Enhanced Intellectual Property Protection: Q&A with Lauren D’Angelo

Lauren D'Angelo
Chief operating officer
Chief commercial officer

Alpha Cognition recently announced that it had secured a patent for the coated tablets that provide a pH-dependent release of Benzgalantamine. Since these tablets are used for the company’s upcoming launch of ZUNVEYL, a treatment for Alzheimer’s disease, this new patent will significantly improve Alpha Cognition’s position in the market. Pharmaceutical Executive spoke with Lauren D’Angelo, chief operating officer and chief commercial officer, about the upcoming launch.

Pharmaceutical Executive: How does the recent patent approval for ZUNVEYL impact your launch strategy?
Lauren D’Angelo: The recent approval significantly bolsters our launch strategy for ZUNVEYL. This patent extends our market exclusivity in the United States through 2044, providing a robust foundation for our long-term growth and commercialization plans.

With this enhanced intellectual property protection, we are strategically positioned to maximize ZUNVEYL's potential as a differentiated treatment for patients with mild to moderate Alzheimer's disease. The timing of this patent approval aligns seamlessly with our planned U.S. launch of ZUNVEYL this quarter, enabling us to proceed with confidence in our market positioning and outreach efforts.

Our leadership team has outlined a comprehensive commercial launch strategy targeting the $2 billion U.S. Alzheimer's long-term care market. This strategy includes detailed plans for market positioning, distribution, and long-term growth objectives, all of which are reinforced by the extended patent protection.

The recent patent approval not only secures our competitive advantage but also empowers us to effectively execute our launch strategy, bringing ZUNVEYL to patients in need while ensuring sustained growth and innovation in the Alzheimer's treatment landscape.

PE: ZUNVEYL is an oral medication for AD, what makes this so significant?
D’Angelo: Most oral AChEIs (donepezil, galantamine, and rivastigmine) are absorbed in the GI tract, which can directly contribute to their GI side effects.Because of this, patch versions have been introduced, which leads to another set of issues including skin irritation, adhesion issues, and misapplication (e.g., falling off, incorrect placement.)ZUNVEYL is the first and only FDA-approved AChEI to utilize prodrug enteric-coated, delayed-release technology to enhance ACh levels while minimizing absorption in the stomach and overstimulation of neurons in the GI nervous system.The prodrug design allows ZUNVEYL to remain inactive until after first pass metabolism in the liver, which then converts to active galantamine.Ultimately, ZUNVEYL is purposefully designed to offer dual protection from peripheral and central cholinergic side effects. Many AD patients in long-term care settings rely on caregivers for medication administration. An oral tablet is significantly easier to manage compared to patches (which need proper application) or IV treatments (which require specialized administration).

PE: What is the global commercialization strategy for ZUNVEYL?
D’Angelo: The global commercialization strategy for ZUNVEYL is designed to maximize market penetration, ensure broad patient access, and establish a strong competitive position in the Alzheimer’s treatment landscape. The strategy focuses on three key areas: U.S. market execution, international expansion, and strategic partnerships.The near-term focus is on establishing market leadership in the U.S. long-term care market, followed by global expansion into high-value international markets. For example, we recently announced a deal with China Medical System Holdings (CMS) for the development and commercialization of ZUNVEYL in Greater China (Mainland China, Hong Kong, Macau, and Taiwan).With strong leadership, an experienced commercial team, and a differentiated product, ZUNVEYL is positioned to become a leading treatment option for Alzheimer’s disease worldwide.

PE: Alpha Cognition recently expanded its commercial and medical teams. How is this impacting the launch of ZUNVEYL?
D’Angelo: The recent expansion of Alpha Cognition’s commercial and medical teams is having a significant positive impact on the ZUNVEYL launch strategy, ensuring a strong market entry and rapid adoption in the U.S. long-term care (LTC) market.

1. Strengthening Commercial Execution

The addition of key commercial leaders has allowed Alpha Cognition to accelerate launch preparations, with a focus on market access, sales execution, and physician engagement.

Sales Leadership & Market Penetration

• The four newly appointed regional sales leaders, all experts in long-term care (LTC) sales, are helping establish rapid commercial traction in key territories.
• Their deep relationships with LTC prescribers (neurologists, geriatricians, and primary care providers) are ensuring early ZUNVEYL adoption in nursing homes, assisted living facilities, and memory care units.

Market Access & Reimbursement Success

• Jack Kelly, Head of Market Access, is leading payer negotiations to ensure Medicare Part D coverage and formulary placement.
• The team is positioning ZUNVEYL’s purposefully designed advanced technology as a differentiator against generic AChEIs, making it a compelling option for payers and prescribers.

Marketing & HCP Engagement

• Amy Kincaid, Executive Director of Marketing and Commercial Strategy, is executing a targeted marketing strategy focused on:
• Digital campaigns to educate physicians and caregivers.
• KOL engagement and speaker programs to drive awareness.
• Medical education initiatives to highlight ZUNVEYL’s unique profile.

2. Medical Affairs: Enhancing Scientific Credibility & Adoption

The expansion of the medical affairs team is ensuring that HCPs, payers, and stakeholders understand ZUNVEYL’s unique clinical value.

Medical Science Liaison (MSL) Deployment

• MSLs are actively engaging with physicians, LTC facilities, and advocacy groups to provide education on ZUNVEYL’s mechanism of action, clinical differentiation, and patient benefits.
• KOL engagement strategies are reinforcing clinical confidence and driving early adoption.

Supporting Real-World Evidence & Data Generation

• The medical team plans to collaborate with LTC providers to generate real-world data (RWD) that further supports ZUNVEYL’s tolerability and efficacy profile.
• These efforts will help drive stronger payer acceptance and physician confidence in prescribing ZUNVEYL.

Alpha Cognition has successfully assembled a complete commercial leadership team in record time, ensuring seamless execution as ZUNVEYL enters the market.

• Fast-Tracked Hiring Process – The entire commercial team, including market access, sales leadership, and marketing, was built in just six weeks.
  Proven Leadership – Many of the new hires have worked with Alpha Cognition’s leadership team before, bringing trust, speed, and executional efficiency to the launch.
• Prepared for Sales Expansion – With commercial infrastructure in place, Alpha Cognition is now positioned to bring on sales representatives for full-scale promotion in LTC and, in the future, to broader HCP markets.

PE: What was the most challenging part of the journey so far?
D’Angelo: Raising capital to bring ZUNVEYL to market was undoubtedly one of the most challenging and demanding parts of the journey. Navigating the complexities of funding for a pharmaceutical launch, especially in a competitive and highly regulated industry like Alzheimer’s treatments, required strategic vision, persistence, and a strong financial network.

Challenges in Fundraising for ZUNVEYL:

• Market Skepticism – Despite the immense potential of Alzheimer’s treatments, there was skepticism about an ALZ company, especially given the high failure rates in the Alzheimer's space. Many investors are hesitant to back programs that high risks.
• Capital Intensity – Developing and launching a treatment like ZUNVEYL requires significant investment in clinical trials, regulatory approvals, and commercialization efforts, which are not only costly but also require long-term commitment.
• Navigating Economic Uncertainty – The broader financial climate and market volatility added another layer of difficulty, making it harder to secure favorable terms and attract the right investors who understood the long-term value of bringing a new Alzheimer’s treatment to market.

Strategic Approaches to Overcome These Hurdles:

• Compelling Value Proposition – Alpha Cognition’s ability to present ZUNVEYL’s clinical advantages, particularly its purposefully designed oral formulation, helped differentiate the company from others in the Alzheimer’s space.
• Investor Relations & Networks – By leveraging relationships with experienced biotech investors and demonstrating deep market knowledge, Alpha Cognition was able to build trust and confidence in the project.
• Public Offering Success – Raising $50 million through a public offering and securing an uplist to Nasdaq was a pivotal moment that provided the necessary capital for ZUNVEYL’s commercialization, despite the challenges in securing funding.
• Partnerships & Strategic Alliances – Collaborations with partners like CMS China were critical in securing non-dilutive capital and expanding ZUNVEYL’s global reach, helping to ease the financial burden on Alpha Cognition.

Despite these immense challenges, the determination and resilience of the team to continue raising money and pushing ZUNVEYL forward has proven successful. The $50 million public offering and Nasdaq uplist were significant milestones, enabling Alpha Cognition to navigate through these financial hurdles and position ZUNVEYL for a successful launch. This journey is a testament to the company’s strength, strategic foresight, and commitment to patients in need of better Alzheimer’s treatments.