drugset / Press release

Eckert & Ziegler Submits Drug Master File for Lu-177 n.c.a.

2023-03-03 · Eckert & Ziegler Radiopharma GmbH · original ezag.com ↗

Eckert & Ziegler Strahlen- und Medizintechnik AG / Key word(s): Miscellaneous Eckert & Ziegler Submits Drug Master File for Lu-177 n.c.a. 03.03.2023 / 10:15 CET/CEST The issuer is solely responsible for the content of this announcement. Berlin, 3 March 2023. Eckert & Ziegler (ISIN DE0005659700, SDAX) has successfully submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration for lutetium ( 177 Lu) chloride solution (containing no-carrier-added radioisotope Lutetium-177), an active pharmaceutical ingredient and received DMF registration number 038043. Drug manufacturers can now refer to this DMF when developing new radiopharmaceuticals for the U.S. market and use the lutetium ( 177 Lu) chloride solution in clinical trials of drugs, for example. A large number of tumor-specific drugs can be labeled with the beta emitter lutetium-177, which brings the radiating effect of the isotope directly to the tumor cell. "We are excited about the access to the U.S. market for lutetium-177 based radiotherapeutics," explains Dr. Lutz Helmke, member of the Executive Board and responsible for the Medical segment at Eckert & Ziegler. "Thanks to our joint venture with Atom Mines LLC, we have excellent access to the scarce and indispensable precursor ytterbium-176 and thus the possibility to supply no-carrier-added lutetium-177 in highest purity and reliably to pharmaceutical customers worldwide." Radionuclide therapy with lutetium-177, is becoming well established as a valuable treatment option within precision oncology for various indications. Eckert & Ziegler is one of the leading partners for the radiopharmaceutical industry, offering complete early development services in addition to the supply of isotopes, including process development and scale-up, CMC development, manufacturing and packaging, product release and stability programs. About Eckert & Ziegler. Eckert & Ziegler Strahlen- und Medizintechnik AG with nearly 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the SDAX index of Deutsche Börse. Contributing to saving lives. Your contact: Eckert & Ziegler AG, Karolin Riehle, Investor Relations Robert-Rössle-Str. 10, 13125 Berlin, Germany Tel.: +49 (0) 30 / 94 10 84-138, [email protected] , www.ezag.com 03.03.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.eqs-news.com Language: English Company: Eckert & Ziegler Strahlen- und Medizintechnik AG Robert-Rössle-Str.10 13125 Berlin Germany Phone: +49 30 941084-138 Fax: +49 30 941084-112 E-mail: [email protected] Internet: www.ezag.de ISIN: DE0005659700 WKN: 565970 Indices: SDAX Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1574365 End of News EQS News Service 1574365 03.03.2023 CET/CEST

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