Myovant Sciences’ stock rocketed 22% on news it was partnering with Pfizer to develop and commercialize relugolix for prostate cancer and women’s health.
Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. The two companies are collaborating in the U.S. and Canada, with Pfizer receiving an exclusive option to develop the drug in oncology outside those two markets except in certain Asian countries.
They will jointly develop and commercialize the drug, under the brand name Orgovyx, in advanced prostate cancer, and if approved, in combination with estradiol 1.0 mg and norethindrone acetate (0.5 mg) in women’s health in the U.S. and Canada. They will begin co-promoting Orgovyx for prostate cancer in early 2021. The two companies will split profits and certain expenses for Orgovyx and the relugolix combination. Myovant will handle regulatory interactions and drug supply, and lead on developing the relugolix combination program.
Pfizer is paying Myovant up to $4.2 billion, including an upfront payment of $650 million and $200 million in potential regulatory milestones, and tiered sales milestones up to $2.5 billion for prostate cancer and for the combined women’s health indications. If Pfizer chooses to exercise the option in oncology outside the U.S. and Canada, it will pay Myovant another $50 million and double-digit sales royalties.
“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, Myovant’s chief executive officer. “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.”
The U.S. Food and Drug Administration (FDA) approved Orgovyx on December 22 for advanced prostate cancer. The approval was built on a Phase III trial comparing Orgovyx to AbbVie’s injectable Lupron. The two drugs work differently. Orgovyx blocks the pituitary gland from producing hormones that signal the amount of testosterone production in the body. AbbVie’s Lupron, which is injected once every three months, overstimulates the body’s hormone production, leading to a temporary shutdown of testosterone. In the trial, Orgovyx suppressed testosterone to castration levels in 96.7% of participants, compared to 88.8% in Lupron.
Orgovyx is priced at $2,313 per bottle for a 30-day supply. Lupron is a once-month or once-every-three-months injection that averages about $8,687, although there is a generic option priced at $2,729.
Regulators in the U.S. are currently reviewing the relugolix combination tablet for women with uterine fibroids, with a target action date of June 1, 2021. It is also being developed for endometriosis, with a New Drug Application expected in the first half of 2021.
“There continues to be a high unmet need among the millions of women who experience the common and debilitating symptoms associated with uterine fibroids and endometriosis,” said Nick Lagunowich, Global President, Pfizer Internal medicine. “We believe our deep heritage and leadership in women’s health combined with our experienced women’s health field force will enable us to maximize these opportunities with Myovant, potentially bringing valuable new treatment options to these women.”