Changing Diabetes - Pharmaceutical Executive


Changing Diabetes
Novo Nordisk's Martin Soeters has a question: How can a nation that leads the world in diabetes research do such a poor job of treating it? He also thinks he has some answers.

Pharmaceutical Executive

Plus, we're looking at the potential for other indications. We called together a number of global experts in the area of hemostasis to help us decide what indications the drug should be targeted to. They said that the drug had potential for 45 indications. We thought we should bring it back and try to prioritize. We brought it down to 24 indications, and we are in close discussions with FDA about two of them. One is for trauma—car accidents and bullet wounds. We also heard that doctors in the army are already using it, in Iraq, when soldiers are bleeding in battle. We are going to start a Phase III study, which could lead to approval for that specific indication.

The second indication that's close to reality is for stroke, in the cerebral hemorrhage, for which there is currently no good alternative. The New England Journal of Medicine reported that the product has extraordinary results. From the published study, it looks almost too good to be true how many people's lives were saved or improved.

In the United States, we are going to do a large Phase III trial to also get the stroke indication approved. We are doing many activities for hemostasis that we have learned from in diabetes, and which the diabetes community probably appreciates.

What's does the future of diabetes treatment look like?

We're working on oral insulin, but the unpredictable absorption from the intestines and the stomach does not lead to a very stable glucose level. With diabetes, it's important that you have a low glucose level, but that low average glucose level is not the only factor. You also don't want to have the variations in ups and downs. And that's the reason why we have short-acting analogs and mixed analogs—you want to prevent and avoid the peaks around meals.

We also are working on self-thinking insulin, which acts when there is high glucose concentration, as soon as it enters the blood stream. That's called insulin mimetics. It's intelligent formulation of insulin.

Our oral compounds that are close to the market are DPP4, new insulin sensitizers, and the glucose kinase activator, which involves a different mechanism for Type II diabetes. We also are coming out with a human GLP1 glucose-like peptide. We are doing late-phase trials in humans.

We acquired California-based Aradigm, now Novo Nordisk Device Technology, at the end of last year. They will be working on a pulmonary insulin product in liquid form for us. We are in late Phase II with that product, but of course you always keep having the concern about what will happen from giving pulmonary insulin for 30 years.

And the two pulmonary insulin products that are further along in development than yours are in powder form?

Yes. But we think that a lot of elderly diabetics, who don't dare take insulin injections, might be well-suited for pulmonary administration. But we all are struggling with the bioavailability. What will it mean if you have pulmonary insulin for 30, 40, or 50 years?

We know what it means to be a diabetic who has been getting 50 years of regular insulin—the Jocelyn Clinic gives medals for living with diabetes for 50 years. But we don't know what it means to get 50 years of insulin via the lungs.

Do you find that having the foundation structure makes it easier to do things like allocate research dollars to finding a cure rather than finding the next treatment?

We have a special unit, Hagadone Research, that is completely different and separate from the rest of Novo Nordisk. They have nothing to do with product research. Those folks only do basic research, and they have their own budget every year. On top of that, they get grants from the Juvenile Diabetes Research Foundation and from NIH.

It's not usually the case that companies have basic researchers looking—independently—at cure and prevention.


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