Dean Y. Li, president, Merck Research Laboratories. With the exercise of the option, Merck will gain global exclusive rights to develop and commercialize opevesostat and other candidates targeting CYP11A1 covered by the agreement. The development and regulatory milestones are determined by the scope of a number of treatment indications and multiple geographies.
Annual sales exceeding several billion US dollars would be required to reach the total amount of the sales milestones and higher end of the royalty rate.
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In addition, as a result of the exercise of the option, Merck will now assume full responsibility for all past and future development and commercialization expenses associated with the candidates covered by the agreement. Orion will retain responsibility for the manufacture of clinical and commercial supply for Merck. No payment is associated with the exercise of this option. The exclusive global license is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, and is expected to become effective in the third quarter of Opevesostat is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer.
By inhibiting CYP11A1 activity, opevesostat is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.
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The trial will enroll an estimated 1, patients around the world. Prostate cancer is the second most common cancer in male patients globally and is associated with a significant mortality rate.
