Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
today announced that the first participant has been dosed in the
Phase 3 SERENE study evaluating the contraceptive efficacy of
relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg,
and norethindrone acetate 0.5 mg) in healthy women ages 18-35 years
who are at risk for pregnancy.
"We are committed to redefining care for women, which means
supporting their overall health and quality of life. Many women
with uterine fibroids and endometriosis need to simultaneously
manage their symptoms and their reproductive choices – including
prevention of pregnancy,” said Juan Camilo Arjona Ferreira, M.D.,
Chief Medical Officer of Myovant Sciences, Inc. “The Phase 3 SERENE
study is designed to assess the potential of relugolix combination
tablet to prevent pregnancy, and will complement data from our
Phase 3 LIBERTY and SPIRIT programs which demonstrated the promise
of relugolix combination therapy as a potential treatment for
uterine fibroids and endometriosis.”
The SERENE study will enroll 900 sexually active, healthy women
ages 18-35 years with presumed normal fertility. The primary
efficacy endpoint is the at-risk Pearl Index, defined as the number
of on-treatment pregnancies per 100 women-years of treatment.
On-treatment pregnancies are pregnancies with an estimated
conception date between the first day of study intervention intake
up to and including seven days after the last intake of study
medication. Women will receive once-daily relugolix combination
tablet for 13 28-day at-risk cycles. Safety data will also be
collected during the study. “The findings of the Phase 1 study
demonstrated that relugolix combination therapy inhibited ovulation
in all the study participants and provided the basis for the SERENE
study to evaluate whether relugolix combination tablet has the
potential to prevent pregnancy in women receiving therapy,” said
James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development
Officer, Internal Medicine and Hospital, Global Product Development
at Pfizer. “The data from this Phase 3 study will provide important
information to patients and healthcare providers when making
treatment decisions for women with endometriosis and uterine
fibroids.”
In April 2020, Myovant announced results from a Phase 1
single-arm, open-label ovulation inhibition study to assess the
effects of relugolix combination therapy (relugolix 40 mg plus
estradiol 1.0 mg and norethindrone acetate 0.5 mg) on ovulation
inhibition, per the Hoogland-Skouby assessment scale (score
< 5). In 67 healthy women over an 84-day treatment period (three
cycles), relugolix combination therapy achieved 100% ovulation
inhibition and was generally well tolerated. Furthermore, 100% of
women resumed ovulation or menses upon discontinuation of
treatment, with an average time to ovulation of 23.5 days. Data
from this study were previously presented at the American Society
for Reproductive Medicine 2020 Virtual Congress.
Relugolix combination tablet is under review by the U.S.
Food and Drug Administration for the treatment of women with
uterine fibroids, with a decision expected by the June 1,
2021 target action date. The submission of a New Drug
Application for the treatment of moderate to severe pain associated
with endometriosis is anticipated in the first half of 2021.
More information can be found at www.clinicaltrials.gov,
identifier: NCT04756037.
About Myovant Sciences Myovant
Sciences aspires to redefine care for women and for men
through purpose-driven science, empowering medicines, and
transformative advocacy. We have one FDA-approved medicine,
ORGOVYX™ (relugolix), for adult patients with advanced prostate
cancer. Our lead product candidate, relugolix combination tablet
(relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5
mg), is under regulatory review in Europe and
the U.S. for women with uterine fibroids and is under
development for women with endometriosis. We are also developing
MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has
completed a Phase 2a study for female infertility as part of
assisted reproduction. Sumitovant Biopharma, Ltd., a wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our
majority shareholder. For more information, please visit our
website at www.myovant.com. Follow @Myovant on
Twitter and LinkedIn.
About Pfizer: Breakthroughs That Change Patients’
Lives At Pfizer, we apply science and our global resources
to bring therapies to people that extend and significantly improve
their lives. We strive to set the standard for quality, safety and
value in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Myovant Sciences Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. In
this press release, forward-looking statements include, but are not
limited to, all statements and quotes reflecting Myovant Sciences’
expectations of the SERENE study, including the timing and quality
of the clinical results and any potential indication that may
result from any regulatory filing; and the expected timing of
Myovant’s other regulatory filings and potential approvals. Myovant
Sciences' 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 the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether and when the FDA may approve the pending
application for relugolix combination tablet for women with uterine
fibroids and the potential application for women with
endometriosis, which will depend on myriad factors, including
making a determination as to whether the product’s benefits
outweigh its known risks and determination of the product’s
efficacy and, if approved, whether relugolix will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of relugolix; and
unforeseen circumstances or other disruptions to normal business
operations arising from or related to the COVID-19 pandemic.
Myovant Sciences cannot assure you that the events and
circumstances reflected in the forward-looking statements will be
achieved or occur. Factors that could materially affect Myovant
Sciences' operations and future prospects or which could cause
actual results to differ materially from expectations include, but
are not limited to, the risks and uncertainties listed in Myovant
Sciences' filings with the United States Securities and Exchange
Commission (SEC), including under the heading "Risk Factors" in
Myovant Sciences' Quarterly Report on Form 10-Q filed on February
11, 2021, as such risk factors may be amended, supplemented or
superseded from time to time. These risks are not exhaustive. New
risk factors emerge from time to time and it is not possible for
Myovant Sciences' management to predict all risk factors, nor can
Myovant Sciences assess the impact of all factors on its business
or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in
any forward-looking statements. You should not place undue reliance
on the forward-looking statements in this press release, which
speak only as of the date hereof, and, except as required by law,
Myovant Sciences undertakes no obligation to update these
forward-looking statements to reflect events or circumstances after
the date of such statements.
Pfizer Disclosure NoticeThe information
contained in this release is as of April 12, 2021. Pfizer assumes
no obligation to update forward-looking statements contained in
this release as the result of new information or future events or
developments.
This release contains forward-looking information about
relugolix combination tablet for women with uterine fibroids,
relugolix combination tablet for women with endometriosis, ORGOVYX
(relugolix) for the treatment of adult patients with advanced
prostate cancer and a collaboration between Pfizer and Myovant
Sciences to develop and commercialize relugolix in advanced
prostate cancer and women’s health, including their potential
benefits, that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, uncertainties regarding the commercial
success of relugolix; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; whether and when the potential
application for relugolix for women with endometriosis will be
filed with the FDA and whether and when any applications may be
filed for relugolix for advanced prostate cancer, for women with
uterine fibroids or for women with endometriosis in additional
jurisdictions or in any jurisdictions for any other potential
indications for relugolix; whether and when the FDA may approve the
pending application for relugolix for women with uterine fibroids
and the potential application for women with endometriosis and
whether and when regulatory authorities may approve any other
applications that may be filed for relugolix in other
jurisdictions, which will depend on myriad factors, including
making a determination as to whether the product’s benefits
outweigh its known risks and determination of the product’s
efficacy and, if approved, whether relugolix will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of relugolix;
whether our collaboration with Myovant Sciences will be successful;
uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Myovant Sciences ContactsRyan Crowe,
Investors+1 (650) 781-9106investors@myovant.com
Albert Liao, Media+1 (650)
410-3055 media@myovant.com
Pfizer ContactsMedia Relations Steve Danehy+1
(212) 733-1538PfizerMediaRelations@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
Pfizer (NYSE:PFE)
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