Covidien to use FDA, Health Canada approved Mo 99 from Maria for manufacturing Tc 99m generators

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.

“Their actions are great news for patients who may have been facing longer delays in receiving critical nuclear medicine diagnostic procedures.”

Tc 99m is a vital medical isotope used in over 80 percent of all nuclear medicine diagnostic and functional studies of organs and anatomical systems. The information from these studies is used by many medical specialists (including radiologists, nephrologists, oncologists and cardiologists) to better diagnose and treat patients. More than 35 million nuclear medicine procedures are performed worldwide each year, more than half in the United States.

On February 17, 2010, in Warsaw, Poland, Covidien and the Institute of Atomic Energy in Poland (IAE POLATOM) announced an agreement for Maria to begin supplying Mo 99. At the time, it was estimated that the Mo 99 supplied from Maria would help meet the needs of more than one million additional patients worldwide in just the first six months.

“We are pleased that both FDA and Health Canada expedited their reviews of our data, resulting in a quick approval,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “Their actions are great news for patients who may have been facing longer delays in receiving critical nuclear medicine diagnostic procedures.”