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Myovant Sciences, Pfizer To Jointly Develop Relugolix

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Myovant Sciences Ltd. (MYOV) and Pfizer Inc. (PFE) said Monday they will collaborate to develop and commercialize relugolix in oncology and women's health in the U.S. and Canada in a deal valued up to $4.2 billion.

Pfizer will receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone and ovarian estradiol. Testicular testosterone is a hormone known to stimulate the growth of prostate cancer, while ovarian estradiol is a hormone known to stimulate the growth of uterine fibroids and endometriosis.

Under the terms of the deal, Myovant will receive an upfront payment of $650 million in addition to potential regulatory and sales milestones for a total payment of up to $4.2 billion.

Myovant will receive $200 million in potential regulatory milestones for approvals by the U.S. FDA for relugolix combination tablet in women's health.

In addition, Myovant will receive tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and for the combined women's health indications.

Myovant and Pfizer will jointly develop and commercialize Orgovyx (relugolix) in advanced prostate cancer. If approved, the companies will also jointly develop and commercialize relugolix combination tablet in women's health in the U.S. and Canada.

Myovant and Pfizer will start to co-promote Orgovyx for advanced prostate cancer in early 2021. The two companies will equally share profits and certain expenses for Orgovyx and relugolix combination tablet, while Myovant will record revenues.

Myovant will remain responsible for regulatory interactions and drug supply as well as continue to lead clinical development for relugolix combination tablet.

Myovant will receive $50 million and can also receive double-digit royalties on sales if Pfizer opts to commercialize relugolix in oncology outside of the U.S. as well as Canada and excluding certain Asian countries.

On December 18, the FDA approved Orgovyx, the first and only oral GnRH antagonist, for the treatment of adult patients 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.

The Relugolix combination tablet is also under development for women with endometriosis, with a New Drug Application submission anticipated in the first half of 2021.

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