NewBridge Pharmaceuticals announced that it has signed an exclusive licensing and distribution agreement with Orexo AB (STO: ORX) that grants NewBridge rights to seek approval for Abstral™, Orexo's product for treatment of breakthrough cancer pain, 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 Abstral™ product. The agreement includes 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 commercialisation in each of the relevant countries.
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 pounds Sterling in the first six months of 2010 in Europe.
◦Abstral™ achieved a 24% market share by tablet volume of short-acting fentanyl products in the top five 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.
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 physicians' abilities to treat patients experiencing breakthrough cancer pain, hence improving quality of life for these patients."
Torbjorn 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 brand. Our partnership with NewBridge will allow Abstral™ to be available for thousand of doctors to help them manage patients suffering breakthrough cancer pain."
