On May 9, 2022 Myovant Sciences (NYSE: MYOV) and Accord Healthcare, Ltd. (Accord) reported 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 (Press release, Myovant Sciences, MAY 9, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-accord-healthcare-ltd-enter-exclusive [SID1234613935]).
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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.
Goldman Sachs & Co. LLC has acted as the exclusive financial advisor to Myovant and Sidley Austin LLP represented Myovant in the transaction.
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 agonists 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.