On August 5, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported 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 (Press release, Myovant Sciences, AUG 5, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-further-financing-support-sumitomo [SID1234562945]).
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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,