Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand
Travere receives a $55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales
Sparsentan is a potential first-in-class treatment to address significant unmet medical needs in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)
SAN DIEGO and ST GALLEN, Switzerland, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and Vifor Pharma today announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand. Sparsentan is a novel investigational product candidate currently being evaluated in pivotal Phase 3 clinical studies for the treatment of FSGS and IgAN, two rare progressive kidney disorders and 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 U.S. and Europe.
Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. Travere will receive an upfront payment of $55 million and be eligible for up to $135 million in payments tied to the achievement of certain regulatory and market access related milestones. 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.
“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, 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.”
“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 commented. “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 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.
About Sparsentan
Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical 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. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.
Sparsentan is currently being evaluated in the pivotal Phase 3 DUPLEX Study for the treatment of FSGS and the pivotal Phase 3 PROTECT Study for the treatment of IgAN. In February 2021, the Company announced that the ongoing DUPLEX Study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, the Company announced that the ongoing PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p