Synergy Pharmaceuticals Announces License Agreement with Luoxin Pharmaceutical Group for TRULANCE® (plecanatide) in China
07 Agosto 2018 - 7:00AM
Business Wire
Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) announced today that
the company has entered into a license agreement with Luoxin
Pharmaceutical Group Co., Ltd., Shandong (Luoxin) providing Luoxin
exclusive rights to develop and commercialize Synergy’s lead
product TRULANCE® (plecanatide) for the treatment of adults with
chronic idiopathic constipation (CIC) and irritable bowel syndrome
with constipation (IBS-C) in mainland China, Hong Kong and
Macau.
“Luoxin is a leading pharmaceutical company in China with strong
capabilities for successfully delivering TRULANCE to patients in
its market,” said Troy Hamilton, Chief Executive Officer of Synergy
Pharmaceuticals Inc. "This partnership builds on the Canadian
licensing deal we announced for TRULANCE earlier this year and
demonstrates our team’s continued execution towards our key
business priorities of optimizing the value of TRULANCE, ensuring a
strong financial foundation, and continuing to explore all
strategic business development opportunities. We look forward to
supporting the Luoxin team in their efforts to bring TRULANCE to
patients suffering from CIC and IBS-C in China.”
“We are pleased to partner with Synergy to bring this exciting
new treatment option to benefit millions of patients suffering from
these chronic gastrointestinal conditions in China,” said Baoqi
Liu, Chairman of Luoxin Pharmaceuticals. “Over the years, Luoxin
Pharmaceuticals has established a strong product line of proton
pump inhibitors to treat gastrointestinal diseases, and we are
conducting a Phase III clinical trial on LXI-15028 (CJ-12420), a
p-CAB inhibitor licensed in from the Korean pharmaceutical company
CJ Healthcare and recently approved by Korean health authorities,
which will further enrich our product line in digestive system. We
believe TRULANCE® will bring a great amount of value to our arsenal
of solutions to fight these conditions. Luoxin Pharmaceuticals
adheres to our corporate mission of ‘Delivering Health’, and we
look forward to working with Synergy on our mutual goal of making
TRULANCE available to as many patients and their health care
providers as possible.”
Under the terms of the agreement, Synergy will receive an
upfront payment of $12 million. Synergy is also eligible, in the
event that certain regulatory and commercial milestones are met, to
receive additional payments of up to $56 million in aggregate. In
addition, Synergy is eligible to receive tiered royalty payments on
aggregate net sales. Luoxin will lead clinical
development in China and be responsible for all activities and
expenses relating to clinical development, regulatory approval, and
commercialization in China. Yafo Capital acted as a financial
advisor on this transaction.
About Synergy Pharmaceuticals Inc.Synergy is a
biopharmaceutical company focused on the development and
commercialization of novel gastrointestinal (GI) therapies. The
company has pioneered discovery, research and development efforts
around analogs of uroguanylin, a naturally occurring human GI
peptide, for the treatment of GI diseases and disorders. Synergy’s
proprietary GI platform includes one commercial product TRULANCE®
(plecanatide) and a second product candidate – dolcanatide. For
more information, please visit www.synergypharma.com.
About LuoxinLuoxin Pharmaceutical is a pharmaceutical
company in China that engages in pharmaceutical research and
development, manufacture, sales, and healthcare services.
Established in 1988, Luoxin has grown into a company with more than
6,500 employees and sales reaching 1.4 billion US dollars. The
company provides pharmaceutical products in gastrointestinal,
respiratory, cardiovascular, infectious diseases and cancer, among
other therapeutic areas. The company has been included in “Top 100
Pharmaceutical Companies” in terms of overall competence nationwide
since 2006, and “Top Pharmaceutical Companies with Competitive
R&D Pipelines” nationwide since 2011. For more information,
please visit www.luoxin.cn.
Forward-Looking StatementThis press release and any
statements made for and during any presentation or meeting contain
forward-looking statements related to Synergy Pharmaceuticals Inc.
under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995 and are subject to risks
and uncertainties that could cause actual results to differ
materially from those projected. These statements may be identified
by the use of forward-looking words such as "anticipate,"
"planned," "believe," "forecast," "estimated," "expected," and
"intend," among others. There are a number of factors that could
cause actual events to differ materially from those indicated by
such forward-looking statements. These factors include, but are not
limited to, the timing and potential for successful development,
launch, introduction and commercial potential of TRULANCE; growth
and opportunity, including peak sales and the potential demand for
TRULANCE, as well as its potential impact on applicable markets;
market size; substantial competition; our ability to fund the
payment of interest and principal of the loan amounts and to
continue as a going concern; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of
government or third party payer reimbursement; dependence upon
third parties; our financial performance and results, including the
risk that we are unable to manage our operating expenses or cash
use for operations, or are unable to commercialize our products,
within the guided ranges or otherwise as expected; and risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products. There
are no guarantees that future clinical trials discussed in this
press release will be completed or successful or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. Investors should read the risk factors set
forth in Synergy's most recent periodic reports filed with the
Securities and Exchange Commission, including Synergy’s Form 10-K
for the year ended December 31, 2017. While the list of factors
presented here is considered representative, no such list should be
considered to be a complete statement of all potential risks and
uncertainties. Unlisted factors may present significant additional
obstacles to the realization of forward-looking statements.
Forward-looking statements included herein are made as of the date
hereof, and Synergy does not undertake any obligation to update
publicly such statements to reflect subsequent events or
circumstances except as required by law.
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Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP,
Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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