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06/06/2012

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

Berlin, Germany

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.

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 68Ga 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 68Ga 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 68Ga diagnostics. We have also applied for marketing authorization to sell the 68Ge/68Ga generators.”

Note: The press release has been taken from www.ezag.com . Eckert & Ziegler obtained Gallium-68 Generator manufacturing authorization for GalliaPharm®. The trademark is not mentioned in the news as it was not finally registered at the time of the press release.

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