- Acquisition adds GALE-401 (Anagrelide CR) to expand Galena's
product pipeline.
- Phase 2 clinical trial expected to begin in mid-2014 with
GALE-401 to treat Essential Thrombocythemia (ET), an orphan
myeloproliferative disorder.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced it has acquired Mills Pharmaceuticals, which
has the worldwide rights to GALE-401 (Anagrelide CR), a patented,
controlled release formulation of anagrelide. Galena expects to
pursue the expedited 505(b)(2) regulatory pathway to seek approval
of GALE-401 for the treatment of Essential Thrombocythemia (ET).
The Company also believes GALE-401 meets the qualifications for
orphan drug status. GALE-401 has an estimated peak market size of
approximately $200 million in the U.S.
"This acquisition is an excellent fit for Galena's focused
business strategy, adding another novel product to our pipeline
which strengthens the depth and breadth of our hematology-oncology
portfolio," said Mark J. Ahn, Ph.D., President and CEO of Galena
Biopharma. "ET is a serious condition in which current agents often
have very debilitating side effects. We believe GALE-401 can
enhance the therapeutic index for ET patients—reducing the side
effects of anagrelide while maintaining efficacy for these
patients. With established guidance from the FDA on the
development process, we are excited to initiate a Phase 2 study in
mid-2014."
Essential Thrombocythemia (ET) is an acquired disease of the
bone marrow, characterized by highly elevated platelet counts, and
is associated with vascular complications including increased risk
of thrombosis and bleeding, and events such as heart attack and
stroke. Anagrelide immediate release (IR) is currently one of
two generic drugs approved to treat ET. However, a significant
number of patients are unable to tolerate fully effective doses of
anagrelide IR and either discontinue treatment or are reduced to a
dose which is insufficient to achieve the target platelet
level.
GALE-401 is expected to greatly decrease the adverse event rate
relative to the approved product. The adverse events of IR
anagrelide—nausea, diarrhea, abdominal pain, palpitations,
tachycardia, headache—are tied to the peak concentration, or Cmax,
and these side effects often limit dose escalation resulting in
inadequate control of disease or discontinuation of therapy.
Existing data strongly suggest reducing the Cmax while maintaining
the overall exposure to the drug, or AUC (area under the curve),
reduces the rate of adverse events without compromising
efficacy. GALE-401 significantly decreases the Cmax by up to
70% while preserving nearly 100% of the AUC.
This favorable pharmacokinetic profile for GALE-401 has been
established in several Phase 1 studies enrolling an aggregate 86
healthy subjects. Across all studies, a dose dependent
reduction in platelet count was observed, and importantly, the
safety profile of GALE-401 was no different from placebo. It
is anticipated that the dosing and tolerability advantages will
potentially allow Galena to expand the market to treat younger and
elderly patient populations with ET who are currently
undertreated.
Based on a regulatory meeting with the U.S. Food and Drug
Administration (FDA), Galena believes a 505(b)(2) regulatory filing
is an acceptable paradigm for approval of GALE-401, with the
reference drug Agrylin® (anagrelide; Shire
Pharmaceuticals). The Phase 1 program has provided the desired
PK/PD (pharmacokinetic/pharmacodynamic) profile to enable the Phase
2 initiation. The FDA has also indicated that only a single
Phase 3 trial is required for approval.
"Many physicians are not satisfied with currently available
treatments for ET due to the fact that they cannot effectively
lower and maintain platelet levels in many of their patients
without unmanageable side effects. GALE-401 (Anagrelide CR)
is designed to deliver anagrelide with controlled release over a
longer period of time to take advantage of the known benefits of
the drug, while reducing the adverse events to offer a better
treatment option for patients," said Srdan Verstovsek, MD, PhD,
Chief, Section for Myeloproliferative Neoplasms (MPNs), Department
of Leukemia, Director, Clinical Research Center for MPNs, The
University of Texas MD Anderson Cancer Center.
Under the terms of the agreement, Galena paid an up-front
payment to Mills Pharmaceuticals' owners. Additionally, Mills
Pharmaceuticals owners are eligible to receive one-time payments of
up to 4,000,000 shares with the achievement of specified regulatory
milestones. The owners of Mills Pharmaceuticals are also
eligible to receive $3 million upon FDA approval of a new drug
application in respect to GALE-401. GALE-401 possesses a broad
patent portfolio and provides intellectual property protection
through at least 2029. Mills Pharmaceuticals is affiliated
with Aceras Partners. Roth Capital Partners acted as financial
advisor to Galena in this transaction.
About GALE-401 (Anagrelide CR)
GALE-401 (Anagrelide CR) contains the active ingredient
anagrelide, an FDA-approved product, which has been in use since
the late 1990s for the treatment of Essential Thrombocythemia (ET).
GALE-401 is a reformulated, controlled release version of
anagrelide that is currently only given as an immediate release
(IR) version. Phase 1 studies have shown the drug to be effective
at lowering platelet levels while reducing side effects that
prevent patients from taking their therapy regularly.
Adverse events such as nausea, diarrhea, abdominal pain,
palpitations, tachycardia, and headache with anagrelide IR are dose
and plasma concentration dependent. Therefore, reducing the maximum
concentration (Cmax) is expected to reduce the side effects, but
preserve efficacy. GALE-401 has been shown to significantly
reduce the Cmax while preserving nearly 100% of the Area Under the
Curve (AUC), or the total amount of drug absorbed by the
body. Thus, GALE-401 is reducing the peak plasma exposure to
lessen the adverse events while maintaining effective therapeutic
levels for platelet inhibition.
About Essential Thrombocythemia
Essential Thrombocythemia (ET) is an acquired disease of the
bone marrow, characterized by highly elevated platelet counts, and
is associated with vascular complications including increased risk
of thrombosis and bleeding events such as heart attack and
stroke. Galena believes ET meets the qualifications of an
orphan drug with prevalence in the U.S. of approximately
80,000-100,000 and an annual incidence rate of about 8,000 new
diagnoses each year, with similar rates in Europe. Initially, many
patients are asymptomatic so the disease goes undiagnosed, but with
increased standard blood testing, the diagnoses are increasing as
well. Only about 75% of diagnosed patients currently receive
therapeutic treatment.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care. For more information
visit www.galenabiopharma.com.
About Aceras Partners
Aceras Partners is a unique healthcare focused investment firm
that specializes in funding the development of novel medical
innovations by collaborating with pharmaceutical companies,
biotechnology companies, and research centers from around the
world. Aceras brings together strong industry expertise and
dedicated capital to offer partnership opportunities and flexible
investment structures to public and private healthcare companies.
For more information visit www.acerasbio.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 planned development of GALE-401, or ANA-CR,
including the expected timing of clinical trials, the expected
regulatory pathway for approval of GALE-401, the market potential
of GALE-401, the expected therapeutic benefits of GALE-401, 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, 2012 and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2013 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
Vice President, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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