GALE
Galena Biopharma Announces Orexo's Filing of a Patent Infringement Lawsuit Against Actavis Concerning Abstral(R) (fentanyl) Sublingual Tablets in the U.S.
PORTLAND, Ore., Feb. 5, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that its partner, Orexo AB, has filed a patent infringement lawsuit in United States District Court for the District of New Jersey, against Actavis Laboratories FL, Inc., Andrx Corporation, Actavis, Inc. and Actavis Pharma, Inc. (collectively "Actavis").
The lawsuit was filed in response to the Abbreviated New Drug Application ("ANDA") filed by Actavis. In its application, Actavis seeks to market and sell generic versions of Abstral® (fentanyl) sublingual tablets in the U.S. prior to the expiration of Orexo's U.S. patents for Abstral listed in the FDA's Orange Book. The listed patents are U.S. patents 6,759,059, 6,761,910 and 7,910,132 with expiration dates in September 2019. Galena currently markets Abstral and is the owner of the New Drug Application in the United States.
Because Orexo initiated a lawsuit against Actavis in a timely manner, the FDA is statutorily precluded from approving Actavis' ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. The 30-month stay period began as of the date Orexo received the Notice Letter from Actavis that notified Orexo of the ANDA filing.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer of Galena Biopharma, commented, "We are confident in the patents listed in the FDA's Orange Book and fully support our partner, Orexo, as they vigorously enforce the intellectual property rights around Abstral. Given the significant sales growth and future market potential for Abstral, ANDA filings of generic versions are not entirely unexpected. Our overall strategy and revenue projections for Abstral are unchanged, and we look forward to continued growth and increased market penetration during 2015."
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