×

Galena Biopharma Receives Notice of Allowance of U.S. Patent Application for GALE-401 (Anagrelide Controlled Release) Composition of Matter

PORTLAND, Ore., Dec. 2, 2014 (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 it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application for GALE-401 composition of matter. GALE-401 is a controlled release formulation of anagrelide for use in reducing platelet counts in patients with Myeloproliferative Neoplasms (MPNs).

"This composition of matter patent is an important component in the building of our patent family for GALE-401," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "We have been successful in securing a range of patents for all of our compounds and products and this adds to the depth of our intellectual property portfolio. Our controlled release version of anagrelide may offer treatment benefits for patients suffering from MPNs who may not be tolerating the currently available immediate release version. We are presenting our Phase 1 and preliminary Phase 2 clinical trial data this weekend, and look forward to the readout of our top line Phase 2 data in mid-year 2015."

The claims cover controlled release formulations of GALE-401 in a broad range of unit dosage forms, articles of manufacture containing GALE-401, and methods of reducing platelet counts in patients with a broad spectrum of diseases and conditions, including MPNs, by administering GALE-401. Once issued, the patent will expire in 2029, not including any patent term extensions.

About GALE-401 (Anagrelide CR)

GALE-401 (Anagrelide CR) contains the active ingredient anagrelide. The currently available immediate release formulation (anagrelide IR) is approved by the FDA for the treatment of high platelet counts in patients with Myeloproliferative Neoplasms (MPNs), including Polycythemia Vera (PV), Chronic Myelogenous Leukemia (CML), Primary Myelofibrosis (PMF), and Essential Thrombocythemia (ET). Adverse events associated with anagrelide IR, such as nausea, diarrhea, abdominal pain, palpitations, tachycardia, and headache, may be dose and plasma concentration dependent. Reducing the maximum plasma concentration (Cmax) is expected to reduce side effects, but preserve efficacy. GALE-401 is a reformulated, controlled release version of anagrelide. In Phase 1 studies in healthy volunteers, GALE-401 was well tolerated at the doses administered and shown to significantly reduce the Cmax of anagrelide while maintaining therapeutic plasma levels to reduce platelet counts. Thus, GALE-401 may reduce treatment-related adverse events while maintaining effective therapeutic levels to decrease platelet production.

About Myeloproliferative Neoplasms

Myeloproliferative neoplasms (MPNs) are a closely related group of hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally. The main MPNs are Polycythemia Vera (PV), Chronic Myelogenous Leukemia (CML), Primary Myelofibrosis (PMF), Essential Thrombocythemia (ET), and all of which are associated with high platelet counts. The MPNs are progressive blood cancers that can strike anyone at any age, and for which there is no known cure.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena's product candidates, including GALE-401, patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

CONTACT: Remy Bernarda VP, Marketing & Communications (503) 405-8258 rbernarda@galenabiopharma.com

Source:Galena Biopharma