ITM and RadioMedix announce drug master file submission for ITM’s 68Ge/68Ga Generator GeGant® for the U.S. market

ITM and RadioMedix announce drug master file submission for ITM’s 68Ge/68Ga Generator GeGant® for the U.S. market

Press releases may be edited for formatting or style | July 10, 2020 Molecular Imaging
GARCHING, Germany & MUNICH & HOUSTON--(BUSINESS WIRE)--ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, announced today that ITM has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, which is manufactured at the RadioMedix Spica Center in Houston, Texas, U.S. and distributed under the brand name GeGant®.

The RadioMedix Spica Center is a 21 CFR 211 compliant, and GMP radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial stage radiopharmaceutical manufacturing and distribution. Thousands of 68Ge/68Ga Generators can be produced, annually at this center. This high production capacity enables us to meet the rapidly increasing demand for Gallium-68 in the United States.

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, and for evaluation of response to therapy. PET-imaging is an excellent approach for healthcare professionals looking for precise localization in diagnostic imaging. GeGant® allows fast and convenient onsite production of high-quality Gallium-68 for radiolabeling. As well as showing a low breakthrough of Germanium-68, GeGant® is available in the sizes of 1 GBq (30 mCi), 2 GBq (50 mCi), and 4 GBq (100 mCi), being among the largest 68Ge/68Ga Generators on the market.

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“We are living in an exciting time in the field of nuclear medicine and the menu of targeted PET imaging agents will only grow. 68Ga is among the most important players in this field” said Dr. Ebrahim Delpassand, CEO of RadioMedix. “We are excited to be able to accomplish this milestone in collaboration with our long-term partner ITM, Germany. RadioMedix will be the manufacturer of ITM 68Ge/68Ga Generators, for the first time in the United States. Our high manufacturing capacity will address the significant shortage of this essential device in the market and increases patients’ access to a variety of 68Ga labeled radiopharmaceuticals in the field of oncology.” continued Dr. Delpassand.

Steffen Schuster, CEO of ITM said: “We are very pleased to see this DMF submission in the U.S. has taken our close and long-term partnership with RadioMedix to a new level and will enable us to take full advantage of RadioMedix’s great production opportunities.” Steffen Schuster added: “With RadioMedix as our strategic partner, we are looking forward to GeGant® significantly increasing the availability of Gallium-68 in the U.S. We are confident that we can make a substantial contribution to meeting the growing demand of Targeted Radionuclide Therapies and Diagnostics within the U.S. market.”

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