Merck and Orion Corporation have converted their co-development and co-commercialization agreement for opevesostat into an exclusive global license for Merck. Opevesostat is an investigational CYP11A1 inhibitor being evaluated in Phase 3 trials for metastatic castration-resistant prostate cancer.
Merck’s President of Research Laboratories, Dr. Dean Y. Li, highlighted the progress made in the collaboration, including the initiation of pivotal Phase 3 trials. Merck will lead the clinical development of opevesostat, aiming to meet the needs of patients with prostate cancer.
Orion’s President and CEO, Liisa Hurme, stated that the license agreement allows Orion to focus on its other development candidates while benefiting from the development and potential commercialization of opevesostat. Orion believes Merck is well-positioned to maximize the potential of opevesostat.
Under the terms of the agreement, Orion is entitled to receive various milestone payments, including development milestones up to $30 million, regulatory milestones up to $625 million, and sales-based milestones up to $975 million. Orion will also receive tiered royalty payments on net sales, ranging from a low double-digit rate to a rate in the low twenties.
Merck will assume responsibility for all past and future development and commercialization expenses. As a result, Orion will release €60 million reserved for development costs, which will be recognized as net sales and operating profit in Q3 2024. Orion remains responsible for manufacturing clinical and commercial supplies for Merck.
The exclusive global license is subject to regulatory approvals and is expected to become effective in the third quarter of 2024.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
