Flutafuranol F-18

Lantheus pitched Meilleur’s amyloid-targeting NAV-4694 as a complement to its PET agent MK-6240, which is aimed at Alzheimer’s tau tangles. Lantheus is expanding its holdings of PET imaging agents for Alzheimer’s disease, with the acquisition of Meilleur Technologies.  The deal grants Lantheus exclusive worldwide rights to Meilleur’s radiopharmaceutical diagnostic that highlights beta amyloid plaques in the brain. The injectable agent—known as NAV-4694, or F18-flutafuranol—is currently in phase 3 development.  The acquisition comes just days after the Centers for Medicare and Medicaid Services proposed a separate payment pathway for certain diagnostic radiopharmaceuticals and nuclear medicine imaging agents—instead of bundling them as part of the procedure, as it had in the past.  The change was put forward in CMS’ proposal for payment systems among hospital outpatient services and ambulatory surgical centers, set for the 2025 calendar year. Lantheus’ stock price jumped nearly 60% on the news. The deal also follows the FDA’s approval earlier this month of Eli Lilly’s Kisunla (donanemab-abzt) treatment for Alzheimer’s, seen as a challenger to Biogen and Eisai’s Leqembi in a newly burgeoning area of anti-amyloid therapies. “This acquisition solidifies our commitment to neurology, specifically for Alzheimer’s disease management, and reinforces our radiopharmaceutical leadership,” Lantheus CEO Brian Markison said in a statement, which pitched Meilleur’s NAV-4694 as a complement to the company’s PET agent MK-6240, aimed at Alzheimer’s tau tangles. The companies estimate that nearly 12 million people are living with mild cognitive impairment or Alzheimer’s disease in the U.S. today, a number that may pass 20 million by 2050.  “With the combination of MK-6240 and NAV-4694, we are poised to provide important insights for guiding the use and assessing the impact of novel disease-modifying Alzheimer’s treatments,” Markison said. Lantheus previously acquired MK-6240, an F18-labeled agent also known as florquinitau, in February 2023 through its buyout of Cerveau Technologies.  While the exact financial terms of Lantheus’ deal with Meilleur were not disclosed, the companies said the stock purchase agreement includes an upfront payment as well as additional R&D and commercial milestones, plus royalties. Meilleur will also provide transitional clinical development services for a set time. “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 Meilleur CEO Rick Hiatt. “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.”

KNOXVILLE, Tenn.--( BUSINESS WIRE )--Enigma Biomedical USA (EB) today announced the appointment of Hartmuth Kolb, PhD as Chief Science Officer (CSO). Dr. Kolb’s passion for innovation and scientific rigor has driven his extensive career and broad recognition. He will join Enigma at the beginning of March, 2024. In his 10 year tenure at Johnson & Johnson Innovative Medicine, he served as the Vice President, Neuroscience Biomarkers and Global Head of Imaging. Before joining Johnson & Johnson, Dr. Kolb had roles as SVP Research at Avid/Lilly and was VP of Biomarker Research (PET Radiopharmaceutical Development) at Siemens Medical Solutions. In this latter role, Kolb and his team developed 18F-T807 (aka Flortaucipir), the first Tau-imaging PET biomarker, now available as Tauvid®. Prior to his tenure at Siemens, Dr. Kolb was Associate Professor of Chemistry at The Scripps Research Institute and Chief Operating Officer and Head of Chemistry at Coelacanth Corporation, a company founded by Professor Barry Sharpless to develop novel chemical technologies. In this role, Kolb became a founding Click Chemist and the first author of the foundational Click Chemistry publication which led to Barry Sharpless being awarded the 2022 Nobel Prize for Chemistry. Dr. Kolb serves as the co-chair of the Neuroscience Steering Committee of the Foundation for NIH (FNIH) biomarkers consortium, where he and the other co-chairs oversee a portfolio of pre-competitive biomarker projects related to neurodegeneration and neuropsychiatric diseases. Dr. Kolb has a PhD in Organic Chemistry from the Imperial College, London. “I am passionate about precision neuroscience, based on objective disease-related biomarkers,” said Dr. Kolb, “and am looking forward to joining the first-class Enigma team to develop new imaging biomarker solutions for diagnosis and staging of CNS disorders, which will enable the development of disease modifying therapies for patients.” “Enigma, and our affiliate companies, are focused on providing information and technologies to researchers and clinicians to enable the improvement of brain health,” said Rick Hiatt, Chief Executive Officer of Enigma Biomedical USA and President and CEO of Meilleur Technologies, Inc. “We are thrilled to have Hartmuth join our team and help us develop our long-term strategies and support our future direction. Hartmuth is joining an already strong EB team in which, along with our recently appointed Chief Medical Officer, Dr. Samantha Budd- Haeberlein, we have deep expertise in drug and biomarker development for neurodegenerative disease and a catalyst to continue to achieve our Company’s mission and vision.” About Enigma Biomedical - USA Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB’s neuroimaging biomarkers, including NAV-4694, provide Pharma and Academic researchers with best-in-class tools for enabling Disease-Modifying Therapy development with the highest possible precision and accuracy. EB also recently announced a partnership with AbbVie for exploration of their novel 4R Tau PET Imaging Biomarkers.