Lantheus Acquires NAV-4694, a Next-Generation ß Amyloid PET Imaging Agent for Alzheimer’s Disease
2024年7月15日 - 9:30PM
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
StatementsThis 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:
LantheusMark KinarneyVice President, Investor
Relations978-671-8842ir@lantheus.com
Melissa DownsSenior Director, External
Communications646-975-2533media@lantheus.com
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