Amylin Reports – The Picture Getting Clearer

Amylin Reports – The Picture Getting Clearer

The best news to come out of this morning’s earnings call for Amylin (NASDAQ:AMLN) is the picture for Bydureon is becoming clearer. The company noted they planned to resubmit Bydureon to the FDA next week and that it should be a Class II resubmission which would mean a 6 month review period. If all goes well that means we would see Bydureon hot the market sometime in the first quarter of 2012.

With the picture for Bydureon becoming clearer attention is now focused on the status of the Amylin Lilly (NYSE:LLY) legal battle. While the case is ongoing and the two sides continue to battle in court, what everyone wants to know is how this legal squabble will impact the launch of Bydureon. Can the two sides set aside their differences, or at least work together well enough to insure that Bydureon gets off to a good start? Given the history between these two companies Diabetic Investor isn’t overly optimistic.

One factor which could change our view is the performance or should we say non-performance of Tradjenta. Based on current trends Lilly could well decide that Tradjenta is truly a dog with flees and begin to back away from the drug. The company just might wake up and realize that they cannot afford to screw up the launch of Bydureon, as it is the only innovative diabetes drug in their pipeline.

As Diabetic Investor has noted before even with the GLP-1 market expanding and the once-weekly delivery of Bydureon, the drug will not sell itself. Novo Nordisk (NYSE:NVO) has done a better than expected job with their once-daily GLP-1 Victoza and while physicians and patients may prefer once-weekly administration, this view could change when they see what’s involved with this once-weekly injection. Although Diabetic Investor does not believe the administration steps of Bydureon are overly obtrusive, it is not as simple as Victoza and Victoza comes with a much smaller needle.

This is what makes the launch so critical, if they screw things up like they did when Byetta was launched, Bydureon will have a much more difficult time getting established and on its way to achieving blockbuster status. The reality is Amylin and Lilly don’t have to hit the ball out of the park when Bydureon first comes to market, as the real bang will come when the Bydureon pen becomes available. Basically what they need to do is show physicians the drug is as powerful as they expect it to be, have them try it out on a select group of patients, become familiar with it and then make an all-out assault when the pen delivery systems becomes available.

The race for GLP-1 leadership is not a sprint but a marathon and as we have seen before winning a marathon does not always go to the fastest runner rather to the runner who best manages the race.