Myovant Sciences + Pfizer announce collaboration to develop and commercialize relugolix in oncology and women’s health.

Myovant Sciences and Pfizer Inc. announced a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries. Under the terms of the agreement, Myovant and Pfizer will jointly develop and commercialize Orgovyx (relugolix) in advanced prostate cancer and, if approved, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada. Myovant and Pfizer will begin co-promoting Orgovyx for advanced prostate cancer in early 2021. Myovant and Pfizer will equally share profits and certain expenses for Orgovyx and relugolix combination tablet with Myovant recording revenues. Myovant will remain responsible for regulatory interactions and drug supply and continue to lead clinical development for relugolix combination tablet. Myovant will receive up to $4.2 billion, including an upfront payment of $650 million, $200 million in potential regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and also for the combined women’s health indications. If Pfizer exercises the option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, Myovant will receive $50 million and be entitled to receive double-digit royalties on sales.