Are Amylin and Lilly Prepared?

Are Amylin and Lilly Prepared?

EASD: Once-Weekly Exenatide Flops Against Liraglutide – this is the headline from a story posted yesterday on medpage Today®.  According to this story the reason Bydureon flopped when compared to Victoza was that patients using the highest dose of the once daily Victoza achieved better HbA1c reductions than those using the once-weekly Bydureon. The article states;

“In the head-to-head study, the mean reduction in HbA1c for patients on the more convenient dosing schedule of exenatide was 1.26%, compared with a 1.48% reduction with liraglutide (P<0.05), reported John Buse, MD, PhD, chief of the division of endocrinology and metabolism at the University of North Carolina in Chapel Hill, at the annual meeting of the European Association for the Study of Diabetes.”

Now before everyone at Novo Nordisk (NYSE:NVO) starts jumping for joy and before the folks at Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) start jumping out of windows, it’s best to remember this is not the first study that showed patients on the highest dose of Victoza achieving better HbA1c reduction than those using Bydureon. The simple fact is both drugs are effective at lowering HbA1c but there are some notable differences between them besides that Victoza is injected once a day while Bydureon is injected just once a week.

The story notes some of these differences; “Of the 450 patients on liraglutide, 20.4% complained of nausea compared with 9.3% of the 461 patients on exenatide. About 13% of patients on liraglutide experienced diarrhea compared with 6.1% of those on exenatide. Vomiting was experienced by 10.7% of patients on liraglutide and by 3.7% of those on exenatide, Buse reported.”

Although Diabetic Investor, as we did when this data was first reported, does not believe the differences in HbA1c reduction are significant enough to overcome the fact that patients and their physicians will likely prefer once weekly dosing over once daily dosing. This data does however show the heavy lifting that lies in front of Bydureon when it is approved by the FDA. (As it stands today the PUDFA date for Bydureon is January 28, 2012.) As Diabetic Investor has been stating consistently Amylin and Lilly, who are currently involved in a legal dispute, better get their ducks in a row as Bydureon will not sell itself and while once-weekly dosing is major advantage over once daily; Victoza has its own set of advantages and Novo will use every advantage they can find to counter the once weekly dosing of Bydureon.

The fact is Victoza and Bydureon are both very effective drugs and which drug a physician prescribes will involve several factors and not just dosing frequency. Given the statements made by Novo, Amylin and Lilly better be preparing for a battle when it comes to formulary placement and pricing. As this data shows Amylin and Lilly cannot go to insurers and claim that Bydureon is more effective than Victoza. Given this fact and Novo’s aggressive nature, Diabetic Investor suspects that Novo will add more pressure by pricing Victoza at the same level or lower than Bydureon. Amylin and Lilly must be cognizant of this and be prepared to fight back.

This is why it’s critical that the two companies settle their legal issues and get on with the business of getting ready for a successful Bydureon launch. We’ve said it before and will say it again, the success or failure of Bydureon will come down to execution. The simple fact is these companies cannot afford another screw up like they had when Byetta first came to market. The stakes are enormous and no matter what these companies say publicly the reality is it’s hard to work together on the launch of what could be a ground breaking new drug when the two “partners” are fighting each other in court. The harsh reality is Amylin and Lilly desperately need Bydureon to be a hit.

Based on discussions with physicians and patients Diabetic Investor continues to believe that the once-weekly dosing schedule for Bydureon is a huge advantage. However, only a select group of physicians and patients have any real world experience with Bydureon, while they do have some experience with Victoza. As we have noted before while the needle size for Bydureon is not as large as many have reported it is significantly larger than the needle used with Victoza. It is also true that Victoza comes in a very patient pen delivery system and initially patients on Bydureon will be required to mix the product. This is not an onerous task, especially when you consider it only has to be done once a week; still there is a reason why pen delivery systems are becoming more popular.

The concern Diabetic Investor has lies more with Lilly than it does with Amylin, as Amylin is focused on Bydureon and Lilly continues to screw around with Tradjenta. This data set is just further evidence to Diabetic Investor that the Lilly/ Boehringer Ingelheim partnership is a complete and utter disaster. Tradjenta is going nowhere in a hurry and Novo now has fresh data compiled by their competition that they can use. The real concern here is can Lilly acknowledge that Tradjenta is a bust and switch gears to Bydureon. Can they check their ego’s at the door and repair relations with Amylin?

It’s not an understatement to state the battle for supremacy in the growing GLP-1 market is at stake here. A market that is not only becoming more competitive but also gaining more attention as we have seen with the overblown recent reports on GLP-1 side effects. While Diabetic Investor believes this concern over side effects is greatly exaggerated, the fact remains they are gaining attention and will need to be dealt with by all the players in the market. Amylin and Lilly will not only have to battle Novo but the growing critics of GLP-1 therapy, no matter how off base they may be.

The bottom line here is really comes down to how well Amylin and Lilly have prepared themselves for the fight that lies ahead. As Nolan Richardson, then coach of the National Champion Arkansas Razorbacks, noted; “Preparation prevents piss-poor performance.”