Life is just SWEET this time of year. Summer, warm breezes even in San Francisco, walking on Chrissy Field, children chasing birds, food like gazpacho, drinks like mojitos, lilles, - and ADA!!!!
Yes, the ADA is coming up in nine days and the abtracts came out on the ADA's website today. We'll have a full report in our June DCU, which will be published Wednesday, June 7. In the meantime, excitement is ABOUNDING for us. We love every spec of getting ready for ADA and we've been hard at work, pouring through the oral presentation descriptions, deciding on sessions (we'll have a top-flight team of seven there), developing all our questions, reading in and between the abstract lines. WOW!
We'll save most of our thoughts for DCU, but we do point out that Amylin posted its abstracts on its website, hurrah! Would that every company would make it so easy. Amylin has one of the most impressive ADA schedules we can remember seeing for a company, full stop - this is another Amylin year at ADA, zero doubt about it.
In our view, the highlights, for Amylin:
First, Dr Alain Baron is doing a talk on obesity titled "Can We Cut our Losses?" This promises to be an extraordinarily interesting perspective on the biggest public health epidemic of our time. Of course, there is great interest in weight losing properties of Amylin's marketed drugs Byetta and Symlin as well as its drugs in development AC-137 (Symlin for obesity), PYY, and Leptin. We'll publish a Leptin 101 in the June DCU, by the way, and have an interview with a foremost expert on this subject. There was what we would term a profoundly interesting patent application involving Leptin over the past couple of weeks ~ we look forward to hearing much more about this at ADA. We've suspected for some time that Leptin is re-emerging -ever since it was announced, actually, that Amylin was purchasing the patent portfolio from Amgen. It makes sense that through combination therapy, Amylin would have something Amgen couldn't develop - read this application, and the way Leptin could interact with Symlin and another recently purchased technology and you'll be caught up too.
Back on the meeting! As we were noting, we heard Dr. Baron at a panel at Dr. David Klonoff's outstanding DT&T meeting last fall, where he discussed Byetta and the potential for the drug to treat at every stage of illness -- from pre-diabetes to advanced complications. Speaking of advanced complications, however, we suspect that Byetta can be used very effectively to help AVOID the complications, both micro- and macrovascular. Talk to any group of endos about Byetta as we have and you realize very quickly that the potential of the drug exceeds what what shown in the (admittedly very positive) AMIGO trials, because the power of weight loss and how that motivates patients to eat and exercise more effectively was not shown so much in the official clinical trials - patients had to follow very strict instruction. Left to their own devices, from anecdotal reports, many seem to lose weight more quickly and to key in on weight loss as a motivator to exercise more, eat better, etc.
Insulin companies, we imagine, particularly Sanofi, must be concerned, because Byetta is so good and the worst part may be no one knows HOW good. It may have been acceptable that Byetta would delay the move to insulin, but Byetta is also prompting patients to come off insulin - although not labeled for this, patients who want it can merely point out that were the drug approved earlier, they may well have gone on it and avoided insulin altogether! Speculation is rampant in this entire post, yes, but we doubt that it's a far cry that Sanofi is singing the Byetta blues as well as the rimonabant blues. Next worse off would be Novo, although they will be up next (albeit not for threeish years) with Liraglutide and have strong diversificaton in a growing market already. Lilly would appear the safest and best off as it co-promotes Byetta. What a pity that its co-promotion with Takeda's Actos just ended - promoting both drugs, particularly to patients taking TZDs who gain the most weight, would have been a nice idea, especially for PCPs, where Lilly's diabetes sales force has historically been strong.
Back to the schedule! For its Byetta symposium, Amylin will have dynamite Dr. D'Alessio, powerhouse Dr. Anne Peters, and influential Virginia Valentine speaking at a symposium - three outstanding thought leaders delivering a 2006 update on incretins in type 2 diabetes.
Next, they have two orals - v. prestigeous (very few are granted) - one, by noted insulin expert Dr. Bernard Zinman, is on TZDs, and we're so looking forward to that as we're very interested to hear more about the AMIGO-TZD trial. We believe this indication will be approved shortly, which could add hundreds of millions of dollars to Byetta's current revenue over the next several years - this is going to be very interesting to watch unfold. The other oral focuses on Byetta's impact on gastric emptying; we question ADA's choice here since we think it would have been one zillion times more relevant and interesting for ADA to choose something on LAR for an oral, although anything on Byetta will likely be extremely interesting as well. While it's true that the LAR data has been released for some time now, no doubt there will be details of big interest in the poster, #487P.
Overall, on posters, Amylin has fourteen, which is an outstanding showing. One is a late breaker on Leptin (52-LB), which is excellent! We will have a Leptin 101 article in our next DCU - written is outstanding. There is also great pramlintide poster for obesity (#1722-P) - about satiety - those are the only two on programs in development. There are four symlin posters - one by Dr. Ceriello (#447-P), who is Mr Glycemic Variabilty (Dr.!). This is about oxidative stress, which by the end of the meeting will be one of the top ADA buzzwords. Then, there is one about symlin and glargine (#472P) by Dr. Frias (amylin), one that looks the same but with non-Lantus long acting insulin (#521P), and then one about symlin in the elderly (publication only, #2102-PO). On byetta, there is far far too much to even talk about it. One (#2009-PO) by Dr. Buse looks quite something -- on ALTS (Hepatic Alanine Transaminase), which we although it is publish only. Powerhouse Dr. Dennis Kim will do the LAR poster (#487P), and highly respected Dr. Bob Henry will do the open label update. The latter two are definitely ones we do NOT want to miss ... cannot wait to be standing there with bated breath. Both will be so interesting. While many show little regard for open label data, we're the opposite - sure, it's a specific population for whom Byetta obviously worked - so it's not the randomized group - but Byetta is working so incredibly well for so many people that there's clearly a pretty big sub-group of patients for whom the results may have real implications. What will three-year data show? We look so forward to sharing our thoughts as the meeting unfolds. Excitement abounds ....!