Intas Pharmaceuticals Ltd, in a statement today, said that its arm, Accord Healthcare Ltd, has entered into an exclusive license agreement with UK-based biotech player Myovant Sciences, in order to offer a new treatment option for prostate cancer patients in Europe. This agreement will lead to commercialization of relugolix, 120 mg, under tradename of ORGOVYX® in European Economic Area, United Kingdom, Switzerland and Turkey as of now. The deal also allows negotiable clause for the two companies if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa and India.
Under the agreement, Myovant will receive an upfront payment of US $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million. Myovant is can also recieve 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.
“We’re delighted to join forces with Accord to make available the first and only oral androgen deprivationtherapy for men with advanced hormone-sensitive prostate cancer in Europe,” said David Marek, CEO of Myovant. He further added, “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.”
With this partnership, 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 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,” he added.
This news comes on the heels of European Commission’s decision on April 29 to approve 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 same, however, 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 2022.