Merck Secures Global Rights to Orion's Opevesostat for Prostate Cancer

RAHWAY, N.J.--Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, and Orion Corporation ("Orion") have announced the mutual exercise of an option to transform their ongoing co-development and co-commercialization agreement for the investigational drug opevesostat (MK-5684/ODM-208) and other CYP11A1-targeting candidates into an exclusive global license for Merck.

Dr. Dean Y. Li, president of Merck Research Laboratories, expressed satisfaction with the progress of the collaboration, citing the initiation of two pivotal Phase 3 trials for opevesostat in patients with metastatic castration-resistant prostate cancer (mCRPC). Dr. Li emphasized that Merck will continue to advance the clinical development of opevesostat to address the needs of prostate cancer patients.

Liisa Hurme, president and CEO of Orion, noted that converting the collaboration into a license agreement allows Orion to focus on other promising development candidates while still benefiting from the potential commercialization of opevesostat. She highlighted Merck as the best partner to maximize the potential of the compound, originally discovered by Orion scientists, for treating certain types of prostate cancer.

The original co-development and co-commercialization agreement provided each party with an option to convert the co-exclusive license into an exclusive global license for Merck. Following the exercise of this option, Merck will gain global exclusive rights to develop and commercialize opevesostat and other CYP11A1-targeting candidates covered by the agreement.

Under the terms of the new agreement, Orion is eligible for development milestone payments up to $30 million, regulatory milestone payments up to $625 million, and sales-based milestone payments up to $975 million. Additionally, Orion will receive annually tiered royalty payments on net sales, ranging from a low double-digit rate up to a rate in the low twenties. These milestone payments depend on the scope of treatment indications and multiple geographies. Achieving the full sales milestone payments and higher end of the royalty rate would require annual sales exceeding several billion US dollars.

Following the exercise of the option, Merck will assume full responsibility for all past and future development and commercialization expenses associated with the candidates. As a result, Orion will release €60 million, reserved in July 2022 for development costs, from the balance sheet to net sales and operating profit in Q3 2024. Orion will continue to manufacture 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 2024.

Opevesostat is an oral, non-steroidal, selective inhibitor of CYP11A1, discovered and developed by Orion, and is being investigated for treating hormone-dependent cancers like prostate cancer. By inhibiting CYP11A1 activity, opevesostat is designed to suppress the production of all steroid hormones and their precursors, which may activate the androgen receptor signaling pathway.

In 2023, Merck and Orion initiated two pivotal Phase 3 trials, OMAHA1 and OMAHA2a, to evaluate opevesostat in combination with hormone replacement therapy (HRT) for treating certain patients with mCRPC. OMAHA1 targets patients with later-line mCRPC who have failed one prior new hormonal agent (NHA) and one or two prior taxanes, while OMAHA2a focuses on front-line mCRPC patients who have failed one prior NHA. Both trials measure overall survival (OS) and radiographic progression-free survival (rPFS) by androgen receptor ligand-binding domain (AR LBD) mutation status, among other secondary endpoints.

Prostate cancer is the second most common cancer among men globally and has a significant mortality rate. Despite androgen-deprivation therapy to block male sex hormones, mCRPC continues to grow and spread to other parts of the body. Approximately 10-20% of prostate cancer patients develop castration-resistant prostate cancer (CRPC) within five years, and most of these patients present with metastases at the time of CRPC diagnosis.