Former Shkreli company Travere lands licensing deal with Vifor on kidney drug
Just a month ago, the biotech formerly owned by convicted drug exec Martin Shkreli saw promising data related to its kidney drug sparsentan from a 36-week treatment study. Now, Travere is putting more of its weight behind the drug with a new licensing agreement.
Travere is teaming up with the Swiss pharma Vifor in a joint collaboration and licensing agreement to commercialize sparsentan, a potential drug for FSGS and IgAN, in Europe, Australia and New Zealand.
As part of the arrangement between the two companies, Vifor will pay Travere $55 million upfront and potentially pay another $135 million in regulatory and market access milestones. There are additional options for sales milestones and royalties, but the specifics of those were not disclosed.
There are currently no approved medicines indicated for FSGS or IgAN — kidney disorders that lead to kidney disease and ultimately kidney failure — which is what sparsentan is looking to target.
Sparsentan is still in Phase III pivotal studies, which should have topline data by the second half of 2023, Travere said in a statement. And CEO Eric Dube wants to file for accelerated approval in the first half of next year.
This is not the first time Travere has pushed for accelerated approval of sparsentan. Back in February, Travere said their Phase III study DUPLEX hit an interim endpoint on FSGS, or scarring in the kidneys, and that there was enough data to push for accelerated approval.
But the FDA wasn’t having it. The agency said back in May that “the available data from the interim assessment of the DUPLEX study (of sparsentan) would not be adequate to support an accelerated approval at this time.”
Abbas Hussain, once thought to be a top candidate to become GSK’s CEO in 2017 and now Vifor’s new CEO, commented on the deal.
“This agreement highlights that Vifor Pharma has become a company of choice for organizations committed to partnering innovative nephrology assets,” Hussain said. “With sparsentan, we will further expand our growing nephrology pipeline into FSGS and IgAN.”
Travere and Vifor Pharma will look at submitting a joint marketing authorization application for both FSGS and IgAN next year. Vifor will maintain responsibility for and control over marketing authorizations in Europe, Australia and New Zealand. If sparsentan is approved, Vifor Pharma will be responsible for all commercialization activities in those specific regions.
Travere remains responsible for the clinical development of sparsentan and will retain all rights to the drug in all other global markets.