MSD (known as Merck & Co., Inc. in the US and Canada) and Orion Corporation announced the mutual exercise of an option to convert their co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, into an exclusive global license for Merck.
“We are pleased with the progress made in our collaboration with Orion, including initiating two pivotal Phase 3 trials evaluating opevesostat in patients with metastatic castration-resistant prostate cancer,” said Dr. Dean Y. Li, president of Merck Research Laboratories. “We will continue to advance the clinical development program for opevesostat with speed and rigor to address the needs of patients with prostate cancer.”
“This license agreement allows Orion to focus on other promising candidates while benefiting from the development and potential commercialization of opevesostat and meeting our financial objectives,” said Liisa Hurme, president and CEO of Orion Corporation. “We believe Merck is best positioned to maximize the potential of opevesostat for prostate cancer treatment.”
The original co-development and co-commercialization agreement granted each party an option to convert the co-exclusive license into an exclusive global license for Merck. With the exercise of this option, Merck gains exclusive rights to develop and commercialize opevesostat and other CYP11A1-targeting candidates covered by the agreement.
Under the agreement, Orion is eligible to receive up to $30 million in development milestone payments, up to $625 million in regulatory milestone payments, and up to $975 million in sales-based milestone payments, along with annually tiered royalties from a low double-digit rate up to the low twenties on net sales of any commercialized licensed product. Development and regulatory milestones are determined by the scope of treatment indications and multiple geographies. Merck will assume full responsibility for all development and commercialization expenses. Orion will release €60 million reserved for development costs to net sales and operating profit in Q3 2024. Orion will also retain responsibility for manufacturing clinical and commercial supplies for Merck. No payment is associated with exercising this option.
The exclusive global license is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, expected to become effective in Q3 2024.
About Opevesostat and Clinical Trials
Opevesostat is an oral, non-steroidal, and selective CYP11A1 inhibitor developed by Orion for treating hormone-dependent cancers like prostate cancer. It suppresses all steroid hormones and their precursors, potentially inhibiting the androgen receptor signaling pathway.
In 2023, Merck and Orion initiated two pivotal Phase 3 trials, OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650), evaluating opevesostat with hormone replacement therapy (HRT) in patients with metastatic castration-resistant prostate cancer (mCRPC).
- OMAHA1: A randomized, open-label Phase 3 trial comparing opevesostat with HRT to alternative NHAs (abiraterone or enzalutamide) in later-line mCRPC patients who have failed one prior NHA and one or two prior taxanes. Enrolling approximately 1,200 patients globally, the primary endpoints are 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: A randomized, open-label Phase 3 trial comparing opevesostat with HRT to physician’s choice of NHAs (abiraterone or enzalutamide) in front-line mCRPC patients who have failed one prior NHA. Enrolling approximately 1,500 patients globally, the primary endpoints are OS and rPFS by AR LBD mutation status. Secondary endpoints include TFST, ORR, and DOR.
About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate cancer is the second most common cancer in men globally and has a high mortality rate. It is often driven by male sex hormones called androgens. In mCRPC, prostate cancer grows and spreads despite androgen-deprivation therapy. Approximately 10-20% of prostate cancer patients develop CRPC within five years, with 84% presenting with metastases at CRPC diagnosis. Of those without metastases at CRPC diagnosis, 33% develop metastases within two years.
