NEW YORK and LONDON, June 1,
2020 /PRNewswire/ -- Sumitovant Biopharma Ltd. announced
today that Myovant Sciences (NYSE: MYOV), a healthcare company
focused on redefining care for women and for men, and one of five
healthcare companies in the Sumitovant family of
companies, has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for its
once-daily relugolix combination tablet (relugolix 40 mg, estradiol
1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of
women with heavy menstrual bleeding associated with uterine
fibroids.
"An estimated five million women in the U.S. suffer from
symptoms of uterine fibroids, which may include heavy menstrual
bleeding, pain, and anemia – yet effective non-invasive treatment
options are very limited," said Lynn
Seely, M.D., chief executive officer of Myovant
Sciences. "If approved, we hope to redefine care for these women
with relugolix combination tablet, a potential new treatment that
demonstrated a predictable and clinically-meaningful reduction in
menstrual blood loss while maintaining bone health in the Phase 3
LIBERTY program."
The NDA submission in uterine fibroids is supported by positive
results from the Phase 3 LIBERTY program, which included two
multinational replicate studies and an open-label extension study
through one year. The NDA is the third regulatory application
Myovant has submitted this year, following a Marketing
Authorization Application to the European Medicines Agency in
uterine fibroids and an NDA in advanced prostate cancer. Myovant is
also advancing the Phase 3 SPIRIT program, evaluating relugolix
combination therapy in women with pain associated with
endometriosis, with data from a second Phase 3 study expected this
quarter.
About the Phase 3 LIBERTY Program in Uterine
Fibroids
Myovant's Phase 3 clinical program for
uterine fibroids consisted of two multinational,
placebo-controlled, replicate pivotal clinical studies (LIBERTY 1
and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg
plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women
with heavy menstrual bleeding associated with uterine fibroids for
24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2
studies were offered the opportunity to enroll in an active
treatment extension study in which all women received relugolix
combination therapy for an additional 28-week period for a total
treatment period of 52 weeks, designed to evaluate the safety and
efficacy of longer-term treatment. Upon completion of this 52-week
total treatment period, eligible women could elect to participate
in a second 52-week randomized withdrawal study designed to provide
two-year safety and efficacy data on relugolix combination therapy
and to evaluate the need for maintenance therapy. Across studies, 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.
LIBERTY 1 and 2 met their primary endpoints (p < 0.0001) with
73.4% and 71.2% of women receiving relugolix combination therapy
achieving the responder criteria compared with 18.9% and 14.7% of
women receiving placebo at 24 weeks, respectively. On average,
women receiving relugolix combination therapy in both studies
experienced an 84.3% reduction in menstrual blood loss from
baseline at Week 24 (p < 0.0001). Bone mineral density was
comparable between the relugolix combination therapy and placebo
groups in LIBERTY 1 and 2. The distribution of the change in bone
mineral density, including outliers, was similar for the relugolix
combination therapy and placebo groups at 24 weeks, as assessed by
dual energy x-ray absorptiometry (DXA). The overall incidence of
adverse events in the relugolix combination and placebo groups was
comparable in both studies.
The open-label extension study also met its primary endpoint
with relugolix combination therapy demonstrating an 87.7% response
rate at one year, showing the durability of the response observed
in LIBERTY 1 and 2. In addition, women experienced, on average, an
89.9% reduction in menstrual blood loss from baseline at Week 52.
Changes in bone mineral density through one year, as assessed by
DXA every three months, were consistent with LIBERTY 1 and 2. The
incidence of adverse events over one year was consistent with that
observed in LIBERTY 1 and 2, with no new safety signals
observed.
About Uterine Fibroids
Uterine 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 Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone
(GnRH) receptor antagonist that reduces ovarian estradiol
production, a hormone known to stimulate the growth of uterine
fibroids and endometriosis, and testicular testosterone production,
a hormone known to stimulate the growth of prostate
cancer. Myovant is developing a relugolix combination tablet
(relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5
mg) for women with uterine fibroids and for women with
endometriosis. Myovant is also developing a relugolix
monotherapy tablet (120 mg once daily) for men with advanced
prostate cancer.
About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare company
focused on redefining care for women and for men. The company's
lead product candidate is relugolix, a once-daily, oral GnRH
receptor antagonist. The company has three late-stage clinical
programs for relugolix in uterine fibroids, endometriosis, and
prostate cancer. The company is also developing MVT-602, an
oligopeptide kisspeptin-1 receptor agonist, that has completed a
Phase 2a study for the treatment of female infertility as part of
assisted reproduction. Takeda Pharmaceuticals International
AG, a subsidiary of Takeda Pharmaceutical Company Limited, the
originator of relugolix, previously granted the company a
worldwide license to develop and commercialize relugolix
(excluding Japan and certain other Asian countries) and
an exclusive license to develop and commercialize MVT-602 in all
countries worldwide. Sumitovant Biopharma, Ltd., a wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is the
majority shareholder of Myovant. For more information, please
visit the company's website at www.myovant.com.
Follow @Myovant on Twitter and LinkedIn.
About Sumitovant Biopharma Ltd.
Sumitovant is a global
biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder
of Myovant and Urovant, and wholly owns Enzyvant, Spirovant, and
Altavant. Sumitovant's promising pipeline is comprised of
early-through late-stage investigational medicines across a range
of disease areas targeting high unmet need. Sumitovant is a wholly
owned subsidiary of Sumitomo Dainippon Pharma. For further
information about Sumitovant, please
visit https://www.sumitovant.com. Follow Sumitovant on
LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo
Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan, operating
globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo
Dainippon Pharma is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd.
Today, Sumitomo Dainippon Pharma has more than 6,000 employees
worldwide. Additional information about Sumitomo Dainippon Pharma
is available through its corporate website at
https://www.ds-pharma.com.
Forward-Looking Statements
This press-release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include all statements regarding Myovant
Sciences' intent, belief, or expectations regarding future events
or results and can be identified by words such as "anticipate,"
"aspire," "believe," "can," "continue," "could," "estimate,"
"expect," "intend," "likely," "may," "might," "objective,"
"ongoing," "plan," "potential," "predict," "project," "should," "to
be," "will," "would," or the negative or plural of these words or
other similar expressions or variations, although not all
forward-looking statements contain these identifying words. In this
press release, forward-looking statements include, but are not
limited to, statements and quotes regarding Myovant Sciences'
aspirations to redefine care for women and men; the potential of
relugolix combination tablet, if approved, to be the first
once-daily, oral treatment for women with heavy menstrual bleeding
associated with uterine fibroids in the U.S., redefine care for
women and achieve a predictable and clinically-meaningful reduction
in menstrual blood loss while maintaining bone health; any
expectations regarding the approval of relugolix combination tablet
and the timing of any approval; any anticipated market size; and
the expected timing of data for the second Phase 3 study in women
with endometriosis. 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. 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' Annual Report on Form 10-K filed on May
18, 2020, 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.
Investor Contact:
Frank
Karbe
President and Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com
Media Contacts:
Sumitovant Biopharma
Mary
Stutts
SVP, Corporate Relations
media@sumitovant.com
Myovant Sciences
Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com
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