Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing hematology and oncology therapeutics that address unmet
medical needs, today announced it has reaffirmed its partnership
with BioVascular, Inc. regarding the development of GALE-401.
Working in conjunction with SELLAS Life Sciences, Galena’s proposed
merger candidate, BioVascular has withdrawn its notice of
termination, and
Galena and BioVascular have amended the previous license
agreement to advance the asset either through internal clinical
development or by seeking a licensing partner. GALE-401 is a
controlled release version of the approved drug anagrelide for the
treatment of elevated platelets in patients with myeloproliferative
neoplasms (MPNs). Galena has completed the majority of work
for initiation of a Phase 3 trial in patients with essential
thrombocythemia (ET).
“GALE-401 is a Phase 3-ready asset, and this joint collaboration
between Galena, SELLAS, and BioVascular endorses our mutual belief
in the value of the program for patients with ET or other MPN
disorders,” said Stephen F. Ghiglieri, Interim Chief Executive
Officer. “We remain committed to the advancement of GALE-401,
and believe the future collaboration with SELLAS and BioVascular
can uncover the true value of the asset.”
“Over the last several years, Galena advanced anagrelide
controlled release from Phase 1 to now be ready to enter a Phase 3
clinical trial. Given Galena’s proposed merger with SELLAS,
we are optimistic that the combined company, with experience in the
MPN space, will share a renewed emphasis on collaborating with
BioVascular to determine the most viable path to advance
development of GALE-401,” added John H. Parrish, President and CEO
of BioVascular, Inc.
About GALE-401 (Anagrelide Controlled
Release)
GALE-401 is a controlled release formulation of anagrelide
(Anagrelide CR) currently in clinical development for essential
thrombocythemia. The currently available immediate release
formulation (Agrylin® or anagrelide IR) is approved by the FDA 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 new, controlled
release formulation of anagrelide that increases the half-life and
reduces the maximum plasma concentration (Cmax) of the drug and is
expected to reduce side effects, but preserve efficacy. A
Phase 2 pilot study with GALE-401 has been completed.
About Essential Thrombocythemia
Essential Thrombocythemia (ET) is a chronic myeloproliferative
neoplasm (MPN) characterized by the overproduction of platelets by
megakaryocytes in the bone marrow. The U.S. prevalence of ET is
between 120,000 and 185,000 with approximately seventy-five percent
of patients receiving treatment.1 Common symptoms include headache,
vision disturbances or migraines, dizziness or lightheadedness,
coldness or blueness of fingers or toes, burning, redness, and pain
in the hands and feet. Complications for patients with ET
include blood clotting or bleeding or may be thromboembolic in
nature such as stroke, heart attack, or transient ischemic
attack.
As with other MPNs, ET is a progressive blood cancer that can
strike at any age, and for which there is no known cure; and, there
is no single treatment option that is appropriate or effective for
all ET sufferers. While some ET patients may be asymptomatic and
require no treatment, others may require various treatments and
therapies based on the symptoms, their risk factors, and potential
complications. The treatment options are limited and are
generally hydroxyurea prescribed first line, followed by other
treatments including anagrelide immediate release, interferon,
aspirin or other agents depending on the patient’s condition. Of
these, only anagrelide IR is approved for treatment of ET
patients.
1Sources: Mehta et al, (2014) Epidemiology of myeloproliferative
neoplasms in the United States, Leukemia & Lymphoma, 55:3,
595-600, DOI: 10.3109/10428194.2013.813500; United States Census
Bureau.
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), 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.
About BioVascular Inc.
BioVascular Inc. is a privately held biotechnology company that
develops drugs for control of platelet mediated
disorders.
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company developing
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 its
novel cancer immunotherapy programs including NeuVax™
(nelipepimut-S) and GALE-301/GALE-302. For more information, visit
www.galenabiopharma.com.
Safe Harbor Statements
Additional Information about the Proposed Merger and
Where to Find It
In connection with the proposed merger, Galena Biopharma, Inc.
and SELLAS Life Sciences Group Ltd intend to file relevant
materials with the Securities and Exchange Commission, or the SEC,
including a registration statement on Form S-4 that will contain a
proxy statement /prospectus / information statement. Galena
and SELLAS will mail the final proxy statement / prospectus /
information statement to their respective stockholders.
Investors and stockholders of Galena and SELLAS are urged
to read these materials when they become available because they
will contain important information about Galena, SELLAS and the
proposed merger. The proxy statement / prospectus /
information statement and other relevant materials (when they
become available), and any other documents filed by Galena with the
SEC, may be obtained free of charge at the SEC web site at
www.sec.gov. In addition, copies of the documents filed with the
SEC by Galena will be available free of charge on the Company’s
website at www.galenabiopharma.com (under “Investors” –
“Financials”) or by directing a written request to: Galena
Biopharma, Inc., 2000 Crow Canyon Place, Suite 380, San Ramon, CA
94583, Attention: Investor Relations or by email to:
ir@galenabiopharma.com. Investors and stockholders are urged to
read the proxy statement / prospectus / information statement and
the other relevant materials when they become available before
making any voting or investment decision with respect to the
proposed merger.
Non-Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
Galena and its directors and executive officers and SELLAS and
its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Galena in connection with the proposed transaction. Information
regarding the special interests of these directors and executive
officers in the proposed merger will be included in the proxy
statement / prospectus / information statement referred to above.
Additional information regarding the directors and executive
officers of Galena is also included in Galena Annual Report on Form
10-K for the year ended December 31, 2016 and the proxy statement
for Galena’s 2017 Annual Meeting of Stockholders. These documents
are available free of charge at the SEC website (www.sec.gov), the
Investors section of Galena Biopharma’s website at the address
above, and from Investor Relations at Galena at the mailing address
described above.
Forward Looking Statements
This Press Release contains statements that include the words
“expect,” “intend,” “plan,” “believe,” “project,” “estimate,”
“may,” “should,” “anticipate,” “will” and similar statements of a
future or forward looking nature identify forward-looking
statements for purposes of the federal securities laws and
otherwise. Forward-looking statements are neither historical facts
nor assurances of future performance. All statements, other than
statements of historical facts, included in this press release
regarding strategy, future operations, future financial position,
prospects, plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to the timing and completion of the
proposed merger; the combined company’s ability to successfully
initiate a phase 3 clinical trial within the time periods set forth
in the Amendment and the ability of the combined company to
sublicense the technology of the License Agreement. The combined
company may not actually achieve the plans disclosed in the
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, risks
and uncertainties associated with stockholder approval of and the
ability to consummate the proposed merger through the process being
conducted by Galena and SELLAS, the ability to project future cash
utilization and reserves needed for contingent future liabilities
of the Amendment and License Agreement, the availability of
sufficient resources of the combined company to initiate
clinical trials, the fact that the results of earlier studies and
trials may not be predictive of future clinical trial results, the
protection and market exclusivity provided by the intellectual
property of the License Agreement, risks related to the drug
discovery and the regulatory approval process and the impact of
competitive products and technological changes. Additional risks
and uncertainties relating to Galena and its business can be found
under the caption “Risk Factors” and elsewhere in the Company’s SEC
filings and reports, including in Galena’s Annual Report on Form
10-K, filed with the SEC on March 15, 2017 and the Quarterly Report
on Form 10-Q, filed with the SEC on August 14, 2017 and in
subsequently filed Form 10-Qs. Galena and SELLAS each disclaims any
intent or obligation to update these forward-looking statements to
reflect events or circumstances that exist after the date on which
they were made.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact:
Remy Bernarda SVP, Investor Relations & Corporate
Communications(925) 498-7709ir@galenabiopharma.com
Source: Galena Biopharma, Inc.
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