Bayer and Orion (Fermion) experiences in development of API process for Darolutamide

In 2015, Bayer and Orion partnered up to co-develop a novel anticancer treatment for advanced, non-metastatic castration resistant prostate cancer. The project involves a new chemical entity, Darolutamide, which is now in its final development stage.  “Darolutamide is an exciting anticancer drug. I have always wanted to be part of such a submission project in the final phase,” says Dr. Michael Lögers, Senior Director of Process Chemistry, Project Manager for external Drug Substance projects. All milestones met on time Lögers’ colleague Dr. Jan-Bernd Lenfers, VP, Chemical Development, Head of External Cooperations, adds that managing a project from early clinical development stages to launch, with all the CMC activities handled by Orion and its subsidiary Fermion, is both inspiring and interesting. “The project and the cooperation between Bayer and Orion has proceeded very well. We’ve been able to achieve all the milestones – such as the scale-up to industrial scale, the handling of the solid state properties of Darolutamide as well as the timely assembly of the CMC submission package – on schedule. Our expectations have been fully met by Orion’s and Fermion’s expertise.” Reliable routine production established quickly Lögers and Lenfers give credit to Fermion’s technical expertise, chemical process development and analytical expertise. “They meet all of Bayer’s criteria for an external manufacturer. Fermion’s strengths are: state-of-the-art production equipment, experienced people in chemical process development and analytical development. You can clearly tell that they have a lot of routine production experience for the pharmaceutical market,” Lögers says. “We’ve been especially impressed by how skilfully they were able to establish a reliable production process for Darolutamide,” adds Lenfers.