Biotech Values

[DewDiligence]

SNY/ZEAL.CO/NVO—FDA delays decision on IGlarLixi (f/k/a Lixilan):

http://www.fiercebiotech.com/biotech/fda-delays-decision-sanofi-zealand-s-diabetes-drug-handing-lead-to-novo-nordisk

Sanofi and Zealand were 8 working days away from an FDA decision date when they revealed the regulator had pushed their PDUFA date back by up to three months. The delay, while short, means Novo Nordisk ($NVO) now has a lead in the race to bring an insulin-GLP-1 agonist combination product to market in the U.S. Sanofi showed how much a few months mean to its flagging diabetes franchise when it used its $245 million priority review voucher to shave four months off the approval process for IGlarLixi.

The FDA’s request for more information means that gamble won’t have the desired effect. Having won the 16-0 backing of an FDA advisory committee vote by in May, Novo’s IDegLira is on track to receive FDA approval in the coming weeks. In contrast, Sanofi and Zealand are now thinking of the timeline in terms of months, not weeks. The new PDUFA date is set for the end of November, close to when Sanofi would have received a decision had it not redeemed its priority review voucher.