On July 13, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Orion Corporation ("Orion") reported 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 (Press release, Merck & Co, JUL 13, 2022, View Source [SID1234616638]). 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).
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Under the terms of the agreement, Orion and Merck, acting through its subsidiary, Merck Sharp & Dohme LLC, will co-develop and co-commercialize ODM-208. Merck will make an upfront payment to Orion of USD 290 million, 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 220 million as income at the time of signing and approximately EUR 60 million 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.
"Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We believe ODM-208 has the potential to complement our existing program in prostate cancer and look forward to working with the team at Orion."
"We are delighted to enter this collaboration with Merck, which is committed to extend and improve the lives of patients with cancer and has a strong commercial presence globally," said Timo Lappalainen, president and chief executive officer, Orion. "This agreement positions Orion to harness the potential of ODM-208 for the good of patients while continuing to invest in our other programs without compromising our financial targets."
About ODM-208
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.
About Metastatic Castration-Resistant Prostate Cancer
Globally, prostate cancer is the second most common cancer in people assigned male at birth, with an estimated 1.4 million 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.