- Begins Process to Maximize Value of Eagle’s
Product Portfolio Worldwide –
- $12.5 Million Upfront Payment Plus Future
Potential Milestones and Royalty Payments -
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the
Company”) and SymBio Pharmaceuticals Limited (“SymBio”) (Tokyo
Stock Exchange/JASDAQ 4582) today announced that the Company has
licensed to SymBio rights under Eagle’s intellectual property to
develop, market and sell Eagle’s bendamustine hydrochloride
(“bendamustine HCl”) ready-to-dilute (“RTD”) and rapid infusion
(“RI”) injection products in Japan.
SymBio will be responsible for securing regulatory approval of
the RTD and RI injection products using the licensed technology in
Japan with a target for approval of a product in 2020. SymBio
currently markets TREAKISYM® in Japan, a lyophilized powder
formulation of bendamustine HCl indicated for chronic lymphocytic
leukemia (“CLL”); relapsed or refractory low-grade Hodgkin’s
lymphoma (“NHL”); mantle cell lymphoma (“MCL”); and as a first line
treatment of low-grade NHL and MCL. According to SymBio, 12-month
sales ended June 30, 2017 in Japan for TREAKISYM were $52 million,
due to the approval of first line treatment for NHL and MCL in
December 2016. SymBio has estimated that sales of TREAKISYM are
estimated to grow to $90 million in 2018.
A 50 ml RI or rapid infusion presentation of bendamustine
hydrochloride injection is currently marketed in the U.S. by Teva
Pharmaceutical Industries, Ltd. (“Teva”) as BENDEKA® (bendamustine
HCl) Injection. BENDEKA currently has a 97% market share of the
bendamustine market, and Teva has forecasted the North American
market for bendamustine to be approximately $600 - $660 million in
sales in 2017. BENDEKA’s low volume infusion and short infusion
time represents an important benefit to both patients and
healthcare providers.
Pursuant to the terms of the license with SymBio, Eagle will
receive a $12.5 million upfront milestone payment, and may be
entitled to additional milestone payments upon approval and the
achievement of cumulative sales thresholds. The Company will also
receive royalties on future net sales of the licensed bendamustine
products.
“This is an important example of the value of the Eagle
portfolio to patients worldwide and a first step in expanding
outside the U.S. for our differentiated products. We look forward
to SymBio’s future approval and successful commercialization of
bendamustine HCI in Japan,” stated Scott Tarriff, Chief Executive
Officer of Eagle Pharmaceuticals.
Mr. Fuminori Yoshida, President and Chief Executive Officer of
SymBio, stated, “In-licensing Eagle’s ready-to-dilute and rapid
infusion injection products will enable SymBio to extend the
product life and continue to maximize the value of TREAKISYM over
the product life while bringing significant benefits to patients
and healthcare providers in Japan.”
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: forecasted sales of
$90 million in 2018; forecasted sales of Bendeka in 2018; SymBio’s
plans to secure regulatory approval of bendamustine HCl in a 500ml
ready to infuse and/or a 50 ml rapid infusion presentation;
SymBio’s target to market the smaller volume product in Japan in
2020; the success of Eagle’s commercial relationship with SymBio
and the companies’ ability to successfully work together; payments
due to Eagle under the license with SymBio, including milestone and
royalty payments; 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: whether SymBio will be successful at commercializing the
licensed products; whether Eagle and SymBio will perform their
respective obligations under the license agreement; inaccurate
sales forecasts and estimates; the ability of SymBio to obtain
regulatory approval for its bendamustine products; 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.
About TREAKISYM®
TREAKISYM® (non-proprietary name: bendamustine HCl), a cytocide
anti-cancer drug, is now widely used in more than 50 countries with
indications for low-grade non-Hodgkin’s lymphoma, mantle cell
lymphoma, and chronic lymphocytic leukemia.
TREAKISYM® Intravenous Infusion 100 mg was approved in October,
2010 for manufacturing and marketing for the indication of
relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and
mantle cell lymphoma in Japan.
TREAKISYM® was approved for the additional indication of chronic
lymphocytic leukemia in Japan in August, 2016.
TREAKISYM® Intravenous Infusion 25 mg, a standard low-dose
product, was approved for manufacturing and marketing in Japan in
September, 2016.
TREAKISYM® was approved for the additional indication of
first-line treatment of low-grade B-cell non-Hodgkin’s lymphoma and
mantle cell lymphoma in Japan in December, 2016.
TREAKISYM® has been marketed in Japan through Eisai Co., Ltd.
since December, 2010.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March, 2005 by
Fuminori Yoshida who previously served concurrently as Corporate VP
of Amgen Inc. and founding President of Amgen Japan. In May, 2016
SymBio incorporated its wholly-owned subsidiary in the U.S., called
SymBio Pharma USA, Inc. (Headquarters: Menlo Park, California,
President: Mr. Fuminori Yoshida). SymBio’s underlying corporate
mission is to “deliver hope to patients in need” as it aspires to
be a leading global specialty biopharmaceutical company dedicated
to addressing underserved medical needs with main therapeutic focus
in oncology, hematology and pain management.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170920005614/en/
Investor Relations for Eagle Pharmaceuticals, Inc:Lisa M.
Wilson, 212-452-2793lwilson@insitecony.comorSymBio Pharmaceuticals
LimitedFuminori Yoshida,Representative DirectorPresident and Chief
Executive Officer(Securities Code: 4582)T: 03-5472-1125
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