Shares in Lexicon Pharmaceuticals climbed as much as nearly 38% on Tuesday after it announced that Sanofi will pay the company $260 million, including $208 million upfront and the rest within 12 months, to terminate its partnership for the development and commercialisation of the add-on diabetes treatment Zynquista (sotagliflozin). Lexicon added that it also settled its "related disputes" with the French drugmaker.
In July, Sanofi announced plans to end the partnership with Lexicon for Zynquista, a once-daily dual SGLT1 and SGLT2 inhibitor, in all ongoing type 1 and type 2 diabetes programmes in response to results from the SOTA-CKD3 and SOTA-CKD4 trials. At that time, Lexicon, which initially granted Sanofi a global licence to Zynquista in 2015 in a deal worth as much as $1.7 billion, suggested the French drugmaker was in breach of contract.
Under the termination agreement, Lexicon said it will regain complete rights to Zynquista and assume sole responsibility for its global development and commercialisation in both type 1 and type 2 diabetes. Sanofi will also work with Lexicon regarding the transition of responsibility for ongoing clinical trials and other activities.
Lexicon CEO Lonnel Coats, who described the four-year alliance with Sanofi as "productive," said regaining worldwide rights will help his company "realise the full value" of Zynquista as it prepares for regulatory filings in the US and in Europe in type 2 diabetes. He indicated that data will become available over the next few months from the remainder of the core Phase III studies and over the longer term from two outcomes trials, "with potential for demonstrating cardiovascular and renal benefits."
Zynquista was authorised in the EU in April as an adjunct to insulin therapy in certain adults with type 1 diabetes. However, the FDA rejected the therapy earlier this year after agency staff had expressed concerns that Zynquista "clearly increases" the risk of diabetic ketoacidosis in patients with type 1 diabetes, "and the risk may be unpredictable."
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