Abstral® approved in Canada

Abstral® approved in Canada

Uppsala, Sweden- February 22, 2010 - Orexo AB (STO: ORX) today announces
that ProStrakan's partner, Paladin Labs Inc. has been informed by Health
Canada, the Canadian Government Department with responsibility for
public health, that it has approved Abstral®.

Abstral is a rapidly-disintegrating, sublingual (under the tongue)
formulation of fentanyl. The product is approved for the treatment of
breakthrough pain in patients receiving opioid analgesics for underlying
chronic cancer pain.

Orexo has out-licensed the rights for Abstral in Europe and North
America to ProStrakan. The rights to the Canadian markets were
sub-licensed by ProStrakan to Paladin in 2008. Orexo will receive
royalty on sales in Canada and payment on achievement of certain sales
targets.

Abstral was in January 2011 approved by the US Food and Drug
Administration, where ProStrakan plans to launch this product in Q1
2011.

Anders Lundström, Orexo's President and CEO, said: “We are very pleased
to be able to announce this approval. The Canadian pharmaceutical market
is significant - one of the top 10 markets in the world, and one of the
fastest growing. We are confident that Paladin will be an excellent
partner for ProStrakan and Orexo in enabling Canadian patients suffering
from breakthrough cancer pain to get better relief with Abstral. This is
another important step for Orexo in providing the right solutions to
pain for clinicians and their patients.”

 

For further information please contact:

Anders Lundström, President & CEO
Tel: +46 (0)70-667 22 66
Email: anders.lundstrom@orexo.com (anders.lundstrom@orexo.com)

Robin Wright, EVP and CFO
Tel: +44 7720 300025
Email: robin.wright@orexo.com (robin.wright@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 February 22, 2011 at 14:30 a.m. CET.

About Abstral®
Abstral is a fast-acting and rapidly disintegrating sublingual tablet
formulation of fentanyl citrate designed for oral transmucosal delivery.
The product offers patients and clinicians a simple, patient friendly
and predictable way of delivering fentanyl transmucosally while
retaining the individualized dose titration aspects required for optimal
treatment of breakthrough pain.
Abstral was approved for marketing in the US in January 2011. ProStrakan
will launch Abstral in the US during Q1 2011. Abstral will be the only
fast-acting sublingual tablet for breakthrough cancer pain in the US
market. The overall annual market value in the US for fast-acting
fentanyl products is $550m (source: Wolters Kluwer, August 2010. MAT).
ProStrakan started sales of Abstral in Europe in 2009. During 2010,
sales amounted to GBP 17 million. By June 2010, the product had an
average share of 24% of the fast-acting fentanyl market across the five
largest European markets (source: IMS, June 2010).

About Orexo
Orexo is a pharmaceutical company focusing on developing treatments for
pain and inflammation. Orexo is developing proprietary products based on
its proven reformulation technologies, targeted at the Specialty
Pharmaceutical market. Orexo intends to commercialize some of these
products itself in one or more major markets. Its development activity
builds on Orexo's core competences in R&D, which have previously
resulted in several successful products, currently out-licensed through
worldwide partnership agreements to larger pharmaceutical companies.
Today, Orexo has four products on the market of which Abstral is a
leading product for the treatment of breakthrough pain in cancer
patients. Orexo also has three significant partnerships with major
pharmaceutical companies for research and development programs:
discovery stage collaborations with Ortho-McNeil Janssen and Janssen
Pharmaceutica in respiratory inflammation and with Boehringer Ingelheim
for inflammation and pain, both within the arachidonic acid cascade and
a clinical stage development agreement with Novartis for the treatment
of gastrointestinal disorders. Orexo's head office is located in
Uppsala, Sweden. More information can be found at
www.orexo.com (http://www.orexo.com/sv/).