Turning its focus to neurology and following a successful acquisition of Life Molecular Imaging, Lantheus is on the path to revolutionize Alzheimer’s disease diagnosis by advancing its two late-stage diagnostic imaging agents, MK-6240, which targets tau, and NAV-4694, which targets beta-amyloid. Together these complementary radiodiagnostics could enable precise and accurate detection of these hallmarks of Alzheimer’s disease for earlier and ongoing diagnosis.
How does Lantheus fit into the Alzheimer’s disease landscape? Can you describe your newest cutting-edge imaging solutions for Alzheimer’s disease? And tell us about your developing radiodiagnostics that detect tau (MK-6240) and beta amyloid (NAV-4694) proteins?
Worldwide, 55 million people are living with Alzheimer’s disease (AD) and other dementias. It’s an exciting time for progress in AD research and treatment as there are now two approved therapies on the market, and more than 100 in clinical development—many targeting beta-amyloid and tau proteins. Diagnostics like beta-amyloid and tau PET imaging allow clinicians to detect the specific hallmarks of AD with a high degree of accuracy, even in the early stages of disease, and are becoming essential tools in modern AD care. Our two late-stage AD diagnostics, MK-6240, which targets tau, and NAV-4694, which targets beta-amyloid, are highly complementary to Neuraceq (florbetaben F 18 injection), our globally approved F-18 PET-imaging agent used to detect beta-amyloid plaques in patients at risk of AD. We believe our portfolio puts us in a strong position to support patients and physicians across the full AD continuum—from early diagnosis to ongoing treatment—and illustrates how these kinds of diagnostics could one day help guide individuals to the most appropriate therapies for their stage of disease and their specific proteinopathy profile.
Tell us about the acquisition of Life Molecular Imaging and how it has advanced your capabilities in Alzheimer’s disease?
We are building a commercial radiodiagnostic franchise focused on AD, fueled by our recent acquisition of Life Molecular Imaging (LMI). This acquisition brought Neuraceq, as well as additional radiopharmaceutical research and development (R&D) expertise, talented individuals and AD commercial infrastructure, while expanding our presence in Europe and enhancing our pipeline with highly complementary clinical assets targeting diseases with significant patient needs.
By leveraging our go-to-market infrastructure and expertise in F-18 radiochemistry, we’re aiming to make a meaningful impact across diagnosis, staging, patient selection and monitoring—areas that are going to become even more critical as new therapies become available. With Neuraceq approved, and both tau- and beta-amyloid-imaging agent candidates advancing toward commercialization, we’re well positioned to serve as a comprehensive diagnostic partner for clinicians managing patients with AD and dementia.
Lantheus is a newcomer to neurology. Can you tell us about your neurology pipeline?
We are advancing a growing neurology pipeline with an initial focus on AD. MK-6240, our tau-targeting tracer, is advancing toward FDA submission with the potential to become an essential tool for early and accurate diagnosis. Other neurology products in late-stage development include NAV-4694, which is a beta-amyloid-imaging agent, and LNTH-2620/PI-2620, which is a tau PET agent granted fast-track designation by the FDA for use in AD, progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD).
But neurodegenerative conditions are complex, and difficult to differentiate and treat, so we are evaluating how markers of other processes such as inflammation play a role. Imaging provides extensive data combining biological signature with disease location, and we are continuously exploring opportunities to expand our portfolio with tools that can provide additional insight into complex and multi-factorial neurodegenerative conditions.
How does Lantheus hope to impact the AD diagnostic landscape?
Over 7 million Americans are living with AD, and that number is projected to rise to almost 13 million by 2050. Lantheus aims to transform AD diagnosis by advancing high-quality imaging agents for beta-amyloid and tau, enabling earlier, more-precise and more-accessible detection. Our acquisition of LMI accelerated our entry into this space, building a strong commercial and R&D platform. With AD cases expected to nearly double, there is a critical need for better tools to support earlier intervention, improved patient management, and the development of new therapies. This effort aligns with our strategy to drive innovation in radiodiagnostics and address significant unmet medical needs. The PET imaging market also represents a significant growth opportunity with a US market potential of approximately $1.5 billion by the end of the decade and aligns directly with our strategy and existing capabilities.
Why is Lantheus bringing two different AD radiodiagnostics to market at a similar time?
These products are highly complementary, as AD and related neurodegenerative conditions are multifactorial with localization and impact changing across the course of disease. The potential to add Neuraceq to our commercial portfolio and bring both a tau-targeting and a beta-amyloid-targeting radiodiagnostic to market, allows us to offer a more complete solution for AD, both scientifically and clinically. AD is a complex disease with two key pathological hallmarks: beta-amyloid tends to show up early; while tau accumulation is more closely linked to disease progression and cognitive decline. Clinicians increasingly recognize the value of imaging both biomarkers to gain a comprehensive understanding of disease status. Having both diagnostics available would enable physicians to more clearly determine where a patient is along the disease continuum.