Sanofi ends partnership with Lexicon after release of Phase 3 data
pharmafile | July 29, 2019 | News story | Sales and Marketing | Lexicon, Sanofi, Zynquista, diabetes, pharma
French firm Sanofi has said it is ending its partnership with Texas-based firm Lexicon Pharmaceuticals over the development of diabetes drug Zynquista (sotagliflozin).
Sanofi terminated its partnership with Lexicon over the once daily, dual SGLT1 and SGLT2 inhibitor, used in combination with insulin for both Type 1 and Type 2 diabetes. Shares in Lexicon dropped by as much as 48% on announcement of the news.
The decision comes after Zynquista did not show a statistically significant reduction in HbA1c in patients with chronic kidney disease (CKD4) in a Phase 3 trial, compared to placebo. The drug did however show statistically significant improvements in two other Phase 3 trials.
In a statement Lexicon said it considered the termination of the partnership invalid. Lexicon said in a statement: “Sanofi has delivered to Lexicon a notice purporting to terminate the alliance. Lexicon has notified Sanofi that it considers the notice invalid and Sanofi to be in breach of contract. The collaboration and license agreement provides that, even if a valid termination of the alliance had been delivered, Sanofi has continuing contractual obligations to transition rights to sotagliflozin and continue to fund ongoing clinical trials for a contractually specified period of time following termination.”
“While we are disappointed in the position taken by Sanofi, we are confident in the strength of the data we have seen thus far in the type 2 diabetes program and are optimistic about achieving continued success in the balance of the core Phase 3 program, which we expect will be completed in the coming month,” Lexicon said.
“In the event of a valid termination of the Sanofi alliance, we will also look forward to regaining full rights to Zynquista in type 1 diabetes in the United States, as well as rights in the remainder of the world, notably including the European Union, in which Zynquista has already received approval.”
Sanofi said: “At this time, the ongoing Phase 3 clinical trials will continue and there will be no immediate changes. Sanofi has expressed willingness to work with Lexicon to ensure a smooth transition of the studies. Sanofi remains committed to working and supporting the investigators and patients enrolled in the studies while next steps are discussed with Lexicon.”
The termination comes after the FDA declined to approve the drug for use with insulin in patients with type 1 diabetes after a panel raised concerns about the risk of diabetic ketoacidosis (DKA).
Louis Goss
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