Competition in the GLP-1 market is heating up. Byetta (Exenatide) was first to the market but was quickly overtaken once Novo Nordisk (NVO) released Victoza (Liraglutide). Victoza now makes up 13% of Novo Nordisk's revenue and with 35% growth last quarter it leads all their other medications in growth prospects. Eli Lilly (LLY) has grand ambitions to expand their product line in the diabetes market which is Novo Nordisk's bread and butter. Their first salvo looks to be a GLP-1 agonist called Dulaglutide. Currently Victoza (Liraglutide) controls 68%of the GLP-1 market. With GLP-1 drugs steadily increasing in use it will end up being a much larger market.
There are no direct studies comparing Victoza and Dulaglutide so we can't compare the two drugs directly, but we can compare the data that is available for each drug. Comparing two drugs that aren't in a head to head trial is a inexact science but we have to work with the data we have. Eli Lilly is planning a head to head comparison between the two drugs so we won't have to speculate forever. Also keep in mind Dulaglutide has the advantage of being given once a week while Victoza has to be given every day. Novo Nordisk was investigating a longer acting formulation of Victoza but abandoned it and is focusing their research on a different once weekly GLP-1 agonist called semaglutide which just recently entered Phase III trials.
-Compared Dulaglutide to twice daily Byetta (Exenatide)
-Both doses of Dulaglutide were superior to 10mcg twice daily of Exenatide at decreasing A1C%
-No statistical difference in weight loss between the Exenatide 10mcg twice daily and Dulaglutide 1.5mg at 52 weeks
-Patients taking Dulaglutide had one case of pancreatitis while Exenatide had none
-Low dose Dulaglutide had statistically significantly less nausea and Diarrhea than Exenatide
-Compared Dulaglutide and oral placebo to Metformin and an injectable placebo
-After 52 weeks 0.75mg Dulaglutide was noninferior to Metformin while the 1.5mg dose was statistically superior at reducing A1C
-Metformin was statistically superior at decreasing body weight than the 0.75mg dose of Dulaglutide after 52 weeks
-Adverse events between to the two drug were similar
-No cases of pancreatitis reported
-Compared Dulaglutide to Januvia (Sitagliptin) which is made by Merck (MRK)
-Both 1.5mg and 0.75mg were statistically significantly better at reducing A1C compared to sitagliptin
-After 52 weeks A1C was brought down by 1.10% for patients receiving 1.5mg of Dulaglutide compared to a decrease of 0.39% for sitagliptin
-Both doses of Dulaglutide statistically significantly decreased weight compared to placebo and sitagliptin after 26 weeks
-No cases of pancreatitis for patients on Dulaglutide
-Patients on Dulaglutide had increased rates of GI Adverse Events compared to Sitagliptin
These studies showed that Dulaglutide is very effective at reducing A1C levels in diabetic patients. While the GI side effects were substantial that is expected with these drugs. Also there was only one case of pancreatitis in all 3 studies which is good because that a concern with this class of medication.
-compared once daily Liraglutide to once weekly Bydureon (Exenatide)
-patients taking Liraglutide showed greater weight loss
-Exenatide failed to establish non-inferiority compared to Liraglutide
-patients taking Exenatide were less likely to suffer from GI side effects than Liraglutide
-patients were not blinded
-funded by the makers of Bydureon
-compared 1.2mg and 1.8mg Liraglutide to 8mg glimepiride in patients taking no other diabetes medications
-both doses of Liraglutide were statistically superior at reducing A1C than glimepiride
-patients taking Liraglutide had more nausea than patients taking glimepiride
-Compared Liraglutide 1.8mg to open label insulin glargine in patients also taking meformin and glimepiride
-Liraglutide was superior at reducing A1C than glargine
-Liraglutide had a increased number of adverse events compared to glargine
- study compared twice daily Byetta (Exenatide) to Liraglutide
- Liraglutide was shown to significantly decrease A1C levels better than exenatide
- patients taking Liraglutide had less persistent nausea and minor hypoglycemia then patients taking exenatide
Both Byetta and Bydureon (Exenatide) will probably be biggest losers when Dulaglutide comes out. Both Dulaglutide and Liraglutide have been shown to be superior to Byetta at reducing A1C. Also Liraglutide was shown to be superior at reducing A1C than Bydureon. Byetta and Bydureon are owned and marketed by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN). They currently have about 30% of the GLP-1 market it will probably only go down from here. While they may hold onto the patients that are currently taking them, they will both most likely see their percentage of new scripts drop in the coming years.
I really like that Eli Lilly is being aggressive and going right after Victoza with a head to head trial. A lot of times you don't see this and hopefully it will give physicians a clear choice as to which drug is best for their patients. To me it shows Lilly is serious about turning Dulaglutide into a blockbuster, within three to four years I could see it approaching $750 million in annual sales.
While I still believe Novo Nordisk is a good investment in the long term (5-10 years) the next couple years could be rough. To maintain their high PE compared to their peers Novo has to keep growing at a rapid clip and I think that is going to be difficult until Tresiba gets approved in the United States which could take at least two years. Combine that with increased competition and maturation in the GLP-1 market which should slow Victoza's growth and you could see a slowdown in overall revenue growth for Novo Nordisk.