Merck & Co. opts in on Orion's hormone-dependent cancer candidates

Merck & Co. is expanding a research partnership with Orion into an exclusive licensing pact, putting more than $1.6 billion biobucks on the table for cancer candidates targeting CYP11A1, an enzyme important in steroid production.

The initial deal, inked back in 2022, centered on Orion’s opevesostat, a clinical-stage CYP11A1 inhibitor designed to treat prostate cancer. At the time, Merck dished out $290 million upfront to help co-develop and co-commercialize the oral, nonsteroidal drug.

Now, the companies are exercising the option to alter the pact into a licensing agreement, giving Merck exclusive global licensing rights to opevesostat and other CYP11A1 programs.  

Under the terms of the new agreement, Merck is giving Orion the chance to make up to $30 million in development milestone payments and up to $625 million in regulatory milestones payouts. The Big Pharma is also offering sales-based milestone payments up to $975 million, plus yearly tiered royalty payments for any commercialized licensed product, though annual sales would have to surpass several billion to reach the total biobucks amount, according to a July 1 release.

Given the new terms, Merck is taking responsibility for all past and future development and commercialization costs, meaning Orion has to pay back 60 million euros ($64 million) that Merck had allocated in the original $290 million for development. Orion will continue to manufacture a clinical and commercial supply for Merck.

Opevesostat is designed to treat hormone-dependent cancers by suppressing the production of all steroid hormones that may activate the androgen receptor signaling pathway. Last year, Merck and Orion launched two pivotal phase 3 trials studying the asset in combo with hormone replacement therapy for certain patients with metastatic castration-resistant prostate cancer.

“The conversion of this collaboration into a license agreement allows Orion to focus our resources to progress our other promising development candidates while both remaining well positioned to benefit from the development and potential commercialization of opevesostat and meeting our financial objectives,” Orion President and CEO Liisa Hurme said in a company statement. “We believe Merck provides the best choice to maximize the potential of opevesostat, a compound discovered by Orion’s scientists, for the treatment of patients with certain types of prostate cancer.”

The initial 2022 deal with Merck had come at a pivotal time for Orion. At the time, the Finnish drugmaker had just rebooted its R&D strategy, narrowing its pipeline focus to cancer and pain, while laying off up to 37 staff members. Hurme was part of the reshuffle, joining in November 2022.

The company continues to focus on cancer and pain R&D, with 2023 net sales of 1.19 billion euros ($1.27 billion) and 3,600 employees on the payroll at the end of the year.