Companies also announce the extension and expansion of their
existing commercial supply agreement for nuclear products through 2020
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Apr. 25, 2017--
Lantheus
Holdings, Inc. (NASDAQ: LNTH), parent company of Lantheus
Medical Imaging, Inc. (collectively, “Lantheus”), and GE
Healthcare (NYSE:GE), today announced the signing of a definitive
license agreement (the “definitive agreement”) for 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), the most common form of heart disease. The definitive
agreement follows the signing of a term sheet previously announced in
late February 2017.
Under the definitive agreement, GE Healthcare will lead and fund the
development program of flurpiridaz F18, including the second Phase III
clinical study. GE Healthcare will also have exclusive worldwide rights
for the commercialization of flurpiridaz F18. Lantheus will collaborate
in both the development and commercialization process through a joint
steering committee. Lantheus also maintains the option to co-promote the
agent in the U.S.
Lantheus will receive a USD 5 million upfront cash payment and, if
successful, up to USD 60 million in regulatory and sales milestones
payments, plus double-digit royalties on U.S. sales and single-digit
royalties on sales outside of the U.S.
Separately, the companies have also extended and expanded their current
commercial agreement under which Lantheus will continue to supply GE
Healthcare with TechneLite® (Technetium Tc99m Generators),
Gallium-67 (Gallium Citrate Ga 67 Injection), and Xenon-133 (Xenon Xe
133 Gas) through December 31, 2020.
Mary Anne Heino, President and CEO of Lantheus commented, “With our
definitive agreement for flurpiridaz F 18 in place, we look forward to
collaborating with GE Healthcare to complete the development and
commercialization efforts to bring this novel PET cardiac imaging agent
to market. On the nuclear medicine products contracting strategy front,
we are excited to extend and expand our longstanding commercial
relationship with GE through a multi-year supply agreement.”
Emmanuel Ligner, General Manager of Core Imaging for GE Healthcare said,
“We are committed to strengthening and expanding our nuclear portfolio
through this strategic partnership with Lantheus and potentially offer a
new diagnostic option to clinicians and patients in CAD. I’m thrilled to
bring GE Healthcare’s proven track record of new product development and
commercialization to this agreement as well as the quality and
reliability that our customers expect globally.”
About Flurpiridaz F 18 and Coronary Artery Disease
Flurpiridaz 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 MPI
PET 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 Healthcare
GE 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 Statements
This 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.
2National 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 April 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
April 2017.
5National Institutes of Health. NIH Clinical Center.
Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/.
Accessed April 2017.
6Society 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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Source: Lantheus Holdings, Inc.
Lantheus Holdings, Inc.
Meara Murphy, 978-671-8508
or
Gary
Santo, 978-671-8960
