WOODCLIFF LAKE, N.J - Tuesday, February 24th 2015 [ME NewsWire]
(BUSINESS
WIRE) -- Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”)
(Nasdaq:EGRX) today confirmed that the U.S. Food and Drug Administration
(FDA) has granted seven years of market exclusivity in the U.S. to
Ryanodex® (dantrolene sodium) for Injectable Suspension for the
treatment of malignant hyperthermia (MH). Ryanodex was designated an
orphan drug in August 2013 and was approved by the FDA in July 2014 for
this indication.
“We are very pleased that the anticipated market
exclusivity for this important orphan drug has been formally granted,”
said Scott Tarriff, President and Chief Executive Officer. “The response
to Ryanodex has been positive since its launch late last August, and we
look forward to further market penetration going forward.”
About Ryanodex
Ryanodex
is a novel formulation of the antidote for management of malignant
hyperthermia (MH), a potentially fatal disorder described in more detail
below. Ryanodex is available in single-use vials containing 250mg of
dantrolene sodium in lyophilized powder form. It is formulated for rapid
reconstitution and administration in less than one minute to patients
in malignant hyperthermia crisis. Ryanodex should be administered by
continuous rapid intravenous push beginning with a loading dose of 2.5
mg/kg, and continuing until symptoms subside. Ryanodex is the first
significant enhancement to the management of malignant hyperthermia in
more than three decades, and has the potential to become the new
standard of care in malignant hyperthermia management.
About Malignant Hyperthermia
Malignant
Hyperthermia is a condition that can be triggered when genetically
susceptible individuals come in contact with certain inhaled (volatile)
anesthetics or the muscle relaxant succinylcholine. These patients can
experience tachycardia, elevated blood pressure, raised carbon dioxide
levels, and very high body temperature levels. If not treated
immediately, the hypermetabolic episode can be fatal.
About Eagle Pharmaceutical, 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. The Company’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 “expect(s),” “feel(s),” “believe(s),”
“will,” “may,” “intends,” “anticipate(s),” “look forward,” “upcoming,”
“plan,” “enables,” “potentially,” “entitles,” and similar expressions
are intended to identify forward-looking statements. These statements
include, but are not limited to, statements regarding future market
penetration of Ryanodex. All of such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of the Company, 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, the successful marketing of Ryanodex,
and other risks described in Eagle’s Annual Report on Form 10-K for the
year ended September 30, 2014, and its other 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.
Ryanodex® is a registered trademark of Eagle Pharmaceuticals, Inc.
Contacts
In-Site Communications, Inc.
Lisa M. Wilson
President
212-452-2793
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