Eckert & Ziegler obtains manufacturing authorization for pharmaceutical Gallium-68 generators

BERLIN--(BUSINESS WIRE)--Eckert & Ziegler Radiopharma GmbH, a subsidiary of Eckert & Ziegler AG, has been given the manufacturing authorization for its pharmaceutical ⁶⁸Ge/⁶⁸Ga generators at the newly-built, GMP-compliant manufacturing facilities in Berlin. The authorization given by the local German competent authority allows the manufacture of pharmaceutical ⁶⁸Ge/⁶⁸Ga generators for use in clinical studies.

“We are proud to have reached this milestone. Having enabled the availability of Ga-68 labelled diagnostics for clinical use, we would like to encourage academic research, as well as research and development in the departments of international pharmaceutical corporations, by bringing more compounds into clinical development. The potential for “theranostics”

⁶⁸Ge/⁶⁸Ga generators enable Gallium-68 radionuclide production for use in Positron Emission Tomography (PET). The radionuclide can be coupled with a multipurpose diagnostic biomolecule to locally create ready-for-use pharmaceuticals used in PET scan diagnoses. Currently, clinical uses of Gallium-68-labelled diagnostic pharmaceuticals are mostly in oncology. However, vast strides have been made in the development of pharmaceuticals in cardiology and in degenerative nerve diseases. In contrast to Fluorine-18 or Carbon-11-based PET diagnostics, Gallium-68-based technology does not require the use of expensive cyclotrons, thereby reducing costs and enabling increased flexibility in the practice of nuclear medicine diagnostic imaging.

Dr. André Heß, Board Member and head of the Eckert & Ziegler’s Radiopharma Segment stated, “We are proud to have reached this milestone. Having enabled the availability of Ga-68 labelled diagnostics for clinical use, we would like to encourage academic research, as well as research and development in the departments of international pharmaceutical corporations, by bringing more compounds into clinical development. The potential for “theranostics” is also highly promising. The “theranostic” approach entails initial diagnosis using a Ga-68 labeled molecule in a PET scan followed by therapy where Yttrium-90 is coupled with the same carrier molecule. The newly-obtained manufacturing authorization will encourage and enable clinical studies for Ga-68 diagnostics. We have also applied for marketing authorization to sell the ⁶⁸Ge/⁶⁸Ga generators.”

Eckert & Ziegler operates a network of cyclotrons in Central Europe and is the manufacturer of pharmaceutical Yttrium-90 (European Marketing Authorization “Yttriga”). Eckert & Ziegler has developed a customized technology platform for the local manufacture of radiopharmaceuticals (in particular Ga-68 and Y-90-based pharmaceuticals), which allows the clinical user to implement all processes from synthesis and quality control to dose filling.

Eckert & Ziegler is exhibiting at booth number #407 at the Society for Nuclear Medicine (SNM) Annual Meeting 2012 from 9-13 June in Miami, Florida.

Eckert & Ziegler (ISIN DE0005659700), which has approximately 590 employees, is one of the world's largest suppliers of isotope technology components for radiation therapy and nuclear medicine.