On December 8, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has issued the Drug Master File (DMF no. 34938) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, distributed under the brand name GeGant (Press release, ITM Isotopen Technologien Munchen, DEC 8, 2020, View Source [SID1234572456]).The DMF will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use GeGant in clinical tests for radiopharmaceuticals and in other settings.
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The GeGant Generators will be manufactured at the RadioMedix Spica Center in Houston, Texas, U.S., a GMP radiopharmaceutical manufacturing facility that is dedicated to late-stage investigational and commercial stage radiopharmaceutical manufacturing and distribution. At this center, thousands of 68Ge/68Ga Generators can be produced annually. This high production capacity enables ITM and RadioMedix to meet the rapidly increasing demand for Gallium-68 in the United States and across the world.
The medical, short-lived radioisotope Gallium-68 is used for Positron Emission Tomography (PET) imaging when labeled to a tumor-specific targeting molecule for diagnosis and staging of various cancers, like neuroendocrine tumors or prostate cancer. PET-imaging is a state-of-the-art approach for precise localization of tumors or metastases pre-therapy as well as the evaluation of treatment response post-therapy. It is a highly sensitive method, providing quick procedures with short imaging time. GeGant allows onsite production of high-quality Gallium-68 for radiolabeling with disease specific tracers. As well as showing a low breakthrough of Germanium-68, GeGant is available in different sizes, and with 4 GBq (100 mCi), being among the largest 68Ge/68Ga Generators on the market.
"This announcement by the U.S. FDA takes us another step closer toward full adaptation of the GeGant Generators in the U.S market. The consumption of Gallium-68, as an on-demand positron emitter, will only increase in the field of Nuclear Medicine. There is exponential growth of several exciting molecules labeled with Gallium-68 and RadioMedix’s manufacturing bandwidth is prepared to respond to this unmet need", said Ebrahim Delpassand, M.D., CEO of RadioMedix.
Steffen Schuster, CEO of ITM said: "The Drug Master File in the U.S. will enable us to take full advantage of our long-term partner RadioMedix’s production capacity which is needed to address the rapidly growing demand for Gallium-68 in the United States as one of the largest markets for Targeted Radionuclide Therapies and Diagnostics. Together with Radiomedix, we are looking forward to scaling up the production of GeGant to provide high quality products for patients in need in North America as well as the global market."