Mo-99: The Workhorse of Nuclear Medicine
Only Coquí Pharma has the proven technology, using a previously FDA approved process, and expert know-how to ensure a reliable and scalable domestic supply of Mo-99.
Molybdenum-99 (Mo-99) is the world’s most widely used medical radioisotope. It’s the parent isotope of Technetium-99m, which is used in 80 percent of nuclear medicine procedures worldwide. Annually in the U.S., over 18 million procedures use Mo-99 to diagnosis and treat diseases including brain, heart, lung, liver, renal, oncologic, and muscle skeletal diseases. Scientists and doctors also use Mo-99 in their research to study organ structure and function, and to find cures for Parkinson’s disease, Alzheimer’s disease, cancer, and cardiac diseases, to name a few.
The Impact of Mo-99 Supply Shortages
Most Mo-99 is produced from weapons grade U-235 (i.e., highly enriched uranium or HEU) in a nuclear reactor. Mo-99 has a half-life of 66 hours, which means that it cannot be stockpiled. This presents a unique distribution challenge since the U.S. relies on imports for its Mo-99 supply and doesn’t have a domestic production source. Only a small number of facilities have the capacity to commercially produce radioisotopes. Many of these reactors are over 50 years old and are nearing their end-of-life. The increasingly unreliable supply of Mo-99 has led to shortages that deprived patients from receiving lifesaving diagnostics and treatment. The Mo-99 crisis of 2009 is the most notable example and served as a wake-up call to take action.
Establishing a Reliable Supply of Mo-99
Since 2009, the Department of Energy’s National Nuclear Security Administration (NNSA) has ramped up efforts to create a reliable domestic supply of Mo-99 that does not rely on the use of HEU in the production process. This work became even more critical after Congress passed the American Medical Isotopes Production Act of 2012, making it a national priority to produce Mo-99. This led to NNSA’s Mo-99 program, through which NNSA is working with commercial partners to accelerate the establishment of a reliable domestic supply of Mo-99.
Of the six projects that have received government endorsement, only Coquí Pharma has the proven technology, using a previously FDA approved production process, and expert know-how to ensure a reliable and scalable domestic supply of Mo-99.