Orion Bags Another Big Pharma Partner With Merck & Co Prostate Cancer Deal

The Finnish group has concluded an extensive search to partner its first-in-class CYP11A1 inhibitor, banking an impressive $290m upfront fee for the Phase II drug which is being evaluated for metastatic castration-resistant prostate cancer.

Source: Orion

Having successfully partnered Nubeqa with a pharma major in Bayer AG, Orion Corporation has teamed up with an even bigger player, Merck & Co., Inc., for another prostate cancer candidate, picking up a big upfront into the bargain.

The Finland-based group has unveiled a licensing deal with Merck for ODM-208, a first-in-class CYP11A1 inhibitor which is in a Phase II trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the deal, which covers other candidates targeting CYP11A1, an enzyme important in steroid production, Orion will receive an upfront payment of $290m.

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, Orion would be eligible to receive milestone payments as well as tiered double-digit royalties and while no other financial details were disclosed, Orion acknowledged that "the total amount potentially accrued from multiple regulatory and sales milestone events represents a substantial opportunity."

After the deal was announced, Orion upgraded its full-year outlook, saying that it estimates net sales and operating profit in 2022 "to be clearly higher than in 2021." Last year, those figures were €1.04bn and €243m, respectively, driven by the Espoo-headquartered firm's Easyhaler portfolio of asthma and COPD therapies and the entacapone-based Parkinson’s disease drugs Stalevo and Comtan.

Orion had previously revealed that it had been involved with multiple interested partners in licensing ODM-208 and getting Merck onboard is quite a coup. CEO Timo Lappalainen said the deal "positions Orion to harness the potential of ODM-208 ... while continuing to invest in our other programs without compromising our financial targets.”

The deal comes just a few months after Orion announced plans to refocus its R&D efforts on cancer and pain and halt investment in neurodegenerative and rare diseases. Oncology is where the company has had most success recently with Nubeqa (darolutamide), which was approved in the EU in March 2020 and the US in July 2019 for non-metastatic CRPC.

Partner Bayer is now forecasting at least €3bn in peak sales for the drug, up from its earlier estimate of €1bn, based on promising new data from the Phase III ARASENS trial evaluating Nubeqa as a treatment for metastatic hormone-sensitive prostate cancer (mHSPC); the German group made a submission to the US Food and Drug Administration for that indication earlier this year. (Also see "Bayer's Faith In Pharma Pipeline Paying Off" - Scrip, 21 Feb, 2022.)

As for Merck, Dean Li, president of MSD Research Laboratories, said: “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.”

The US giant is no stranger to the mCRPC space as it has an established partnership with AstraZeneca PLC for the latter's PARP inhibitor Lynparza (olaparib). The drug is approved for patients with mCRPC with homologous recombination repair (HRR) mutations who have progressed following treatment with Johnson & Johnson's Zytiga (abiraterone) or Pfizer Inc./Astellas Pharma, Inc.’s Xtandi (enzalutamide); the companies are hoping for approval in the first-line setting irrespective of HRR mutation status based on positive data from the PROpel study.  (Also see "Data PROpel Lynparza To Potential Prostate Cancer Megablockbuster" - Scrip, 24 Sep, 2021.) (Also see "AstraZeneca/Merck Reinforce Lynparza’s Prostate Cancer Position With First-Line Data" - Scrip, 21 Jun, 2022.).

Merck has had less success with a combination of Lynparza and its immunotherapy blockbuster Keytruda (pembrolizumab) in prostate cancer. Earlier this year, the KEYLYNK-010 study was discontinued after a planned interim analysis found that the combo did not have a significant overall survival benefit compared with the control arm using Zytiga or Xtandi. (Also see "Rare Setback For Merck & Co And AstraZeneca’s Keytruda-Lynparza Combo In Prostate Cancer" - Scrip, 16 Mar, 2022.)

No drugs in the PD-1/PD-L1 class have gained approval for prostate cancer but Merck has not given up. It is collaborating with Seagen Inc. , which could soon be taken over by Merck if the rumor mill is correct, on antibody-drug conjugate ladiratuzumab vedotin both as monotherapy and in combination with Keytruda for prostate cancer as well as other solid tumors. (Also see "Merck & Co Closing In On Seagen Acquisition" - Scrip, 8 Jul, 2022.)

The Orion/Merck pact is one of the biggest licensing deals of the year to date. The upfront is only topped by Gilead Sciences, Inc. paying $300m in May for global licensing rights to a tri-specific natural killer cell engager candidate for solid tumors from Dragonfly Therapeutics, Inc.. (Also see "Deal Watch: Dragonfly Adds Gilead To Its List Of Big-Name Partners" - Scrip, 2 May, 2022.)