Company Update (NASDAQ:GALE): Galena Biopharma Inc Expands GALE-401 Intellectual Property Protection with Patent Issuance in Japan

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 (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. (Original Source)

Shares of Galena Biopharma closed last Friday at $0.38, down $0.02 or -4.04%. GALE has a 1-year high of $2.49 and a 1-year low of $0.28. The stock’s 50-day moving average is $0.43 and its 200-day moving average is $1.09.

On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on August 16, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $2, which represents a potential upside of 426.3% from where the stock is currently trading. Separately, on August 11, Maxim’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $1.00.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Jason McCarthy have a total average return of -14.9% and 0.1% respectively. Bernardino has a success rate of 28% and is ranked #3998 out of 4124 analysts, while McCarthy has a success rate of 36.5% and is ranked #2449.

Galena Biopharma, Inc. engages as a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. It 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. Its products include Abstral (fentanyl) sublingual tablets and Zuplenz (ondansetron) oral soluble film. 


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