Some Good News From Amylin
This morning according to jointly issued press release Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) announced that “the U.S. Food and Drug Administration (FDA) recently indicated that the ongoing extension of the DURATION-1 study is appropriate to use as the basis for demonstrating comparability between intermediate-scale clinical trial material made in Alkermes’ manufacturing facility, and commercial-scale drug product made at Amylin’s manufacturing facility.
"Following feedback from FDA, we now have an appropriate pathway to demonstrate manufacturing comparability of exenatide once weekly. This is a very important step for the submission of exenatide once weekly," said Orville G. Kolterman, M.D., senior vice president, research and development at Amylin Pharmaceuticals. "We remain confident that our NDA submission is on track to be completed by the end of the first half of 2009."
Final acceptance of the comparability data is dependent upon DURATION-1 study extension results that are expected in early 2009.”
This announcement comes just three days after the companies announced that the FDA’s decision on Byetta as a monotherapy may not be completed in 2008 and could extend into 2009. The companies are also awaiting a decision on what type of label change may be in store for Byetta due to the concerns over pancreatitis.
Looked at collectively one just might get the impression that the FDA is sending different messages to Amylin and Lilly. Diabetic Investor believes the mixed messages has more to do with the confusion inside the FDA as they wait for the new administration to appoint a new commissioner rather than a problem with Byetta or the once-a-week version of Byetta, Byetta LAR.
It should also be noted that during today’s update from Lilly, the company sees the long term value in GLP-1 therapy in the growing diabetes market. Besides their relationship with Amylin the company has two compounds in early stage development GLP-Fc and GLP1-PEG. Both compounds are injectable, dosed once weekly and according to the company will use smaller gauge needles.
Many have speculated about the needle size for Byetta LAR and believe it could limit LAR’s sales potential. Diabetic Investor has never been concerned about needle size just as we weren’t concerned that Byetta would be delivered via twice daily injection. As we correctly predicted Byetta would be widely adopted and this supposed fear of injection would be overcome when patients discovered Byetta’s weight loss capabilities.
The same will be true with Byetta LAR, which is even more powerful than Byetta, as patients and physicians will prefer once-weekly administration over therapies which require daily administration. Finally it should be noted that the needle size for Byetta LAR while larger than a current insulin needle it is not the harpoon imagined by Byetta LAR critics.
The fact that GLP-Fc and GLP1-PEG can use smaller needle sizes should not send a negative message about Byetta LAR. Rather should be viewed as a natural evolution of GLP-1 therapy. Just as insulin needles have become smaller, thinner and lubricated over time it makes perfect sense that GLP-1 needles will follow this evolutionary path.
The most promising aspect of GLP-Fc and GLP1-PEG is their once weekly administration. With a long history in diabetes Lilly understands that one of the biggest issues facing patients and physicians is not having effective therapy options but patient compliance with these therapy options. Given the trend towards combination therapy for treating type 2 diabetes, whether that is insulin plus orals, multiple oral medications or multiple daily injection therapy poor patient compliance is a major contributing factor as to why 75% of patients are not reaching control. The bottom line, which should be obvious, is the less frequently a patient needs to administer their medication the better.
Just as important as fewer injections are to patient compliance, the fact that patients using GLP1 therapy have no need to regularly monitor their glucose levels or worry about what or when they eat will only accelerate the adoption of long acting therapy options.
The reality in the diabetes market, particularly with type 2 patients, is effective therapy options that are delivered less frequently will garner the majority of prescriptions and it won’t make a bit of difference if this less frequent administration is delivered via injection.
What all this news tells Diabetic Investor is that Amylin and Lilly are still not out of the woods. There are still hurdles that must be overcome. However, these positive developments indicate that these hurdles can be overcome. This is very good news not just for Amylin and Lilly but for millions of type 2 patients.