Lantheus Medical Imaging, Inc. and SHINE Medical Technologies, Inc. announced yesterday that they are joining forces to ensure that there is a consistent and secure supply of molybdenum-99 (Mo-99) in the future.
As part of the agreement, SHINE will produce Mo-99 with their low-enriched uranium (LEU) solution technology to be used in Lantheus' TechneLite to generate technetium-99m. SHINE estimates that they will start production at the beginning of 2018 once their facility is operational and obtains the required regulatory approvals.
"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," Greg Piefer, founder and CEO of SHINE, said in a statement.
President Obama signed the American Medical Isotopes Production Act of 2011 into law in January 2013, which promotes the production of LEU Mo-99 and the elimination of the export of highly enriched uranium (HEU) from the U.S.
Additionally, CMS cited in the 2013 final Medicare payment rules for Medicare Hospital Outpatients that they will provide incremental reimbursement for every diagnostic dose of Tc-99m that is generated from non-HEU sourced Mo-99.
Lantheus introduced TechneLite in January 2013, which they claim is the first Tc-99m generator in the U.S. that contains Mo-99 produced from at least 95 percent LEU. The company's goal is to increase their use of LEU-sourced Mo-99 to 100 percent by 2016.
SHINE has a Cooperative Agreement with the U.S. Department of Energy's National Nuclear Security Administration to create a dependable supply of Mo-99 produced without HEU.
Their manufacturing process for LEU Mo-99 produces less waste because it doesn't use a nuclear reactor and re-uses their uranium target solution. It also produces high-specific activity Mo-99, which is compatible with the country's current supply chain.
"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," Jeff Bailey, president and CEO of Lantheus, said in a statement.
