Court Issues Decision in Favor of Eagle Pharmaceuticals Granting Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine...
June 11 2018 - 6:50AM
Business Wire
--Generic TREANDA entry now not expected
until December 2022--
-- Further Protects Longevity of BENDEKA
franchise --
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or the
“Company”) announced today that the U.S. District Court for the
District of Columbia (the Court) has issued a decision requiring
the FDA to grant seven years of orphan drug exclusivity (ODE) in
the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or
bendamustine HCI), a liquid, low-volume (50 mL) and short-time
10-minute infusion formulation of bendamustine hydrochloride.
As a result of the Court’s decision, the FDA will not be able to
approve any drug applications referencing BENDEKA until the ODE
expires in December 2022. Moreover, the Company now does not expect
generic TREANDA® entrants into the market until 2022, rather
than November 2019.
“We are delighted with the court’s decision to grant orphan drug
exclusivity for BENDEKA, further extending the longevity of this
important product,” said Scott Tarriff, Chief Executive Officer.
“With thirteen Orange Book listed patents extending from 2026
through 2033, and additional pending patent applications, the
market protection for BENDEKA is likely to be intact for many
years. We also believe it will provide for continued profitability
and building long-term value for Eagle,” concluded Tariff.
Orphan drug exclusivity is granted by the FDA Office of Orphan
Products Development to drugs or biologics that treat rare diseases
or conditions affecting fewer than 200,000 patients in the U.S. The
designation typically provides the drug developer with a seven-year
period of U.S. marketing exclusivity upon approval, bars FDA from
approving any other application (ANDA, 505(b)(2) or “full” NDA or
BLA) for the same drug for the same orphan disease, and offers
certain financial incentives that can help support its
development.
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.
Eagle’s 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 “likely,” “will,” “may,” “can,” “could be,” “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: the FDA’s
ability to approve any drug applications referencing BENDEKA prior
to December 2022; the ability of generic TREANDA products to enter
the market prior to 2022; Eagle’s market protection for BENDEKA;
the commercial success of Eagle’s commercial portfolio, including
BENDEKA; successful compliance with FDA and other governmental
regulations; 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, 2017,
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, future
growth and market protection, including with respect to BENDEKA;
whether the FDA will comply with the Court’s decision; whether
Eagle will maintain successful compliance with FDA and other
governmental regulations; 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: https://www.businesswire.com/news/home/20180611005268/en/
Investor Relations for Eagle Pharmaceuticals, Inc:Lisa M.
Wilson, 212-452-2793Presidentlwilson@insitecony.com
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