RARE Daily

Travere Signs Licensing Deal with Renalys to Develop and Commercialize Sparsentan in Asia

January 26, 2024

Rare Daily Staff

Travere Therapeutics entered into an exclusive licensing agreement with Renalys Pharma to bring its treatment for IgA nephropathy, sparsentan, 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.

“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.” said Eric Dube, president and CEO of Travere Therapeutics.

IgA nephropathy (IgAN), also called Berger’s disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine, protein in the urine, and a progressive loss of kidney function. Other symptoms of IgAN may include swelling and high blood pressure. IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease.

Sparsentan, a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, received U.S. regulatory accelerated approval in 2023 and is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression

Following successful meetings with the Pharmaceuticals and Medical Devices Agency 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 their agreement, Travere will receive an upfront payment and be eligible to receive up to $120 million 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.

“As the first non-immunosuppressive treatment for IgA nephropathy, and one that will likely be used in combination therapy regimens as new agents are approved in the future, sparsentan is–without question–the kind of foundational medicine we are focused on bringing to Japan to stem the rising tide of kidney failure due to IgAN,” said BT Slingsby, CEO of Renalys Pharma.

Photo: Eric Dube, president and CEO of Travere Therapeutics

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