Galena Biopharma Expands GALE-401 Intellectual Property Protection with Patent Issuance in Japan

SAN RAMON, Calif., Sept. 12, 2016 -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today 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 (C_max), 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.

About Myeloproliferative Neoplasms and Essential Thrombocythemia

Myeloproliferative neoplasms (MPNs) are a closely related group of progressive blood cancers in which the bone marrow typically overproduces one of the mature blood elements. Other shared features include tendencies toward blood clotting/bleeding, organ enlargement, bone marrow scarring (fibrosis) and a possibility of transformation. The main MPNs are polycythemia vera (PV), chronic myelogenous leukemia (CML), primary myelofibrosis (PMF), and essential thrombocythemia (ET), 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.

Thrombocythemia is a myeloproliferative blood disorder. It is characterized by the production of too many platelets in the bone marrow. Too many platelets make normal clotting of blood difficult. It can be either reactive or primary (also termed essential and caused by a myeloproliferative disease). Primary Thrombocytosis (essential thrombocythemia or ET) is due to a failure to regulate the production of platelets (autonomous production) and is a feature of a number of myeloproliferative disorders. About a third of patients are asymptomatic at the time of diagnosis.

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by its hematology asset, GALE-401, and novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. 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 development of Galena’s product candidates, including GALE-401, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. 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, 2015 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.

NeuVax is a trademark of Galena Biopharma, Inc.
Agrylin is registered trademark of Shire

Contact:

Remy Bernarda 
SVP, Investor Relations & Corporate Communications
(925) 498-7709
[email protected]