Galena Biopharma has entered into an agreement with Orexo AB to acquire Abstral (fentanyl) Sublingual Tablets for sale and distribution in the U.S. Galena will pay $10 million upfront and $5 million in the first 12 months of closing, plus royalties and milestones based on sales.
Abstral is a new treatment option for inadequately controlled breakthrough cancer pain (BTcP) in patients who are receiving, and tolerant to, opioid therapy for cancer pain. The Abstral formulation delivers the analgesic power of fentanyl in a sublingual tablet that dissolves under the tongue. It was approved by the FDA in January 2011 and achieved sales of $54 million in Europe by ProStrakan/Kyowa Hakko Kirin in 2012. It’s marketed in Canada by Paladin Labs, and has been filed for approval in Japan by Kyowa Hakko Kirin.
"The acquisition of Abstral diversifies and strengthens our pipeline, providing Galena with an FDA-approved product that will become a cornerstone of our commercial strategy and bring revenues to the company in 2014 to support the development of our pipeline," said Mark J. Ahn, Ph.D., president and chief executive officer of Galena Biopharma. "Galena's launch of Abstral will build relationships with future prescribers of NeuVax, which is currently in Phase III trials in node positive HER2 IHC 1+/2+ breast cancer patients."
"With Galena Biopharma, Orexo has found a very committed partner for Abstral in the U.S., who is well positioned to realize the significant potential that exists for Abstral. I have been impressed by the competence, experience and commitment to Abstral from the Galena Biopharma management team," said Nikolaj Sorensen, president and chief executive officer of Orexo.