GARCHING, Germany, June 3, 2015 /PRNewswire/ —
The ITM Group announced today that the European Medicines Agency (EMA) has validated
the company’s Marketing Authorization Application (MAA) of the medicinal product
EndolucinBeta, a radiopharmaceutical precursor. EndolucinBeta is not intended for direct
use in patients but will be used for radiolabeling of specific carrier molecules for
Targeted Radionuclide Therapy of serious and difficult to treat cancer forms.
EndolucinBeta is the brand name of first-in-class no-carrier-added (n.c.a.) Lutetium-177
and the first medicinal product containing n.c.a. Lutetium-177 seeking Marketing
Authorization in the European Union.
EndolucinBeta as a radiopharmaceutical precursor will be used only for radiolabeling
of carrier molecules such as peptides or antibodies. The nature of the disease to be
treated will be determined by the pharmaceutical substance to be radiolabeled. The
successful MAA validation results in the start of procedure seeking centralized marketing
authorization in the European Union.
About n.c.a. Lutetium-177
Therapeutic n.c.a. Lutetium-177 is a medium energy beta emitter providing a tissue
penetration range that is very effective for selective delivery of therapeutic dose of
ionizing radiation to the tumor cell. In addition, n.c.a. Lutetium-177 emits quantifiable
imagable gamma rays which provide the additional benefit of carrying out simultaneous
scintigraphy making it a theranostically superior radioisotope for Targeted Radionuclide
Therapy.
About the ITM Group
The ITM Group is a privately held group of specialized radiopharmaceutical companies
dedicated to the development of innovative radioisotopes, radiopharmaceuticals and next
generation radiomedical devices. Its commitment to quality, convenience and security of
supply has become an integral part of all products giving them the competitive opportunity
to lead the radiopharmaceutical market. The ITM Group’s innovative platform technologies
also enable manufacturers of conventional therapeutic agents not only to improve the
efficacy of their candidates but also to benefit from ITM Group’s exceptionally advanced
infrastructure and global logistics services.
Contact
Sebastian Marx
Head of Sales
Phone: +49-89-329898618
Mail: [email protected]
Steffen Schuster
Chief Executive Officer (CEO)
Phone: +49-89-329898622
Mail: [email protected]
ITM Isotopen Technologien Muenchen AG
Aufsichtsratsvorsitzender - Udo J. Vetter, Vorstandsvorsitzender - Steffen Schuster,
Sitz der Gesellschaft - Lichtenbergstr. 1, 85748 Garching - HG Muenchen - HRB 154944
SOURCE ITM Isotopen Technologien Muenchen AG
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