In July, Vancouver-based Alpha Cognition —a biopharmaceutical company with a North Texas office in Frisco—received FDA approval for its  ZUNVEYL oral therapy to treat mild-to-moderate Alzheimer’s disease. The company said this week it remains “on track” to launch ZUNVEYL in the United States in the first quarter of 2025. And now it’s taken a big step toward commercializing the drug on the far side of world. 

The company has signed a licensing agreement with China Medical System Holdings Limited (CMS), a platform company linking pharmaceutical innovation and commercialization with “strong product lifecycle management capability” in the People’s Republic of China.

The exclusive licensing agreement is for the development, manufacturing, and commercialization of ZUNVEYL in Asia (excluding Japan), Australia, and New Zealand.

ZUNVEYL, the brand name for benzgalantamine, is a next-generation acetylcholinesterase inhibitor approved in the U.S. for the treatment of mild-to-moderate Alzheimer’s disease. 

The agreement includes $6 million in total upfront payments split into tranches and development and commercial milestone payments, Alpha Cognition said.

Alpha Cognition is eligible to receive royalties on net sales of ZUNVEYL in the above-named region and countries, while CMS is responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories, the company added.

‘Significant potential’

Michael McFadden

Alpha Cognition CEO Michael McFadden said ZUNVEYL “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.”

“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,” McFadden added in a statement.

In July, McFadden called the FDA approval of ZUNVEYL “a pivotal moment in the fight against Alzheimer’s disease as it’s only the second oral AD treatment to be approved in more than a decade” and said the drug was designed “to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”

“We’re delighted, as this represents a major breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease,” McFadden added in July.

The company was previously named a ‘Rising Star’ at the 2023 BioNTX iC3 Summit.

‘One of the largest and fastest-growing healthcare markets in the world’

Lauren D’Angelo

Lauren D’Angelo, the Frisco-based COO and chief commercial officer at Alpha Cognition, shared on LinkedIn the “incredible news” of the CMS agreement, calling China “one of the largest and fastest-growing healthcare markets in the world.”

“This is a huge step forward in expanding our global reach and delivering hope to more patients and families.” D’Angelo added. “I’m proud of what our team has accomplished and excited about what this means for the future of Alpha Cognition as we continue to make a meaningful impact worldwide.”

Earlier this week, D’Angelo offered insight into how Alpha Cognition is ramping up its commercialization team, by posting a welcome on LinkedIn to five new team members. They include Regional Business Directors Greg Anderson, Trierre Shanks, Michael Spence, and Jennifer Lane-Watson, as well as Senior Manager of Commercial Operations Nam Huynh.  

“This team brings unparalleled experience, energy, and passion to Alpha Cognition, and I’m confident they’ll play a pivotal role in bringing our innovative solutions to those who need them most,” D’Angelo wrote.

Get on the list.
Dallas Innovates, every day.

Sign up to keep your eye on what’s new and next in Dallas-Fort Worth, every day.