Companies also announce the extension and
expansion of their existing commercial supply agreement for nuclear
products through 2020
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.
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 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.
5 National Institutes of Health. NIH Clinical Center. Positron
Emission Tomography Department Overview.
http://clinicalcenter.nih.gov/pet/. Accessed April 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/20170425005873/en/
Lantheus Holdings, Inc.Meara Murphy, 978-671-8508orGary Santo,
978-671-8960
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