Myovant Sciences (NYSE: MYOV), a healthcare company focused on
developing innovative treatments for women's health and prostate
cancer, today announced that it has entered into a landmark
agreement with Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a
leading Japanese pharmaceutical company, on a $350 million
low-interest, five-year term loan facility and an Investor Rights
Agreement. This agreement was made in conjunction with Myovant’s
founding shareholder, Roivant Sciences, and Sumitomo Dainippon
Pharma entering into a definitive agreement for the creation
of a broad strategic alliance. At closing, the
alliance entity will assume Roivant’s ownership interest in
Myovant, which is expected to represent not less than a majority of
Myovant’s outstanding shares.
“Sumitomo Dainippon Pharma is committed to supporting Myovant
through commercialization and profitability as the robust potential
of relugolix is unlocked for women with uterine fibroids or
endometriosis, and for men with prostate cancer,” said Hiroshi
Nomura, Representative Director, President and CEO of Sumitomo
Dainippon Pharma.
“Myovant is delighted to have the support of Sumitomo Dainippon
Pharma,” said Lynn Seely, M.D., President and CEO of Myovant. “With
total cash and committed financing of approximately $500 million,
including the Sumitomo Dainippon Pharma term loan facility, we will
be in a strong financial position to advance the commercialization
of relugolix.”
Sumitomo Dainippon Pharma has committed to provide Myovant a
$350 million low-interest, five-year term loan facility, with no
repayments due until the end of the term to fund Myovant’s
operating expenditures. Myovant will be able to access the facility
on a quarterly basis, subject to certain terms and conditions. The
agreement will become effective upon close of the Sumitomo
Dainippon Pharma transaction with Roivant.
Myovant and Sumitomo Dainippon Pharma will also enter into an
Investor Rights Agreement, which provides that the Myovant Board of
Directors will continue to include a minimum of three independent
directors who will have approval rights over certain corporate
actions, including related-party transactions between Myovant and
Sumitomo Dainippon Pharma. The ratio of independent to
non-independent directors is also expected to remain unchanged. The
Investor Rights Agreement will further include standstill
provisions including a non-waivable condition requiring approval by
a majority of the minority shareholders for any transaction that
would cause Sumitomo Dainippon Pharma to hold beneficial ownership
of Myovant of greater than 60%. Additionally, for a standstill
period of three years, any such transaction must also be made on a
confidential basis to the independent directors and is subject to
approval by a majority of the independent directors.
Subject to the closing of the strategic alliance transaction,
Sumitomo Dainippon Pharma has also agreed that upon Myovant’s
request, the parties will discuss terms upon which Sumitomo
Dainippon Pharma will provide Myovant access to its U.S. commercial
infrastructure and operational support as Myovant moves forward
with the commercialization of relugolix.
Earlier this year, Myovant announced positive topline data from
two Phase 3 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 expects to announce topline results
from its Phase 3 study, HERO, evaluating relugolix monotherapy in
men with advanced prostate cancer later this year and results from
two Phase 3 studies, SPIRIT 1 and SPIRIT 2, evaluating relugolix
combination therapy in women with endometriosis in the first and
second quarters of 2020.
About Myovant SciencesMyovant
Sciences aspires to be the leading healthcare company focused
on innovative treatments for women’s health and prostate cancer.
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 granted the company 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. For more information, please visit the
company’s website at www.myovant.com. Follow @Myovant on
Twitter and 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.
About Roivant Sciences Roivant
Sciences aims to improve health by rapidly delivering
innovative medicines and technologies to patients. Roivant
Sciences 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 Sciences 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 Myovant Sciences’
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 the expected share ownership interest of Sumitomo
Dainippon Pharma or its affiliates in Myovant; the commitments of
Sumitomo Dainippon Pharma to Myovant, including statements
regarding the expected terms of a term debt facility; the expected
terms of an investor rights agreement between Sumitomo Dainippon
Pharma and Myovant, including the expected Sumitomo Dainippon
Pharma and independent director representation and ratio on
Myovant’s Board of Directors and the terms of an expected
standstill; Sumitomo Dainippon Pharma’s commitment to supporting
Myovant Sciences through commercialization and profitability; the
expected access that Sumitomo Dainippon Pharma will provide Myovant
Sciences to its U.S. commercial infrastructure and operational
support to facilitate Myovant Sciences’ path toward product
commercialization and operational efficiency; statements regarding
Myovant Sciences’ aspirations to become the leading healthcare
company focused on innovative treatments for women’s health and
prostate cancer; and Myovant Sciences’ clinical development plans
and timelines.
Myovant Sciences’ 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.
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 Sciences and Sumitomo Dainippon Pharma may
not complete the transactions contemplated by their definitive
agreement on the terms or timing described in this press release or
at all, whether due to their inability to obtain required
governmental approvals or the failure of other conditions to
closing the transaction to be satisfied, or otherwise; 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.
Investor Contact:Frank KarbeChief Financial
OfficerMyovant Sciences, Inc.investors@myovant.com
Media Contact:Albert LiaoDirector, Corporate
CommunicationsMyovant Sciences, Inc.media@myovant.com
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