NICE, nice to Bydureon

NICE, nice to Bydureon

Today the National Institute of Health and Clinical Excellence (NICE) in the United Kingdom, published preliminary recommendations for the National Health Service recommending Bydureon, the once weekly GLP-1 from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS); for patients with type 2 diabetes.  This is not just good news for these companies, its further confirmation that GLP-1 market is becoming more important by the day.

This is actually the second GLP-1 NICE has recommended as they recommended Victoza, the once-daily GLP-1 from Novo Nordisk (NYSE:NVO), for use with type 2 patients back in June.

What we will be really interesting is with this recommendation we’ll finally see the much anticipated battle between Novo and Amylin/Lilly for GLP-1 supremacy and could provide some clues how this battle will play out when it reaches this side of the pond. (Bydureon is still awaiting FDA approval and has a PUDFA date of January 28, 2012.) Based on filing documents Bydureon will cost £73.36 ($115.90) for a pack of four single-dose kits containing one vial of exenatide 2mg powder and a pre-filled syringe of solvent. By comparison Victoza costs £78.48 for a 30 day supply at 1.2mg per day, or £117.72 for the 1.8mg daily dose.

Given that at present Victoza is actually priced higher than Bydureon, it will be worth watching whether Novo lowers the price. It should be noted that in the head to head studies between the two drugs, Victoza has performed better when the 1.8mg daily dose is compared to Bydureon. As Diabetic Investor has noted previously we do not believe the performance differential between the two drugs is significant and that once-weekly dosing will trump once daily dosing. Given this decision by NICE we’ll now see if this theory turns to fact.

We’ll also see if factors such as needle size and mixing impact Bydureon sales or will the convenience of once-weekly dosing win out. As Diabetic Investor has stated consistently as good as we believe Bydureon is the drug will not sell itself and does have issues that must be addressed.

This battle is not just important to Novo, Lilly and Amylin as Sanofi Aventis (NYSE:SNY) also has a once-daily GLP-1 under development and surly is watching to see how to position their product when it finally gets here.

As much as Diabetic Investor is looking forward to this battle, what’s happening in the UK is merely the preliminary bout and the real title fight will occur when the FDA approves Bydureon. Will Amylin/Lilly, who are fighting between themselves, follow what they have done in the UK and price Bydureon lower than Victoza here in the US? Will Novo attempt a pre-emptive strike and begin discounting Victoza before Bydureon hits the market? Will Amylin and Lilly kiss and make up before the FDA approval or will they continue their foolish behavior and jeopardize the launch of Bydureon?

No matter what happens, one thing is certain it will be fun to watch. Bring it on!!