Travere Therapeutics and Vifor Pharma Establish Licensing Agreement for Commercialization

Sparsentan has been granted exclusive marketing rights in Europe, Australia, and New Zealand by Vifor Pharma.

FREMONT, CA: Travere Therapeutics, Inc. and Vifor Pharma have formed a joint venture and licensing agreement to develop and commercialize sparsentan in Europe, Australia, and New Zealand. Sparsentan is a novel investigational product candidate undergoing crucial Phase 3 clinical trials to treat FSGS and IgAN. These two rare progressive kidney diseases are significant causes of end-stage kidney disease. At the moment, there are no licensed medications for FSGS or IgAN. Sparsentan has been given Orphan Drug Designation in the United States and Europe to treat FSGS and IgAN.

“Our goal is for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; this collaboration marks an important step forward in this journey,” says Eric Dube, Ph.D., Chief Executive Officer of Travere Therapeutics. “Vifor Pharma is a global leader in nephrology with established commercialization expertise in Europe, Australia and New Zealand and this agreement aligns our two companies with the common goal of maximizing the number of people who can access sparsentan, if approved in these regions. In addition, this collaboration will further strengthen our financial foundation and allow our organization to focus on planned future launches of sparsentan in the U.S.”

Vifor Pharma will get exclusive commercialization rights for sparsentan throughout Europe, Australia, and New Zealand under the agreement terms. Travere will receive a $55 million upfront payment and be entitled to additional payments of up to $135 million based on completing particular regulatory and market access objectives. 

Vifor Pharma will also make other payments in the form of sales milestones and tiered double-digit royalties on sparsentan's net sales in Europe, Australia, and New Zealand, with the maximum royalty rate being 40 percent.

“This agreement highlights that Vifor Pharma has become a company of choice for organizations committed to partnering innovative nephrology assets,” Abbas Hussain, chief executive officer of Vifor Pharma Group, comments. “With sparsentan, we will further expand our growing nephrology pipeline into FSGS and IgAN. There are currently no effective or approved therapies for these two rare kidney disorders, resulting in a significant unmet medical need among these patient populations. We look forward to working closely with Travere, who is responsible for the ongoing clinical development program of sparsentan, and to leveraging our commercial expertise to bring this highly promising, innovative treatment option to more than 150,000 patients living with FSGS and IgAN in the licensed territories as soon as possible.”

Following the recently disclosed good topline interim findings from the current pivotal Phase 3 PROTECT Study of sparsentan in IgAN, Travere and Vifor Pharma will assess sparsentan's regulatory approach in Europe including the possibility of filing a joint marketing authorization application for both FSGS and IgAN in 2022. Eventually, Vifor Pharma will assume responsibility for and control of marketing authorizations in the licensed areas. Vifor Pharma will be responsible for all commercialization activities in the licensed regions if sparsentan is authorized. Travere will continue to be accountable for sparsentan's clinical development and retain all rights to sparsentan in the United States and the rest of the globe. Travere is still liable to pay Ligand Pharmaceuticals upon the achievement of certain regulatory and commercial milestones, as well as an annual royalty of between 15 percent and 17 percent of global net product sales.