Orexo's AbstralTM receives two further large EU market approvals in France and Spain

Orexo's AbstralTM receives two further large EU market approvals in France and
Spain

Orexo (NASDAQ-OMX:ORX), announces that AbstralTM has received Marketing
Authorisation from the French and Spanish regulatory authorities for the
treatment of breakthrough cancer pain.

AbstralTM is expected to be launched during the second half of 2009 in France
and Spain, following pricing and reimbursement negotiations with the relevant
authorities, by ProStrakan (LSE:PSK), Orexo's exclusive licensing partner for
AbstralTM in Europe and North America.  The two new approvals mean that
AbstralTM has been approved in five European markets including Sweden, the UK
and Germany since March of 2008, with further approvals anticipated in 2009. 
The approvals in France and Spain trigger milestone payments of EUR 1.3 million
to Orexo. 

Commenting on the news, Torbjörn Bjerke, President and CEO of Orexo, said
“AbstralTM is a very important product for helping cancer patients manage their
pain and with this approval patients across the majority of the European market
can now benefit from the product.  The royalty stream that this product will
generate will bring us closer to our goal of becoming a sustainable, profitable
pharmaceutical company.  ProStrakan is doing an excellent job of rolling out
AbstralTM to the major European markets, and together we are anticipating to be
in a position to file for USA approval for the product in 2009. We look forward
to continuing our successful partnership with ProStrakan in Europe and North
America in the near future.”

AbstralTM is a sublingual (under the tongue) tablet for the fast administration
of fentanyl, an opioid commonly used to treat breakthrough cancer pain in
patients who are already receiving opioid analgesics. AbstralTM's formulation is
based on Orexo's unique sublingual tablet technology in which a rapidly
dissolving tablet is placed under the tongue and the active substance is
absorbed by the mucous membrane, resulting in very rapid pain relief for
patients suffering from breakthrough pain. 

AbstralTM received a positive recommendation for approval in Europe by the
EMEA's Committee for Medicinal Products for Human Use in June 2008.  It is
currently launched in 
reference country Sweden, the UK and Germany.  

ProStrakan is Orexo's exclusive licensing and distribution partner for AbstralTM
in Europe and North America. Orexo also recently signed a licensing and
distribution agreement for AbstralTM with NovaMed for China and with Neopharm
for Israel.  Orexo already has other partnership agreements for AbstralTM in
Eastern Europe and the CIS with Gedeon Richter, in Japan with Kyowa Hakko Kirin
and for the other territories in Southeast Asia with Hospira.


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

Johan Andersson, IR-manager, Orexo 
Tel: +46 (o) 702-10 04 51 
E-mail: johan.andersson@orexo.com


Notes to Editors 

About Orexo
Orexo is a pharmaceutical company focusing on developing treatments for pain and
inflammation. The company has three products on the market as well as a
competitive product 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. 
Product portfolio 
Commercialised products with distribution- and marketing agreements
Product Indication Status
AbstralTM/Rapinyl Acute pain Marketed in EU, Phase III in US and Japan
Partnered with: ProStrakan, Gedeon Richter, Hospira, Kyowa Hakko Kirin, Neopharm
and NovaMed
Diabact® UBT Diagnosis - Helicobacter pylori Marketed in EU and other
territories*
Heliprobe™ System Diagnosis - Helicobacter pylori Marketed in EU and other
territories*
*Marketed through Kibion AB, subsidiary of Orexo

Outlicensed development projects - deals with future milestones and royalties
Product Indication Development phase Partner(s)
Sublinox™ Insomnia	Registration Meda
OX-NLA Rhinitis Phase III-ready Meda
OX-MPI Pain, inflammation Pre-clinical development Boehringer Ingelheim

Prioritized projects for which licensing discussions have begun
Product Indication Development phase
OX17 GERD Phase II/III - in development agreement
OX914 COPD/Asthma Phase II
Arachidonic Acid Franchise (OX2477/OX-CLI) Asthma/COPD Pre-clinical
OX641 Migraine Pre-clinical
OX-PKX Various projects with the PharmaKodex platform	
OX19 Incontinence Phase I PK Study

Projects with potential for further development
OX-LSAID Asthma Phase II
OX219 Opioid addiction Early clinical phase
OX30 Abuse-Proof Pain medication Formulation

More information can be found at www.orexo.com.  

About ProStrakan
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company
engaged in the development and commercialisation of prescription medicines for
the treatment of unmet therapeutic needs in major markets.
ProStrakan's head office is situated in Galashiels in Scotland. The company's
development capabilities are centred on Galashiels and Bedminster, New Jersey,
USA.  Sales and marketing of ProStrakan's portfolio of products are handled by
commercial subsidiaries in the UK, US, France, Germany, Spain and other EU
countries.
More information can be found at www.prostrakan.com 


About Abstral
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 and Germany and is approved
for marketing in France and Spain.

The product AbstralTM is also known as Rapinyl in the US and some other
territories.


Breakthrough cancer pain
It is estimated that there are in excess of five million people with cancer in
Europe (1), that 30% of these suffer pain as a result(2) and that 65% of these
have breakthrough cancer pain(3).
Breakthrough cancer pain is a brief and often severe flare of pain experienced
by patients suffering from cancer that occurs even though a person may be taking
pain relief medicine regularly for their persistent pain. It is known as
breakthrough pain because it is pain that "breaks through" a regular pain
medicine schedule. It may be caused by the cancer itself or it may be related to
cancer treatment. For some people, breakthrough pain occurs during certain
everyday activities, such as walking or dressing. For others, it occurs
unexpectedly without any apparent cause.
Sources:
(1) Cancer Prevalence in European Registry Areas. Micheli et al, Annals of
Oncology 13: 840-865, 2002
(2) Management of Cancer Pain. Levy M., & Samuel, T Semin Oncol 32: 179-193,
2005
(3) Breakthrough Cancer Pain Characteristics and Syndromes in Patients with
Cancer Pain. An International Survey. Caraceni et al, Palliative Medicine 2004;
18: 177 et seq


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 March 2, 2009 at 08:00 CET.