--Eagle to explore ARS indication to treat
individuals exposed to high doses of radiation such as nuclear
power plant leakage or nuclear weapons; additional research ongoing
to evaluate hematopoietic syndrome in certain cancer patients
undergoing radiation therapy--
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced positive results of a proof-of-concept
(POC) study in a Total-Body Radiation Animal Model. The objective
of the study was to evaluate the efficacy of intravenous
administration of RYANODEX® to prevent or mitigate Acute Radiation
Syndrome (ARS) in a total body irradiated C57BL/6 male mouse
hematopoietic model.
Animals in each treatment group received a well-characterized,
high-dose of radiation to their whole body and also received
randomly-assigned RYANODEX in different treatment modalities. In
this study, the RYANODEX treatment group had overall less mortality
post-treatment than non-treated animals with ARS. Additional
details will be provided when available.
Based on the study results to date, Eagle intends to further
explore an investigational indication for RYANODEX for the
treatment of hematopoietic syndrome in individuals exposed to high
doses of radiation, such as nuclear power plant leakage or nuclear
weapons. Due to its nature, this indication is likely to be
developed under the U.S. Food and Drug Administration’s “Animal
Rule”.
The Company plans to conduct further research for treatment of
post-irradiation hematopoietic syndrome, which could include
treating the hematological side effects in certain cancer patients
undergoing radiation therapy.
“This initial data provides the basis for better
characterization of the underlying mechanisms of ionizing-radiation
bone marrow suppression and the radioprotective effects of
RYANODEX,” said Adrian Hepner MD, Chief Medical Officer of
Eagle.
“We believe these study data support further investigation of
RYANODEX as a therapy in patients with ARS exposed to high doses of
radiation. We plan to focus additional research efforts in specific
cancer populations undergoing radiation therapy, a significant area
of unmet medical need and look forward to reporting our progress,”
said Scott Tarriff, Chief Executive Officer of Eagle.
About Acute Radiation Syndrome
Acute Radiation Syndrome (ARS), also known as radiation toxicity
or radiation sickness, is an acute medical condition caused by
irradiation of the whole body (or a significant portion of the
body), by a high dose of penetrating radiation in a short period of
time, generally minutes. The leading cause of ARS is depletion of
pluripotent cells in specific tissues. ARS generally follows a
predictable clinical course and is characterized by signs and
symptoms that are manifestations of cellular deficiencies and the
reactions of various tissues and organs to ionizing radiation.
High-dose ionizing radiation exposures to the whole or substantial
parts of the body often result in life-threatening injuries,
primarily to those radiosensitive, self-renewing tissues, but most
markedly to the hematopoietic systems. The survival rate of
patients with the hematopoietic syndrome decreases with increasing
radiation exposure. The primary cause of death is the destruction
of the bone marrow, resulting in infection and hemorrhage.
About RYANODEX
RYANODEX® (dantrolene sodium) for injectable suspension is
indicated for the treatment of malignant hyperthermia in
conjunction with appropriate supportive measures, and for the
prevention of malignant hyperthermia in patients at high risk.
Important Safety Information
RYANODEX® is not a substitute for appropriate supportive
measures in the treatment of malignant hyperthermia, including:
Discontinuing triggering anesthetic agents
Increasing oxygen
Managing the metabolic acidosis
Instituting cooling when necessary
Administering diuretics to prevent late kidney injury due to
myoglobinuria (the amount of mannitol in RYANODEX® is insufficient
to maintain diuresis).
Precautions should be taken when administering RYANODEX®
preoperatively for the prevention of malignant hyperthermia,
including monitoring vital signs, avoiding known triggering agents,
and monitoring for early clinical and metabolic signs of malignant
hyperthermia that may indicate additional treatment is needed.
The administration of dantrolene sodium is associated with loss
of grip strength and weakness in the legs, as well as drowsiness,
dizziness, dysphagia, dyspnea, and decreased inspiratory capacity.
Patients should not be permitted to ambulate without assistance
until they have normal strength and balance. Care must be taken to
prevent extravasation of RYANODEX® into the surrounding tissue due
to the high pH of the reconstituted RYANODEX® suspension and
potential for tissue necrosis.
RYANODEX® full Prescribing Information can be found at
www.RYANODEX.com
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle’s strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
Company’s website at www.eagleus.com.
Forward-Looking Statements
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other securities laws. Forward-looking
statements are statements that are not historical facts. Words and
phrases such as “anticipated,” “forward,” “will,” “would,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” and similar expressions are intended to
identify forward-looking statements. These statements include, but
are not limited to, statements regarding future events including,
but not limited to: Eagle’s ability to advance RYANODEX in the
treatment of ARS; Eagle’s plans to continue to evaluate the data
with respect to RYANODEX in the treatment of ARS; and Eagle’s plans
to conduct further research with respect to RYANODEX in the
treatment of ARS. All of such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond Eagle’s control, that could cause actual results
to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. Such
risks include, but are not limited to: whether the Company can
successfully advance its product candidates, including RYANODEX;
the risks inherent in the early stages of drug development and in
conducting pre-clinical studies and clinical trials; the
possibility that the study results with respect to RYANODEX in the
treatment of ARS may be inaccurate or incomplete; and other factors
that are discussed in Eagle’s Annual Report on Form 10-K for the
year ended December 31, 2017, filed with the U.S. Securities and
Exchange Commission (SEC) on February 26, 2018 and its other
filings with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof, and the Company does not undertake any obligation
to revise and disseminate forward-looking statements to reflect
events or circumstances after the date hereof, or to reflect the
occurrence of or non-occurrence of any events.
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version on businesswire.com: https://www.businesswire.com/news/home/20181127005093/en/
Investor RelationsLisa M. WilsonIn-Site Communications,
Inc.T: 212-452-2793E: lwilson@insitecony.com
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