Healthcare company Myovant Sciences Ltd. (MYOV:NYSE), which is focused on developing innovative treatments for women's health and prostate cancer, today announced that it entered into a collaboration agreement with pharmaceutical research giant Pfizer Inc. (PFE:NYSE) to develop and commercialize relugolix as a mono and combination therapy in the U.S. and Canada.
The company explained that relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that is being developed for treatments in both oncology and women's health. The agreement also will provide Pfizer with the exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries if certain medical approvals and milestones are achieved.
Myovant Sciences' CEO Lynn Seely, M.D., commented, "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...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 collaboration agreement, Myovant and Pfizer will partner to jointly develop and commercialize ORGOVYX™ (relugolix) for use in treatment of advanced prostate cancer and plan to begin co-promoting ORGOVYX for advanced prostate cancer in early 2021. Should Pfizer choose to exercise the option to commercialize relugolix in oncology in markets outside of the U.S. and Canada, excluding certain Asian countries, it will be required to pay Myovant $50 million along with double-digit royalties on those sales.
In addition, if approved, the firms will also work together to develop and market a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for certain women's health indications in Canada and the U.S.
The report stated that "Myovant and Pfizer will equally share profits and certain expenses for ORGOVYX and relugolix combination tablet with Myovant recording revenues."
The release noted that Myovant will continue to be fully responsible for the clinical development and approval process for relugolix combination tablet. If successful, the company will then have the opportunity to receive up to $4.2 billion from Pfizer. This amount would include "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."
Andy Schmeltz, global president of Pfizer Oncology, remarked, "We are excited to join forces with Myovant and combine our capabilities to bring ORGOVYX to patients with advanced prostate cancer...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."
"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...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," stated Nick Lagunowich, global president of Pfizer Internal Medicine.
The company advised that "the FDA approved ORGOVYX on December 18, 2020 for the treatment of adult patients with advanced prostate cancer." The firm noted that a relugolix combination tablet is currently under regulatory review by the FDA for treating uterine fibroids and is also in development by the company for treating women with endometriosis.
The firm explained that relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer and noted that "ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer." The company added that relugolix also reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis.
Myovant Sciences Ltd. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of women's health, prostate cancer and endocrine diseases.
Pfizer is a research-based global biopharmaceutical firm based in New York City that is engaged in the discovery, development and manufacture of healthcare products including medicines and vaccines. Its global portfolio is composed of many household name brand prescription medications including Celebrex, Eliquis, Lipitor, Prevnar 13, Pristiq, Viagra and Xeljanz. The company's shares trade on the NYSE and it has a market cap of greater than $207 billion.
Myovant Sciences started the day with a market cap of around $2.1 billion with approximately 90.59 million shares outstanding and a short interest of about 3.1%. MYOV shares opened greater than 30% higher today at $30.18 (+$7.43, +32.66%) over Friday's $22.75 closing price and reached a new 52-week high this morning of $30.90. The stock has traded today between $27.51 and $30.90 per share and is currently trading at $28.39 (+$5.64, 24.79%).
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