Chronic kidney disease’s progression can lead to problems beyond the kidney as mineral deposits form in blood vessel walls and heart valves, limiting blood flow. Vifor Pharma has reached deals toacquire两家公司Sanifit疗法和Inositec, with clinical-stage drug candidates that address these disease complications.
The Sanifit deal is the bigger of the two transactions. Switzerland-based Vifor said Monday that it has agreed to pay €205 million (about $230.9 million) up front to acquire all of the shares in Sanifit, securing global rights to that biotech’s lead drug candidate, SNF472. Development and regulatory milestones could bring another €170 million (about $191.5 million) in milestone payments; sales-based milestones are in the high triple digit million range at peak sales.
Sanifit is developing SNF472 as a treatment for two types of calcification in chronic kidney disease patients. Calcific uremic arteriolopathy (CUA) is a rare condition characterized by the buildup of calcium deposits that block small blood vessels in skin and fat tissue. In the more common peripheral artery disease (PAD), the calcium buildup causes a narrowing of the arteries in the legs. The Palma, Spain-based biotech’s drug is a small molecule designed to bind to hydroxyapatite crystals, preventing them from building up into calcium deposits.
Sanifit explains how SNF472 works in this video:
In a Phase 2 study testing SNF472 as a way to slow arterial calcification, Sanifit reported that the drug met the main goal of reducing coronary artery calcium progression in patients over 52 weeks compared to a placebo. The company has advanced the drug to Phase 3 testing in CUA patients. The goal of that clinical trial is to measure for wound healing and pain. A separate Phase 3 test in PAD evaluating the drug in patients on dialysis is expected to begin next year. Vifor estimates that the addressable PAD population in the U.S. and Europe is ore than 600,000. The ultra-rare CUA patient population in both markets is about 10,000.
In the other acquisition, Vifor is paying 20 million Swiss francs (about $21.5 million) for Inositec and its small molecule calcification inhibitor, INS-3001. Milestone payments are in the low triple digit million range. A Phase 1 study is expected to dose its first patient by the end of this month. Depending on the results, Vifor plans to advance the drug to two Phase 2 tests in 2023, one in non-dialysis chronic kidney disease patients who have PAD, and the other in patients who have aortic valve stenosis, which is a progressive deterioration of the aortic valve due to calcification. Current treatment for the condition is surgical implantation of a new valve. Aortic valve stenosis is rare; Vifor estimates that 1.1 million patients in the U.S. and Europe are eligible for treatment.
“We are gaining momentum with our ambitious strategic growth plans as we today add Sanifit, Inositec and their promising assets to our strong nephrology portfolio,” Vifor Pharma CEO Abbas Hussain said in a prepared statement. “These acquisitions are a perfect fit for our expanding nephrology pipeline, which now includes vascular calcification inhibition treatments across various stages of non-dialysis [chronic kidney disease] and even [non-chronic kidney disease] patient populations.”
Vifor expects to close the Inositec acquisition by the end of the year. The Sanifit deal will take a little longer. The company expects that transaction will close in the first quarter of 2022.
Image: Getty Images, magicmine