Eagle Pharmaceuticals, Inc. Granted Final FDA Approval for Bendamustine Hydrochloride Ready-to-Dilute Solution in a 500ml Adm...
May 16 2018 - 6:50AM
Business Wire
-- Eagle to ship 500ml admixture product
immediately --
Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”)
(Nasdaq:EGRX) today announced that the U.S. Food and Drug
Administration (FDA) has granted final approval for Eagle’s
ready-to-dilute (RTD) bendamustine hydrochloride (HCl) solution in
a 500ml admixture for the treatment of patients with chronic
lymphocytic leukemia (CLL) and patients with indolent B-cell
non-Hodgkin lymphoma (NHL) that has progressed during or within six
months of treatment with rituximab or a rituximab-containing
regimen. Eagle’s bendamustine HCl injection does not require
reconstitution and is administered as a 500ml admixture over 30 or
60 minutes.
“This approval expands our bendamustine product offering, is
complementary to BENDEKA®, and enables us to provide value to a
cost-conscious segment of the market that we are uniquely
positioned to fill. We intend to launch our ready-to-dilute product
with our internal sales force. Based upon our view of the market,
we anticipate over time achieving up to a 12% market share,
increasing our overall profitability,” stated Scott Tarriff, Chief
Executive Officer of Eagle Pharmaceuticals.
Eagle has 13 U.S. patents covering different bendamustine
formulations and methods.
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,” “may,” “remain,”
“potential,” “prepare,” “expected,” “believe,” “plan,” “near
future,” “belief,” “anticipate,” “intend” 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 Company’s ability
to successfully ship, market, and sell its bendamustine HCl 500ml
solution; the Company’s forecasted market penetration for Eagle’s
bendamustine HCl 500ml solution; and the Company's ability to
continue to deliver value over the long term. 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 will incur unforeseen expenses or
liabilities or other market factors; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; the outcome of litigation involving any of
our products or that may have an impact on any of our products,
successful compliance with FDA and other governmental regulations
applicable to product approvals, manufacturing facilities, products
and/or businesses; general economic conditions; the strength and
enforceability of our intellectual property rights or the rights of
third parties; competition from other pharmaceutical and
biotechnology companies and the potential for competition from
generic entrants into the market; the timing of product launches;
the successful marketing of our products; the risks inherent in the
early stages of drug development and in conducting clinical trials;
and other factors that are discussed in Eagle’s Annual Report on
Form 10-K for the year ended December 31, 2017, as 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180516005392/en/
Investor Relations for Eagle Pharmaceuticals,
Inc.:In-Site Communications, Inc.Lisa M. Wilson,
212-452-2793lwilson@insitecony.com
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