Travere in $120M licensing deal with Renalys to develop sparsentan in Asia

Travere Therapeutics announced that it has entered into an exclusive licensing agreement with Renalys Pharma, to bring sparsentan, a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, to patients in Japan and other countries in Asia. Renalys will hold regional rights to sparsentan for Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. “We’re pleased to partner with Renalys, a company led by distinguished renal experts with a strong track record of launching kidney disease treatments,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Renalys Pharma has the expertise and resources to rapidly advance sparsentan to enable people living with IgAN in Japan and other Asian countries to have access to this innovative therapy as quickly as possible.” Following successful meetings with the Pharmaceuticals and Medical Devices Agency PMDA in 2023, Renalys plans to initiate an open label registrational study of sparsentan in Japan in the second quarter of 2024 to support potential approval of sparsentan in Japan. Results from the urine protein/creatinine ratio endpoint in the study are expected in the second half of 2025 to support a submission for approval to PMDA. Under the terms of the agreement, Travere will receive an upfront payment and be eligible to receive up to $120M in regulatory, development and sales-based milestone payments. As part of the collaboration, Travere has obtained a minority equity stake in Renalys and will be eligible to receive tiered royalties on net sales of sparsentan in Japan, South Korea, Taiwan, and the specified Southeast Asian nations. Renalys will be responsible for development, regulatory matters, and commercialization in the licensed territories.