The Stakes Just Got Higher

The Stakes Just Got Higher

This morning Amylin (NASDAQ:AMLN), Alkermes (NASDAQ:ALKS) and Lilly (NYSE:LLY) announced that Bydureon™, their once-weekly GLP-1, has received marketing authorization in Europe. The companies also noted they will be submitting additional data to the FDA in the second half of this year, as Bydureon continues to move through the agency. Although Diabetic Investor expects the FDA to approve Bydureon we won’t hazard a guess as to when this will happen. As we have seen in the past anything can and usually does happen at the FDA when it comes to approving new diabetes drugs no matter how badly they are needed.

While this is good news for Amylin, Alkermes and Lilly one has to wonder what impact, if any, this news will have on the lawsuit between Lilly and Amylin. As Diabetic Investor noted yesterday based on their action Lilly appears to be focused on promoting Tradjenta™ and has regulated Amylin to the back burner as the two company’s battle in court.

This announcement is also further evidence that America is becoming a third world country in terms of having access to advanced therapy options. While the FDA continues to investigate every conceivable possibility with a new drug, Europe is taking a more realistic approach and seems to understand the simple concept of risk/reward. Unlike the FDA, European regulators actually understand that there is no such thing as a perfect drug and that when it comes to a disease like diabetes, which continues to grow at epidemic rates; patients need more, not less, weapons to fit their diabetes.

Although we have not heard any comment on today’s new from that crusading cardiologist Dr. Steven Nissen, one has wonder how the good doctor feels about the mess he created at the FDA. As much as the good doctor tries to deflect the role he has played in slowing the drug approval process to a crawl, the ultra-conservative nature of the FDA can be almost directly linked to Dr. Nissen and his zealous pursuit of Avandia.

Not content with creating one disaster, the good doctor is now going for a twofer and is taking on how the FDA approves medical devices. As Diabetic Investor noted last week if the good doctor has his way and the FDA revamps their medical device approval process you can basically kiss innovation goodbye.

Diabetic Investor is not aware if the good doctor will be attended the American Diabetes Associations Scientific Sessions later this week, but if he is, Diabetic Investor would be delighted to have a sit down. Contrary to popular belief Diabetic Investor does not dislike the good doctor and we strongly believe everyone, even someone with crazy ideas, should be given the opportunity to share their point of view. Unfortunately we know even if he is in attendance the good doctor isn’t likely to break bread with Diabetic Investor given his fondness for only sitting down with people who just happen to agree with his point of view.

There are two things everyone should know about the good doctor, first, he’ll never miss an opportunity to be on television and second, there is no room for debate it’s his view or nothing. The simple fact is if you have the audacity to disagree with the good doctor he basically believes you are an idiot. Yet Diabetic Investor remains undaunted and issues an open invitation to the good doctor for a sit down. This is America after all and even fools deserve the right to be heard.