NEW YORK--(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 Luoxin
Luoxin 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 Statement
This 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.
