On December 26, 2020, Myovant Sciences GmbH ("Myovant"), a subsidiary of Myovant Sciences Ltd., reported that it entered into a Collaboration and Licensing Agreement (the "Agreement") with Pfizer Inc., pursuant to which Myovant and Pfizer will collaborate to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health indications in the U.S. and Canada (Filing, 8-K, Myovant Sciences, DEC 26, 2020, View Source [SID1234573276]). Pfizer will also receive an option to acquire exclusive commercialization and development rights to relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries (the "Pfizer Territory").
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Under the terms of the Agreement, Myovant and Pfizer will jointly develop and commercialize ORGOVYXTM (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 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 will continue to lead clinical development for relugolix combination tablet in the women’s health indications, while development for ORGOVYX will be shared equally among both companies.
Myovant is eligible to receive total potential payments of up to $4.2 billion, including an upfront payment of $650 million, regulatory milestones of $100 million upon each potential U.S. Food and Drug Administration approval for relugolix combination tablet in uterine fibroids and endometriosis, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and the combined women’s health indications. In addition, if Pfizer exercises its option to acquire exclusive commercialization and development rights to relugolix in oncology in the Pfizer Territory, Myovant will receive an option exercise fee of $50 million and will be entitled to receive double-digit royalties on sales of relugolix. Pfizer will bear 100% of costs incurred in the Pfizer Territory. The term of the Agreement continues until either no products are sold and all development activities have terminated or, in the case Pfizer exercises its option for relugolix in the Pfizer Territory, when its obligation to pay royalties expires, in each case subject to early termination under the terms of the Agreement.