The European Commission approves the Ge-68/Ga-68 radionuclide generator GalliaPharm. -Eckert & Ziegler Radiopharma GmbH .

The generator was first launched in 2014 and is today approved in 17 European countries and many other key international markets. With the EC approval, an additional 14 countries in the European Economic Area (EEA) will gain access to GalliaPharm, once national approval procedures have been completed. Consequently, it will soon be the first generator for the production of Gallium-68 commercially available in the entire EEA.

"Over the past decade, diagnostics with Gallium-68-based drugs have experienced a huge growth, which we were able to actively influence with our GalliaPharm ," explained Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. "We are happy that our continued efforts to shape the landscape of nuclear medicine in Europe and around the world, are improving patient access and driving innovation forward."

Radionuclide generators offer a cost-effective alternative for the radiolabeling of biomolecules, which can be used in positron emission tomography (PET) or other applications. To date, radiolabeled products have mainly been a cancer diagnostic tool, with Gallium-68-based PET diagnostics being used primarily for tumors of the prostate or neuroendocrine system.

For other diseases, radioisotopes such as fluorine-18 are mostly used to radiolabel biomolecules. This requires millions to be invested in cyclotrons. The Ge-68/Ga-68 generator, on the other hand, has a compact size and can be purchased much more affordably. This reduces costs in nuclear medicine clinics and practices and increases flexibility.