Lantheus Acquires NAV-4694, a Next-Generation ß Amyloid PET Imaging Agent for Alzheimer’s Disease

BEDFORD, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced its acquisition of Meilleur Technologies, Inc., which includes NAV-4694, expanding Lantheus’ Alzheimer’s disease pipeline.

Through this acquisition, Lantheus now has the worldwide exclusive rights to ß amyloid PET (positron emission tomography) imaging agent, NAV-4694, also known as F18-flutafuranol. NAV-4694 is currently in Phase 3 development and is also being used in academic and industry investigational therapeutic trials. The acquisition of this asset broadens Lantheus’ Alzheimer’s diagnostic portfolio and complements Lantheus’ next generation F18-labeled PET imaging agent candidate, MK-6240 (also known as florquinitau), which targets tau tangles in Alzheimer’s disease.

Recently published updated guidelines developed by a working group of the National Institute on Aging and the Alzheimer's Association (NIA-AA) state that Alzheimer’s disease should be defined biologically, using protein-based biomarkers. These guidelines recommend that biomarkers, including both amyloid- and tau-PET imaging, may be used to diagnose Alzheimer's disease and provide an indication of its severity.¹

“This acquisition solidifies our commitment to neurology, specifically for Alzheimer’s disease management, and reinforces our radiopharmaceutical leadership,” said Brian Markison, CEO, Lantheus. “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.”

Under the terms of the agreement, Lantheus will provide an upfront payment as well as potential additional development and commercial milestone payments. Additionally, Lantheus will make royalty payments for research revenue and commercial sales. Structured as a stock purchase, the agreement specifies, among other things, that the sellers will also provide transition and clinical development services for a prescribed time following the closing of the transaction.

“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, Inc. “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.”

Alzheimer’s disease is a degenerative neurological disorder that causes a decline in cognition and function. In the U.S., there are nearly 12 million people living with mild cognitive impairment or Alzheimer’s disease. As the population ages, it is likely that the prevalence of this disease will continue to rise and, by 2050, the number of people 65 and older with mild cognitive impairment and Alzheimer’s disease may grow to more than 20 million.²

Chestnut Partners, Inc. acted as exclusive financial advisor to Meilleur Technologies, Inc. in this transaction and Goodwin Procter LLP acted as legal advisor. Foley Hoag LLP acted as legal advisor to Lantheus in connection with the transaction.

About Lantheus 
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

About Meilleur Technologies, Inc.
Meilleur’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.

Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "continue,” “may,” “poised,” “potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) our ability to successfully continue existing clinical development partnerships using NAV-4694 as a research tool; (ii) the timing and potential outcomes of clinical studies using NAV-4694; (iii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for NAV-4694; (iv) our ability to launch NAV-4694 as a commercial product; (v) the market receptivity to NAV-4694 as a radiopharmaceutical diagnostic; (vi) the existence, availability and profile of competing products; (vii) our ability to obtain and maintain adequate coding, coverage and payment for NAV-4694; (viii) the safety and efficacy of NAV-4694; (ix) the intellectual property protection of NAV-4694; (x) our ability to successfully develop and scale the manufacturing capabilities to support the launch of NAV-4694; and (xi) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).

¹Jack CR, et.al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimer’s Dement 2024;1-27. https://doi.org/10.1002/alz.13859

²Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5).

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com