NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced the first commercial shipment of Xenon Xe 133 Gas (Xenon 133) using unprocessed radiochemical Xenon 133 supplied by the Institute for Radioelements (IRE) in Belgium. The commercial availability of Xenon 133 sourced from IRE supports Lantheus’ commitment to ensuring the medical community has continued reliable access to Xenon 133 through 2016 and beyond. Lantheus is the market leader in the U.S. for the supply of finished vials of Xenon 133, an inhaled radiopharmaceutical imaging agent used for the evaluation of pulmonary function and imaging the lungs.
Earlier this month, Lantheus received approval from the U.S. Food and Drug Administration (FDA) for IRE to be a supplier of unprocessed radiochemical Xenon 133 for processing and finishing by Lantheus. IRE’s supply will supplement and eventually replace Lantheus’ current Xenon 133 supply when the National Research Universal (NRU) reactor in Canada no longer provides a regular supply of medical isotopes to the marketplace in October 2016.
“As the leading provider of Xenon 133, we have delivered on our commitment to the U.S. medical imaging community to secure consistent supply of this important imaging agent to meet the needs of patients now and in the future,” said Bill Dawes, Vice President of Manufacturing and Operations at Lantheus. “Through our exceptional quality, regulatory, technical and commercial collaboration with IRE, a world leader in the production of medical isotopes, we continue to provide solutions to our customers and the patients that they serve. We look forward to a long and productive relationship with IRE for Xenon 133 and Molybdenum-99.”
“We are happy to be working with Lantheus and expanding our commitment to patients in the United States,” said Jean-Michel Vanderhofstadt, CEO of IRE. “Providing for an uninterrupted high-quality supply of Xenon 133 and Molybdenum-99 are key priorities for our team while we simultaneously work to ensure that our important LEU conversion program meets the needs of its global stakeholders in the future. I am particularly grateful to the project team for outstanding cooperation and team work - - Lantheus and IRE have completed in record time an important project which has averted the potential shortage of a critical diagnostic imaging agent. We look forward to our continued work with Lantheus and our continued role in providing important medical isotopes to clinicians and patients in North America.”
About Xenon Xe 133 Gas (Xenon 133)
Xenon 133 is an inhaled
radiopharmaceutical imaging agent used for the evaluation of pulmonary
function and for imaging the lungs.
INDICATIONS AND USAGE:
Inhalation of Xenon 133 has proved
valuable for the evaluation of pulmonary function and for imaging the
lungs. It may also be applied to assessment of cerebral flow.
CONTRAINDICATIONS:
None known.
Important Safety Information:
Adverse reactions related to
the use of this agent have not been reported to date.
WARNINGS:
Xenon 133 delivery systems, i.e., respirators or
spirometers, and associated tubing assemblies must be leak proof to
avoid loss of radioactivity into environs not specifically protected by
exhaust systems.
Xenon 133 adheres to some plastics and rubber and should not be allowed in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic.
The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.
PRECAUTIONS:
General: Xenon 133, as well as other
radioactive drugs, must be handled with care and appropriate safety
measures should be used to minimize radiation exposure to patients and
to clinical personnel.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Please see full prescribing information on www.lantheus.com.
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, distribution 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. The
Company is headquartered in North Billerica, Massachusetts with offices
in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.
About the Institute for Radioelements
Located in Fleurus,
Belgium, the Institute for Radioelements (IRE) is a public utility
foundation that was created in 1971 to use nuclear technologies to
improve public health and environmental control. IRE is one of the
largest producers worldwide of radionuclides for use in nuclear medicine
and exports its products throughout the world. IRE produces
radionuclides used both for imaging (early screening for malignant
tumours, analysis of organ malfunction) and therapies (cancer
treatment). It is also responsible for the radiological monitoring of
the Belgian territory. IRE helps to improve the health and save the
lives of millions of individuals throughout the world every year. For
more information, please visit www.ire.eu.
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. 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.
