RARE Daily

Travere Licenses Sparsentan to Vifor Pharma for Commercialization in Europe, Australia, and New Zealand

September 16, 2021

Travere Therapeutics licensed rights to commercialize its experimental therapy sparsentan to Vifor Pharma in Europe, Australia, and New Zealand for an upfront payment of $55 million and potential milestones of up to $135 million.

Photo: Eric Dube, CEO of Travere Therapeutics

For Travere, the deal expands its market reach and strengthens its finances as it readies for the U.S. launch of sparsentan. For Vifor, the deal expands the company’s growing nephrology portfolio.

Sparsentan is in pivotal phase 3 clinical studies for the treatment of FSGS and IgAN, two rare progressive kidney disorders that are leading causes of end-stage kidney disease. There are currently no approved medicines indicated for FSGS or IgAN. Sparsentan has been granted Orphan Drug designation for the treatment of FSGS and IgAN in the United States and Europe.

Sparsentan is a dual endothelin angiotensin receptor antagonist (DEARA). Preclinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways, in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation.

In addition to the upfront and milestone payments, Vifor Pharma will also make further payments in the form of sales milestones, and tiered double-digit royalties on net sales of sparsentan in Europe, Australia, and New Zealand up to 40 percent at the high end of the royalty range.

Following the recently announced positive topline interim results from the ongoing pivotal phase 3 PROTECT Study of sparsentan in IgAN, Travere and Vifor Pharma will further evaluate the regulatory strategy for sparsentan in Europe, including the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022.

Ultimately, the responsibility for and control over marketing authorizations in the licensed territories will be transitioned to Vifor Pharma. If sparsentan is approved, Vifor Pharma will be responsible for all commercialization activities in the licensed territories.

Travere remains responsible for the clinical development of sparsentan and will retain all rights to sparsentan in the United States and rest of world. Travere remains obligated to make payments to Ligand Pharmaceuticals upon achievement of certain regulatory and sales milestones, as well as an escalating annual royalty between 15 percent and 17 percent of global net product sales.

“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,” said Eric Dube, CEO 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.”

Author: Rare Daily Staff

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