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 August 2020.
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 about the AURORA study, please visit
https://clinicaltrials.gov/ct2/show/NCT03354273.
Forward-Looking StatementsThis document contains
"forward-looking statements" - that is, statements related to
future, not past, events. In this context, forward-looking
statements often address our expected future business and financial
performance and financial condition, and often contain words such
as "expect," "anticipate," "intend," "plan," "believe," "seek,"
"see," "will," "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 forward-looking statements.
About FlurpiridazIn 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. Follow us
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Pulse for latest news, or visit our
website, www.gehealthcare.com, for more information.
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. 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.
References:1. National Heart, Lung, and Blood
Institute website. Coronary heart disease (also known as coronary
artery
disease).http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html.
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.
2016;133:e38-e360.3. European Heart Network. European
Cardiovascular Disease Statistics, 2017 edition.
http://www.ehnheart.org/images/CVD-statistics-report-August-2017.pdf.
Accessed July 25, 2018.
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GE HealthcareClaudia Scarpelli, +49 173
5811032claudia.scarpelli@ge.comorLantheusMeara Murphy, + 1
978-671-8508meara.murphy@lantheus.com
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