BOSTON & NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Jul. 31, 2018--
GE Healthcare and Lantheus Holdings, Inc. (NASDAQ: LNTH), parent company
of Lantheus Medical Imaging, Inc. (collectively “Lantheus”), have
started a second Phase 3 clinical trial of Flurpiridaz 18F
(called the AURORA study), an investigational agent being evaluated for
the detection of coronary artery disease (CAD), the most common form of
heart disease.1 CAD affects an estimated 15.5 million
Americans 20 years of age or older2 and is the leading cause
of death in the United States1 and in Europe, where CAD is
responsible for 19% of all deaths among men and 20% of deaths among
women each year. 3
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The AURORA study is an international, multicenter study to evaluate
diagnostic efficacy of Flurpiridaz 18F Injection
positron-emission tomography (PET) myocardial perfusion imaging (MPI) in
the detection of CAD. In this prospective, open-label, study, patients
with suspected CAD, for whom an intracoronary angiography (ICA) has been
indicated, will undergo a single-photon emission computed tomography
(SPECT) MPI and Flurpiridaz 18F Injection PET MPI prior to
the performance of coronary angiography. The primary endpoint is the
diagnostic efficacy (sensitivity and specificity) of Flurpiridaz 18F
Injection PET MPI for the detection of significant CAD. The first
patient was enrolled in the study in June 2018. A total of 650 patients
will be enrolled, with the last patient follow-up projected to occur in
Kevin O’Neill, General Manager of Core Imaging for GE Healthcare, said,
“We are thrilled to see this critical stage of the study move forward.
We are committed to the development of a potential new diagnostic option
for clinicians and their CAD patients in the future.”
Mary Anne Heino, President and CEO of Lantheus, commented, “The second
Phase 3 study of Flurpiridaz 18F represents a significant
milestone in the development of this promising investigational agent.
Importantly, it illustrates our strong collaboration with GE Healthcare,
and we look forward to the continued progress of the clinical program.”
For more information abouttheAURORA study, please visit https://clinicaltrials.gov/ct2/show/NCT03354273.
This document contains
"forward-looking statements" - that is, statements related to future,
not past, events. In this context, forward-looking statements often
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"would," “estimate,” “forecast,” "target," “preliminary,” or “range.”
Forward-looking statements are based on current plans, estimates, and
expectations that are subject to risks, uncertainties, and assumptions.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those indicated or anticipated by such forward-looking
statements. The inclusion of such statements should not be regarded as a
representation that such plans, estimates or expectations will be
achieved. Important factors that could cause actual results to differ
materially from such plans, estimates, or expectations include, among
others: events could cause the AURORA study to be stopped; the AURORA
study could fail to meet its primary endpoint; regulatory agencies may
reject the study data or fail to approve our new drug application; our
collaboration with Lantheus could encounter issues that lead to delays
or additional problems completing the development plan; changes in
general economic and/or industry-specific conditions; actions by third
parties, including government agencies could delay or stop development;
and other risk factors as detailed from time to time in GE’s respective
reports filed with the U.S. Securities and Exchange Commission (SEC),
including GE’s annual reports on Form 10-K, periodic quarterly reports
on Form 10-Q, periodic current reports on Form 8-K, and other documents
filed with the SEC. The foregoing list of important factors is not
exclusive. Any forward-looking statements apply only as of the date of
this communication. GE undertakes no obligation to update any
forward-looking statements, whether as a result of new information or
development, future events, or otherwise, except as required by law.
Readers are cautioned not to place undue reliance on any of these
In 2017, GE Healthcare and Lantheus
Holdings, Inc, parent company of Lantheus Medical Imaging, Inc,
announced the signing of a definitive
license agreement for the continued Phase 3 development and
worldwide commercialization of Flurpiridaz18F. Under this
agreement, GE Healthcare will lead and fund the development of
Flurpiridaz 18F, including the second Phase 3 clinical study.
GE Healthcare will also have exclusive worldwide rights for the
commercialization of Flurpiridaz18F. 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 United States.
About GE Healthcare:
GE Healthcare is the $19 billion
healthcare business of GE (NYSE: GE). As a leading provider of medical
imaging, monitoring, biomanufacturing, and cell and gene therapy
technologies, GE Healthcare enables precision health in diagnostics,
therapeutics, and monitoring through intelligent devices, data
analytics, applications, and services. With over 100 years of experience
in the healthcare industry and more than 50,000 employees globally, the
company helps improve outcomes more efficiently for patients, healthcare
providers, researchers, and life sciences companies around the world.
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for more information.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
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. Lantheus provides a
broad portfolio of products, which are primarily used for the diagnosis
of cardiovascular diseases. Lantheus' 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. Lantheus is
headquartered in North Billerica, Massachusetts with offices in Puerto
Rico and Canada. For more information, visit www.lantheus.com.
1. National Heart, Lung, and Blood
Institute website. Coronary heart disease (also known as coronary artery
Accessed July 25, 2018.
2. Mozaffarian D, Benjamin EJ, Go
AS, et al. Heart disease and stroke statistics–2016 update: a report
from the American Heart Association. Circulation.
3. European Heart Network. European
Cardiovascular Disease Statistics, 2017edition. http://www.ehnheart.org/images/CVD-statistics-report-August-2017.pdf.
Accessed July 25, 2018.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180731005219/en/
Source: Lantheus Holdings, Inc.
Claudia Scarpelli, +49 173 5811032
Murphy, + 1 978-671-8508