Lantheus Medical Imaging, Inc. (“LMI”), a subsidiary of Lantheus
Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), and GE Healthcare
(NYSE:GE), today announced the signing of a term sheet relating to
the continued Phase III development and worldwide commercialization
of flurpiridaz F 18, an investigational positron emission
tomography (PET) myocardial perfusion imaging (MPI) agent that may
improve the diagnosis of coronary artery disease (CAD).
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Under the proposed transaction, GE Healthcare would fund the
second Phase III flurpiridaz F 18 clinical study, worldwide
regulatory approvals and its worldwide launch and
commercialization, with LMI collaborating in both development and
commercialization through a joint steering committee. LMI would
also maintain the option to co-promote the agent in the U.S. GE
Healthcare’s development plan would focus on obtaining regulatory
approval in the U.S., Japan, Europe and Canada.
Mary Anne Heino, President and CEO of Lantheus commented, “We
are excited about the prospect of GE Healthcare being our global
partner to complete the development of flurpiridaz F 18 and bring
this next generation agent to market, as they touch every level of
the PET diagnostic delivery continuum and share our commitment to
serving the nuclear medicine community. The collaboration would
enable us to participate in the long-term economic success of
flurpiridaz F 18. LMI will also continue to advance our other
pipeline assets and pursue additional near-term business
development opportunities to drive growth.”
Emmanuel Ligner, General Manager, Core Imaging, GE Healthcare,
said: “Pursuing this agreement with LMI will further strengthen our
nuclear medicine portfolio and demonstrates our commitment to
cardiovascular PET imaging. It is a key focus of our strategy to
increase the number of tools at the disposal of clinicians around
the world diagnosing and treating patients with cardiovascular
disease.”
Under the proposed transaction, LMI would receive a USD 5
million upfront cash payment and, if successful, up to USD 60
million in regulatory and sales milestones payments, plus tiered
double-digit royalties on U.S. sales and mid-single-digit royalties
on sales outside of the U.S. LMI also would receive an option to
co-promote in the U.S. Subject to satisfactory due diligence and
necessary approvals, the parties anticipate entering into a
definitive agreement for the proposed transaction in the second
quarter of 2017. However, there is no assurance that the parties
will enter into a definitive agreement on these terms or at
all.
About Flurpiridaz F 18 and Coronary Artery
DiseaseFlurpiridaz F 18, a fluorine 18-labeled agent that binds
to mitochondrial complex 1 (MC-1)1, was designed to be a novel PET
imaging agent that may better evaluate patients with known or
suspected CAD, which is the most common form of heart disease2,
affecting an estimated 15.5 million Americans 20 years of age or
older3. CAD is the leading cause of death in the United States for
both men and women2. Each year more than 400,000 Americans die from
CAD2. In the first phase 3 study, flurpiridaz F 18 demonstrated
improved CAD detection and reduced radiation exposure over standard
single photon emission computed tomography (SPECT). In subgroup
analyses, the risk-benefit profile of flurpiridaz F 18 PET imaging
appeared to be favorable in women, obese patients and patients with
multi-vessel disease. It is important to note that, with a 110
minute half-life, flurpiridaz F 18 can be used in conjunction with
treadmill exercise, which is not feasible with other currently
available PET tracers for MPI.
About PET and MPIPET imaging or a PET scan is a type of
nuclear medicine imaging procedure4 that provides information about
the function and metabolism of the body’s organs, unlike computed
tomography (CT) or magnetic resonance imaging (MRI), which
primarily show anatomy and structure5. MPI is a non-invasive test
that utilizes a small amount of radioactive material
(radiopharmaceutical) injected into the body to depict the
distribution of blood flow to the heart. MPI is used to identify
areas of reduced blood flow to the heart muscle. The test is
typically conducted under both rest and stress conditions, after
which physicians examine and compare the two scans and predict
whether the patient has significant coronary artery disease6.
Although SPECT is most commonly used for MPI7, PET imaging has
gained considerable support and use in the field of cardiovascular
imaging, as it offers many advantages to SPECT, including higher
spatial and contrast resolution, resulting in higher image quality
and improved diagnostic accuracy, accurate attenuation correction
and risk stratification8.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging,
Inc.Lantheus Holdings, Inc. is the parent company of Lantheus
Medical Imaging, Inc., a global leader in the development,
manufacture and commercialization of innovative diagnostic imaging
agents and products. LMI provides a broad portfolio of products,
which are primarily used for the diagnosis of cardiovascular
diseases. LMI’s key products include the echocardiography contrast
agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable
Suspension; TechneLite® (Technetium Tc99m Generator), a
technetium-based generator that provides the essential medical
isotope used in nuclear medicine procedures; and Xenon (Xenon Xe
133 Gas), an inhaled radiopharmaceutical imaging agent used to
evaluate pulmonary function and for imaging the lungs. LMI is
headquartered in North Billerica, Massachusetts with offices in
Puerto Rico and Canada. For more information, visit
www.lantheus.com.
About GE HealthcareGE Healthcare provides
transformational medical technologies and services to meet the
demand for increased access, enhanced quality and more affordable
healthcare around the world. GE (NYSE: GE) works on things that
matter - great people and technologies taking on tough challenges.
From medical imaging, software & IT, patient monitoring and
diagnostics to drug discovery, biopharmaceutical manufacturing
technologies and performance improvement solutions, GE Healthcare
helps medical professionals deliver great healthcare to their
patients. For more information about GE Healthcare,
visit www.gehealthcare.com.
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, including with regard to the finalization and
execution of a definitive agreement relating to completion of the
development of, and expected value of, the flurpiridaz F 18
program. Such forward-looking statements are subject to risks and
uncertainties that may be described from time to time in our
filings with the Securities and Exchange Commission. 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.
1 Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J,
Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP.
Mechanism of uptake and retention of 18F BMS-747158-02 in
cardiomyocytes: A novel PET myocardial imaging agent. Journal
Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.
2 National Institutes of Health, National Heart, Lung, and Blood
Institute. Coronary Artery Disease: Who Is At Risk.
http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html.
Accessed January 2017.
3 Heart Disease and Stroke Statistics. 2016 Update: A Report
From the American Heart Association. Circulation.
2016;133:e38-e360.
4 Radiology Info. What is Positron Emission Tomography –
Computed Tomography (PET/CT) Scanning.
http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed
January 2017.
5 National Institutes of Health. NIH Clinical Center. Positron
Emission Tomography Department Overview.
http://clinicalcenter.nih.gov/pet/. Accessed January 2017.
6 Society of Nuclear Medicine. Procedure Guidelines for
Myocardial Perfusion Imaging. Version 3.0 June 2002.
http://interactive.snm.org/docs/pg_ch02_0403.pdf.
7 Salerno, M and Beller, GA, Noninvasive Assessment of
Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.
8 Heller, G, Calnon, D and Dorbala, S. Recent Advances in
Cardiac PET and PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol
2009; 16:962-9.
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version on businesswire.com: http://www.businesswire.com/news/home/20170221006543/en/
Lantheus Holdings, Inc.Meara Murphy, 978-671-8508orGary Santo,
978-671-8960orGE HealthcareErin Bryant, 774-843-7178
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