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news.NewBridge Pharmaceuticals has entered into an exclusive licensing and distribution agreement with Orexo to seek approval for Orexo's cancer pain product Abstral in the Middle East and Africa and, where approval is granted, to market and sell the product in these territories.
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Abstral is a rapidly-disintegrating tablet for sublingual 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.
Orexo said that Abstral was launched in the European markets during the course of 2009 and is awaiting a decision from the US Food & Drug Administration (FDA) in respect of its approval in the US.
As per the terms of the agreement, Orexo is expected to supply NewBridge with Abstral product, while NewBridge is expected to be responsible for managing the regulatory approval process and commercialisation in each of the relevant countries.
Additionally, the agreement includes milestone and revenue sharing payments.
NewBridge president and CEO Joe Henein said that Abstral was a valuable addition to enhance their growing oncology portfolio.
“We believe that Abstral has a potential in the territory and will contribute to physicians’ abilities to treat patients experiencing breakthrough cancer pain, hence improving quality of life for these patients,” Henein said.
Orexo president and CEO Torbjorn Bjerke said that the agreement with NewBridge will enable sales of Abstral in additional geographic territories.