NorthStar Medical Radioisotopes Receives $11.75 Million from National Nuclear Security Administration

MADISON, Wis. – NorthStar Medical Radioisotopes LLC has received $11.75 million from the U.S. Department of Energy’s (DOE) National Nuclear Security Administration (NNSA) for continued development and commercialization of two technologies to produce the medical radioisotope molybdenum-99 (Mo-99) without the use of highly enriched uranium (HEU).

NNSA provided $8.86 million to support NorthStar’s neutron capture production process and $2.89 million for the company’s accelerator production process. The awards were made as part of separate cooperative agreements between NorthStar and NNSA. As is the case with all DOE/NNSA cooperative agreements for domestic Mo-99 partners, NNSA is matching NorthStar funding dollar for dollar and each agreement is capped at $50 million in total funds from both parties.

Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used radioisotope in medical diagnostic imaging. Currently, nearly all Mo-99 is generated using weapons-useable HEU at aging facilities located outside of the United States, leading to chronic product shortages in the past as well as creating safety and national security concerns.

The neutron capture production process award will be used to further scale up Mo-99 production capacity to 3,000 6-day curies by the fourth quarter of 2016. The award is the balance of support outlined in the neutron capture cooperative agreement, making NorthStar the first company participating in the NNSA Mo-99 cooperative agreement program to become fully funded at $25 million in NorthStar funding and $25 million in matching NNSA awards.

The accelerator production cooperative agreement award will be used to continue developing the technology. The cooperative agreement currently has a value of $11.4 million – $5.7 million coming from NorthStar and $5.7 in matching awards from NNSA.

The cooperative agreements are provided through the Office of Material Management and Minimization, which was established by the NNSA to achieve permanent threat reduction by minimizing and, when possible, eliminating weapons-usable nuclear material around the world. One of its goals is to support the development of a supply of Mo-99 that is produced domestically without the use of HEU.

“These awards are clear indications of the progress that NorthStar is making toward bringing a viable domestic supply of Mo-99 to the United States – something we have not had since 1990,” said NorthStar President and Chief Executive Officer George P. Messina. “They are significant milestones toward ensuring that medical professionals here have reliable access to this vital isotope, enabling them to make accurate diagnoses and conduct important research, while also addressing important safety and national security concerns.”

He added, “We appreciate the continued support we have received from NNSA, including its financial assistance through the cooperative agreement program and its technical support via the national laboratories.”

NorthStar Mo-99 Production Technologies
Both of the technologies that NorthStar is developing produce Mo-99 from stable isotopes of molybdenum without the use of HEU. Both produce only a benign waste stream.

The neutron capture production process is used by the University of Missouri Research Reactor (MURR®) in Columbia, Missouri to supply Mo-99 through its Master Drug File. The Mo-98 is irradiated in the reactor, capturing an additional neutron in its nucleus to become Mo-99.

The accelerator process starts with Mo-100 and uses a linear accelerator, rather than a nuclear reactor. The Mo-100 interacts with a high-velocity electron, creating X-rays. The photons then interact with other Mo-100 nuclei, causing a neutron to be ejected from the Mo-100 nucleus to create Mo-99.

In both production processes, the Mo-99 is dissolved into a solution, which is packaged and delivered to radiopharmacies nationwide. There, NorthStar’s intelligent isotope separation system – the RadioGenix™, the first true technological breakthrough in Mo-99/Tc-99m systems in nearly 45 years – is used to extract Tc-99m for use in nuclear medicine procedures.

Continued Progress
The NNSA grants are the latest significant steps toward commercialization of NorthStar’s technologies. In May, NorthStar completed the first production-scale test run of its proprietary aliquoting system at the MURR site, filling source vessels with Mo-99 and shipping them to the company’s facility in Beloit. That success led MURR to grant NorthStar permission to regularly operate the aliquoting system, enabling the company to establish a weekly production schedule and increase its output of Mo-99.

Late this year, NorthStar expects to take the next step in the regulatory approval process for the neutron capture technology – submission of a final amendment to its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

NorthStar also plans to introduce the RadioGenix to the market in the near future.

NorthStar Medical Radioisotopes LLC
Based in Madison, NorthStar Medical Radioisotopes LLC (northstarnm.com) was founded in 2006 to address the needs of the nuclear medicine market in the United States. A wholly owned subsidiary of NorthStar Medical Technologies LLC, the company is committed to resolving industry-wide supply challenges that have caused shortages of vital medical isotopes, negatively impacting patient care and stalling clinical research. Its patented technologies include innovative non-uranium based molybdenum-99 production methods, a novel separation chemistry system and tools for the nuclear medicine market.

National Nuclear Security Administration
Established by Congress in 2000, NNSA (nnsa.energy.gov) is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science. NNSA maintains and enhances the safety, security, reliability and performance of the United States’ nuclear weapons stockpile without nuclear testing; works to reduce 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 United States and abroad. Follow NNSA news via the agency’s Blog and on Facebook, Twitter, YouTube and Flickr.

University of Missouri Research Reactor (MURR)
MURR (murr.missouri.edu) has a long history of safe reliability. With its 10 megawatt reactor and a 6½-days-per-week, 52-week-per-year operating schedule, MURR supports research and education while also providing short-lived isotopes for medical applications. MURR provides a range of radioisotopes that help medical professionals diagnose and treat many diseases, including cardiovascular disease and cancer. The nation’s largest university research reactor also supports undergraduate and graduate education programs that train the next generation of nuclear engineers and chemists.