ADA Day Two
Sunday at the ADA was certainly not a day of rest as several important developments took place:
1. Novartis (NYSE:NVS) and Merck (NYSE:MRK) booth announced results from clinical trails for their respective DPP-4’s. With drugs before the FDA awaiting approval, the companies have already begun an all out assault to gain the attention of the medical community. Based on the conversations DI has had with researchers and endocrinologists, neither compound appears to be a threat to Byetta or Actos/Avandia.
The major question isn’t whether the drugs work rather do they work well enough to justify the additional cost of therapy. It will be interesting to see how managed care reimburses for these drugs especially when in many cases it would be the third oral agent taken by a patient. It should also be noted that while patients on the drugs did see some improvements in A1c, there was no positive effect on weight.
Given Byetta’s proven weight loss capabilities and Actos/Avandia vascular benefits, DI sees a narrow application no matter which drug comes to market first.
2. Besides the benefit of being associated with Byetta, Lilly (NYSE:LLY) announced positive data for their AIR® inhaled insulin system. Partnered with Alkermes (NASDAQ:ALKS) on this project, DI has seen the delivery device which is far superior to Exubera’s device. While Exubera continues to garner its share of attention here a consensus is building among the attendees that maybe this isn’t the greatest thing since sliced bread after all. Pfizer (NYSE:PFE) is betting heavily on the fear of needle factor while physicians are wondering will patients use such a complicated device for a drug that works no better than regular injectable insulin.
The company has also introduced a new insulin pen, which we are sorry to say is nothing to be overly impressed with. While superior to their current pen, this new pen offers users the ability to track their last 16 insulin doses. Novo Nordisk (NYSE:NVO) maintains its lead with pen delivery options.
3. Speaking of Novo, DI has learned that the company is developing its own disposable insulin pump with a new insulin formulation. Novo is now just one of many who are racing to catch upstart Insulet. The OmniPod has turned the insulin pump market on its head, given what we’ve seen so far Insulet has nothing to worry about.
4. More news from Dexcom (NASDAQ:DXCM) and this time its bad news for Abbott (NYSE:ABT). With the Navigator still awaiting FDA approval, Dexcom is taking full advantage of its opportunity of being the most affordable continuous glucose monitoring system announcing the results of two studies that showed their 7 day sensor to be safe and effective. Interestingly the 7 sensor has performed even better than their current 3 day sensor with over 97% of the results falling in the A B zone of the Clarke Error Grid, more impressive is the fact that over 70% of the results came in zone A and there were no results in zone E.
With the Navigator bogged down at the FDA, Medtronic concentrating on the Paradigm® REAL-Time system, Dexcom is moving towards a 7 day sensor. The company is moving aggressively towards establishing a presence in this new market and with a 7 day sensor, something DI expects will happen in the next 6 to 8 months, the company will have one more advantage over the yet to be approved but widely anticipated Navigator.
5. Finally, although the Amylin (NASDAQ:AMLN) Investor meeting isn’t until later this evening what we can from what we seen so far can be summed up in one word: IMPRESSIVE. We’ll have a full update tomorrow.
6. Don’t forget David Kliff will appear live tomorrow from the ADA on CNBC at 4pm EST.