Just exactly where is this LEADing?

Just exactly where is this LEADing?

It appears Novo Nordisk (NYSE:NVO) is doing their best to take advantage of time they have as Amylin (NASDAQ:AMLN) responds to the FDA’s complete response letter for their once weekly GLP-1 Bydureon™. This morning Diabetes Care published online the results of the LEAD 6 extension study. According to a Novo press release; “LEAD™ 6 was a 26-week randomized, open-label study in type 2 diabetes comparing the efficacy and safety of Victoza 1.8 milligrams, once a day + OAD, to exenatide 10 micrograms, twice a day + OAD.  In the 14-week extension, patients were switched from exenatide 10 micrograms to Victoza. Exenatide patients were switched to Victoza by titrating the Victoza dose in 0.6 milligram increments weekly to reach the target dose of 1.8 milligrams per day.  Patients randomized to Victoza in the initial phase of the study continued on the 1.8 milligram dose.”

According to the study; “Switching from exenatide to liraglutide further and significantly reduced A1C (0.32%), FPG (0.9 mmol/L), bodyweight (0.9 kg), and SBP (3.8 mmHg) with minimal minor hypoglycemia (1.30 episodes/patient-year) or nausea (3.2%). Among patients continuing liraglutide, further significant decreases in bodyweight (0.4 kg) and SBP (2.2 mmHg) occurred with 0.74 episodes/patient-year of minor hypoglycemia and 1.5% experiencing nausea.”

The authors also state; “The greater efficacy of liraglutide may be due to sustained levels achieved over 24 hours by once-daily dosing compared with biphasic levels achieved during the 2.4-hour half-life of exenatide after dosing within 1 hour of breakfast and dinner (12).

Further studies are required to investigate the durability of these responses. Given the likely preference for once-daily, meal-independent dosing, liraglutide appears to be a useful addition to the diabetes treatment armamentarium.” (Highlighting added by Diabetic Investor)

From the very beginning Diabetic Investor has noted that Novo does have a small window of opportunity to establish Victoza® in the marketplace. However, this window of opportunity closed somewhat when the FDA approved Victoza® with a Black Box warning. What Novo truly is hoping for is that the Amylin responds slowly to the FDA’s requests and then the FDA moves slowly to complete the Bydureon™ approval. The bottom line is Novo knows they really don’t have much time before Bydureon™ receives full approval and steals the little thunder Victoza® has at the moment.

In what surly could be an ironic twist Novo’s own study could come back to haunt them. As the authors of this study speculate; “The greater efficacy of liraglutide may be due to sustained levels achieved over 24 hours by once-daily”. Anyone who has seen the study data for Bydureon™ knows that it outperforms both the current version of Byetta and Victoza®. Although Victoza® and Bydureon™ are two different compounds it stands to reason that even greater efficacy would be seen with a drug that works for 7 days.  

The authors note that patients will likely prefer once-daily injections over twice daily injections. While this may seem obvious it’s surprising how many analysts just don’t get it and that less frequent administration is better. The simple fact is if patients like once daily administration they will absolutely love once weekly injections.

The reality here is Novo is running out of time and they know it. They see the handwriting on the wall and realize they have a limited amount of time to establish Victoza in the marketplace. While Diabetic Investor sees Bydureon™ as a better drug than Victoza®, we have been around long enough to know that no one drug works with every patient and there will be a market for Victoza®, just not a big market. So it looks like Novo has listened to some Janis Joplin music who in one of her songs stated,  “You got to get it while you can.”