Lantheus Medical Imaging and SHINE Medical Announce Mo-99 Supply Agreement

November 3, 2014 at 5:40 PM EST

Agreement Supports U.S. Efforts to Ensure Future Reliable Supply of Non-HEU Mo-99

N. BILLERICA, Mass. (November 3, 2014) – Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents, and SHINE Medical Technologies, Inc., a Wisconsin-based company dedicated to being the world leader in safe, clean, affordable production of medical isotopes, today announced that the companies have entered into a strategic agreement for the future supply of molybdenum-99 (Mo-99). The supply agreement, which marks Lantheus’ first with a prospective U.S. supplier of Mo-99, demonstrates both companies’ ongoing commitment to ensuring that the medical imaging community has future reliable and secure access to Mo-99 to meet the needs of patients.

Under the terms of the supply agreement, SHINE will provide Mo-99 produced using its proprietary low-enriched uranium (LEU)-solution technology for use in Lantheus’ TechneLite® (Technetium Tc99m Generator) generators once SHINE’s facility becomes operational and receives all necessary regulatory approvals, which SHINE estimates will occur in early 2018. Mo-99 is the parent isotope of technetium-99m (Tc-99m), an essential tracer in a variety of diagnostic tests and the most widely-used isotope in nuclear medicine.

As a leader in the radiopharmaceutical business, Lantheus has aggressively undertaken key initiatives to implement a globally diversified and balanced supply chain of Mo-99 for its TechneLite generators. SHINE has a Cooperative Agreement with the U.S. Department of Energy’s National Nuclear Security Administration to establish reliable supply of Mo-99 produced without highly enriched uranium (HEU). SHINE’s LEU Mo-99 manufacturing process does not require a nuclear reactor and is compatible with the nation’s existing supply chain for Mo-99.

“Strategic sourcing of Mo-99 is a key priority at Lantheus, and our agreement with SHINE is one important step in our ongoing proactive efforts to strengthen and diversify our supply to ensure the nuclear medicine community and patients have reliable access to TechneLite in the future,” said Jeff Bailey, President and Chief Executive Officer of Lantheus Medical Imaging. “We have been the industry leader in adopting the use of LEU-produced Mo-99 in our TechneLite generators, and adding SHINE as a prospective U.S. supplier further demonstrates our commitment to new domestic Mo-99 technology and the U.S. government’s global nuclear security strategy to encourage reliable future supplies of medical radioisotopes produced from non-HEU sources.”

“This definitive agreement with Lantheus signals the beginning of a new era for the production of radioisotopes in North America, in which a private producer can thrive. This agreement, along with another agreement earlier this year, show that SHINE is important to the future of medical isotope generation,” said Greg Piefer, founder and Chief Executive Officer of SHINE. “We could not be more pleased that this agreement is with Lantheus—a long-time global leader in the production of Tc‑99m generators, and a pioneer in the area of LEU-conversion. We look forward to serving their needs with our cost effective, safe, and environmentally-friendly production technology.”

Currently, Lantheus receives Mo-99 from four of the five major processors and seven of the eight associated reactors. As the medical imaging community moves toward LEU-based Mo-99 supply, Lantheus' LEU TechneLite generator and gradual conversion to a 100 percent LEU-derived Mo-99 supply chain ensures that Lantheus customers will have access to Tc-99m, now and in the future.

About Molybdenum-99 and Technetium-99m
Mo-99 is the parent isotope of the diagnostic imaging agent Tc-99m, which is the most widely-used radioisotope in nuclear medicine. Tc-99m is a critical component of many medical tests, including scans of the heart, brain, kidneys and some types of tumors. 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 Tc99m Sestamibi for Injection), the benchmark for myocardial perfusion imaging, and Neurolite® (Kit for the Preparation of Technetium Tc99m Bicisate for Injection), a neurological imaging agent. 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.

About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc. is a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents. The Company 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 has more than 500 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.

 

About SHINE Medical Technologies, Inc.
Founded in 2010, SHINE is a development-stage company working towards becoming a manufacturer and distributor of radioisotopes for nuclear medicine. The SHINE system uses a patented proprietary manufacturing process that offers major advantages over existing and proposed production technologies as it does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for Mo-99. SHINE has announced the execution of two definitive supply agreements in 2014. Learn more at www.shinemed.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. 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.

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