Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
today announced that the Phase 3 SPIRIT long-term extension study
of the investigational once-daily relugolix combination therapy
(relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate
0.5 mg) in women with endometriosis reported clinically meaningful
reductions in dysmenorrhea (menstrual pain) and non-menstrual
pelvic pain over one year (52 weeks) with minimal and stable bone
mineral density loss. The data are consistent with the efficacy and
safety profile observed through 24 weeks in the Phase 3 SPIRIT 1
and SPIRIT 2 studies. These results will be included in the New
Drug Application to the U.S. Food and Drug Administration for
relugolix combination tablet for the treatment of women with
endometriosis, anticipated to be submitted in the first half of
2021.
“Given the debilitating impact that endometriosis can have on
women in their daily lives, often over many years, we need
non-invasive and long-term treatment options,” said Linda
Giudice, M.D., Ph.D., Distinguished Professor in the Center for
Reproductive Sciences at the University of
California, San Francisco (UCSF) and SPIRIT Program
Steering Committee Member. “The one-year data from the Phase 3
SPIRIT extension study offers promising evidence that relugolix
combination therapy has the potential to significantly and durably
reduce pain in women with endometriosis, while remaining well
tolerated.”
In the SPIRIT long-term extension study, 84.8% and 73.3% of
women receiving relugolix combination therapy over one year
achieved clinically meaningful pain reductions in dysmenorrhea and
non-menstrual pelvic pain, respectively. On average, women reported
an 82.8% reduction on the 11-point Numerical Rating Scale (0-10)
for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain) over one
year.
“Building on the strength of our one-year data of relugolix
combination therapy in uterine fibroids, we are pleased by the
one-year safety and efficacy data in women with endometriosis,
which further our vision for a one pill, once-a-day treatment
option suitable for long-term use in both diseases,” said Juan
Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant
Sciences, Inc. “We look forward to submitting a New Drug
Application for this potential new treatment for women with
endometriosis in the first half of this year.”
“Endometriosis is a common and painful condition, which impacts
approximately 10 percent of women during their reproductive
lifetime,” said James Rusnak, M.D., Ph.D., Senior Vice President,
Chief Development Officer, Internal Medicine and Hospital, Global
Product Development at Pfizer. “We believe the results from the
one-year extension study show the encouraging potential of
relugolix combination therapy to evolve the treatment paradigm for
women with endometriosis.”
Bone mineral density remained stable through Week 52 in women
treated with relugolix combination therapy after minimal,
non-clinically meaningful bone loss through Week 24. The incidence
of adverse events over one year was consistent with that observed
in SPIRIT 1 and SPIRIT 2, with no new safety signals observed. The
most commonly reported adverse events in at least 10% of women
treated with relugolix combination therapy were headache,
nasopharyngitis, and hot flashes. There was one pregnancy reported
in the relugolix combination therapy group (n = 278).
Data from SPIRIT 1 and SPIRIT 2 studies were previously
presented at the American Society for Reproductive
Medicine (ASRM) 2020 Virtual Congress. Complete results
from the SPIRIT long-term extension study will be submitted for
presentation at a future scientific meeting and publication in a
medical journal.
In December 2020, Myovant and Pfizer entered into a
collaboration for the development and commercialization of
relugolix in oncology and women’s health in the U.S. and Canada.
Under the terms of the agreement, Myovant and Pfizer will jointly
develop and commercialize ORGOVYX™ (relugolix) in advanced prostate
cancer and, if approved, relugolix combination tablet (relugolix 40
mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in uterine
fibroids and endometriosis.
About the Phase 3 SPIRIT Program in
EndometriosisThe Phase 3 clinical program for
endometriosis consists of two multinational, replicate pivotal
clinical studies (SPIRIT 1 and SPIRIT 2) of relugolix combination
therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone
acetate 0.5 mg) in over 1,200 women with pain associated with
endometriosis. Women received treatment either with relugolix
combination therapy for 24 weeks, relugolix 40 mg once daily
monotherapy for 12 weeks followed by relugolix combination therapy
once daily for an additional 12 weeks, or placebo once daily for 24
weeks. Eligible women who completed the SPIRIT 1 or SPIRIT 2
studies were offered the opportunity to enroll in an active
treatment extension study in which all women receive relugolix
combination therapy for an additional 80-week period, resulting in
a total treatment period of up to 104 weeks, designed to evaluate
the safety and sustained efficacy of longer-term treatment.
About EndometriosisEndometriosis is an
estrogen-dependent, inflammatory disease in which tissue similar to
the uterine lining is found outside the uterine cavity, commonly in
the lower abdomen or pelvis, on ovaries, the bladder, and the
colon. This endometrial-like tissue outside the uterus results in
chronic inflammation and can cause scarring and adhesions.
The symptoms associated with endometriosis include painful
periods and chronic pelvic pain, painful ovulation, pain during or
after sexual intercourse, heavy bleeding, fatigue, and infertility.
Endometriosis can also impact general physical, mental, and social
well-being, requiring a multi-disciplinary approach to care.
For endometriosis-associated pain, per current guidelines,
initial treatment options include hormonal contraceptives and
over-the-counter pain medications. In more severe cases, LHRH
agonists such as leuprolide acetate are used for short-term
treatment. An estimated six million women in
the U.S. suffer from symptoms of endometriosis, and an
estimated one million women are inadequately treated by current
medical therapy and require further treatment. Almost 200 million
women are affected globally.
About Myovant
Sciences Myovant
Sciences aspires to redefine care for women and for men
through purpose-driven science, empowering medicines, and
transformative advocacy. Our lead product candidate, relugolix, is
a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is
FDA-approved as ORGOVYX™ for adult patients with advanced
prostate cancer. 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, including Myovant Sciences’ aspiration to redefine
care for women and for men; the expected timing and strength of
Myovant’s regulatory filings; the potential for relugolix
combination therapy to significantly and durably reduce pain in
women with endometriosis with a well-tolerated safety profile; the
potential for relugolix combination therapy to evolve the treatment
paradigm for women with endometriosis; and Myovant’s vision for a
one pill, once-a-day, treatment option suitable for long-term use
in uterine fibroids and 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, including 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 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 November 12, 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.
Pfizer Disclosure NoticeThe information
contained in this release is as of January 26, 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 endometriosis,
relugolix combination tablet for women with uterine fibroids,
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 and potential regulatory submission, 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 the potential application for relugolix combination tablet 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 or relugolix combination tablet 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 combination tablet 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 or
relugolix combination tablet 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 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
Grafico Azioni Pfizer (NYSE:PFE)
Storico
Da Feb 2024 a Mar 2024
Grafico Azioni Pfizer (NYSE:PFE)
Storico
Da Mar 2023 a Mar 2024