Market Overview

RadioMedix and ITM Announce Agreement for Manufacturing of Ge-68/Ga-68 Generators in U.S.


RadioMedix Inc. and ITM Isotopen Technologien München (ITM), a group of
specialized radiopharmaceutical companies, announced today that ITM's
subsidiary, Isotope Technologies Garching GmbH (ITG), and RadioMedix
have signed a manufacturing and supply agreement for the production of
the next generation of Ge-68/Ga-68 (Germanium-68/Gallium-68) generators
at the new RadioMedix Spica Center (RSC) in Houston, Texas. RSC is a 21
CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated
to late stage investigational and commercial stage radiopharmaceuticals.

The medical radionuclide Gallium-68, which is produced in Ge-68/Ga-68
generators, is used in the field of Targeted Radionuclide Therapy to
diagnose cancers like prostate cancer and neuroendocrine tumors. When
labeled to a disease-specific targeting molecule, the medical
radioisotope can produce diagnostic images via positron emission
tomography (PET), which maps the location of the specific cancer
throughout the body.

"RadioMedix has been the exclusive distributor of ITG products in
North America since 2013, including their Ge-68/Ga-68 generators. With
the opening of this state-of-the-art facility, our partnership will
address the global supply shortage of Ga-68 generators. RadioMedix Spica
Center has been selected as the manufacturing site for the newest
generation of ITG generators and given the scale of this new facility,
cannot only supply the needs of North America but potentially the global
market. Ge-68/Ga-68 generators serve as an on demand source of a
positron emitter that has recently revolutionized the R&D and clinical
developments in the field of PET Radiopharmaceuticals,"
said Dr.
Ebrahim S. Delpassand, Chairman and CEO of RadioMedix Inc. "The
United States is one of the largest markets for these generators and a
local manufacturing site as well as a DMF at the U.S. FDA for this
product creates significant efficiencies in availability, cost, and
distribution of this product in our country,"
added Dr. Delpassand.

"We are delighted to expand our trusted partnership with RadioMedix
for the production of our Ge-68/Ga-68 generators in the U.S.,"
Steffen Schuster, CEO of ITM. "Targeted Radionuclide Therapy is a
unique theranostic approach and has been used increasingly in recent
years due to its excellent efficacy with comparatively few side effects.
To meet the medical community's growing demand for radionuclides, we
already partnered with a North American nuclear power company to achieve
new scalability of the generators' therapeutic companion, Lutetium-177.
Our extended partnership with RadioMedix now gives us the opportunity to
significantly improve our supply capabilities of our diagnostic
radioisotope, Gallium-68. This cooperation is an important further step,
as it helps us secure the supply of high-quality medical radioisotopes
for Targeted Radionuclide Therapy to cancer patients worldwide."

- Ends -

View Comments and Join the Discussion!