Lantheus Acquires Meilleur Technologies, PET Imaging Agent

Lantheus Holdings, a radiopharmaceutical company, announced on July 15, 2024 that it has acquired Meilleur Technologies. The acquisition includes the worldwide exclusive rights to ß amyloid positron emission tomography (PET) imaging agent, NAV-4694, expanding Lantheus’ Alzheimer’s disease pipeline. Currently in Phase III development, NAV-4694 is being used in both academic and industry trials and complements Lantheus’ next-generation F18-labeled PET imaging agent candidate, MK-6240, which targets tau tangles in Alzheimer’s disease (AD).

Lantheus will provide upfront payments as part of the acquisition agreement. Additional development and commercial milestone and royalty payments will be made by Lantheus. The sellers will provide transition and clinical development services for a time after the agreement closes.

“We are excited by the potential of NAV-4694 for earlier identification of Alzheimer’s patients, empowering clinicians to select suitable candidates for timely therapeutic interventions,” said Rick Hiatt, chief executive officer, Meilleur Technologies, in a press release. “With Lantheus’ expertise in radiopharmaceutical diagnostics and ability to scale operations, I am confident that Lantheus is the ideal company to bring this late-stage biomarker through pivotal trials and into commercialization to one day benefit patients at risk of Alzheimer’s disease.”

A degenerative neurological disease, Alzheimer’s impacts nearly 12 million people in the United States, with numbers expected to increase to more than 20 million by 2050 (1,2). The National Institute on Aging and the Alzheimer’s Association recommend that protein-based biomarkers, including both amyloid- and tau-PET imaging, may be used to diagnose Alzheimer’s (1,3).

Both industry and the public have had an invested interest in finding treatments for Alzheimer’s. In March 2024, FDA issued a draft guidance for developing treatments for early Alzheimer’s (4). The purpose of the guidance document is to assist sponsors who are in the clinical phases of development of drugs for treating the stages of sporadic Alzheimer’s disease that occur before dementia becomes overt. FDA states in the document that there has been an effort to use biomarkers that reflect underlying AD pathophysiological changes and to include study subjects with early Alzheimer’s. “These efforts are particularly important because there may be an opportunity to intervene very early in the disease process of AD, given the slowly progressive course of AD and the development of characteristic pathophysiological changes that greatly precede the development of clinically evident findings,” the document states. “Delaying or, preferably, halting or reversing the pathophysiological process that will lead to the initial clinical deficits of AD is the ultimate goal of presymptomatic or very early symptomatic intervention, and treatment directed at this goal must begin before there are overt clinical symptoms. This opportunity carries with it the need to understand ways to assess treatment benefit in these earlier stages of disease” (5).

In July 2024, the agency approved a once-monthly monoclonal antibody injection for intravenous infusion to treat adults with early symptomatic AD, including those with mild cognitive impairment or who are in the mild dementia stage of the disease with confirmed amyloid pathology (6). The therapy targets amyloid plaques, excessive buildup of which in the brain can result in thinking or memory issues consistent with AD (6).

References

1. Lantheus. Lantheus Acquires NAV-4694, a Next-Generation ß Amyloid PET Imaging Agent for Alzheimer’s Disease. Press Release. July 15, 2024. https://investor.lantheus.com/news-releases/news-release-details/lantheus-acquires-nav-4694-next-generation-ss-amyloid-pet
2. Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024, 20 (5).
3. Jack CR, et.al. Revised Criteria for Diagnosis and Staging of Alzheimer's Disease: Alzheimer's Association Workgroup. Alzheimer’s Dement 2024,1–27. DOI: 10.1002/alz.13859
4. Haigney, S. FDA Give Guidance on Developing Treatments for Early Alzheimer’s. PharmTech.com. March 15, 2024.
5. FDA. Early Alzheimer’s Disease: Developing Drugs for Treatment, Guidance for Industry, Draft Guidance (CDER, CBER, March 2024).
6. Eli Lilly and Company. Lilly's Kisunla (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease. Press Release. July 2, 2024.