Jubilant Organosys's US based subsidiary Draximage LLC has received US FDA approval for its ANDA for Draximage's generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite. The company has an exclusive distribution agreement with GE Healthcare to distribute and sell Sestamibi through GE Healthcare's nuclear pharmacy network in the US.
Draximage Sestamibi, is a generic kit used in the preparation of Technetium (TC-99m) Sestamibi injection - a diagnostic cardiac imaging agent used in Myocardial Perfusion Imaging (MPI), to evaluate the flow of blood to the heart. The MPI market size is currently estimated t US$ 400 million.
Shyam Bhartia, chairman and Hari Bhartia, co-chairman of Jubilant Organosys, said, "We are very excited to receive the US FDA approval of one of our key radiopharma products which strengthens our position in this business. We are ready to launch Draximage Sestamibi in the market and will see a steady flow of revenues from this product from Q1 FY10. As we are the second generic player in the market and there is very limited competition, we expect moderate price erosion for this product."
The Draximage's generic Sestamibi US FDA approval is a significant milestone for the company's radiopharma business. Along with the earlier approvals in Canada and distribution agreement with Guerbet for Europe, the company is well positioned to capture a significant market share for this product in the regulated markets. Going forward the company plans to introduce this product in the Asian markets, Australia and rest of the world.