Following rejection from the FDA earlier this year, Sanofi has agreed to pay Lexicon Pharmaceuticals $260m to end the alliance formed to develop and commercialise Zynquista (sotagliflozin).
The Sanofi/Lexicon partnered drug for type 1 diabetes was being co-developed as an add-on therapy to insulin injections to help improve blood sugar control.
The drug is a dual inhibitor of SGLT1 and SGLT2 and was thought to work by reducing glucose absorption in the gastrointestinal tract and glucose reabsorption by the kidneys, as well as stimulating the release of GLP-1.
Sanofi/Lexicon had hoped that the dual targeting may provide added glucose control with fewer side effects relative to selective SGLT2 inhibitors.
However, this fell apart when the FDA rejected the drug in a complete response letter in March. Issues surrounding the higher rate of diabetic ketoacidosis (DKA) in the SGLT arm of the clinical trial led to the complete rejection.
Sanofi now no longer wishes to continue the deal it made for $300m in 2015, and has paid $208m of the overall sum upfront to exit. The remainder will be payable within 12 months, and Sanofi will coordinate with Lexicon during the transition on the responsibility for ongoing clinical trials of the drug.
“Regaining worldwide rights allows us to advance our efforts to realise the full value of the Zynquista programme as we prepare for regulatory filings in the US and in Europe in type 2 diabetes, with data coming over the next few months from the remainder of the core phase 3 studies and over the longer term from two outcomes studies with potential for demonstrating cardiovascular and renal benefits,” said Lexicon’s chief executive officer Lonnel Coats.
“We believe that this potential, along with a European approval in type 1 diabetes, offer an attractive opportunity for potential collaborators as we work to maximize the global potential for Zynquista and to achieve greater operational flexibility,” he added.
Zynquista was a key element in Sanofi’s plans to rebuild its diabetes franchise following the loss of patent protection for its basal insulin Lantus (insulin glargine).
The blockbuster has seen a step decline in sales due to biosimilar competition in Europe and pricing pressure in the US, which has hit Sanofi hard and led to job cuts following an R&D restructuring.