Draximage has granted GE Healthcare the exclusive right to market, distribute and sell its generic Draximage Sestamibi in the US market through its US and Canadian radiopharmacy network, once the primary innovator patent expires and marketing authorizations are received from the 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 authorizations.
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.
John Chiminski, president and CEO of GE Healthcare’s Medical Diagnostics business, said: “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.”