UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 18, 2020
(Exact name of registrant as specified in its charter)
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Item 8.01 Other Events.
On December 18, 2020, the U.S. Food and Drug Administration approved ORGOVYXTM (relugolix) as the first and only oral gonadotropin-releasing hormone (GnRH) therapy for the treatment of adult patients with advanced prostate cancer. Myovant expects ORGOVYX to be available in January 2021.
In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval (CI): 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). ORGOVYX lowered prostate-specific antigen (PSA), on average, by 65% at Day 15 and by 83% at Day 29. In a substudy, 55% of men treated with ORGOVYX achieved normal testosterone levels (> 280 ng/dL) or returned to baseline within 90 days of treatment discontinuation. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea.
The wholesale acquisition cost for ORGOVYX in the United States will be $2,313 for a bottle containing thirty (30) 120 mg tablets. Myovant is committed to ensuring that men in the United States who are prescribed ORGOVYX can obtain access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant is launching the ORGOVYX Patient Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two (2) months of therapy, and patient assistance for qualifying uninsured patients.
Forward-Looking Statements
The statements above regarding Myovant’s expectation that ORGOVYX will become available in January 2021, that the wholesale acquisition cost for ORGOVYX in the United States will be $2,313 for a bottle containing thirty (30) 120 mg tablets, Myovant’s plans to offer a patient assistance program for patients and the expected features of such patient assistance program, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including, but not limited to: unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic; Myovant’s ability to sustain a commercial field organization and distribution network; and Myovant’s reliance on third parties for the manufacture of ORGOVYX. Myovant cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. You should not place undue reliance on these forward-looking statements, which speak only as of the date hereof, and, except as required by law, Myovant undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Myovant Sciences Ltd. | ||||||||||||||
| Date: | December 18, 2020 | By: | /s/ Matthew Lang | |||||||||||
| Name: | Matthew Lang | |||||||||||||
| Title: | General Counsel and Corporate Secretary | |||||||||||||