Orexo and ProStrakan Extend Licensing Agreement for Rapinyl/Abstral and change Partner in North America


Orexo and ProStrakan Extend Licensing Agreement for Rapinyl/Abstral and change
Partner in North America

Uppsala, Sweden, 31 July, 2008 - Orexo AB (OMX: ORX), the Swedish pharmaceutical
company, and ProStrakan Group plc, the Scottish-based international specialty
pharmaceutical company, have extended their existing European licensing
agreement for Rapinyl™ (Abstral®), for breakthrough cancer pain, to include
North America. This change of partner in North America follows the decision made
by Endo Pharmaceuticals Holdings Inc. today following its own internal strategy
changes to return all rights for Rapinyl™ (Abstral®) to Orexo. Endo has invested
approximately $40 million in the development of Rapinyl™, and Orexo has received
an additional $26.9 million in licensing payments. Endo will finalize and
finance the current phase III studies of Rapinyl™ expected to end in December
2008.

ProStrakan is currently Orexo's exclusive partner for sales and marketing of
Rapinyl™ in most of Europe where, last month, Rapinyl™ received a positive
opinion, recommending the  product's approval, from the Committee for Medicinal
Products for Human Use of the European Medicines Agency.  The plan is to launch
the product, branded as Abstral®, in Sweden in Q3 2008, with further EU launches
taking place from the end of 2008.

Under the terms of the new agreement with Orexo covering North America,
ProStrakan will commit to upfront and certain regulatory and sales milestone
payments totalling $29m, including a $2m signing fee.

In connection with the new agreement the conditions have changed in Europe. The
approval milestones for the five biggest markets in Europe will change from 5
MEUR to 5 MUSD. Royalties for Europe have been increased by 7-9 percent units
and the royalty rate for North America will be increased by the same percent
units compared to the agreement with Endo.

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.  The product is
currently in the latter stages of a Phase III, efficacy and safety trial in the
US. The efficacy study has already met an interim-analysis point, which was
successful, demonstrating the painkilling qualities of Rapinyl™ compared to
placebo. Subject to successful conclusion of these trials, the plan is to submit
the new drug approval for Rapinyl™ (Abstral®) in 2009.

Subsequent approval by the US Food and Drug Administration (FDA), ProStrakan
plans to market Rapinyl™ alongside its other oncology support product, Sancuso -
for the prevention of chemotherapy-induced nausea & vomiting (CINV) - which is
currently under consideration for approval by the FDA.  In advance, ProStrakan
has established a US head office and management team including field-based
Medical Science Liaison staff, and is currently recruiting a 67-strong sales
force in association with NovaQuest, the partnering group of Quintiles
Transnational Corp. 

It is estimated that 1.4 million people in the US are diagnosed with cancer each
year, that between 30% and 40% of these people suffer pain as a result and that
64% of this group experience breakthrough pain. The US market for products for
treating breakthrough cancer pain is estimated to be worth in excess of $500m.

Torbjörn Bjerke, President and Chief Executive of Orexo, said:
“We are delighted to expand our current partnership with ProStrakan to include
the North American market. Our existing European partnership with ProStrakan has
been successful, so it is natural for us to develop this relationship further.
The new agreement and the higher royalties for both Europe and North America
that it will provide demonstrate our commitment to delivering a profitable
business in Orexo.”

Dr Wilson Totten, Chief Executive of Prostrakan, said:
“As an existing partner in Europe, obtaining the North American rights to
Rapinyl™ makes strong strategic sense for ProStrakan and we were delighted to be
able to seize the opportunity to extend our Rapinyl franchise, and our
successful relationship with Orexo.
“This deal allows us to leverage our extensive knowledge of this product and
potentially provides us with a further oncology support product to be marketed
by our specialist US sales force.”

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 & CFO, Orexo AB 
Tel: +46 (0)18-780 88 44 
E-mail: claes.wenthzel@orexo.com

TO THE EDITORS
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 have out-licensed the market rights for Abstral®/Rapinyl™ for the
US, the 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® will be 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 international 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 and development facilities are situated in Galashiels
in Scotland. EU-wide sales and marketing of ProStrakan's portfolio of products
are handled by commercial subsidiaries in the UK, France, Germany, Spain and
other EU countries. ProStrakan has recently commenced the expansion its
operations into the US.
www.prostrakan.com

Attachments

07302325.pdf