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Acquisition adds GALE-401 (Anagrelide CR) to expand Galena's product pipeline.
Phase 2 clinical trial expected to begin in mid-2014 with GALE-401 to treat Essential Thrombocythemia (ET), an orphan myeloproliferative disorder.
PORTLAND, Ore., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has acquired Mills Pharmaceuticals, which has the worldwide rights to GALE-401 (Anagrelide CR), a patented, controlled release formulation of anagrelide. Galena expects to pursue the expedited 505(b)(2) regulatory pathway to seek approval of GALE-401 for the treatment of Essential Thrombocythemia (ET). The Company also believes GALE-401 meets the qualifications for orphan drug status. GALE-401 has an estimated peak market size of approximately $200 million in the U.S.
"This acquisition is an excellent fit for Galena's focused business strategy, adding another novel product to our pipeline which strengthens the depth and breadth of our hematology-oncology portfolio," said Mark J. Ahn, Ph.D., President and CEO of Galena Biopharma. "ET is a serious condition in which current agents often have very debilitating side effects. We believe GALE-401 can enhance the therapeutic index for ET patients—reducing the side effects of anagrelide while maintaining efficacy for these patients. With established guidance from the FDA on the development process, we are excited to initiate a Phase 2 study in mid-2014."
Essential Thrombocythemia (ET) is an acquired disease of the bone marrow, characterized by highly elevated platelet counts, and is associated with vascular complications including increased risk of thrombosis and bleeding, and events such as heart attack and stroke. Anagrelide immediate release (IR) is currently one of two generic drugs approved to treat ET. However, a significant number of patients are unable to tolerate fully effective doses of anagrelide IR and either discontinue treatment or are reduced to a dose which is insufficient to achieve the target platelet level.