The progression of chronic kidney disease can cause problems beyond the kidneys, because mineral deposits form in the walls of blood vessels and heart valves, which restrict blood flow. Vifor Pharma has concluded a deal get Sanifit Therapeutics and Inositec are two companies with clinical-stage drug candidates that address the complications of these diseases.
Sanifit’s transaction is the larger of the two transactions. Switzerland-based Vifor said on Monday that it has agreed to pay 205 million euros (approximately US$230.9 million) in advance to acquire all shares in Sanifit, thereby ensuring the global rights of the biotechnology’s main drug candidate SNF472. Development and regulatory milestones may result in another 170 million euros (approximately US$191.5 million) in milestone payments; at peak sales, sales-based milestones are in the triple-digit million range.
Sanifit is developing SNF472 for the treatment of two types of calcification in patients with chronic kidney disease. Calcified uremic arteriopathy (CUA) is a rare disease characterized by the accumulation of calcium deposits that block the small blood vessels in the skin and fatty tissues. In the more common peripheral arterial disease (PAD), calcium buildup causes narrowing of leg arteries. The drug of a biotech company based in Palma, Spain is a small molecule designed to bind to hydroxyapatite crystals and prevent them from accumulating into calcium deposits.
Sanifit explains how SNF472 works in this video:
In a phase 2 study that tested SNF472 as a method to slow arterial calcification, Sanifit reported that the drug achieved its main goal of reducing the progression of coronary artery calcification in 52 weeks compared to a placebo. The company has advanced the drug to Phase 3 testing for CUA patients. The goal of this clinical trial is to measure wound healing and pain. A separate PAD Phase 3 test is expected to begin next year to evaluate medications for dialysis patients. Vifor estimates that the addressable PAD population in the United States and Europe exceeds 600,000. The number of rare CUA patients in the two markets is approximately 10,000.
In another acquisition, Vifor paid 20 million Swiss francs (approximately US$21.5 million) for Inositec and its small molecule calcification inhibitor INS-3001. Milestone payments are in the low three-digit million range. A phase one study is expected to administer the drug to the first patient before the end of this month. Based on the results, Vifor plans to advance the drug to two phase 2 trials in 2023, one for non-dialysis chronic kidney disease patients with PAD, and the other for patients with aortic stenosis. This is a gradual Deteriorating aortic valve calcification. The current treatment for the disease is the surgical implantation of a new valve. Aortic stenosis is rare; Vifor estimates that 1.1 million patients in the United States and Europe are eligible for treatment.
Vifor Pharma CEO Abbas Hussain said in a prepared statement: “As we add Sanifit, Inositec and their promising assets to our strong nephrology portfolio today, our ambitious strategy grows The plan is gaining momentum.” “These acquisitions are a great fit for our expanding nephrology pipeline, which now includes vascular calcification suppression therapy across all stages of non-dialysis [chronic kidney disease] and even [non-chronic kidney disease] Patient groups. “
Vifor expects to complete the acquisition of Inositec before the end of the year. Sanifit’s transaction takes longer. The company expects the transaction to be completed in the first quarter of 2022.
Image: Getty Images, magicmine
