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GE Healthcare is appointed to distribute Draximage Sestamibi in the USA

Draxis Health : 21 December, 2007  (New Product)
Draximage, the radiopharmaceutical division of Draxis Health, has appointed GE Healthcare as the exclusive distributor of the Draximage Sestamibi kit in the USA.
Draximage Sestamibi is a generic kit for the preparation of Technetium (Tc-99m) Sestamibi injection, a diagnostic cardiac imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart. Cardiac imaging currently accounts for nearly half of the more than 20 million nuclear medicine procedures conducted in the USA.

Draximage has granted GE Healthcare the exclusive right to market, distribute and sell its generic Draximage Sestamibi in the US market and through its US and Canadian radiopharmacy network once the primary innovator patent expires and marketing authorisations are received from the US Food and Drug Administration (FDA) and Health Canada. Furthermore, GE Healthcare has agreed to purchase Technetium 99m Sestamibi injection exclusively from Draximage. The initial term of the distribution agreement is for a minimum of three years following FDA approval of the Draximage product.

An Abbreviated New Drug Application (ANDA) for Draximage Sestamibi was submitted by Draximage to the FDA in February 2007 and this ANDA is currently under review. In addition, Draximage recently announced the filing of Draximage Sestamibi with European and Canadian regulatory authorities seeking additional marketing authorisations.

'Working with GE Healthcare to bring this major product to the market is a significant opportunity for both partners,' said Jean-Pierre Robert, president of DRAXIS Specialty Pharmaceuticals, the operating subsidiary of Draxis Health. 'Strong distribution in the US, the world's largest market for nuclear medicine, is a key element of the Draximage comprehensive global strategy to enter the cardiac imaging segment and the signing of this pivotal agreement for the US and Canada marks the completion of a major milestone in our strategy,'

'The Draximage team, under Jean-Pierre's leadership, is to be commended for achieving yet another of our key objectives toward fulfilling the commitment made in March 2006 to pursue diagnostic cardiac imaging, a major market not previously served by Draximage,' said Dan Brazier, acting president of Draxis Health. 'As we continue to grow our company to the next level through the implementation of projects like Draximage Sestamibi, strategic alliances with dedicated partners such as GE Healthcare are expected to become a more significant element in our business model.'

GE Healthcare owns and operates a comprehensive network of full-service radiopharmacies dedicated to the practice of nuclear pharmacy in all major urban centres across the USA and in Canada. GE Healthcare also supplies a broad range of equipment, radiopharmaceuticals and other products and services to radiopharmacies and nuclear medicine departments throughout the USA, utilising a well-trained and experienced sales force.

'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,' said John Chiminski, president and CEO of GE Healthcare's Medical Diagnostics business. 'This agreement allows us to remain competitive and further demonstrates our commitment to Nuclear Medicine, through Radiopharmacy performance and the broadest product portfolio in the industry.'

According to Arlington Medical Resources, in 2006 there were more than 8 million cardiac studies conducted in the USA out of a total of over 20 million nuclear medicine procedures; making MPI the most widely performed nuclear medicine scan in the USA. Recent market research estimates indicate that existing MPI products generate revenues in excess of $800 million annually in the USA and that Sestamibi and tetrofosmin account for approximately 90 percent of all MPI procedures.
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