Better late than never? Maybe not.
Victoza is in the same class as Amylin Pharmaceuticals' (Nasdaq: AMLN ) and Eli Lilly's (NYSE: LLY ) Byetta, but is injected just once a day, instead of twice a day for Byetta. That's a pretty good advantage -- except that the marketing window is slowly closing. Amylin has developed a once-weekly version of Byetta using Alkermes' (Nasdaq: ALKS ) extended-release technology. Assuming it doesn't run into the same long delay Victoza saw, the FDA should be making an announcement about once-weekly Byetta in March.
Needless to say, Novo Nordisk is trying its best to hit the ground running with a launch within weeks, but that may not be enough. Doctors who know that once-weekly Byetta could be just a few months off probably will be less likely to switch patients from twice-daily Byetta to once-daily Victoza now.
Even if once-weekly Byetta gets delayed, Novo Nordisk may have trouble getting new patients onto Victoza. The label says the drug shouldn't be used as a first line treatment, probably because of the thyroid cancer seen in studies done in rats. Twice-daily Byetta, on the other hand, is approved as a first-line treatment. While I'm not convinced that many doctors would prescribe Byetta before trying oral medications developed by Merck (NYSE: MRK ) , Bristol-Myers Squibb (NYSE: BMY ) , and others, the FDA's prior approval of Byetta for early use makes it sound safer than Victoza.
At this point, Novo Nordisk's best chance at a victory for Victoza is if once-weekly Byetta gets hung up at the FDA. Or better yet, hung out to dry.
Timing is everything. Except when it's not, says Rex Moore.