The addition of IAE Polatom's Maria research reactor is expected to help Covidien meet the needs of more than 1 million additional patients globally in the first six months after the reactor begins supplying the isotope.
IAE Polatom recently made adjustments to its reactor for medical isotope production and completed a successful test of the manufacturing process this week. "The targets were subsequently processed by our facility in the Netherlands and everything went better than anticipated," said Elaine Haynes, vice president of commercial operations for Covidien's imaging business.
As soon as regulatory hurdles are cleared in Europe, Covidien plans to begin manufacturing and distributing medical isotopes within 30 days.
Haynes said the company currently is working with the U.S. Food and Drug Administration (FDA) to use Mo-99 from the Maria reactor in the U.S. While there is no specific date for supplies to arrive in the U.S., Haynes said, the additional supply in Europe will have a ripple effect in the U.S.
"As soon as we are able to use [Mo-99] in Europe, it begins benefiting the U.S., because we can use the Maria Mo-99 to free up supply from our other sources for Mo-99 for U.S. patients," she said.
Covidien also is seeking similar clearance from Health Canada for use of the medical isotope in that country as well.
The agreement comes two days before Dutch radiopharmaceutical producer Nuclear Research and Consultancy Group (NRG) is scheduled to close its High Flux Reactor in Petten, Netherlands, for six months for scheduled repairs.
Covidien will continue to get Mo-99 from current contracts with the BR2 reactor in Belgium, the Osiris reactor in France, and the Safari reactor in South Africa.
IAE Polatom's Maria research reactor is located approximately 20 miles southeast of Warsaw. It first began operations in 1975 and was taken offline in 1985 for a complete redesign. It resumed normal operations in 1993.
By Wayne Forrest
AuntMinnie.com staff writer
February 17, 2010
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