Myovant Sciences Ltd., a biopharmaceutical company, focuses on redefining care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. The company is a subsidiary of Sumitovant Biopharma Ltd.
Product and Product Candidates
Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist that binds to and inhibits GnRH receptors in the anterior pituitary gland. As a GnRH receptor...
Myovant Sciences Ltd., a biopharmaceutical company, focuses on redefining care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. The company is a subsidiary of Sumitovant Biopharma Ltd.
Product and Product Candidates
Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist that binds to and inhibits GnRH receptors in the anterior pituitary gland. As a GnRH receptor antagonist, relugolix has a clinically-validated mechanism of action in each of the company’s programs, such as advanced prostate cancer; heavy menstrual bleeding associated with uterine fibroids; pain associated with endometriosis; and prevention of pregnancy.
In the company’s Phase 1 dedicated ovulation inhibition study, treatment with relugolix combination therapy inhibited ovulation in 100% of patients from the first cycle. In addition, ovulation or menses returned in 100% of patients once treatment was discontinued. Based on these data, relugolix combination tablet may provide a treatment option for women with uterine fibroids or endometriosis, which also provides reliable prevention of pregnancy. The company’s Phase 3 SERENE study was initiated to demonstrate the contraceptive efficacy of relugolix combination tablet. Although the target population for relugolix combination tablet are women with uterine fibroids or endometriosis, to properly assess the contraceptive efficacy in a fertile population at risk of pregnancy, the SERENE study is being conducted in healthy premenopausal women 18 to 35 years of age.
ORGOVYX
In December 2020, the U.S. Food and Drug Administration (FDA) approved ORGOVYX for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral GnRH receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the company’s Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer.
ORGOVYX became commercially available through authorized specialty distributors in the U.S. in early January 2021. The company’s oncology sales force began promoting ORGOVYX to target prescribers in early January 2021 and the uro-oncology sales force of the company’s collaboration partner, Pfizer Inc. (Pfizer), began actively promoting ORGOVYX to target prescribers in early February 2021.
In March 2021, the company announced that the European Medicines Agency (EMA) validated its previously submitted Marketing Authorization Application (MAA) for relugolix for the treatment of men with advanced prostate cancer. The validation of the application confirmed that the submission is sufficiently complete for the EMA to begin the formal review process. The company expects the European Commission decision on this application in calendar year 2022.
The company and its collaboration partner, Pfizer, may conduct additional clinical studies to support the commercial potential of relugolix monotherapy.
Relugolix Combination Tablet
The company is developing relugolix combination tablet administered orally once-daily, with the intention of maintaining estrogen levels in the low normal range to achieve the long-term benefit of relugolix on symptoms of uterine fibroids and endometriosis, while maintaining bone health and mitigating side effects from a low-estrogen state, such as vasomotor symptoms. It has successfully completed a bioequivalence study, which demonstrated the bioequivalence of relugolix combination tablet with relugolix combination therapy, the co-administered regimen used in the LIBERTY and SPIRIT clinical programs (one relugolix 40 mg tablet plus one tablet containing estradiol 1.0 mg and norethindrone acetate 0.5 mg). The company expects to launch in the women’s health indications, if approved, with its single-tablet regimen.
In April 2021, the company and Pfizer announced that the first patient has been dosed in the Phase 3 SERENE study, which is designed to assess the potential of relugolix combination tablet to prevent pregnancy, and may complement data from its Phase 3 LIBERTY and SPIRIT programs.
The company initiated a Phase 3 clinical program in 2017, evaluating relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids.
In May 2019 and July 2019, the company announced positive top-line results for the LIBERTY 1 and LIBERTY 2 studies, respectively. In February 2020, the company announced positive safety and efficacy data from the Phase 3 LIBERTY long-term extension study. In March 2020, the company announced the submission of a MAA to the EMA for relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids. This application has completed validation and is under evaluation by the EMA. The company expects the European Commission decision on this application in mid-calendar year 2021. If approved, this commercial launch would be executed by Gedeon Richter Plc. (Richter), the company’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.
In May 2020, the company submitted an New Drug Application (NDA) to the FDA for relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, which has been accepted by the FDA with a target action date of June 1, 2021. If approved, the company and Pfizer expect to launch relugolix combination tablet for the treatment of uterine fibroids in the U.S. in June 2021.
In September 2020, the company announced additional data on bone mineral density in women with uterine fibroids from the LIBERTY program and from a prospective observational study. In October 2020, the company presented one-year efficacy and safety data from the LIBERTY long-term extension study at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress.
In February 2021, the company and its collaboration partner, Pfizer, announced publication in the New England Journal of Medicine of the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy in women with uterine fibroids. In March 2021, the company and Pfizer announced positive safety and efficacy data from the LIBERTY randomized withdrawal study.
In April 2020 and June 2020, the company announced positive top-line results from the SPIRIT 2 and SPIRIT 1 studies, respectively. In October 2020, data from the Phase 3 SPIRIT studies were presented at the ASRM 2020 Virtual Congress and the presentation was named the Prize Paper by the Endometriosis Special Interest Group. In January 2021, the company and Pfizer announced positive one-year safety and efficacy data from the Phase 3 SPIRIT long-term extension study.
The company’s U.S. regulatory submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in the second quarter of calendar year 2021. It expects to submit an MAA to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain in calendar year 2021. Richter will be the MAA sponsor.
In April 2021, the company and Pfizer announced that the first patient has been dosed in the Phase 3 single-arm, open-label SERENE study evaluating the contraceptive efficacy of relugolix combination tablet in healthy women ages 18-35 years who are at risk for pregnancy.
MVT-602
As part of the company’s license agreement with Takeda Pharmaceuticals International AG (Takeda), it acquired the worldwide rights to MVT-602, the company’s second product candidate, which previously had been evaluated in over 150 men. MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation; and production of estrogen and progesterone in women and testosterone in men.
MVT-602 is being developed as a potential treatment for female infertility in women as part of assisted reproduction, such as in vitro fertilization (IVF). MVT-602 has the potential to be a safer alternative to human chorionic gonadotropin as a part of assisted reproduction for the treatment of female infertility.
MVT-602, an analog of the naturally-occurring kisspeptin peptide in humans, may mimic natural physiology by inducing a luteinizing hormone surge during IVF and other assisted reproductive technologies, enhancing the likelihood of successful egg maturation and ovulation at the right time without the serious side effect of ovarian hyperstimulation syndrome (OHSS).
In 2018, the company presented data from a Phase 1 study of MVT-602 at the American Society for Reproductive Medicine Annual Congress. Results of the study showed that administration of MVT-602 in healthy premenopausal women in the follicular phase produced a dose-related increase in luteinizing hormone (LH) concentrations and expected effects on follicle-stimulating hormone (FSH) and estradiol. Top-line results from this Phase 2a study were presented at the European Society of Human Reproduction and Embryology in Vienna, Austria in June 2019. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired LH surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol. This study provides information for dose selection for a future study of MVT-602 in infertile women seeking pregnancy.
Collaborations and License Agreements
In December 2020, the company’s subsidiary, Myovant Sciences GmbH (MSG), and Pfizer, entered into a collaboration and license agreement, pursuant to which the company and Pfizer will collaborate to jointly develop and commercialize relugolix in oncology and women’s health in the U.S. and Canada (the ‘Co-Promotion Territory’). In addition, Pfizer received an option to acquire exclusive commercialization and development rights to relugolix in oncology outside the Co-Promotion Territory, excluding certain Asian countries.
In March 2020, the company entered into an exclusive license agreement with Richter for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States (including Russia), Latin America, Australia, and New Zealand.
The company has a license agreement with Takeda (as subsequently amended, the ‘Takeda License Agreement’) pursuant to which Takeda Pharmaceuticals International AG (Takeda), a subsidiary of Takeda Pharmaceutical Company Limited (Takeda Limited), the originator of relugolix, granted to the company an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by Takeda to develop and commercialize relugolix and MVT-602, and products containing these compounds for all human diseases and conditions. The territory for the company’s exclusive license for relugolix covers all countries worldwide, except that Takeda retains exclusive rights to Japan, China, Hong Kong, Indonesia, Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam (including in each case, the territories and possession of each of the foregoing), which the company collectively refers to as the Takeda Territory. Takeda has granted the company a nonexclusive license in the Takeda Territory to manufacture relugolix and to conduct development of relugolix for prostate cancer solely for the purpose of developing, manufacturing and commercializing relugolix in its territory. The territory for the company’s exclusive license for MVT-602 covers all countries worldwide. Its license includes a right of reference to regulatory materials related to relugolix and MVT-602 controlled by Takeda. In 2018, Takeda announced that they entered into a licensing agreement granting ASKA Pharmaceutical Co., Ltd. exclusive commercialization rights for uterine fibroids and exclusive development and commercialization rights for endometriosis in Japan.
Strategy
The key elements of the company’s strategy are to successfully commercialize ORGOVYX in the U.S. for the treatment of adult men with advanced prostate cancer and seek regulatory approval to commercialize relugolix monotherapy tablet in other markets; seek regulatory approval and prepare for potential commercialization of relugolix combination tablet for the treatment of women with uterine fibroids and for women with pain associated with endometriosis; leverage its collaboration with Pfizer to maximize the commercial potential of ORGOVYX and relugolix combination tablet in the U.S. and Canada, while continuing to invest in the clinical development of relugolix for additional potential indications; leverage the company’s collaboration with Richter to seek regulatory approval and commercialize relugolix combination tablet for the treatment of uterine fibroids and endometriosis in certain territories outside of the U.S.; advance assessment and potential clinical development of MVT-602; and expand its product portfolio and pipeline by advancing the company’s existing product candidates and/or acquiring or in-licensing additional clinical-stage product candidates or commercial-stage products.
Suppliers
In 2019, the company entered into a commercial manufacturing and supply agreement with Excella GmbH & Co. KG (Excella) pursuant to which Excella agreed to manufacture and supply the company with certain commercial relugolix active pharmaceutical ingredient (API).
The company has a commercial manufacturing and supply agreement with Takeda pursuant to which Takeda agreed to supply the company with and it agreed to obtain from Takeda certain quantities of relugolix drug substance according to agreed-upon quality specifications.
Sales and Marketing
The company’s oncology sales force markets ORGOVYX in the U.S. primarily to oncologists and urologists. ORGOVYX is sold in the U.S. through specialty distribution and specialty pharmacy channels, which then distribute product to hospitals and other organizations that provide ORGOVYX to end-user patients. The company is establishing a separate women’s health sales force.
Intellectual Property
Under the Takeda license agreement, the company is the exclusive licensee of multiple granted U.S. patents, and pending patent applications, as well as patents and patent applications in numerous foreign jurisdictions relating to relugolix and MVT-602.
For relugolix, the company is the exclusive worldwide licensee, excluding the Takeda Territory. These patents and patent applications cover the relugolix molecule and certain analogs and the use of relugolix to treat sex-hormone dependent prostate cancer and hysteromyoma (uterine fibroids); and methods of manufacturing; and certain formulations. The patent family directed to the relugolix molecule and its use will expire in 2024, subject to any extension of patent term that may be available in a particular country. The company has applied for PTE (patent term extension) based on the approval of ORGOVYX for a patent covering relugolix. If granted, the term of the extended patent may be extended for up to five years, or 2029. The patents and patent applications, if issued, directed to methods of manufacturing relugolix will expire in 2033, subject to any adjustment or extension of patent term that may be available in a particular country. The patents and patent applications, if issued, directed to formulations of relugolix will expire in 2036, subject to any adjustment or extension of patent term that may be available in a particular country. The company has filed patent applications directed to uses of relugolix combination therapy in treating, among other conditions, heavy menstrual bleeding associated with uterine fibroids and for pain associated with endometriosis. These applications are co-owned with Takeda under the Takeda License Agreement. If issued, they will expire in 2037 not including any adjustments or extensions. The company has also filed patent applications directed to the use of relugolix as a monotherapy to treat advanced prostate cancer. The granted U.S. patents, and patent applications in this patent family, if issued, will expire in 2037, not including any adjustments or extensions. These patents and patent applications are also co-owned with Takeda. The company has also filed patent applications directed to particular crystalline forms of relugolix and certain relugolix solvates. The patent applications in these families, if issued, will expire in 2040, not including any adjustments or extensions. The relugolix crystalline form application is co-owned with Takeda under the Takeda License Agreement.
For MVT-602, the company is the exclusive worldwide licensee of multiple patents and patent applications in the U.S. and numerous foreign jurisdictions. These patents and patent applications cover the MVT-602 oligopeptide and its use in treating advanced prostate cancer, as well as certain sustained release formulations containing MVT-602. The patent family directed to the MVT-602 molecule and method of use expires in 2028 in the U.S. (because of patent term adjustment) and in 2026 ex-U.S., subject to any adjustment or extension of patent term that may be available in a particular country. The patents directed to sustained-release formulations of MVT-602, if issued, would expire between 2030 and 2031, subject to any adjustment or extension of patent term that may be available in a particular country. The company intends to apply for PTE for a patent covering MVT-602. If granted, the patent term covering MVT-602 may be extended. The company is also the owner of patent applications directed to uses of MVT-602 in treating infertility. If issued, patents in this family will expire in 2037 subject to any adjustment or extension of patent term that may be available in a particular country. The company has licensed additional patents and patent applications from Takeda directed to other oligopeptides that target the same pathway as MVT-602.
Government Regulation
The company is subject to the Foreign Corrupt Practices Act of 1977, as amended. The company is subject to a variety of financial disclosure and securities trading regulations as a public company in the U.S., including laws relating to the oversight activities of the United States Securities and Exchange Commission and the regulations of the New York Stock Exchange, on which its common shares are traded.
Research and Development (R&D)
The company’s R&D expenses were $136.7 million in the year ended March 31, 2021.
Competition
The company competes with AbbVie Inc.
History
Myovant Sciences Ltd. was founded in 2016. The company was incorporated under the laws of Bermuda in 2016.
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