Galena Biopharma Expands GALE-401 Intellectual Property Protection with Patent Issuance in Japan
September 12 2016 - 7:05AM
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.
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
ir@galenabiopharma.com
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2023 to Apr 2024