Galena Biopharma (GALE) Receives Japanese Patents Related to GALE-401
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Galena Biopharma, Inc. (Nasdaq: GALE) announced the issuance of a second Japanese Patent (JP Patent #5985719) containing composition and method of use claims for GALE-401, the Company’s controlled release version of anagrelide. The patent covers the treatment of patients suffering from myeloproliferative diseases, including myeloproliferative neoplasms (MPNs) such as essential thrombocythemia (ET) and polycythemia vera. The patent provides GALE-401 exclusivity until 2029, not including any patent term extensions.
“With our plans to initiate a Phase 3 trial next year in essential thrombocythemia, we are looking to position GALE-401 as a potential treatment option for MPN patients worldwide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “This Japanese patent further expands our international intellectual property (IP) position complementing our IP estate in the United States. Branded anagrelide immediate release was approved in Japan in 2014.
GALE-401 contains the active ingredient anagrelide. The currently available immediate release formulation (Agrylin® or anagrelide IR) is approved in the U.S., Europe and Japan for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis, and to ameliorate associated symptoms including thrombo-hemorrhagic events. Adverse events associated with anagrelide IR, such as nausea, diarrhea, abdominal pain, palpitations, tachycardia, and headache, may be dose and plasma concentration dependent. GALE-401 is a controlled release formulation of anagrelide, which significantly reduces the maximum plasma concentration (Cmax), and is expected to reduce side effects, but preserve efficacy. A Phase 2 pilot study with GALE-401 has been completed and Galena expects to launch a Phase 3 trial in the first half of 2017.
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