Orexo signs agreement for Abstral™ for the Middle East and Africa

Uppsala, September 16, 2010 - Orexo AB (STO: ORX) announces today that an exclusive licensing and distribution agreement has been signed with NewBridge Pharmaceuticals for Abstral™, Orexo´s product for the treatment of breakthrough cancer pain. The agreement grants NewBridge rights to seek approval for Abstral™ in the Middle East and Africa and, where approval is granted, to market and sell the product in these territories. The agreement covers 64 countries across the Middle East and Africa, and excludes Israel where the product is already partnered.

Under the terms of the agreement, Orexo will supply NewBridge with AbstralTM product. The agreement includes upfront, milestone and revenue sharing payments; the detailed financial terms are not being disclosed. NewBridge will also be responsible for managing the regulatory approval process and for commercialisation in each of the relevant countries.

Torbjörn Bjerke President and CEO of Orexo
“This agreement with NewBridge will enable sales of Abstral™ in additional geographic territories and is another step in developing Abstral™ into a global product. Our partnership with NewBridge will allow Abstral™ to be available for thousand of doctors to help them manage patients suffering breakthrough cancer pain”.

Joe Henein, President and CEO of NewBridge
“Abstral™ is a valuable addition to enhance our growing oncology portfolio. Across our core geographic region there are many markets with strong economic growth and increased demand for improved health care and more effective products. We strongly believe that Abstral™ has a great potential in the territory and will contribute significantly to the physicians’ abilities to treat patients experiencing breakthrough cancer pain, hence improving quality of life for these patients”.

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

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


To the editors

Key Points
• 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 cancer pain.
• Abstral™ was launched in the principal European markets during the course of 2009 and generated sales of £7.4m in the first six months of 2010 in Europe.
• Abstral™ achieved in June 2010 a 24% market share by tablet volume of short-acting fentanyl products in the top four European markets (Source: IMS data June 2010).
• Abstral™ is awaiting a decision from the United States Food & Drug Administration in respect of its approval in the US.

About Abstral™
Abstral™ is a rapidly disintegrating tablet for sublingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics for their underlying persistent pain. It is based on Orexo´s unique and patented sublingual tablet technology in which a rapidly disintegrating tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral™ is sold in fourteen countries in Europe, and reached sales of £7.4m in the first half of 2010.

About Breakthrough Cancer Pain
Breakthrough pain (“BTP”) is an acute and often severe flare of pain experienced by patients treated with round the clock opioid analgesics for their underlying chronic cancer pain. It is known as breakthrough pain because it is pain that "breaks through" a regular pain medicine schedule. For some patients, breakthrough pain occurs during certain everyday activities, such as walking or dressing. For others, it occurs unexpectedly without any apparent cause.

Between 64% and 89% of patients with cancer experience an average of 4-7 BTP episodes per day. In a recent survey of patients with cancer BTP:
• 89% stated that BTP negatively affected their quality of life
• 73% stated that BTP wakes them from a deep sleep at least once a month
• 76% stated that BTP affects their ability to perform everyday household chores
• 75% stated that BTP is one of the most challenging effects of having cancer
• 35% stated that BTP affects their relationships with their family members
• 82% stated that BTP negatively affects their emotional health

The American Pain Foundation. Breakthrough Cancer Pain Survey Fact Sheet.
Available at: http://www.painfoundation.org/learn/programs/spotlight-on-cancer-pain/breakthrough-pain/btcp-survey-fact-sheet.pdf

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 product 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.

About NewBridge Pharmaceuticals
NewBridge Pharmaceuticals is a specialty pharmaceutical, biologics, and medical device company serving the Middle East, Africa, Turkey, and Caspian regions (collectively, AfMET) to address the unmet needs of diseases with high regional prevalence such as diabetes, obesity, oncology, cardiovascular diseases and other metabolic disorders. NewBridge in-licenses and commercializes FDA and EMA approved therapeutics and devices. Headquartered in Dubai, United Arab Emirates with Business Development Capabilities in the US, NewBridge was founded by Burrill & Company, a San Francisco-based Life Science Venture Capital, Private Equity, Merchant Banking and Media firm. NewBridge Pharmaceuticals is uniquely positioned to be the partner of choice for pharmaceutical, biotechnology and device companies seeking to create value for their products in these high growth emerging markets.  

More information can be found at www.nbpharma.com



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 16, 2010 at 08:00 a.m. CET.