Day Three Wrap Up – Moses Speaks

Day Three Wrap Up – Moses Speaks

Before we get into the heart of today’s lineup a few housekeeping items. First, kudos to the good folks at Dexcom (NASDAQ:DXCM) for what is becoming a must event at every ADA, the Dexcom fun-raiser. Just as the LifeScan Irish Coffee has become a must attend event at AADE, the Dexcom event at ADA is becoming the event to be at. Besides being a great even Dexcom was able to raise funds for diabetes research.

Second, we must admit we were extraordinarily disappointed not to find Tradjenta toilet paper in room last, alas there is always tomorrow and we can only hope.

Now on to the good stuff – yesterday Diabetic Investor had the pleasure of speaking with Dr. Alan Moses, the Chief Medical Officer for Novo Nordisk (NYSE:NVO), while this wide ranging interview covered a wide variety of topics the most interesting moment came when the discussion turned to long acting GLP-1’s. As everyone knows Novo is developing a long acting version of Victoza, a once-daily GLP-1, to compete with Bydureon, the once-weekly GLP-1 from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASADQ: ALKS), which is currently being reviewed by the FDA.

Even with a long-acting GLP-1 in their pipeline Dr. Moses questioned the need for such a product, stating that it may actually be better to stick with (excuse the injection reference)a once daily product like Victoza. Dr. Moses stated that the fact that the patient must inject themselves each day is somehow a pleasant reminder that they must manage their diabetes. That somehow the patient likes this daily reminder that they have a chronic disease and it’s really no big deal to inject their medication each and every day for the rest of their lives.

After Diabetic Investor checked to make sure our ears were working properly and that somehow we had not lost what’s left of our mind, we could not believe what we were hearing. The simple fact is patients with Type 2 diabetes do not want to reminded they have diabetes and would give their right arms if they did not have to constantly manage their disease each and every day of their lives. The reality is it really does not matter if these patients are taking multiple pills, pills plus insulin, GLP-1 injections or multiple injections of insulin per day, patients prefer therapies that require fewer administrations. As we have noted consistently since GLP-1’ hit the market once-daily trumps twice-daily and once-weekly trumps once daily and yes it is that simple.

Frankly Diabetic Investor was astonished that Dr. Moses, who is one very bright guy and who knows diabetes as well as anyone would utter such words. We were even more surprised given the fact that the company he works for is developing not only longer acting GLP-1’s but also longer acting insulin’s. The whole point of the Novo pipeline is basically to make life easier for the patient by producing drugs that are not only safe and effective but also require fewer administrations. This is the future of diabetes management.

Understanding that Dr. Moses had a long and busy day at the conference Diabetic Investor will chalk this one under the category of exhaustion.

Staying with the GLP-1 category for the moment Diabetic Investor attended the Amylin investor event last evening and could not help but feel a little sorry for the company. Here they sit with Bydureon, a drug that has the potential to revolutionize the treatment of Type 2 diabetes and given the sparse attendance last night one just might think they we’re infected with some sort of virus.  One just might think the folks at Lilly, who frankly should be embarrassed for the over the top Tradjenta promotions, would spend less time promoting this loser of a drug and get back to working with Amylin. We’ve said it before and we will say it again – as good as we believe Bydureon is this drug will not sell itself, especially when you consider that in its initial version patients will need to use a 23 gauge 5mm needle. Yes the injection is just once a week but that needle is larger than most insulin needles and much larger than the needle used with Victoza.  Diabetic Investor does believe that this difference in needle size can be overcome but only if Lilly and Amylin get their act together.

One company that really doesn’t need to have their act together but does is Medtronic (NYSE:MDT). This morning Diabetic Investor had a nice sit down with the company who did their best to tell Diabetic Investor about all the wonderful new things they are working on. Yet when it is all said and done the company really has to do nothing more than not screw up a very profitable business. Medtronic knows that it is next to impossible for Animas and Insulet (NASDAQ:PODD) to cut into their huge installed customer base without serious financial considerations. They also know that most pump patients don’t switch from one pump to another easily. Lastly they know that they really don’t need to be that innovative and the pressure is really on the competition to figure out a way to take away share.

Perhaps this one reason the much talked about and much delayed Medtronic patch pump will never see the light of day, at least not the current design. Give the company credit rather than keep giving timeframes for when this system will arrive, timeframes they have never meet in the past, and they will only say we will see this system someday.  All things being equal should the company be truly serious about this market segment they will likely end up buying someone rather build their own. For the time being however, they really don’t have much to worry about.

Overall this has been a pretty dull conference with no real buzz to it. The study data for the many drugs hasn’t been that surprising and the not much new device wise either. Diabetic Investor does not necessarily blame the companies for this lack of buzz as the real truth is the FDA has become the world’s biggest buzz killer.  Although no one is dumb enough to go on the record and publicly bash the FDA, privately they are livid as to how the agency is making their lives miserable.  The bottom line is the FDA is not just hurting business but hurting patients. Until someone, anyone is willing to speak out and let everyone know how bad the agency has become nothing will change.

This is not the time to let Dr. Nissen and his followers set the agenda, the diabetes industry needs to fight back and be heard. Millions of lives are at stake and the good doctor could care less that millions will suffer as he continues his crusade to push diabetes treatments and now devices back to the Stone Age.  The time for silence is over; the time for action is now.