Lilly and Amylin Report

Lilly and Amylin Report

Given recent events and the upcoming PUDFA date for Byetta LAR, Diabetic Investor decided to combine the Lilly (NYSE:LLY) and Amylin (NASDAQ:AMLN) earnings announcements. Amylin announced last night and as expected the actual financial results were overshadowed by the recent approval of Victoza® and the March 5th PUDFA date for Byetta LAR.  Considering that Victoza will come to market with a black box warning concerning a possible link with thyroid cancer, it’s no surprise the company was questioned as to what a LAR approval would look like.

While the company cannot comment on just what the FDA will or won’t do, they did point out that while in the same class Victoza and Byetta LAR are two very different drugs. Additionally Amylin has the benefit of experience with their current version of Byetta. Although Novo Nordisk (NYSE:NVO) is trying to claim that the thyroid cancer issue is a class effect, Diabetic Investor does not believe the FDA will approve LAR with a black box warning as the data does not show a link between Byetta or LAR and thyroid cancer. This won’t stop Novo from making this claim but the FDA obviously sees things differently as they did not require a panel meeting with LAR as they did with Victoza. Considering that Byetta is being used by more than one million patients and there have no thyroid cancer concerns mentioned by the agency Diabetic Investor is very comfortable in stating that the label for LAR will be another advantage over Victoza.

For their part Lilly continues to have a schizophrenic attitude towards their relationship with Amylin. Once again the company was lukewarm in their support of Byetta and Byetta LAR sending a mixed message as they also again touted their own GLP-1 under development which is moving into Phase 3 trails. It’s possible that Diabetic Investor is reading this wrong and Lilly is just being overly cautious. However, it does seem just a little strange they would not be more supportive of LAR given this product has the potential to change the paradigm for the treatment of type 2 diabetes.

Given the importance of their insulin franchise Diabetic Investor’s biggest concern with Lilly has always been how aggressively they would promote LAR given that it could eat away at sales of this core franchise. On the other hand, LAR seems like the perfect vehicle to reinvigorate their presence in diabetes and offer the additional benefit of revenge as Novo has pretty much kicked Lilly’s backside in the insulin market.

It’s also possible that Diabetic Investor is over-estimating the impact of LAR. While the product appears to have a host of positive benefits it is not immune to issues. Even so this would fly in the face of what we’ve been told by the physicians who will be prescribing LAR. While there is no such thing as a perfect therapy option and not every physician will begin prescribing LAR with reckless abandon, these physicians do see numerous benefits to a once-weekly therapy option given that one of the biggest problems they face day in and day out is patient’s being compliant with their therapy regimen.

Often over-looked in the LAR analysis is the fact that even patients using oral therapies to control their diabetes are non-compliant. A major reason for this is that the majority of patients are taking multiple medications for conditions other than diabetes. According to data provided by nearly 80% of patients are taking medications for conditions other than their diabetes, 61% take three or more medications each day.

Additionally as we reported yesterday a study published in the most recent issue of Diabetes Care found that 57% of patients on insulin therapy skip insulin injections, 20% skip injections on a regular basis. According to that study patients with type 2 diabetes were more likely to skip injections than type 1 patients.

The fact is the physicians who see patient’s everyday know this which is why they are anxious for any treatment option that requires fewer administrations. This a major reason why so many type 2 patients use Lantus which is administered once-daily. Offering a once-weekly option, especially one with as many benefits as Byetta LAR, has physicians excited.

Frankly Diabetic Investor has never understood the Lilly and Amylin relationship. Perhaps it’s a regional thing with Amylin based in sunny San Diego while Lilly is headquartered in America’s heartland. Maybe the folks at Lilly are just distracted at the moment as their beloved Colts are playing in the Superbowl. Whatever the reasons this is one the strangest partnerships in diabetes, let’s just hope they can both stay focused. As good as LAR may be it won’t sell itself and the competition won’t sit around without putting up a fight. The GLP-1 category is just too large to ignore and Novo is already gearing up for a nasty street brawl.