UK Marketing Approval Issued for Abstral

UK Marketing Approval Issued for Abstral

Orexo AB (OMX: ORX) confirms the announcement made by ProStrakan Group plc (LSE:
PSK), Orexo's partner for Abstral® in Europe and North America, that the UK
Medicines and Healthcare products Regulatory Agency (MHRA) has issued a
Marketing Authorisation for Abstral (for breakthrough cancer pain). As a result
of the approval, Orexo will receive a milestone payment of USD 1 million.

This earlier than expected authorisation will enable ProStrakan to complete UK
pricing negotiations and launch planning by the end of 2008, enabling UK sales
of Abstral to make a full contribution in 2009. 

Abstral (formerly branded as Rapinyl) is a fast-dissolving tablet for
sub-lingual (under the tongue) administration of fentanyl intended for the
management of breakthrough cancer pain in patients who are already receiving
opioid analgesics.  Orexo AB has a licence agreement with ProStrakan regarding
the exclusive rights to this product in Europe and North America. 

The Committee for Medicinal Products for Human Use of the European Medicines
Agency issued a positive opinion recommending approval of Abstral, in June 2008.
 ProStrakan and Orexo successfully launched Abstral in Sweden, the reference
state, in August 2008 in their Nordic Joint Venture and ProStrakan plans further
EU country launches as additional national licences are granted. 

Commenting on the grant of the UK marketing authorisation for Abstral,  Torbjörn
Bjerke, President and CEO said: 

“Abstral is an important product for cancer patients suffering from the
debilitating effects of breakthrough pain.  Its early UK approval means that
ProStrakan can bring Abstral to their home market even earlier than had been
planned, and they expect it to make a material contribution in 2009. This is a
major achievement for the partnership between Orexo and ProStrakan and the
royalty stream from Abstral will be important for Orexo in becoming a profitable
pharmaceutical company. We look forward to expanding our successful working
partnership in Europe and in the US in the near future.”

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 and CFO, Orexo AB 
Tel: +46 (0)708-62 01 22 
E-mail: claes.wenthzel@orexo.com

About Orexo

Orexo is a pharmaceutical company, focusing on development of new, patented
drugs by combining well-documented substances with innovative technologies, and
the development of new treatments for respiratory and inflammatory diseases.

Orexo has a broad and competitive late-stage product portfolio, including two
marketed products, five products in clinical phase and two in registration
stage.

To date, Orexo has out-licensed the market rights for Abstral/Rapinyl for the
US, EU and Japan markets and the world-wide market rights for Sublinox (OX22)
and OX-NLA, and a out-license and research collaboration with Boehringer
Ingelheim regarding the development of a new class of drugs to treat pain and
inflammation. Abstral/Rapinyl was approved in Europe on June 24, 2008. Orexo has
established a Nordic sales force by entering into a joint venture with
ProStrakan. Abstral was launched in Sweden during Q3 this year.

Orexo has its head office in Uppsala, Sweden and is listed on the OMX Nordic
Exchange Stockholm, Small Cap (ticker: ORX).

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. 

www.prostrakan.com


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