Eagle Pharmaceuticals Commences Pivotal Study for Fulvestrant
December 07 2017 - 6:50AM
Business Wire
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or “the
Company”) today announced that it has begun dosing subjects in its
pivotal study for the Company’s fulvestrant formulation intended as
a monotherapy treatment of hormone receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative advanced breast
cancer in postmenopausal women not previously treated with
endocrine therapy, or HR-positive advanced breast cancer in
postmenopausal women with disease progression following endocrine
therapy or as a combination therapy with palbociclib for the
treatment of HR-positive, human epidermal growth factor receptor 2
(HER2)-negative advanced or metastatic breast cancer in women with
disease progression after endocrine therapy.
This pharmacokinetic and safety pivotal study is an open label
trial in which healthy female volunteers across multiple U.S. sites
will be randomized 1:1 to receive either the Company’s fulvestrant
formulation or the reference drug Faslodex®. The Company
anticipates dosing its last subject during the first half of 2018,
with study completion within twelve months, and an expected NDA
filing in the fourth quarter of 2018.
“We began dosing the first cohort of subjects in our pivotal
study fulvestrant trial on November 30th, following guidance from
the U.S. Food and Drug Administration (FDA) regarding the study
design. We believe our fulvestrant formulation holds the potential
to be a best-in-class treatment option for thousands of patients,”
stated Scott Tarriff, Chief Executive Officer.
“Our innovative formulation, if approved, could offer multiple
potential benefits compared to the current branded fulvestrant
product, Faslodex. Our formulation allows the therapy to be
administered at the recommended dose with one intramuscular
injection instead of two high-viscosity intramuscular injections,
and in far less time – seconds instead of minutes. In addition, it
does not contain castor oil, and our formulation’s lower viscosity
allows for administration with a 23-gauge needle, which is 25%
thinner than the current needle required to administer Faslodex,”
added Tarriff.
Faslodex, manufactured by AstraZeneca, generated worldwide sales
of $925 million in the twelve months ended September 30, 2017.
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,” “intends,” “anticipate(s),” “plan,” “enables,”
“potentially,” “forecasted”, “entitles,” 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: the successful
completion of Eagle’s pivotal Phase III trial of fulvestrant; and
other factors that are discussed in Eagle’s Annual Report on Form
10-K for the year December 2016, 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: the ability of Eagle to manufacture and commercialize its
Pemetrexed product upon final approval; the formation of a market
for Eagle’s Pemetrexed product; and 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/20171207005187/en/
Investor Relations for Eagle Pharmaceuticals, Inc:Lisa M.
Wilson, 212-452-2793lwilson@insitecony.com
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