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

Rhea-AI Summary

Alpha Cognition (ACOG) has entered into a $44 million exclusive licensing agreement with China Medical System Holdings for ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia, and New Zealand. The agreement includes $6 million in upfront payments plus development and commercial milestone payments, along with royalties on net sales.

ZUNVEYL, an FDA-approved oral treatment for mild-to-moderate Alzheimer's disease, will be developed, manufactured, and commercialized by CMS in the licensed territories. The target market includes an estimated 50 million people with Alzheimer's disease in the region. Alpha Cognition maintains its plans for a U.S. launch in Q1 2025.

Positive

• Secured $44 million licensing deal for ZUNVEYL in major Asian markets
• $6 million in upfront payments plus additional milestone payments and royalties
• Access to large market with estimated 50 million Alzheimer's patients
• Partnership reduces costs as CMS handles development and commercialization
• U.S. launch remains on schedule for Q1 2025

Negative

• Revenue generation dependent on CMS's successful execution in Asian markets
• Milestone payments contingent on development and commercial success

Insights

Pharmaceutical Industry Analyst

The $44 million licensing agreement with CMS represents a strategic milestone for Alpha Cognition. The deal structure, combining $6 million in upfront payments with milestone payments and royalties, provides both immediate capital infusion and long-term revenue potential. With China's Alzheimer's patient population of approximately 50 million, even a modest market penetration could generate substantial returns.

The partnership leverages CMS's established presence in Asian markets, particularly their expertise in CNS drug commercialization and regulatory navigation. This significantly reduces ACOG's market entry risks and development costs while maintaining upside exposure through royalties. The deal's timing, coinciding with ZUNVEYL's planned U.S. launch in Q1 2025, suggests a well-coordinated global commercialization strategy.

For a company with a market cap of $93.4 million, this deal represents transformative value, potentially providing sufficient capital runway through the critical U.S. launch phase while opening access to the world's largest Alzheimer's market.

Market Research Analyst

The Asian Alzheimer's market presents a compelling growth opportunity, particularly given China's rapidly aging population and increasing healthcare spending. The deal's structure intelligently mitigates market entry risks while maintaining significant upside potential through milestone payments and royalties.

CMS's selection as a partner is particularly strategic given their deep understanding of local market dynamics and established distribution networks. Their expertise in navigating China's complex regulatory environment could accelerate ZUNVEYL's path to commercialization in these high-potential markets.

Think of this deal as planting a seed in fertile soil - while the initial $6 million upfront payment may seem modest, the total potential value of $44 million plus royalties could yield substantial returns given the massive untapped market opportunity in Asia.

Neuroscience Industry Expert

ZUNVEYL's positioning as a next-generation acetylcholinesterase inhibitor addresses a critical need in Alzheimer's treatment. The FDA approval validates its efficacy profile, while the oral administration route offers practical advantages for patient compliance. In the Chinese market, where traditional medicine still holds significant influence, an FDA-approved Western medicine carries substantial credibility.

The timing is particularly opportune as Asian healthcare systems increasingly prioritize neurodegenerative disease treatments. With an estimated 50 million Alzheimer's patients in the target region, even modest market penetration could translate to significant patient impact and commercial success.

VANCOUVER, British Columbia & DALLAS--(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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250108752271/en/

For further information:

Investor Relations

IR@alphacognition.com

https://www.alphacognition.com/

Source: Alpha Cognition, Inc.

FAQ

What is the value of Alpha Cognition's (ACOG) licensing deal for ZUNVEYL in Asia?

The licensing deal is valued at $44 million, including $6 million in upfront payments plus development and commercial milestone payments, along with royalties on net sales.

When will Alpha Cognition (ACOG) launch ZUNVEYL in the United States?

Alpha Cognition plans to launch ZUNVEYL in the United States in Q1 2025.

Which territories are included in Alpha Cognition's (ACOG) ZUNVEYL licensing agreement with CMS?

The licensing agreement covers Asia (excluding Japan), Australia, and New Zealand.

What is the market size for ZUNVEYL in the licensed territories for Alpha Cognition (ACOG)?

The licensed territories include an estimated 50 million people with Alzheimer's disease.

What are CMS's responsibilities in the ZUNVEYL licensing agreement with Alpha Cognition (ACOG)?

CMS will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories.