SOUTH SAN FRANCISCO, Calif. and
SHANGHAI, June 25, 2020 /PRNewswire/ -- VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and other central nervous system (CNS) diseases and disorders with
high unmet need, and EverInsight Therapeutics Inc., a
biopharmaceutical company focused on developing and commercializing
transformative pharmaceutical products that address critical unmet
medical needs for patients in Greater
China and other parts of Asia, today announced they
have entered into a strategic licensing and collaboration agreement
for the clinical development and commercialization of PH94B,
VistaGen's novel, rapid-onset neurosteroid drug candidate for
multiple anxiety-related disorders, in Greater China, South
Korea and Southeast Asia.
In December 2019, VistaGen received
Fast Track designation from the U.S. Food and Drug Administration
(FDA) for development of PH94B for treatment of social anxiety
disorder (SAD), the FDA's first Fast Track designation for a SAD
drug candidate. The goal of the collaboration is to advance and
support Phase 3 development and commercialization of PH94B as a
potentially groundbreaking anti-anxiety medicine for patients in
Greater China and other important
Asian markets.
Under the terms of the agreement, EverInsight will be
responsible for clinical development, regulatory submissions and
commercialization of PH94B neuroactive nasal spray for acute
treatment of SAD, and potentially other anxiety-related
indications, in markets in Greater
China (Mainland China, Hong
Kong, Macau and
Taiwan), South Korea and Southeast Asia (Indonesia, Malaysia, Philippines, Thailand and Vietnam) (the Territory). EverInsight will
make a non-dilutive upfront payment of $5
million to VistaGen, and VistaGen is eligible to receive
additional development and commercial milestone payments of up to
$172 million. VistaGen will receive
tiered royalties on sales of PH94B in the Territory, if Phase 3
development efforts are successful. VistaGen retains exclusive
rights to develop and commercialize PH94B in all markets outside
the Territory.
"We are pleased to collaborate with EverInsight, a company that
shares our vision and excitement for bringing PH94B, a potentially
transformative treatment for multiple anxiety disorders, to
millions of individuals with unmet needs around the world.
EverInsight is an ideal partner to support Phase 3 clinical
development and commercial launch of PH94B in Greater China and other Asian markets, as we
continue to focus on those activities in the U.S.,"
stated Shawn Singh, Chief
Executive Officer of VistaGen. "Anxiety, including social
anxiety disorder, is a common and potentially debilitating illness
that can have significant emotional, functional and economic
effects on those who suffer, as well as their families, friends and
colleagues. With the recent onset of mental health stressors
associated with the COVID-19 pandemic and social justice unrest,
the rising prevalence of anxiety, depression, and suicide is
alarming. PH94B has a fundamentally different mechanism of action
than all current treatments for social anxiety disorder and
numerous other anxiety disorders, arguably the first new
rapid-onset mechanism of action for treatment of anxiety in several
decades. Our strategic collaboration today with EverInsight
positions PH94B one step closer to becoming a potentially
paradigm-shifting new treatment alternative for individuals
worldwide."
"We partner with innovative companies that develop novel
medicines with large commercial potential in Greater China and other Asian markets. PH94B
is an extremely valuable asset that the world desperately needs
today to provide potential relief from the debilitating impact of
anxiety on daily life," said Sean
Cao, Managing Director of CBC Group, which is currently
funding EverInsight. "We are delighted to partner with VistaGen's
team and are highly confident in our plan to advance PH94B through
the necessary clinical development and approval process focused on
successful commercialization in our core markets."
About VistaGen
VistaGen Therapeutics is a multi-asset,
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety, depression and certain CNS diseases and
disorders where current treatments are inadequate, resulting in
high unmet need. VistaGen's pipeline is focused on three
clinical-stage CNS drug candidates, each with a differentiated
mechanism of action, an exceptional safety profile, and therapeutic
potential in multiple large and growing CNS markets. For more
information, please visit www.vistagen.com and connect with
VistaGen on Twitter, LinkedIn and Facebook.
About EverInsight Therapeutics
EverInsight
Therapeutics Inc. is a biopharmaceutical company focused on
developing and commercializing transformative pharmaceutical
products that address critical unmet medical needs in CNS and
ophthalmology for patients in Greater
China and other Asian markets. The management team of
EverInsight Therapeutics has deep expertise and an extensive track
record of high-quality clinical development, regulatory affairs,
CMC, business development and operations both in China and with leading global pharmaceutical
companies. EverInsight Therapeutics is currently funded by the CBC
Group.
About CBC Group
CBC Group (formerly C-Bridge Capital)
is one of the largest and most active healthcare-dedicated
investment firms in Asia focused
on platform-building and buyout opportunities across three core
areas within the healthcare sector: pharmaceutical & biotech,
medtech and healthcare services. CBC's operationally intensive
approach empowers healthcare sector champions to make
transformative changes to enable sustainable long-term growth,
fulfill unmet medical needs and continuously improve the standard
of living and quality of care in China and the rest of Asia. Founded in 2014, CBC has a strong team
of investment, healthcare and portfolio management professionals
based across Singapore,
Shanghai, Beijing, Hong
Kong and New York.
About PH94B
PH94B is a first-in-class, odorless,
rapid-onset (within approximately 15 minutes) synthetic
neurosteroid nasal spray with therapeutic potential across a broad
range of anxiety-related disorders. Easily self-administered in
microgram doses, PH94B does not require systemic uptake and
distribution to produce its rapid-onset anti-anxiety effects.
VistaGen is initially developing PH94B as a potential fast-acting,
non-sedating, non-addictive new generation acute treatment of
social anxiety disorder (SAD), as well as for adjustment disorder
with anxiety related to the COVID-19 pandemic. With its rapid-onset
pharmacology, lack of systemic exposure and excellent safety
profile, PH94B also has potential as a novel treatment for
postpartum anxiety, post-traumatic stress disorder, preoperative
anxiety, panic disorder and other anxiety-related disorders.
VistaGen is preparing for Phase 3 clinical development of PH94B for
SAD and Phase 2A development for AjDA associated with the COVID-19
pandemic. The FDA has granted Fast Track designation for
development of PH94B as a treatment for SAD, the first such
designation by the FDA for SAD. View more background
information on SAD and a video on PH94B's mechanism of action.
Forward-Looking Statements
Various statements in this
release are "forward-looking statements" concerning VistaGen's
future expectations, plans and prospects, including: the potential
of PH94B to be a paradigm shift in the treatment of SAD and other
anxiety-related disorders; the potential for successful development
and commercialization of PH94B in the U.S. and the EverInsight
markets, including the Territory; and expectations for future
milestones and royalties under the collaboration described herein.
These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: development and review of
PH94B may not be achieved in any market; regulatory authorities in
the U.S. or in the EverInsight markets, including the Territory,
may decide that the design or results of the PH94B clinical program
are not sufficient for regulatory approval for acute treatment of
SAD or any other indication; development of PH94B may not be
successful in any indication; success in nonclinical studies or in
earlier stage clinical trials may not be repeated or observed in
ongoing or future studies which may not support further development
or be sufficient to gain regulatory approval to market the product;
adverse events may be encountered at any stage of development that
negatively impact further development; and even if development
efforts are successful there may be events that limit market
potential or trigger reductions in milestones or royalties under
the collaboration described herein. Other risks and uncertainties
include, but are not limited to, issues related to: adverse
domestic and foreign healthcare reforms and changes of laws and
regulations; general industry and market conditions; changes in
interest rates and currency exchange rates; manufacturing and
marketing risks, which include, but are not limited to, inadequate
capacity to meet demand and unavailability of raw materials; entry
of competitive products; and other technical and other unexpected
hurdles in the development, manufacture and commercialization of
PH94B, as well as those risks more fully discussed in the section
entitled "Risk Factors" in VistaGen's most recent Quarterly Report
on Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in either company's
other filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent the companies'
views only as of today, and should not be relied upon as
representing their views as of any subsequent date. The companies
explicitly disclaim any obligation to update any forward-looking
statements.
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SOURCE VistaGen Therapeutics