-Ryanodex could offer a new standard of care
for this serious and life-threatening condition-
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the
Company”) today announced that it has completed the submission of
its 505(b)(2) New Drug Application (NDA) for Ryanodex® for the
treatment of exertional heat stroke (EHS) to the U.S. Food and Drug
Administration (FDA). There is no currently approved drug treatment
for EHS. Due to the life-threatening nature of EHS and the unmet
need for an effective drug treatment for EHS, Eagle has requested
Priority Review of this NDA for Ryanodex. If granted, as
anticipated, a Prescription Drug User Fee Act (PDUFA) date for a
decision on the NDA would be July 2017; otherwise the Company
anticipates approval later in 2017.
“If approved, Ryanodex for EHS would be the first drug therapy
for athletes, our military and active individuals affected by this
severe, life-threatening condition that can potentially cause
long-term neurological impairment and organ damage. Ryanodex could
offer a new standard of care in the treatment of EHS when combined
with traditional cooling methods,” stated Scott Tarriff, Chief
Executive Officer of Eagle Pharmaceuticals.
EHS is a rare, sudden, and unpredictable medical condition
characterized by severe hyperthermia and neurological dysfunction.
EHS constitutes a medical emergency, mostly affecting young, active
and otherwise healthy individuals. Treatment delay can result in
major complications including brain damage, organ failure and
death. Today, the treatment for EHS is limited to body cooling by
physical methods (i.e. water immersion, ice-packs, water misting),
and supportive measures including intravenous (IV) fluids and
respiratory support. Under normal physiologic conditions, an
individual’s average brain temperature is approximately 0.9°C
higher than core body temperature. Changes of less than 1°C can
result in functional alterations in various areas of the nervous
system. Consequently, individuals whose core body temperature rises
above 104°F (40°C), which is common with individuals experiencing
EHS, risk severe organ dysfunction, and long-term disability.
Approximately 30% of EHS survivors have persistent neurologic
complications despite the use of aggressive cooling.
“We look forward to working with the FDA in its review process.
If approved, we aim to bring Ryanodex to market for the treatment
of heat stroke as early as this summer. This would be Eagle’s most
significant self-launched product to date. We are actively aligning
resources to build commercial strength for our launch and driving
awareness of EHS to support its successful commercialization,”
added David Pernock, President and Chief Commercial Officer of
Eagle Pharmaceuticals.
The NDA is seeking approval of Ryanodex for the treatment of
patients with exertional heat stroke, which is one of the most
severe forms of heat stroke. Eagle’s Ryanodex for the treatment of
exertional heat stroke has previously been granted Orphan Drug
designation by the FDA, and therefore may be eligible for seven
years of exclusivity upon approval. Ryanodex is protected by two
filed and five issued patents. Ryanodex for the treatment of EHS
has also been granted Fast Track designation.
The NDA is supported by data from animal work completed in
December 2016 and a clinical trial in EHS patients completed
following the Hajj pilgrimage in 2015. The studies supported the
product’s known and well-characterized safety profile and
demonstrated that administration of Ryanodex in addition to body
cooling showed substantial evidence of increased clinically
meaningful effectiveness in treating patients with EHS, compared to
body cooling alone.
“Our innovative formulation of dantrolene sodium has unique
properties that may allow Eagle’s low-volume high-concentration
Ryanodex formulation, with its simple, rapid reconstitution and
fast administration to be a potentially suitable therapy for the
treatment of EHS in emergency settings,” added Adrian Hepner, MD,
PhD, Chief Medical Officer of Eagle Pharmaceuticals.
Information regarding Eagle’s pivotal animal study can be found
in Eagle’s press release dated December 13, 2016. Additional
information regarding Eagle’s human clinical study and its outcomes
can be found in Eagle’s press release dated December 17, 2015.
About EHS
EHS is a rare, sudden and unpredictable disorder that
constitutes a medical emergency which may result in severe
multi-organ dysfunction and death. EHS is more commonly seen in
young people undergoing exertional physical activity in a hot
weather environment, and is one of the leading causes of death in
young athletes and non-combat related fatalities in the military.
EHS cases are also observed in construction workers, firefighters,
military personnel, and farmers.
Currently, there is no approved drug product for the treatment
of EHS, one of the most severe form of heat-related illness,
characterized by core body temperature of 104° F (40° C) or greater
and significant neurological dysfunction. EHS carries high rates of
morbidity and mortality. The central nervous system is very
sensitive to hyperthermia, which may lead to severe neurologic
complications and permanent brain damage.
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 such
as “will,” “may,”, “believe,” “intends,” “anticipate(s),” “plan,”
“enables,” “potentially,” “entitles,” and similar expressions are
intended to identify forward-looking statements. These statements
include statements regarding future events including, but not
limited to: Eagle’s ability to gain successful FDA approval of the
Ryanodex for exertional heat stroke and the impact, if any of such
approval; the timing and level of success of a future launch of
Ryanodex for exertional heat stroke; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; the strength of the patent portfolio
protecting Ryanodex and the ability of Eagle to defend against
third party attempts to design around or invalidate those patents;
successful compliance with FDA and other governmental regulations
applicable to manufacturing facilities, products and/or businesses;
the commercial success of Eagle’s commercial portfolio, including
Ryanodex for exertional heat stroke once launched; the ability of
Eagle to deliver sustained shareholder value over time; and other
factors that are discussed in Eagle’s Annual Report on Form 10-K
for the year ended December 31, 2015, and its other filings with
the U.S. Securities and Exchange Commission. 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 Eagle’s management and/or board of directors will be
effective in managing Eagle’s business and future growth, as well
as the other risks described in Eagle’s filings with the U.S.
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak
only as of the date hereof, and we do 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: http://www.businesswire.com/news/home/20170123005166/en/
Investor Relations for Eagle Pharmaceuticals,
Inc.:In-Site Communications, Inc.Lisa M. Wilson,
212-452-2793lwilson@insitecony.com
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