Isotope Technologies Garching announces successful Validation of EndolucinBetaTM (n.c.a. Lutetium-177) Marketing Authorization Application by the European Medicines Agency

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.

ITM Isotopen Technologien München AG

Aufsichtsratsvorsitzender - Udo J. Vetter, Vorstandsvorsitzender - Steffen Schuster, Sitz der Gesellschaft - Lichtenbergstr. 1, 85748 Garching - HG München - HRB 154944

CONTACT:

Sebastian Marx

Head of Sales

phone +49 89 329898618

e-mail: Sebastian.Marx@itg-garching.de

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Steffen Schuster

Chief Executive Officer (CEO)

phone +49 89 329898622

e-mail: Steffen.Schuster@itm.ag