vTv Therapeutics Inc. (Nasdaq:VTVT) today announced that vTv
Therapeutics LLC has entered into a licensing agreement with
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong
Pharmaceutical”), a wholly-owned subsidiary of Huadong
Medicine Co., Ltd. (SZSE: 000963.SZ), for rights to develop and
commercialize vTv Therapeutics’ GLP-1r agonist program in China and
other Pacific Rim countries.
Under the agreement, vTv has granted Huadong Pharmaceutical an
exclusive license to develop, manufacture and commercialize vTv
Therapeutics’ GLP-1r agonist program in China, Hong Kong,
Macau, Taiwan, Thailand, Vietnam, Indonesia, Malaysia, Philippines,
Singapore, Myanmar, Cambodia, Laos, Brunei, South Korea and
Australia. Under the terms of the agreement, vTv Therapeutics will
run a Phase 2 Multi-Regional Clinical Trial (MRCT) including sites
in the US and other regions in the Pacific Rim.
The licensing agreement includes rights to TTP273, an oral small
molecule GLP-1R agonist, which met its primary endpoint and
demonstrated a statistically significant reduction in HbA1c in a
Phase 2 trial of type 2 diabetes. The compound was well-tolerated,
with negligible incidences of nausea and vomiting across all arms
of the study. Trends towards weight loss were also observed.
vTv will receive an $8 million upfront payment in connection
with the signing of the agreement subject to satisfaction of
customary conditions and is eligible for up to an additional $75
million in milestone payments related to development, regulatory
and commercial milestones. In addition, vTv will be eligible to
receive royalty payments on sales of commercialized products in the
territories.
“Worldwide, the number of people with type 2 diabetes has
quadrupled over the last 35 years, and there are approximately 160
million people with diabetes in the Western Pacific region,” said
Steve Holcombe, president and CEO of vTv Therapeutics. “We are
extremely pleased to partner with Huadong, one of the largest and
most successful pharmaceutical companies in China. Our partnership
has the potential to expand the treatment options for patients with
type 2 diabetes in the licensed Asian countries where there is a
proven need for an oral small molecule therapy that demonstrates
benefits similar to the injectable diabetes GLP-1 peptides without
the commonly associated side effects.”
Bangliang LI, Chairman of Huadong Pharmaceutical, said,
"Diabetes medications constitute the core product line of Huadong
Pharmaceutical, and also the key area for Huadong's R&D and
innovative drug strategy in the future. The signing of the vTv
license agreement is an important milestone for Huadong
Pharmaceutical, as it accelerates its transformation from a generic
drug company to an innovative drug company, elevates the profile of
its international strategy, and furthers its mission of providing
more and better products to the greatest number of patients. I wish
this cooperation a complete success."
About TTP273
TTP273 is an oral small molecule that works by activating the
GLP-1 receptor. Activation of the GLP-1 receptor leads to the
enhancement of insulin secretion and suppression of glucagon
production and decreased food intake. There are currently several
marketed injectable GLP-1 peptide therapies. These agents have
demonstrated notable glucose lowering in addition to weight loss;
however, their widespread use may be hindered by the route of
administration (injection) and by the high incidence of
gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use
insulin properly to control sugar in the bloodstream. Type 2
diabetes represents up to 95% of diabetes patients, imposing a
growing burden on healthcare systems globally. Diabetes remains the
7th leading cause of death in the United States, costing the
healthcare system $245 billion annually. According to the American
Diabetes Association, there are 29.1 million Americans, or 9.3% of
the population, living with diabetes.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical
company engaged in the discovery and development of orally
administered small molecule drug candidates to fill significant
unmet medical needs. vTv has a pipeline of clinical drug candidates
led by programs for the treatment of Alzheimer’s disease and
diabetes as well as treatment of inflammatory disorders and the
prevention of muscle weakness.
About Huadong Pharmaceutical Company
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, is a wholly
owned subsidiary of Huadong Medicine Co., Ltd. The company was
incorporated in December 1992 and is a comprehensive pharmaceutical
company that integrates traditional Chinese medicine, western
medicine, bio-tech products API and dosage forms. The company
has formed a series of
drugs in the field of diabetes treatment
and is in a leading position of domestic
manufacturers in China. One of the company’s main products Acarbose
has more than $ 220 million in sales in 2016. The company currently
has more than 20 varieties in the field of diabetes in the
development process, in which liraglutide of GLP-1 received the
first clinical approval in China in August 2016.
Forward-Looking Statements
This release contains forward-looking statements, which involve
risks and uncertainties. These forward-looking statements can be
identified by the use of forward-looking terminology, including the
terms “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” “would” and, in each case, their
negative or other various or comparable terminology. All statements
other than statements of historical facts contained in this
release, including statements regarding the timing of our clinical
trials, our strategy, future operations, future financial position,
future revenue, projected costs, prospects, plans, objectives of
management and expected market growth are forward-looking
statements. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Important factors that
could cause our results to vary from expectations include those
described under the heading “Risk Factors” in our Annual Report on
Form 10-K and our other filings with the SEC. These forward-looking
statements reflect our views with respect to future events as of
the date of this release and are based on assumptions and subject
to risks and uncertainties. Given these uncertainties, you should
not place undue reliance on these forward-looking statements. These
forward-looking statements represent our estimates and assumptions
only as of the date of this release and, except as required by law,
we undertake no obligation to update or review publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise after the date of this release. We
anticipate that subsequent events and developments will cause our
views to change. Our forward-looking statements do not reflect the
potential impact of any future acquisitions, merger, dispositions,
joint ventures or investments we may undertake. We qualify all of
our forward-looking statements by these cautionary statements.
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Investors:vTv Therapeutics Inc.Mike Biega,
617-221-9660IR@vtvtherapeutics.comorMedia:W2OpureKatie Engleman,
910-509-3977Katie@w2ogroup.com
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