Canadian radiopharmaceutical developer Draxis Health of Mississauga, Ontario, has signed a deal with GE Healthcare giving the Chalfont St. Giles, U.K.-based company rights to sell Draxis generic technetium-99m sestamibi in the U.S.
Draxis Health's DraxImage radiopharmaceutical unit has given GE exclusive rights to sell DraxImage Sestamibi in the U.S. and Canada once patent protection expires for Cardiolite, technetium sestamibi nuclear cardiology radiopharmaceutical marketed by Bristol-Myers Squibb Medical Imaging of North Billerica, MA. GE has also agreed to purchase technetium sestamibi exclusively from DraxImage.
DraxImage must also receive U.S. and Canadian regulatory approvals for its version of technetium sestamibi before commercial sales can begin. DraxImage submitted an abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration in February 2007, and has also made regulatory filings with European and Canadian agencies.
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