- USD 200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma to further support planned commercialization of relugolix across multiple indications
- Agreement with Sunovion Pharmaceuticals provides access to well-established commercial infrastructure currently utilized across multiple successful products
BASEL, Switzerland, Aug. 05, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced a USD 200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), bringing its total financing support for Myovant to USD 600 million, further bolstering Myovant’s cash and committed funding and increasing the company’s financing flexibility as it prepares for multiple potential product launches to treat advanced prostate cancer, uterine fibroids, and endometriosis.
Additionally, Myovant announced that it has entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals Inc. (Sunovion), an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma, for services to support the planned commercialization of investigational drug candidate relugolix. Under the agreement, Sunovion will provide third-party logistics, trade and retail distribution, contract operations, and market access account management services to Myovant and will become a non-exclusive distributor of relugolix for prostate cancer and the exclusive distributor of relugolix combination tablet for uterine fibroids and endometriosis in the U.S.
“The financial and operational support we are receiving from Sumitomo Dainippon Pharma puts Myovant in a unique position with the potential to strengthen our launch readiness, enhance our financial performance, and maximize the opportunity for relugolix, as we head toward significant milestones for the company and stakeholders,” said Frank Karbe, president and chief financial officer of Myovant Sciences. “We have made tremendous progress in building internal commercial capabilities across a number of areas and have forged important third-party relationships to leverage other well-established capabilities, as demonstrated by today’s agreement to access Sunovion’s successful and well-honed commercial infrastructure.”
“We are pleased to enter into this commercial collaboration with Myovant,” said Thomas Gibbs, senior vice president and chief commercial officer of Sunovion. “Our agreement enables access to Sunovion’s commercial and market access expertise to complement the commercial capabilities of Myovant, and we look forward to working closely with our partners at Myovant to prepare for the launch of relugolix.”
The terms of the new loan facility are expected to be largely consistent with the initial USD 400 million low-interest, five-year term loan facility from Sumitomo Dainippon Pharma that was announced in December 2019, and does not provide Sumitomo Dainippon Pharma with any rights to relugolix. Myovant will be able to access the facility on a quarterly basis, subject to certain terms and conditions, with no repayments due until the end of the term subject to certain exceptions. The additional funds will be used to fund Myovant’s operating expenditures, including preparation for the commercialization of relugolix.
Relugolix (120 mg) is under Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Additionally, Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 and a New Drug Application to the FDA in May 2020 for relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with uterine fibroids. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.
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 a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Urovant and Myovant, 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. For further information about Sumitovant, please visit https://www.sumitovant.com.
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 Sunovion Pharmaceuticals Inc.
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.
Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu, and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.
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 be the leading healthcare company focused on redefining care for women and for men; the commitments of Sumitomo Dainippon Pharma to Myovant, including statements regarding the expected terms of a USD 200 milliondebt facility; the statements regarding Sunovion Pharmaceuticals’ ability to provide distribution, logistics, and other commercial-related services to Myovant; and the statements regarding the benefits from Sumitomo Dainippon Pharma’s financial and operational support, including Myovant’s potential to strengthen its launch readiness, to enhance its financial performance, and to maximize the opportunity for relugolix; and the timing of any potential regulatory filings and approvals in any indication. 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. 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 possibility that the Company and Sumitomo Dainippon Pharma may not complete the debt facility transaction on the terms or timing described in this press release or at all, the possibility that Sunovion may be unable to perform the services under the agreement and 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. 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.
President and Chief Financial Officer
Myovant Sciences, Inc.
Director, Corporate Communications
Myovant Sciences, Inc.