Myovant Sciences and Accord Healthcare, Ltd. enter into exclusive license agreement to commercialize Orgovyx for advanced hormone-sensitive prostate cancer in Europe.
Myovant Sciences and Accord Healthcare, Ltd. 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.
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.
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