to the FDA for approval in the USA

Uppsala, Sweden, August 6, 2009 - Orexo AB (STO: ORX) today announces that its
partner, UK-based international specialty pharmaceutical company ProStrakan
Group plc (LSE: PSK), has submitted the New Drug Application (NDA) for Abstral™
(for the treatment of breakthrough cancer pain in opioid-tolerant patients) to
the US Food and Drug Administration (FDA). 

The filing of AbstralTM will generate a milestone payment to Orexo as part of
the agreement with ProStrakan for North America that in total can give USD 27
million in certain regulatory and sales milestone payments. In addition, Orexo
will receive royalties on product sales.

Commenting on the filing, Torbjörn Bjerke, Orexo's President and CEO, said:
“This submission is the first stage of bringing Abstral™ to the thousands of
patients in the USA we believe will benefit from this novel, convenient and
effective treatment.  The US market is the world's largest market for
breakthrough cancer pain with the number of breakthrough cancer pain attacks
amounting to approximately 376 million per year(1). We are excited about the
prospect of a US launch of Abstral™ by ProStrakan, Orexo's partner for AbstralTM
in both North America and Europe.” 

The filing of Abstral™ has yet to be validated by the FDA before being accepted
for review, and therefore no PDUFA date has yet been assigned.

1) Source: Datamonitor 2006, Pipeline Insight: Breakthrough Pain

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 AbstralTM
AbstralTM 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 AbstralTM is sold in Sweden, UK, Germany and France. The
product is also being prepared for registration in Japan.

License agreements for AbstralTM have been signed with ProStrakan for Europe and
North America and with Kyowa Hakko Kirin for Japan. Distribution agreements
regarding AbstralTM 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.



Note:
This is information that Orexo AB (publ) is required to disclose pursuant to the
Swedish Securities Markets Act. The information was provided for public release
on August 6, 2009 at 08:30 CET.