Press Releases

May 10, 2016

EMA/CHMP adopts positive opinion for ITM’s EndolucinBeta®

ITM Isotopen Technologien München AG, a specialized radiopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion on the Marketing Authorization Application (MAA) for EndolucinBeta® of ITM’s subsidiary ITG Isotope Technologies Garching GmbH.

EndolucinBeta® respectively 177Lutetium chloride is used in targeted radionuclide therapy in the field of precision oncology. It is a radiopharmaceutical precursor, used for the radiolabeling of carrier molecules, such as peptides, monoclonal antibodies, vitamins or other substrates. The active substance of EndolucinBeta® is no-carrier-added (n.c.a.) Lutetium (177Lu) chloride, a radioactive isotope of Lutetium that emits predominantly beta radiation. 177Lutetium has a half-life of 6.7 days.

The clinical utility of EndolucinBeta® when attached to relevant carrier molecules has already been demonstrated in receptor targeted radionuclide therapies. Biomolecules radiolabeled with n.c.a. 177Lutetium bind to specific receptors on the tumor’s surface. Subsequently they deposit cytotoxic doses of ionizing radiation precisely at the tumorsite by means of transmitting low-energy beta particles. 177Lutetium reaches cells within a maximum of a 1.7 mm radius, which means that toxicity is highly localized and healthy tissue in the surroundings of the targeted tumor is minimally affected.

ITM has developed a unique methodology to produce no-carrier-added (n.c.a.) 177Lutetium, which provides the highest specific activity, highest purity and the best preconditions for radiolabeling biomolecules. Furthermore, n.c.a. 177Lutetium features the highest achievable radionuclide purity (no metastable longlived 177m-Lutetium impurity). This ensures effective and economical waste management and environmental sustainability as compared to alternative forms and production routes of the 177Lutetium radioisotope.

EndolucinBeta® will be available with an activity concentration of 40 GBq/ml at ART (activity reference time) as a solution with a total content of 3 - 150 GBq Lutetium (177Lu).

Steffen Schuster, Chief Executive Officer of the ITM Group, commented: “We are very pleased that the CHMP has recommended EndolucinBeta® for marketing authorization. In our view the radiopharmaceutical industry is currently undergoing a significant transformation globally. Advanced targeted radiotherapeutics are likely to create enormous opportunities in new effective cancer therapies in the coming years. We believe EndolucinBeta® has the potential to be a key platform for a variety of therapies, providing the highest possible quality and performance standard for 177Lutetium for the radiolabeling of therapeutic biomolecules.”

For further information please see “CHMP summary of opinion for EndolucinBeta” at www.ema.europa.eu/ema

About ITM

ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established the GMP manufacturing and a robust global supply network of a novel, first-in-class medical radionuclides and -generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine-, prostate- and skin cancers as well as bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality-of-life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of targeted radionuclide therapies in precision oncology.

For more information about ITM, please visit: www.itm.ag