The Fallout from the Byetta situation hits Novo Nordisk
This morning Novo Nordisk (NYSE:NVO) announced that the FDA has scheduled an advisory committee for Liraglutide their once-daily GLP-1 currently awaiting FDA approval. According to their press release; “Novo Nordisk submitted the NDA to the FDA on 23 May 2008, meaning that an action letter from the agency to the NDA could be expected on 23 March 2009 following a standard 10-month review period. Since the Advisory Committee meeting is held shortly before this date, the agency has indicated that it will most likely have to extend the date of completing their assessment by a couple of months.”
No doubt the people at Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) will be watching this meeting with great interest as it could provide the first public glimpse into how the agency plans to deal with the concerns over pancreatitis.
As Diabetic Investor has stated we don’t believe there is a casual relationship between Byetta usage and pancreatitis. The currently available evidence just does not support this. It bears repeating that the incidence rate of pancreatitis in Byetta users is LOWER than incidence rates in the general population and that people with diabetes are at greater risk of developing pancreatitis just because they have diabetes.
It will be interesting to see how Novo handles this meeting. In what surly will be a data filed meeting the company must walk a delicate tight rope. Prior to the pancreatitis issue, it appeared the company was pulling out all the stops as they prepared to do battle with Amylin. Yet they also must realize that a very lucrative drug category could be at risk and without defending their turf they risk millions in sales even if that means that by default they are helping their biggest competitor.
We have been down this road before when Avandia came under siege and the folks at Takeda where in the position of defending Actos. Like Novo, Takeda had to prove their drug was safe even though it was in the same class as Avandia. This is almost the exact position Novo finds itself in.
Novo could go for the knockout punch and claim that the pancreatitis issue is limited to Byetta. Diabetic Investor sees this as a very risky strategy as the FDA has more experience with Byetta and has already publicly acknowledged that they consider pancreatitis and Byetta usage “a rare and uncommon event.”
The stakes here are enormous as the GLP-1 market has the potential to become a multi-billion dollar market. When it’s all said and done Novo and Amylin just might have to put their differences aside for the greater good of both companies. Or as Thomas Fuller wrote; “Pray for thy enemy; for if thou beset a good Man thyself, thou canst not but rejoice to see thy worst Enemy become a good Man too.”