• New manufacturing plant in Neufahrn near Munich increases ITM's production capacity tenfold
• Ceremonial opening by Minister of State, Dr. Florian Herrmann, Head of the Bavarian State Chancellery

Neufahrn / Garching / Munich, June 13, 2023 – ITM Isotope Technologies Munich SE (ITM) announced the opening of its new production facility for therapeutic radionuclides in Neufahrn near Munich, Germany in the presence of Minister of State, Dr. Florian Herrmann and other high-ranking guests. ITM’s new facility is the world’s largest production site of lutetium-177, an innovative medical isotope used in targeted cancer therapies. Due to its medical properties, lutetium-177 has gained importance in precision oncology treatments internationally as a valuable starting material for the production of various radiotherapeutics in recent years.

Once the new NOVA production facility is fully operational, ITM will increase its capacity to supply clinics, pharmaceutical partners and its own drug pipeline tenfold. This will help ITM meet the rapidly growing demand for radiopharmaceuticals used in patient care worldwide.

"Radiopharmaceutical research and development has been playing an increasingly important role in medicine for years. The world's largest lutetium-177 production facility for targeted radionuclide therapies against cancer, opened by ITM, is therefore an important milestone - both for the company, the research and production location of Bavaria as a whole and, of course, the patients. The commitment of rapidly growing companies like ITM once again underscores the pioneering role that Bavaria plays in the biotechnology sector within Germany and Europe,” commented Dr. Florian Herrmann, Head of the State Chancellery and Minister of State for Federal Affairs and Media. “As a local member of parliament, I am particularly pleased that the production facility is being built here in Neufahrn near Freising. This is a strong signal for the community and the entire region. As the Free State of Bavaria, we have been supporting the development of ITM practically from the very beginning. The Bavarian Research Foundation has already provided financial support for many of the company’s important research projects. We will continue to support the research and development of innovative cancer drugs moving forward. We want Bavaria and Germany to remain international leaders in nuclear medicine in the future."

"Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients. ITM's additional production site is an important contribution to medical research and drug supply for patients in Germany and worldwide," said Udo J. Vetter, Chairman of the Supervisory Board of ITM and Chairman of the Advisory Board of Vetter Pharma. "Equipped with state-of-the-art manufacturing facilities and expertly trained employees, ITM has the knowledge and the skills to take on this important responsibility and to meet the highest quality and safety standards for patients at all times - with innovative cancer drugs made in Germany."

"With the significant expansion of our production capacities we are solidifying our leading market position while, as the world’s largest manufacturer of n.c.a. lutetium-177, supporting the growth of the radiopharmaceutical industry globally, for which we are a driver and a partner. Together, it is our goal to develop and provide innovative diagnostics and therapeutics for the treatment of cancer patients," added Steffen Schuster CEO of ITM. "The excellent regional conditions surrounding our facilities coupled with our strong team and established logistics network will enable the fastest possible delivery of high-quality radioisotopes to anywhere in the world."

The development and production of medical radioisotopes by ITM was enabled, in part, by years of collaboration with the Garching Research Reactor (FRM II) and the Technical University of Munich (TUM).

ITM will operate the new production site at NOVA Neufahrn industrial park in addition to its existing manufacturing facility IAZ at the main site in Garching near Munich. All technical authorization processes required for commissioning as well as official approvals have been initiated or are scheduled. The first test runs of the facility are planned to begin within the next few months, with final official approvals expected in the coming year.

Operating at an industry 4.0 technical level, the new production site, which covers around 7,000 m², features a high degree of automation in the production process and internal logistics. Together with its direct connection to Munich Airport, it therefore enables the prompt dispatch of therapeutic isotopes with short half-lives and radiopharmaceuticals worldwide. The new site offers clean rooms, laboratories and offices that can be used by up to 200 employees for research as well as radiopharmaceutical manufacturing and aseptic production with the highest quality standards.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy applies very small amounts of radioactive compounds to diagnose and treat various solid tumor indications. Injected in vivo, radiopharmaceuticals accumulate directly in the affected organ or tumor, largely sparing surrounding healthy tissue. The high specificity of radiopharmaceutical diagnostics and therapeutics has the potential to detect and target even the smallest tissue changes such as tumor metastases. Due to these properties and its safety profile, Targeted Radionuclide Therapy is already being used for the treatment of various cancers including neuroendocrine tumors (NETs) and certain metastatic prostate tumors.

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ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

ITM Contact

ITM Corporate Communications
Julia Hofmann / Svenja Gärtner
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com

ITM Investor Contact
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: Ben.Orzelek@itm-radiopharma.com

Attachments

• 230613 ITM PR Neufahrn Production Site
• ITM opens new production facility_ITM COO Dr. Mark Harfensteller_ITM Chairman of the Board Udo Vetter_Minister of State Dr. Florian Herrmann_ITM CEO Steffen Schuster_Mayor Neufahrn Franz Heilmeier
• Minster of State Dr. Florian Herrmann with ITM CEO Steffen Schuster at a mock-up hot cell for the production of lutetium-177