[June 27, 2014] |
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Eckert & Ziegler: European approval process for Gallium-68 generator successfully completed - world's first authorization for new, inexpensive method for PET radiolabeling
BERLIN --(Business Wire)--
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 installation
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.
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