Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
today 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 (relugolix
40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in
women with uterine fibroids. As previously reported, both studies
achieved the primary endpoint of response rates in menstrual blood
loss in addition to six of the seven key secondary endpoints, while
maintaining bone mineral density comparable to placebo as part of a
well-tolerated safety profile over 24 weeks.
“Women with uterine fibroids often suffer from symptoms such as
heavy menstrual bleeding and pain, which can significantly impact
their quality of life over many years,” said Ayman Al-Hendy,
M.D., Ph.D., Professor of Obstetrics and Gynecology, University of
Chicago, and lead author of the publication. “In the LIBERTY
studies, relugolix combination therapy improved the most bothersome
symptoms of uterine fibroids and had a well-tolerated safety
profile including maintenance of bone mineral density comparable to
placebo. The data published in the New England Journal of Medicine
underscore the potential of relugolix combination therapy to
provide an important new treatment option for this common
disease.”
LIBERTY 1 and LIBERTY 2 each met the primary endpoint, with
73.4% and 71.2% of women in the relugolix combination therapy
groups achieving the responder criteria compared with 18.9% and
14.7% of women in the placebo groups at Week 24, respectively (both
p < 0.001). A response was defined as a menstrual blood loss
volume of less than 80 mL and a 50% or greater reduction from
baseline in menstrual blood loss volume during the last 35 days of
treatment measured using the alkaline hematin method. On average,
women receiving relugolix combination therapy experienced an 84.3%
reduction in menstrual blood loss from baseline in each study (both
p < 0.001 compared to placebo).
“We are pleased that the New England Journal of Medicine
recognized the importance of our Phase 3 LIBERTY program and
published the study results, which support the potential of
once-daily relugolix combination therapy in women with uterine
fibroids,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical
Officer of Myovant Sciences, Inc. “As we approach our FDA target
action date of June 1, we look forward, if approved, to providing a
one pill, once-a-day treatment for the millions of women with
uterine fibroids who need and deserve new options.”
In LIBERTY 1 and LIBERTY 2, six of seven key secondary endpoints
measured at Week 24 achieved statistical significance, including
mean reduction in menstrual blood loss, amenorrhea, reduction in
pain in women with pain at baseline, improvement on the Bleeding
and Pelvic Discomfort scale, reduction in uterine volume (all p
< 0.001 compared to placebo), and improvement in anemia in those
women with anemia at baseline (both p < 0.05 compared to
placebo). In addition, among the approximately 50% of women with
moderate-to-severe pain at baseline, a significantly greater
proportion of women receiving relugolix combination therapy
reported minimal-to-no pain (maximum score of 1 on a 0 to 10
Numerical Rating Scale) during the last 35 days of treatment
compared to placebo (43% vs. 10% and 47% vs. 17%, respectively;
both p < 0.001). A seventh key secondary endpoint for reduction
in fibroid volume was not achieved in either study.
Data showed changes in bone mineral density were comparable
between the relugolix combination and placebo groups at the end of
treatment in LIBERTY 1 and LIBERTY 2. The overall incidence of
adverse events in the relugolix combination and placebo groups were
also comparable (62% vs. 66% and 60% vs. 59%, respectively),
including hot flashes (11% vs. 8% and 6% vs. 4%, respectively).
There were no pregnancies reported in the relugolix combination
groups in either study.
“The heavy bleeding and pain that women with uterine fibroids
commonly experience can have a significant impact on their everyday
lives,” said James Rusnak, M.D., Ph.D., Senior Vice President,
Chief Development Officer, Internal Medicine and Hospital, Global
Product Development at Pfizer. “These data offer strong evidence
that relugolix combination therapy, if approved, could be an
important new oral treatment with the potential to help patients
living with this debilitating condition.”
Data from LIBERTY 1 and LIBERTY 2, in addition to the 28-week
long-term extension study, were included in the New Drug
Application for relugolix combination tablet for uterine fibroids,
with an FDA decision expected by the June 1, 2021 target action
date. Myovant previously announced results from the LIBERTY
long-term extension study in February 2020. At one year, 87.7% of
women receiving relugolix combination therapy met the responder
criteria. In addition, women experienced, on average, an 89.9%
reduction in menstrual blood loss from baseline at one year.
Changes in bone mineral density and the incidence of adverse events
were consistent with those in LIBERTY 1 and LIBERTY 2.
About Uterine FibroidsUterine fibroids are
noncancerous tumors that develop in or on the muscular walls of the
uterus and are among the most common reproductive tract tumors in
women. In addition to an individual's genetic predisposition,
estrogens are well known to play an important role in the
regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause
debilitating symptoms such as heavy menstrual bleeding (frequently
resulting in anemia and fatigue), pain (including painful periods,
abdominal pain, painful intercourse, backache), increased abdominal
girth and bloating, urinary frequency or retention, constipation,
pregnancy loss, and, in some cases, infertility. These symptoms can
also lead to loss of productivity at work, limitations in normal
activities of daily living, and social embarrassment.
An estimated five million women in the U.S. suffer
from symptoms of uterine fibroids, and an estimated three million
women are inadequately treated by current medical therapy and
require further treatment.
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 0.5mg), 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, including Myovant Sciences’ aspiration to redefine
care for women and for men; Drs. Al-Hendy, Arjona Ferreira and
Rusnak’s quotes regarding the potential for relugolix combination
tablet for uterine fibroids; the expected timing and strength of
Myovant’s regulatory filings; and Myovant’s vision for a one pill,
once-a-day, treatment option suitable for long-term use in uterine
fibroids.
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 unforeseen
circumstances or other disruptions to normal business operations
arising from or related to the COVID-19 pandemic, the risk that
clinical trial data are subject to differing interpretations and
assessments by regulatory authorities and whether regulatory
authorities will be satisfied with the design of and results from
the clinical studies. Myovant Sciences 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. 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 February 17, 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, including a potential indication for
women with uterine fibroids, 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 ORGOVYX; 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 any
applications may be filed for relugolix for advanced prostate
cancer or relugolix combination tablet for women with uterine
fibroids in any other jurisdictions or for women with endometriosis
or any other potential indications in any jurisdictions; whether
and when the FDA may approve the pending application for relugolix
combination tablet for women with uterine fibroids and whether and
when regulatory authorities may approve any other applications that
may be filed for relugolix or relugolix combination tablet in any
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 and relugolix
combination tablet 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 or relugolix combination tablet;
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, 2019 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) 410-3055media@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
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