Myovant Sciences’ Founding Shareholder Roivant Sciences, and Sumitomo Dainippon Pharma Enter into a Memorandum of Unders...
September 06 2019 - 3:01AM
Myovant Sciences (NYSE: MYOV) today announced that its founding
shareholder, Roivant Sciences, and Sumitomo Dainippon Pharma Co.,
Ltd. (TSE: 4506) (“Sumitomo Dainippon”), a leading global Japanese
pharmaceutical company, have announced their entry into a
non-binding memorandum of understanding for the creation
of a broad strategic alliance. The Sumitomo
Dainippon-Roivant Alliance (“Alliance”) is expected to create a new
corporate entity which will be wholly owned by Sumitomo Dainippon
and will assume Roivant’s ownership interest in Myovant Sciences.
The Alliance is expected to support Myovant Sciences through
commercialization and profitability. Roivant and Sumitomo
Dainippon have stated that they expect to sign the definitive
agreement for the Alliance by the end of October 2019. The
transaction will be subject to customary closing conditions and any
required governmental approvals.
“We are excited to be part of this new Alliance which we believe
would provide significant advantages for us as we prepare for the
launch of relugolix,” said Lynn Seely, M.D., President and CEO of
Myovant Sciences. “Our planned NDA filings and launch preparations
for relugolix are well underway and we would benefit from the
support we anticipate from the Sumitomo Dainippon-Roivant
Alliance.”
Earlier this year, Myovant Sciences announced positive top-line
data from two Phase 3 clinical studies, LIBERTY 1 and LIBERTY 2,
evaluating relugolix combination therapy in women with uterine
fibroids, as well as positive results from a separate
bioequivalence study supporting a potential one pill, once-a-day
dosing regimen of relugolix combination therapy. Myovant Sciences
is on-track to submit a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) by the end of this calendar year.
Myovant also expects to announce topline results from its Phase 3
prostate cancer study later this year and results from its two
Phase 3 endometriosis studies in the first and second quarters of
calendar year 2020.
About Myovant SciencesMyovant Sciences aspires
to be the leading healthcare company focused on innovative
treatments for women’s health and prostate cancer. Myovant
Sciences’ lead product candidate is relugolix, an oral, once-a-day
small molecule that acts as a GnRH receptor antagonist. Myovant
Sciences has three late-stage clinical programs for relugolix
ongoing in uterine fibroids, endometriosis and prostate cancer.
Myovant Sciences 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 granted
Myovant Sciences an exclusive, 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. Over time, Myovant Sciences
intends to expand its development pipeline to include other
potential treatments for women’s health and prostate cancer. For
more information, please visit Myovant Sciences’ website at
www.myovant.com. Follow @Myovant on Twitter and LinkedIn
(https://linkedin.com/company/myovant-sciences/).
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.
About Roivant Sciences Roivant aims
to improve health by rapidly delivering innovative medicines and
technologies to patients. Roivant does this by
building “Vants” – nimble, entrepreneurial biotech and
healthcare companies with a unique approach to sourcing talent,
aligning incentives, and deploying technology to drive greater
efficiency in R&D and commercialization. Roivant today is
comprised of a central technology-enabled platform and 20 Vants
with over 45 investigational medicines in clinical and preclinical
development and multiple healthcare technologies. For more
information, please visit www.roivant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include all statements that are not historical
statements of fact and statements regarding the Company’s intent,
belief or expectations and can be identified by words such as
“anticipate,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,”
“strive,” “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 regarding Roivant Sciences and Sumitomo
Dainippon Pharma’s plans with respect to the Alliance, including
the timing of entry into the definitive agreement, expected
commitments by Sumitomo Dainippon Pharma and Roivant Sciences,
including support by Sumitomo Dainippon Pharma to Myovant and
options to leverage commercialization and infrastructure;
statements regarding Myovant Sciences’ aspirations to become the
leading healthcare company focused on innovative treatments for
women’s health and prostate cancer, Myovant Sciences’ intentions to
expand its development pipeline to include other potential
treatments for women’s health and prostate cancer and Myovant
Sciences’ plans to submit an NDA to the FDA by the end of 2019, to
report the results from its Phase 3 prostate cancer study later
this year and results from its two Phase 3 endometriosis studies in
the first and second quarters of calendar year 2020.
The Company’s forward-looking statements are based on
management’s current expectations and beliefs, and are subject to a
number of risks and uncertainties that could lead to actual results
differing materially from those projected, forecasted or expected.
Although the Company believes that the assumptions underlying these
forward-looking statements are reasonable, they are not guarantees
and the Company can give no assurance that its expectations will be
attained. Factors that could materially affect the Company’s
operations and future prospects or which could cause actual results
to differ materially from expectations include, but are not limited
to: the possibility that Roivant and Sumitomo Dainippon Pharma may
not enter into a definitive agreement on the terms or timing
described in this press release or at all; the possibility that
Roivant and Sumitomo Dainippon Pharma may be unable to obtain
required governmental approvals or that other conditions to closing
the transaction may not be satisfied, such that the transaction
will not close or that the closing may be delayed; and other risks
and uncertainties listed in the Company’s filings with the United
States Securities and Exchange Commission (SEC), including under
the heading “Risk Factors” in the Company’s most recently filed
Annual Report on Form 10-K and any subsequent Quarterly Reports on
Form 10-Q filed with the SEC, as such risk factors may be amended,
supplemented or superseded from time to time by other filings with
the SEC. 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, the Company undertakes no
obligation to update these forward-looking statements to reflect
events or circumstances after the date of such statements.
The Memorandum of Understanding is not legally binding with the
exception of some stipulations. The two companies will continue to
conduct necessary due diligence and engage in mutual consultations
as required as they work toward the conclusion of a legally binding
definitive agreement concerning detailed conditions, etc. of the
Strategic Alliance by the end of October 2019.
Investor Contact:Frank KarbeChief Financial
OfficerMyovant Sciences, Inc.investors@myovant.com
Media Contact:Sheryl SeapyPure
Communicationssseapy@purecommunications.com949.903.4750
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