Business & Finance
US Merck, Orion Forge Global Collaboration for the Development and Commercialization of ODM-208, an Investigational Steroid Synthesis Inhibitor for the Treatment of Metastatic Castration-Resistant Prostate Cancer
14 July 2022 - - US-based pharmaceutical company Merck (NYSE: MRK) and Finnish pharmaceutical company Orion Corp. have inked a global development and commercialization agreement for Orion's investigational candidate ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production, the companies said.

ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Under the terms of the agreement, Orion and Merck, acting through its subsidiary, Merck Sharp and Dohme LLC, will co-develop and co-commercialize ODM-208.

Merck will make an upfront payment to Orion of USD 290m, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results.

Of this upfront payment, Orion recognizes approximately EUR 220m as income at the time of signing and approximately EUR 60 m is reserved to cover Orion's share of ODM-208 development cost to be accrued in the future.

Orion will be responsible for the manufacture of clinical and commercial supply of ODM-208.

In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck.

If the option is exercised, Merck would assume full responsibility for all accrued and future development and commercialization expenses associated with the program.

Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 as well as tiered double-digit royalties on sales if the product is approved.

The total amount potentially accrued from multiple regulatory and sales milestone events represents a substantial opportunity for Orion.

ODM-208 is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer.

By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

Globally, prostate cancer is the second most common cancer in people assigned male at birth, with an estimated 1.4 m patients diagnosed worldwide in 2020.

Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop metastases at the time of CRPC diagnosis.

Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.

Orion is a globally operating Finnish pharmaceutical company. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients.

Orion's net sales in 2021 amounted to EUR 1,041m and the company had about 3,350 employees at the end of the year. Orion's A and B shares are listed on NASDAQ Helsinki.