- Abstral® was approved in the U.S. in 2011 and is the first and only fentanyl sublingual tablet for the management of breakthrough cancer pain in opioid tolerant patients.
- Abstral® product launch targeted in the 4th Quarter of 2013.
- To fund the acquisition and product launch, Galena plans to enter into a non-dilutive debt financing of up to $15 million.
LAKE OSWEGO, Ore., March 18, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has entered into an agreement with Orexo AB (ORX.ST), an emerging specialty pharmaceutical company based in Sweden, to acquire Abstral® (fentanyl) Sublingual Tablets for sale and distribution in the United States.
Abstral is an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) in patients who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. BTcP has been shown to affect as many as 40-80 percent of cancer patients, with reported episodes of 4 per day and a median duration of 30 minutes. The innovative Abstral formulation delivers the analgesic power of fentanyl in a convenient and easy to use sublingual tablet, which dissolves under the tongue within seconds. Abstral provides rapid relief of BTcP, predictable dosing, and is convenient and easy to use.
Abstral was approved by the U.S. Food and Drug Administration (FDA) in January 2011; and, it is the transmucosal immediate-release fentanyl (TIRF) market leader in Europe where it achieved sales of $54 million by ProStrakan/Kyowa Hakko Kirin in 2012. It is marketed in Canada by Paladin Labs, and has been filed for approval in Japan by Kyowa Hakko Kirin, Co. Ltd. In 2012, the U.S. market for TIRFs was $400 million.