Healthcare Industry News:  ProStrakan Group 

Biopharmaceuticals Regulatory

 News Release - December 11, 2008

Abstral receives marketing approval in Germany

Orexo (OMX: ORX) - (HSMN NewsFeed) - confirms the announcement made by ProStrakan Group plc (LSE: PSK), Orexo´s partner for Abstral® in Europe and North America, that it has received a Marketing Authorisation from the German regulatory authority, BfArM for Abstral (for breakthrough cancer pain). ProStrakan now plans to launch Abstral in Germany and the UK in the first few weeks of 2009, with further launches across Europe during the year. As a result of the approval, Orexo will receive a milestone payment of EUR 650 000.

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 has a license agreement with ProStrakan regarding the exclusive rights to this product in Europe and North America.

In June 2008, the EMEA´s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Abstral in Europe. ProStrakan and Orexo successfully launched Abstral in Sweden (EU´s reference country) in August 2008 through their Nordic joint-venture company. In September 2008, the British regulatory authority, MHRA, issued a marketing authorization for Abstral in the UK.

"Abstral is an important product for cancer patients suffering from breakthrough pain. As a result of the approval in Germany and the previous approvals in the UK and Sweden, Abstral will now be sold on a significant share of the European market in 2009. This is a major success for the partnership between Orexo and ProStrakan and the royalty stream Abstral is expected to generate represents an important step in Orexo becoming a profitable pharmaceutical company. We look forward to further expanding our co-operation in Europe and North America in the near future", says Torbjörn Bjerke, President and CEO of Orexo.

For more information, contact:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708-66 19 90

Claes Wenthzel, Executive Vice President and CFO, Orexo AB
Tel: +46 (0)708-62 01 22

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 out-licensed the market rights for Abstral/Rapinyl for the US, EU and Japan markets and the worldwide market rights for Sublinox and OX-NLA, and a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation.

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

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.

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.


(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


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 December 11, 2008 at 08:00 a.m. CET.

Source: Orexo

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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