First LEU-Produced Molybdenum-99 Approved for Patient Use Arrives in U.S.

Press Release
Dec 6, 2010

WASHINGTON, D.C. – The National Nuclear Security Administration (NNSA) and the South Africa Nuclear Energy Corporation (Necsa) today announced that the first shipment of the medical isotope molybdenum-99 (Mo-99) produced with low enriched uranium (LEU) and approved for patient use has arrived in the United States. 

With support from NNSA’s Global Threat Reduction Initiative (GTRI), NTP Radioisotopes, Ltd. – a subsidiary of Necsa – delivered the first FDA-approved, large-scale shipment of the medical isotope Mo-99 using LEU fuel and targets on December 6, 2010.  Today’s announcement means that NTP Radioisotopes, Ltd. has become the world’s first supplier of large-scale LEU-based Mo-99 to the global market.

“We applaud South Africa’s world leadership on minimizing the use of highly enriched uranium (HEU),” said Gary Samore, White House weapons of mass destruction (WMD) coordinator and U.S. Sherpa for the Nuclear Security Summit.  “Their choice to move towards LEU-based medical isotope production shows an important confluence between peaceful uses of nuclear technology and nuclear security goals. Years ago we needed HEU to provide the isotopes for diagnosis and treatment of disease. Now we can do it without using highly sensitive nuclear materials. We encourage all countries to follow South Africa’s lead in moving toward all-LEU production and we also note the contributions from many others in advancing this new technology.”

Through GTRI, NNSA is providing up to $25 million to support Necsa’s efforts to produce Mo-99 with LEU.  This partnership was in direct response to the April 2010 Nuclear Security Summit in Washington, D.C.  At the conclusion of the Nuclear Security Summit, the leaders of 47 countries issued a communiqué and endorsed a work plan that calls for participating states, as appropriate, to collaborate to research and develop new technologies that require neither HEU fuels for reactor operation nor HEU targets for producing medical or other isotopes, and encouraged the use of LEU and other proliferation-resistant technologies and fuels in various commercial applications such as isotope production.

“South Africa’s success in producing large-scale quantities of Mo-99 using LEU marks a significant milestone toward ending the use of highly enriched uranium in medical isotope production around the world,” said NNSA Administrator Thomas D’Agostino.  “It reduces a major hurdle to global threat reduction efforts by demonstrating that we can work together to meet the global demand for critical medical isotopes in a way that also promotes the global nuclear nonproliferation agenda.  This cooperation between Necsa and NNSA shows our shared commitment to implementing the international commitments made at the April 2010 Nuclear Security Summit in Washington D.C.” 

On December 6, Lantheus Medical Imaging, located near Boston, Massachusetts, received the first shipment of LEU-produced medical isotopes that have been approved for patient use.  The shipment from South Africa marks significant progress towards the minimization of the use of HEU in civilian applications.  

“Lantheus Medical Imaging is pleased to be the first company in North America to receive FDA approval for the commercial sale and distribution of our TechneLite® generators using Mo-99 produced from LEU targets,” said Don Kiepert, president and chief executive officer. “Lantheus is committed to working with government officials, such as NNSA, to secure global nuclear safety by converting production of Mo-99 from HEU to LEU and to ensure a stable and reliable supply of Mo-99.”

The United States currently does not have the capability to produce Mo-99 domestically and imports 100 percent of its domestic supply from foreign producers. 

Mo-99 is a crucial radioisotope that is used in approximately 80 percent of all nuclear medicine diagnostic procedures and in roughly 50,000 diagnostic and therapeutic nuclear medicine procedures performed every day in the United States.

Mo-99’s primary uses include the detection of disease, including heart disease and cancer, and to study organ structure and function.  The isotope’s short half-life and excellent binding properties make it uniquely suited for medical procedures.  However its 66-hour half-life prevents it from being stockpiled during periods of shortage.

While the Mo-99 is an important example of a peaceful use of nuclear technology, the use of HEU in its production contributes to global proliferation challenges.  The conversion of those production facilities to use LEU helps meet a global demand while promoting nuclear nonproliferation. 

South Africa’s ability to convert their Mo-99 production to use LEU targets without negatively impacting the fragile Mo-99 supply stream illustrates South Africa’s leadership and tremendous commitment to the stability of supply of medical isotopes.

For more information on NNSA’s efforts to address the global Mo-99 shortage, click here.

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Established by Congress in 2000, NNSA is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science in the nation’s national security enterprise. NNSA maintains and enhances the safety, security, reliability, and performance of the U.S. nuclear weapons stockpile without nuclear testing; reduces the global danger from weapons of mass destruction; provides the U.S. Navy with safe and effective nuclear propulsion; and responds to nuclear and radiological emergencies in the U.S. and abroad.