Pfizer, Myovant ink $4.2B deal for relugolix development

BASEL, Switzerland & NEW YORK—The end of the year might be a time to relax for most, but for Myovant Sciences and Pfizer Inc., it's a time to set up big plans for the upcoming year. The two companies have established a collaboration centered on the development and commercialization of relugolix in oncology and women's health in the United States and Canada.

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that was approved by the FDA as Orgovyx for the treatment of advanced prostate cancer in adults in December, making it the first and only oral GnRH antagonist for men with this cancer type. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is undergoing regulatory review in Europe and the U.S. for the treatment of uterine fibroids and is also being developed for endometriosis as well.

“We are excited to join forces with Myovant and combine our capabilities to bring ORGOVYX to patients with advanced prostate cancer,” said Andy Schmeltz, global president of Pfizer Oncology. “This strategic collaboration builds on our leadership in serving prostate cancer patients in the U.S. and aligns with our goal to deliver more breakthroughs across the prostate cancer treatment paradigm.”

Per the terms of the agreement, the partners will jointly develop and commercialize Orgovyx in advanced prostate cancer and relugolix combination tablet in women's health (should it gain approval) in the U.S. and Canada. Myovant and Pfizer will co-promote Orgovyx in advanced prostate cancer in early 2021, and will share certain expenses and profits equally for Orgovyx and relugolix combination tablet, with Myovant recording revenues. Myovant will retain responsibility for regulatory interactions and drug supply, and will continue to lead clinical development for relugolix combination tablet. Pfizer will pay Myovant up to $4.2 billion, which includes an upfront payment of $650 million, $200 million in potential regulatory milestones for FDA approval 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.

In addition, this deal also provides Pfizer with an exclusive option to commercialize relugolix in oncology outside of the United States and Canada, excluding certain Asian countries. Should Pfizer elect to exercise this option, Myovant will receive a payment of $50 million as well as rights to double-digit royalties on sales.

“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,” Dr. Lynn Seely, CEO of Myovant Sciences, remarked in a statement. “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.”

“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,” added Nick Lagunowich, global president of 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.”

Keith Speights of Motley Fool reported that Myovant's shares were up 26.7 percent in the wake of the collaboration news, noting that “There's definitely a great fit between Pfizer and Myovant. The former has been a key player in both the prostate cancer and women's health markets. The big drugmaker's sales force will almost certainly make relugolix a bigger commercial success more quickly than Myovant would have been able to do on its own.”