NORTH BILLERICA, Mass.--(Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced that the Company has added a Low-Enriched Uranium (LEU) TechneLite® (Technetium Tc 99m Generator) generator to the Company’s nuclear imaging product portfolio. Lantheus’ LEU TechneLite® generator is the first technetium-99m (Tc-99m) generator in the United States that contains molybdenum-99 (Mo-99) produced from at least 95 percent LEU. With greater access to LEU Mo-99 through its supply chain diversification strategy, Lantheus can now move closer to its goal of eventually eliminating Highly Enriched Uranium (HEU)-sourced Mo-99 from its supply chain. Lantheus’ first LEU TechneLite® generator was shipped on January 7, 2013.)--
“We continue to be committed to providing a stable, balanced and reliable supply of Mo-99 to our customers”
With the introduction of the LEU TechneLite® generator, Lantheus fully supports the U.S. government’s global nuclear security strategy to encourage reliable supplies of medical radioisotopes produced from non-HEU sources. On January 2, 2013, President Obama signed into law the American Medical Isotopes Production Act of 2011 (AMIPA) as part of the 2013 National Defense Authorization Act. The AMIPA encourages the domestic production of LEU Mo-99 and provides for the eventual prohibition of the export of HEU from the United States. In addition, the Centers for Medicare and Medicaid Services (CMS) recently stipulated in the 2013 final Medicare payment rules, for Medicare Hospital Outpatients, that CMS will provide incremental reimbursement for every Tc-99m diagnostic dose produced from non-HEU sourced Mo-99. Lantheus’ LEU TechneLite® generator satisfies the new reimbursement requirements under the CMS 2013 rules.
“We are pleased to be the first company to offer a Tc-99m generator produced using at least 95 percent LEU,” said Don Kiepert, President and Chief Executive Officer of Lantheus Medical Imaging. “As leaders in nuclear medicine, an important component of our global sourcing strategy is to increase our use of LEU-sourced Mo-99 with a goal of 100 percent by 2016. Our TechneLite® generator is used in many critical diagnostic imaging procedures, including scans of the heart, brain, bone, kidneys and some types of tumors. The introduction of our LEU TechneLite® generator expands our nuclear medicine product portfolio and meets CMS’ new reimbursement requirements for Medicare Hospital Outpatients in 2013, while supporting the government’s non-proliferation goal of moving away from the use of HEU in the production of medical isotopes.”
Mo-99 is the parent isotope of Tc-99m, which is the radioisotope most widely used for nuclear imaging tests.Tc-99m is used in approximately 15 million doses in the U.S. annually.1 As a leader in the radiopharmaceutical business, Lantheus has secured the most globally diversified and balanced Mo-99 supply chain in the industry, and receives the medical isotope from four of the five major processors and seven of the eight associated reactors.
In 2012, Lantheus announced expanded access to LEU-sourced Mo-99 with an extended agreement with NTP Radioisotopes in South Africa. Under the five-year agreement, Lantheus will receive an increasing supply of Mo-99 produced from LEU targets from NTP Radioisotopes (NTP) and Australian Nuclear Science and Technology Organisation (ANSTO). Additionally, Lantheus announced continued supply of Mo-99 from Nordion, which will be used in the production of the company’s non-LEU TechneLite® generators.
“We continue to be committed to providing a stable, balanced and reliable supply of Mo-99 to our customers,” said Cyrille Villeneuve, Chief Commercial Officer of Lantheus Medical Imaging. “Our gradual transition to LEU-sourced Mo-99 and the addition of the LEU TechneLite® generator ensures that our customers will have continued access to Tc-99m, now and in the future. We believe our LEU strategy gives us a strong position in the generator market and provides a differentiated offering for our customers.”
Technetium-99m (Tc-99m) is used in Lantheus Medical Imaging’s TechneLite® generators, which are distributed to hospitals and radiopharmacies as a source of Tc-99m for diagnostic imaging procedures. Tc-99m is also used with Cardiolite® (Kit for the Preparation of Technetium Tc-99m Sestamibi for Injection), the most successful radiopharmaceutical agent, which has been used to image more than 40 million patients.2 In diagnostic use, Tc-99m is attached to a specific molecule and injected into the patient, where it emits gamma radiation that can be used to produce an image of the region.
Indication and Important Safety Information Regarding TechneLite®
INDICATIONS AND USAGE: Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Brain Imaging (including cerebral radionuclide angiography), Thyroid Imaging, Salivary Gland Imaging, Placenta Localization, Blood Pool Imaging (including radionuclide angiography), Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux, Nasolacrimal Drainage System Imaging.
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Brain Imaging (including cerebral radionuclide angiography), Thyroid Imaging, Blood Pool Imaging, Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
IMPORTANT SAFETY INFORMATION: Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc99m Injection.
WARNINGS: Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children.
PRECAUTIONS: Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.
Please see full Prescribing Information at www.technelite.com.
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The Company’s proven success in the field of diagnostic imaging provides a strong platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. Lantheus imaging products include the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, TechneLite® (Technetium Tc 99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.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. 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. Such forward-looking statements include, but are not limited to, the Company’s outlook and expectations relating to the supply of LEU-sourced Mo-99, and other statements that are not historical or current facts. 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. ©AMR Imaging Market Guide – US (H1 2012). AMR/Arlington Medical Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.
2. ©AMR Imaging Market Guides – US (1990-2011). AMR/Arlington Medical Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.