Alpha Cognition Announces a $44 Million Exclusive Licensing Agreement for the Development and Commercialization of ZUNVEYL (benzgalantamine), an FDA-Approved Treatment for Mild-to-Moderate Alzheimer’s Disease, in China
January 08 2025 - 8:30AM
Business Wire
Alpha Cognition, Inc. (Nasdaq: ACOG) (“ACI” or the “Company”), a
biopharmaceutical company developing novel therapeutics for
debilitating neurodegenerative disorders, and China Medical System
Holdings Limited (CMS) (867.HK), a platform company linking
pharmaceutical innovation and commercialization with strong product
lifecycle management capability in the People’s Republic of China,
today announced an exclusive licensing agreement for the
development, manufacturing and commercialization of ZUNVEYL
(benzgalantamine) in Asia (excluding Japan), Australia and New
Zealand. ZUNVEYL is a next generation acetylcholinesterase
inhibitor approved in the US for the treatment of mild-to-moderate
Alzheimer’s disease.
Terms of the agreement total $44 million, which includes $6
million in total upfront payments split into tranches and
development and commercial milestone payments. Additionally, ACI is
eligible to receive royalties on net sales of ZUNVEYL in Asia
(excluding Japan), Australia and New Zealand. CMS will be
responsible for the regulatory, development, manufacturing, and
commercialization of ZUNVEYL in the licensed territories.
“We are excited to partner with CMS to distribute ZUNVEYL, an
FDA-approved oral treatment for mild-to-moderate Alzheimer’s
disease. The product has significant potential in China and we
believe that CMS has the commitment and expertise to manage the
complex regulatory and commercial landscape in these territories,”
said Michael McFadden, CEO of Alpha Cognition. “With their strong
track record of developing and commercializing CNS therapies in
China, we believe CMS is the ideal partner to advance ZUNVEY’s
regulatory development in a region where 50 million people are
estimated to have Alzheimer’s disease.”
Alpha Cognition remains on track to launch ZUNVEYL in the United
States in Q1 2025. The company will provide a corporate update and
present its Launch Strategy on January 28, 2025 at 4pm EST.
About CMS
CMS is a platform company linking pharmaceutical innovation and
commercialization with strong product lifecycle management
capability, dedicated to providing competitive products and
services to meet unmet medical needs. CMS focuses on the global FIC
and BIC innovative products, and efficiently promotes the clinical
research, development and commercialization of innovative products.
CMS deeply engages in several specialty therapeutic fields, such as
cardio-cerebrovascular, central nervous system, gastroenterology,
dermatology and ophthalmology, and has developed proven
commercialization capabilities, extensive networks and expert
resources, resulting in leading academic and market positions for
its major marketed products. For more information about CMS, please
visit https://web.cms.net.cn/en/home.
About Alpha Cognition Inc.
Alpha Cognition Inc. is a commercial stage, biopharmaceutical
company dedicated to developing treatments for patients suffering
from neurodegenerative diseases, such as Alzheimer’s disease and
Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for
which there are currently no approved treatment options.
ZUNVEYL is a patented drug approved as a new generation
acetylcholinesterase inhibitor for the treatment of Alzheimer’s
disease, with expected minimal gastrointestinal side effects.
ZUNVEYL’s active metabolite is differentiated from donepezil and
rivastigmine in that it binds neuronal nicotinic receptors, most
notably the alpha-7 subtype, which is known to have a positive
effect on cognition. ALPHA-1062 is also being developed in
combination with memantine to treat moderate to severe Alzheimer’s
dementia, and as an intranasal formulation for Cognitive Impairment
with mTBI.
Forward-looking Statements
This news release includes forward-looking statements within the
meaning of applicable securities laws. Except for statements of
historical fact, any information contained in this news release may
be a forward‐looking statement that reflects the Company’s current
views about future events and are subject to known and unknown
risks, uncertainties, assumptions and other factors that may cause
the actual results, levels of activity, performance or achievements
to be materially different from the information expressed or
implied by these forward-looking statements. In some cases, you can
identify forward‐looking statements by the words “may,” “might,”
“will,” “could,” “would,” “should,” “expect,” “intend,” “plan,”
“objective,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “target,” “seek,” “contemplate,” “continue”
and “ongoing,” or the negative of these terms, or other comparable
terminology intended to identify statements about the future.
Forward‐looking statements may include statements regarding the
potential benefits of the licensing agreement for the development
and commercialization of ZUNVEYL in Asia (excluding Japan),
Australia and New Zealand, the Company’s timing and planned
activities to launch ZUNVEYL in the U.S. and China, the timing for
the Company’s planned corporate update call, the potential timing
for the availability of ZUNVEYL in the U.S. and China, the
potential future developments of ZUNVEYL in China, the potential
market size for ZUNVEYL in China, the Company’s business strategy
for the launch of ZUNVEYL in China, the market size and demand for
ZUNVEYL in China, the Company’s potential growth opportunities in
China, the timing and results of the Company’s milestone payments
for China, the Company’s regulatory submissions in China, and the
potential regulatory approval and commercialization of the
Company’s products in China. Although the Company believes to have
a reasonable basis for each forward-looking statement, we caution
you that these statements are based on a combination of facts and
factors currently known by us and our expectations of the future,
about which we cannot be certain. The Company cannot assure that
the actual results will be consistent with these forward-looking
statements. These forward-looking statements are subject to certain
risks, including risks regarding our ability to raise sufficient
capital to implement our plans to commercialize ZUNVEYL, risks
regarding the efficacy and tolerability of ZUNVEYL, risks related
to ongoing regulatory oversight on the safety of ZUNVEYL, risk
related to market adoption of ZUNVEYL, risks related to the
Company’s intellectual property in relation to ZUNVEYL, risks
related to the commercial manufacturing, distribution, marketing
and sale of ZUNVEYL, risks related to product liability and other
risks as described in the Company’s filings with Canadian
securities regulatory authorities and available at www.sedar.com
and the Company’s filings with the United States Securities and
Exchange Commission (the “SEC”), including those risk factors under
the heading “Risk Factors” in the Company’s Form S-1/A registration
statement as filed with the SEC on November 6, 2024 and available
at www.sec.gov. These forward‐looking statements speak only as of
the date of this news release and the Company undertakes no
obligation to revise or update any forward‐looking statements for
any reason, even if new information becomes available in the
future, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20250108752271/en/
For further information: Investor Relations
IR@alphacognition.com https://www.alphacognition.com/
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