Ardelyx said it licensed its phosphate transport NaP2b inhibitor program (also known as NaPi2b, Npt2b, and SLC34A2) for kidney disease to Sanofi, in a deal that could generate up to $198 million for the seven-year-old biopharma.
The NaP2b program includes a portfolio of minimally absorbed NaP2b inhibitors in discovery and preclinical stages. NaP2b is an intestinal phosphate transporter whose activity accounts for a significant portion of dietary phosphate absorption in humans. The inhibition of NaP2b is under study as a possible treatment of hyperphosphatemia in patients with end-stage renal disease and other forms of chronic kidney disease.
Ardelyx said it received an undisclosed upfront payment from Sanofi, with potential for future payments tied to development and regulatory milestones, plus royalties. Sanofi will have full responsibility for further discovery efforts and development of any products—though the deal also leaves Ardelyx with an option to participate in co-promotional activities for the U.S. market.
"Sanofi's R&D and commercial capabilities in phosphate management are rivaled by no other company, including their ability to test and understand our NaP2b inhibitor compounds in relation to phosphate binders and other available phosphate management strategies," Ardelyx CEO Mike Raab said in a statement.
The Sanofi deal adds another pharma giant to Ardelyx’ roster of partners. Ardelyx has licensed its lead product to AstraZeneca (AZ), which has given the company $50 million in funding to develop tenapanor (known as AZD1722 and RDX5791) and other NHE3 sodium transport inhibitors in earlier stages. Tenapanor is a minimally absorbed, orally administered NHE3 sodium transport inhibitor being evaluated both for prevention of sodium and fluid overload in patients with kidney and heart disease and for constipation-predominant irritable bowel syndrome.
AZ’s collaboration could generate up to $237.5 million for Ardelyx. To date, AZ has paid Ardelyx $35 million upfront and a $15 million payment last month after achieving an undisclosed development milestone.
Ardelyx focuses on developing nonabsorbed and minimally absorbed, first-in-class oral therapeutics that target specific gut transporters and receptors for cardiorenal, metabolic, and gastrointestinal diseases. The company’s pipeline of products is designed to act locally and specifically in the gastrointestinal tract, with the goal of limiting potential for systemic side effects while impacting targets and pathways that modulate systemic diseases.
Ardelyx has also raised $56 million in angel and venture funding since its founding in 2007.