Update on the FDA review for Abstral™

Update on the FDA review for Abstral™

Uppsala, September 7, 2010 - Orexo AB (STO: ORX) announces that the US
Food and Drug Administration (“FDA”) has informed Orexo's partner,
ProStrakan Group plc (LSE: PSK), the international specialty
pharmaceutical company, that it will not yet be making a decision under
the Prescription Drug User Fee Act (“PDUFA”) for Abstral™.

Discussions between ProStrakan and the FDA on the review of Abstral™ are
ongoing and constructive and are focused on the Risk Evaluation and
Mitigation Strategy (“REMS”) programme. However due to the ongoing
nature of these discussions, the FDA has indicated to ProStrakan that it
will not meet its previously expected PDUFA date for Abstral™ in early
September. ProStrakan remains confident of approval in the near term and
awaits further information from the FDA.

Abstral™ is a rapidly-disintegrating tablet for sublingual (under the
tongue) administration of fentanyl intended for the management of
breakthrough pain in cancer patients who are already receiving opioid
analgesics for their underlying persistent pain.

 

Torbjörn Bjerke, Orexo's Chief Executive Officer, said:
“We are confident in the positive benefit-risk profile of Abstral™ as
demonstrated from its solid clinical development and its extensive in
market use in Europe, and will do everything we can to assist our
partner ProStrakan in its ongoing discussions with the FDA.”

 

Contact details:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708 66 19 90
Email: torbjorn.bjerke@orexo.com (torbjorn.bjerke@orexo.com)

Robin Wright, EVP and CFO, Orexo AB
Tel: +44 7720 300025
Email: robin.wright@orexo.com (robin.wright@orexo.com)

 

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 commercialise 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 AbstralTM is a
leading brand for the treatment of breakthrough pain in cancer patients
in most of Europe. 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 pain, both within the arachidonic acid cascade and a clinical stage
development agreement with Novartis in gastrointestinal disorders.
Orexo's head office is located in Uppsala, Sweden.

More information can be found at www.orexo.com (http://www.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 September 7, 2010 at 08:15 a.m. CET.