Zevacor Pharma, Inc. (fka “IBA Molecular North America, Inc.”), a leader in the manufacture and distribution of radiopharmaceuticals, announced that it has been selected to supply Gallium 68 (Ga-68) DOTATATE doses prepared with a novel kit to U.S. hospitals and imaging centers for Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA”). SomaKit-TATE is a patented kit currently in development for the preparation of 68Ga-DOTATATE for injection, to help diagnose and manage somatostatin receptor-positive neuroendocrine tumor patients using Positron Emission Tomography (“PET“). The kit has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“). The FDA has also granted Priority Review to AAA’s New Drug Application (“NDA”) for the kit. The license application for the kit is currently under review by the FDA and the agreement between Zevacor and AAA is in anticipation of NDA approval.
Zevacor’s U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver SomaKit-TATE patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated.