DULLES, Va., Jan. 26, 2016 (GLOBE NEWSWIRE) -- 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.
“We are pleased to work with AAA on this promising diagnostic compound,” noted Peter Webner, Interim Executive Vice President and COO of Zevacor. “Zevacor’s expertise in providing scalable manufacturing and distribution for clinical research doses makes us the premier partner for AAA to use in developing and introducing this new, targeted radiopharmaceutical.”
“I believe that SomaKit-TATE has the potential to improve the accuracy of diagnosis while reducing radiation exposure for patients compared to the existing standard,” said Stefano Buono, Chief Executive Officer, Advanced Accelerator Applications. “We are pleased to have signed this non-exclusive agreement with Zevacor for the preparation and delivery of SomaKit-TATE. We believe that Zevacor is a flexible and proactive partner who shares our commitment to driving innovation. Zevacor’s ability to service and support our sites across the country will be important for the US commercialization of this innovative product. We believe the establishment of broadly available doses of Ga-68 radiopharmaceuticals will also mark an important milestone in the development of PET imaging, a development similar to the establishment of unit dose supply of Fluorine-18 labeled radiopharmaceuticals in the early 2000’s.”
About SomaKit-TATE
Somakit-TATE is a novel patented Kit developed by AAA for the preparation of 68Ga-DOTATATE for injection, to help diagnose and manage somatostatin receptor-positive NET patients using Positron Emission Tomography (“PET”). SomaKit-TATE has the potential to improve the accuracy of diagnosis while reducing radiation exposure for patients. The kit has been designated orphan drug status by the EMA and the FDA and is currently under evaluation to help diagnose Gastro-Entero-Pancreatic Neuroendocrine cancers via PET/CT imaging. The U.S. Food and Drug Administration (“FDA”) has granted Priority Review to AAA’s NDA for SomaKit-TATE.
