FDA has issued Drug Master File for ITM’s Gallium Generator GeGant®

GeGant^® for the U.S. market will be produced and distributed by ITM’s long-term partner RadioMedix

GARCHING, Germany & HOUSTON–(BUSINESS WIRE)–ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, today announced 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^®.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.

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. (Read more…) 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.”