Tuesday, December 29, 2020
Sumitovant Biopharma Ltd., the majority shareholder of Myovant Sciences, announced that Myovant Sciences, a healthcare company focused on redefining care for women and for men, and one of the five healthcare companies in the Sumitovant family of companies, and Pfizer Inc.have formed 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.
“We have been anticipating and planning for the commercial launch of the first product in our family of companies”, said Myrtle Potter, Chief Executive Officer of Sumitovant Biopharma. “With the approval of ORGOVYX, we are now realizing that goal and have taken steps to position ORGOVYX for success by supporting Myovant in forming an empowering collaboration between Myovant Sciences and Pfizer.”
“We are thrilled to partner with Pfizer to unlock the full potential of ORGOVYX in advanced prostate cancer and relugolix combination tablet in uterine fibroids and endometriosis, advancing our mission to redefine care for women and for men,” said Lynn Seely, M.D., Chief Executive Officer, Myovant Sciences, Inc. “Pfizer is the ideal partner for Myovant given its impressive capabilities and track record across both oncology and women’s health. This transformative collaboration will significantly strengthen the upcoming launch of ORGOVYX and the potential launches of relugolix combination tablet in women’s health, while substantially enhancing our financial position and enabling us to expand our pipeline of potential new medicines.”
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 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 U.S. Food and Drug Administration (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.
The FDA approved ORGOVYX on December 18, 2020 for the treatment of adult patients with advanced prostate cancer. ORGOVYX is the first and only oral GnRH antagonist for men with advanced prostate cancer. Relugolix combination tablet is currently under regulatory review by the FDA for women with uterine fibroids, with a target action date of June 1, 2021. Relugolix combination tablet is also under development for women with endometriosis, with a New Drug Application submission potentially anticipated in the first half of 2021.
