August 8, 2021 | Berlin
Eckert & Ziegler Receives Manufacturing Authorization for Thorium and Lutetium Compounds
Eckert & Ziegler Radiopharma GmbH in Braunschweig, has now received manufacturing authorization from the Lower Saxony authorities for several thorium and lutetium compounds in accordance with the German Medicines Act. This authorization enables Eckert & Ziegler to supply its customers in the pharmaceutical industry with therapeutic radioisotopes for clinical trials and beyond. The radioisotopes are the central active ingredients in a series of innovative cancer drugs that are currently being tested in advanced phases by numerous drug manufacturers.
Obtaining the manufacturing authorization also entitles the Eckert & Ziegler Group to milestone payments for successful technology developments. The profits from these milestones, however, have already been accounted for in the recently updated guidance for 2021.
“Due to the large number of studies in which lutetium-177 is being clinically tested worldwide, we expect an increasing demand for this isotope and related services in the coming years. With the new technology and production facilities in Europe, Asia, and North America, we see ourselves as being excellently positioned to meet this demand,” explained Dr. Lutz Helmke, member of the Executive Board of Eckert & Ziegler AG.
Radiotherapeutic agents that are coupled with lutetium-177 prior to injection are currently under development for several types of cancer. Lutetium-177-based drugs for the treatment of metastatic prostate cancer are already in the clinical phase III trials. Therapeutic agents for other tumor types are also awaiting approval. In addition to its efficiency, the advantage of lutetium treatment is that it can be coupled with very precise diagnostics. The carrier substance of the therapeutic agent can be linked to a diagnostic radioisotope, for example gallium-68. Using special devices, so-called PET scanners, the response rate for the patient and thus the usefulness of treatment can be predicted with high precision in advance.