Orion and MSD Grant MSD Exclusive Global Rights to Opevesostat for Treating Metastatic Castration-Resistant Prostate Cancer

Orion Corporation and MSD have mutually agreed to convert their ongoing co-development and co-commercialization agreement for the investigational drug opevesostat, also known as MK-5684/ODM-208, into an exclusive global license for MSD. This decision grants MSD exclusive rights to develop and commercialize opevesostat and other related candidates targeting CYP11A1.

Liisa Hurme, President and CEO of Orion Corporation, remarked that this conversion allows Orion to allocate resources towards other promising projects while benefiting from the potential development and commercialization of opevesostat. Dr. Dean Y. Li, President of MSD Research Laboratories, expressed satisfaction with the collaboration's progress and emphasized their commitment to advancing the clinical development program for opevesostat to meet the needs of prostate cancer patients.

Under the original agreement, both companies had an option to convert their co-exclusive license into an exclusive global license for MSD. With the exercise of this option, MSD now holds global exclusive rights to develop and commercialize opevesostat and other candidates under the agreement.

The terms of the agreement entitle Orion to receive development milestone payments up to USD 30 million, regulatory milestone payments up to USD 625 million, and sales-based milestone payments up to USD 975 million. Orion will also receive annually tiered royalty payments ranging from a low double-digit rate up to the low twenties on net sales for any commercialized product. These milestones are determined by the scope of treatment indications and multiple geographies. To reach the total sales milestones and higher-end royalty rates, annual sales must exceed several billion US dollars. MSD will assume full responsibility for all past and future development and commercialization expenses associated with the candidates covered by the agreement. Consequently, Orion will release EUR 60 million, previously reserved to cover development costs, from the balance sheet to net sales and operating profit in Q3 2024. Orion will retain responsibility for manufacturing clinical and commercial supplies for MSD. No payment is required for 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, with effectiveness expected in the third quarter of 2024. Opevesostat, discovered and developed by Orion, is an oral, non-steroidal, and selective inhibitor of CYP11A1. It is being investigated for the treatment of hormone-dependent cancers, like prostate cancer, by suppressing the production of steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

In 2023, Orion and MSD initiated two pivotal Phase 3 clinical trials, OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650), to evaluate opevesostat in combination with hormone replacement therapy (HRT) for certain patients with metastatic castration-resistant prostate cancer (mCRPC).

OMAHA1 is a randomized, open-label Phase 3 trial assessing opevesostat with HRT in treating later-line mCRPC patients who have failed one prior new hormonal agent (NHA) and one or two prior taxanes, compared to an alternative NHA (abiraterone or enzalutamide). The trial aims to enroll approximately 1,200 patients globally, with primary endpoints being overall survival (OS) and radiographic progression-free survival (rPFS) by androgen receptor ligand-binding domain (AR LBD) mutation status. Secondary endpoints include time to first subsequent therapy (TFST), objective response rate (ORR), and duration of response (DOR).

OMAHA2a is another randomized, open-label Phase 3 trial evaluating opevesostat with HRT for front-line mCRPC patients who have failed one prior NHA, compared to the physician’s choice of NHA (abiraterone or enzalutamide). This trial will enroll approximately 1,500 patients worldwide, with primary endpoints being OS and rPFS by AR LBD mutation status. Secondary endpoints include TFST, ORR, and DOR.

Prostate cancer is the second most common cancer in men globally and has a significant mortality rate. Castration-resistant prostate cancer (CRPC) develops in 10-20% of prostate cancer patients within five years, with a large majority presenting with metastases at diagnosis. Opevesostat represents a potential new treatment avenue for these patients.