[May 28, 2018]

ITM: Marketing Authorization for TOCscan® (68Ga-Edotreotide) in Germany, Austria and France

ITM Isotopen Technologien München AG, a specialized radiopharmaceutical company, announced today that its subsidiary, ITG Isotope Technologies Garching GmbH, received marketing authorization for the ready-to-use radiopharmaceutical ⁶⁸Ga-Edotreotide (Gallium-68-DOTATOC) in Germany, Austria and France. The diagnostic agent ⁶⁸Ga-Edotreotide will be distributed under the brand name TOCscan^® (Sogacin^® in Austria / France).

TOCscan^® will be used to diagnose neuroendocrine tumors (NETs) and localize metastases through the Targeted Radionuclide Therapy approach, which includes diagnosis as well as therapy. The diagnostic tool TOCscan^® binds specifically to SST receptors on the tumor's surface by using the targeting molecule Edotreotide. Diagnostic images are produced via positron emission tomography (PET) by mapping the location of the medical radioisotope ⁶⁸Ga. This allows for the precise characterization of NETs pre-therapy as well as the evaluation of treatment response post-therapy. The quality of diagnostic imaging has improved significantly as a result of the use of PET with ⁶⁸Ga-DOTA-conjugated peptides such as TOCscan^®. Another advantage of PET, in addition to the high sensitivity, is the ability to provide quick procedures with reduced imaging time. This has the effect of exposing the patient to less radioactivity.¹

Following the determination of SSTR expression using PET, Targeted Radionuclide Therapy with n.c.a. ¹⁷⁷Lu-labeled Edotreotide for personalized treatment can be applied. ITM´s therapeutic radiopharmaceutical for NET (News - Alert), known as Solucin^® (¹⁷⁷Lu-Edotreotide / ¹⁷⁷Lu-DOTATOC), is currently in the phase III clinical trial COMPETE. Solucin^® and TOCscan^® as the companion diagnostic act as an excellent theranostic pair for Precision Oncology. This personalized medicin approach is regarded as a substantial improvement to patient outcome and safety.

Steffen Schuster, Chief Executive Officer of the ITM Group, commented: "We are delighted to have received marketing authorization for TOCscan^®. As there are only few suitable and well tolerated treatment options for NET, we are looking forward to bringing TOCscan^® as the diagnostic element of our Targeted Radionuclide Therapy approach to market. Theranostics offer a unique promise for the personalized treatment of cancer since we have the chance to »see what to treat«!"

References
¹Mojtahedi, Alireza; Thamake, Sanjay; Tworowska, Izabela; Ranganathan, David; Delpassand, Ebrahim S (15 August 2014). "The value of 68Ga-DOTATATE PET/CT in diagnosis and management of neuroendocrine tumors compared to current FDA approved imaging modalities: a review of literature". American Journal of Nuclear Medicine and Molecular Imaging. 4 (5): 426-434. ISSN 2160-8407. PMC 4138137. PMID 25143861.

ITM Isotopen Technologien München AG
Chairman of the Supervisory Board - Udo J. Vetter, Executive Board - Steffen Schuster (Chairman), Thomas Dürre
Registered Office of the Company - Lichtenbergstr. 1, 85748 Garching - Commercial Register Munich - HRB 154944

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