Orion and MSD announce global collaboration to develop and commercialise ODM-208

14-Jul-2022

Agreement strengthens and complements MSD’s oncology pipeline

Orion Corporation and MSD (tradename of Merck & Co., Inc. Rahway, NJ, US) have announced a global development and commercialisation agreement for Orion’s investigational candidate ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production.

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

Under the terms of the agreement, Orion and MSD, acting through its subsidiary, Merck Sharp & Dohme LLC, will codevelop and cocommercialise ODM-208. MSD will make an upfront payment to Orion of $290 million, which will be expensed by MSD in the third quarter of 2022 and included in non-GAAP results.

Of this upfront payment, Orion recognises approximately €220 million as income at the time of signing and approximately €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 codevelopment and cocommercialisation agreement into a global exclusive license to MSD. If the option is exercised, MSD would assume full responsibility for all accrued and future development and commercialisation expenses associated with the programme.

Orion would be eligible to receive milestone payments associated with progress in the development and commercialisation 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.

“We are delighted to enter this collaboration with MSD, 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 CEO of Orion Corporation.

“This agreement positions Orion to harness the potential of ODM-208 for the good of patients while continuing to invest in our other programmes without compromising our financial targets.”

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“Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer,” said Dr Dean Li, President, MSD 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.”

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