December 27, 2007 - GE Healthcare announced today that it has entered into an agreement with DRAXIMAGE, a division of DRAXIS Health Inc. of Montreal, Canada, to become the exclusive distributor of DRAXIMAGE Sestamibi upon its approval by the FDA and the expiration of the primary innovator patent.
An abbreviated New Drug Application (ANDA) for DRAXIMAGE Sestamibi was submitted by DRAXIMAGE to the FDA in February 2007, and is currently under review.
“We are delighted to announce this agreement, and continue to expand our portfolio of diagnostic imaging products through our North American radiopharmacy network,” said John Chiminski, president & CEO of GE Healthcare’s Medical Diagnostics division. “Our expertise in nuclear cardiology as the innovator of Myoview makes us ideally suited to make this new product available through our Radiopharmacy Operation that has the highest standards in the industry.”
Technetium-labeled radiopharmaceuticals, which include Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), are used in approximately 90 percent of nuclear medicine studies performed to detect coronary artery disease. Over eight million patients receive myocardial perfusion imaging each year, as the increasing rates of obesity, diabetes, and hypertension (heart failure) continue to contribute to disease progression. According to the American Heart Association, coronary artery disease is responsible for more than half of the deaths associated with cardiovascular diseases (2006).
“Nuclear cardiology is a proven technology, and we’re confident that our partnership with DRAXIMAGE will expand the access to and applicability of these procedures when and where they are needed. This agreement further demonstrates our commitment to Nuclear Medicine, through outstanding Radiopharmacy performance and the broadest product portfolio in the industry,” Chiminski added.