Eckert & Ziegler: European approval process for Gallium-68 generator successfully completed – world’s first authorization for new, inexpensive method for PET radiolabeling

Eckert & Ziegler Radiopharma GmbH has received a recommendation from the European Medicines Agency for approval of its pharmaceutical ⁶⁸Ge/⁶⁸Ga generators. This achievement marks the conclusion of a comprehensive decentralized evaluation procedure and the first time a gallium generator has been approved for the clinical development of highly specific diagnostic agents. Approval for sale in the respective countries is expected within the next one to two months.

Gallium generators provide an inexpensive alternative for radiolabeling diagnostic probes using positron emission tomography (PET), an imaging process that can be used to determine whether tissue is diseased. The process is mainly used in cancer treatment. Until now, fluorine-18 or carbon-11 PET radioisotopes have usually been used to radiolabel diagnostic probes; these radioisotopes are produced using cyclotrons that are capitally intensive, large-scale dedicated installations requiring millions in investment. In contrast, the gallium generator is approximately the size of a thermos and can be sourced for far less money, lowering costs and increasing flexibility at nuclear medicine clinics.

Once it has received approval, Eckert & Ziegler will also submit its documents to the U.S. Food and Drug Administration (FDA), establishing a Drug Master File with the agency. This will allow parties interested in developing new drugs to refer to the dossier and use the generator in clinical tests of medications and in other settings.

Dr. André Heß, Member of the Executive Board of Eckert & Ziegler AG and Head of the Radiopharma segment, says: "We are proud to have gotten the ball rolling on the world’s first approval of a pharmaceutical ⁶⁸Ge/⁶⁸Ga generator. We would also like to encourage academic research and development departments in the global pharmaceutical industry to introduce more substances that can be radiolabeled with Ga-68 into clinical development. ‘Theranostic’ approaches that combine diagnosis using Ga-68 PET with treatment using Yttrium-90, coupled using the same carrier molecule, are also very promising.”

Eckert & Ziegler operates a network of cyclotrons in central and eastern Europe and manufactures pharmaceutical Yttrium-90 (EU-approved product: Yttriga). The company has developed a customized technology platform for the local production of radiopharmaceuticals (designed especially for Ga-68 and Y-90-based pharmaceuticals) that allows clinical users to perform all processes, from synthesis and quality control to patient dose preparation.

Eckert & Ziegler (ISIN DE0005659700), with approximately 700 employees, is one the world’s largest providers of isotope technology for radiation therapy and nuclear medicine.