Sanofi said the termination of the partnership comes after the results of three late-stage studies of the oral drug, Zynquista, which is being jointly developed by the two companies.
In a separate statement, Lexicon said it had not yet received the underlying data from the studies and that it expects to conduct its own review. The company also said it considers Sanofi to be in breach of contract and the termination invalid.
Received preliminary top-line results from Sanofi (SNY) for three Phase 3 trials of Zynquista (sotagliflozin) for type 2 diabetes from the InSynchrony clinical program -- co had granted Sanofi an exclusive worldwide license (excluding Japan) to develop, manufacture, and commercialize Zynquista, but following the results, Sanofi notified co that it is terminating the Zynquista collaboration in all ongoing global type 1 and type 2 diabetes programs. Co has notified Sanofi that it considers that notice invalid and that it considers Sanofi to be in breach of contract. At this time, the ongoing clinical trials will continue. Among those top-line results, Zynquista 400 mg demonstrated numerical improvement on A1C in the SOTA-CKD3 study but did not achieve a statistically significant reduction on A1C in the subpopulation of patients with stage 3B chronic kidney disease, and in SOTA-CKD4, it achieved a clinically meaningful effect but narrowly missed statistical significance on A1C reduction vs placebo in patients with stage 4 CKD at 26 weeks. Co expects to conduct its own analysis of results when it receives the underlying data. Downgraded to Hold from Buy at Stifel. At new lows.
No comments:
Post a Comment