Myovant Sciences and Accord Healthcare, Ltd. Enter into Exclusive License Agreement to Commercialize ORGOVYX® for Advanced Hormone-Sensitive Prostate Cancer in Europe
• Myovant to receive an upfront payment of $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million • Myovant also eligible to receive tiered royalties from the high-teens to mid-twenties on net sales AHMEDABAD, India, May 9, 2022 /PRNewswire/ -- Myovant Sciences (NYSE: MYOV) and Accord Healthcare, Ltd. (Accord) today announced that they have entered into an exclusive license agreement for Accord to commercialize relugolix for the treatment of advanced hormone-sensitive prostate cancer under the trade name ORGOVYX® (relugolix, 120 mg) in the European Economic Area, United Kingdom, Switzerland and Turkey, with the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa and India.
Under the terms of the agreement, Myovant will receive an upfront payment of $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million. In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales. Myovant will continue to lead the global development of relugolix and provide initial product supply to Accord. Accord will be responsible for certain local clinical development, all commercialization for its territories, and has the option to manufacture relugolix in the future.
''We're delighted to join forces with Accord to make available the first and only oral androgen deprivation therapy for men with advanced hormone-sensitive prostate cancer in Europe,'' said David Marek, Chief Executive Officer of Myovant. ''Accord has a longstanding commitment to oncology with proven commercial capabilities that they will leverage to accelerate the launch to reach more patients with this meaningful therapy.'' ''We are proud to launch ORGOVYX® in Europe, as an addition to our specialty brand offerings,'' said Binish Chudgar, Managing Director of Accord. ''Accord currently supplies around 1 in 3 injectable oncology medicines in Europe and this agreement underpins our commitment to patients with cancer and our continued investment in novel therapies. With over 1.9 million men living with prostate cancer in Europe, our partnership with Myovant will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option.'' On April 29, 2022, the European Commission approved the marketing authorization application for ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The decision applies to all 27 European Union member states plus Iceland, Norway, and Liechtenstein. The marketing authorization application for ORGOVYX® is pending review by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). Accord expects to launch ORGOVYX® in Europe in the second half of calendar year 2022.
About Prostate Cancer In 2020, the total number of men in Europe with prostate cancer was approximately 1.9 million according to the World Health Organization's Agency for Cancer Research WHO IntlAgencyCancerResearch PC.
Prostate cancer is considered advanced when it has spread beyond the prostate, is localized to the prostate and unlikely to be cured by surgery or radiation or has comeback after initial treatment and cannot be treated with salvage surgery. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. LHRH antagonists are associated with an initial surge in testosterone levels that may exacerbate clinical symptoms in some patients and delayed testosterone recovery after the drug is discontinued due to their depot injection formulation.
About ORGOVYX® (relugolix) ORGOVYX® (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a gonadotropin-releasing hormone (GnRH) receptor antagonist ORGOVYX® blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.
About Accord Healthcare, Ltd.
Headquartered in the United Kingdom (UK), Accord Healthcare, Ltd. is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints among European companies in its category ensuring that over 95% of European patients get access to vital medicines. Accord has over 40 oncology and oncology-related treatments making it one of the largest suppliers of chemotherapy products in Europe with an additional 20 treatments which are currently in development and scheduled for launch over the next 5 years. Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide.
About Myovant Sciences Myovant Sciences Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women's health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. The company also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. The company has a supplemental New Drug Application in endometriosis-associated pain pending with the U.S. FDA. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational 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 Pharma Co., Ltd., is Myovant's majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn. Myovant Sciences' Forward-Looking Statements This 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 reflecting Myovant Sciences' expectations, including but not limited to: statements regarding Myovant's expected upfront payment and other milestone payments, as well as tiered royalties on net sales in the high teens to mid-twenties; Myovant's continued responsibility to lead the global development of relugolix and provide initial product supply to Accord; Accord's responsibility for certain local clinical development and all commercialization for its territories, as well as having the option to manufacture relugolix; the statement with respect to Accord's ability to leverage to accelerate the launch to reach more patients in Mr. Marek's quote; the statement that the partnership between Myovant and Accord will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option in Mr. Chudgar's quote; and the expected timeline of ORGOVYX's launch in Europe by Accord.
For a further discussion of factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations, see 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 January 26, 2022, 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.
Investor Contact: Uneek Mehra Chief Financial and Business Officer Myovant Sciences, Inc.
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