Novo Nordisk Pushes Ahead In Challenging Year

[nemzter]

news.investors.com/091013-670467-novo-nordisk-stock-recovering-from-setbacks.htm?ven=yahoocp&src=aurlled&ven=yahoo

I don't know about you guys, but I would prefer to inhale vs inject myself at mealtime ...

IBD: Would the launch of MannKind's Afrezza inhaled insulin product have an impact on your business?

Brandgaard: We have been down the road of inhaled insulin, and we terminated our projects after Pfizer (PFE) had to conclude that their Exubera (inhaled insulin) product was not commercially successful. The challenge we see with Afrezza is that it is solely a product you use for mealtime. Typically, patients who need mealtime insulin will also need long-acting insulin. Since you then anyway have to inject yourself with the long-acting insulin, one could question how big the benefit is of being able to take your insulin by inhalation for the mealtime. So we're not intending to go down that route again.

We think our approach of trying to make insulin in a tablet form could probably be more interesting, because where we see the injection as being the major hurdle is predominantly in Type 2.

In Type 2 diabetes, the insulin the patients would need to start with would predominantly be a long-acting insulin. We see the inhalable insulin more as a specialist product.

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[MnkdMainer (MM)]

Why would Afrezza have to be accompanied by a basil insulin injection in Type 2 patients (95% of all diabetics)? Currently, many of those patients are on oral meds, and many more on nothing at all.

In any event, the multiple daily sticks from prandial insulin injections that could be avoided with Afrezza makes it appealing even for those who might still have to inject a basil insulin once daily.

Anyone have any thoughts on this?

[brentie]

Sept 12, 2013 14:35:28 GMT -5 MnkdMainer (MM) said:

Why would Afrezza have to be accompanied by a basil insulin injection in Type 2 patients (95% of all diabetics)? Currently, many of those patients are on oral meds, and many more on nothing at all.

In any event, the multiple daily sticks from prandial insulin injections that could be avoided with Afrezza makes it appealing even for those who might still have to inject a basil insulin once daily.

Anyone have any thoughts on this?

Yes, Al does......

Aren’t most Type 2s currently treated with a basal insulin only, instead of mealtime dosing?

Yes, but that’s the wrong way around. The correct therapy should be a good prandial insulin and not long-term insulin — Afresa in particular because it turns off glucose production and delivery from the liver. Our latest trials of 600 patients are showing even more significant benefits from the product than our original trials; the most recent trial appears to show that this should replace frontline treatment for all Type 2 patients.

www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.html

[MnkdMainer (MM)]

Thanks, Brentie, for this excellent clarification.

Do you or anyone else know how many Type 2 patients are being treated with oral medications alone, that is, without a basal insulin?

My understanding is that the 175 study involved Type 2 patients who were not on any basal insulin.

What was the point of that study if most Type 2 patients are on a basal insulin?

[liane]

I don't have the exact numbers in front of me, but was using them this past weekend - so this is off the top of my head. There are ~1M T1s who use insulin, ~6M T2s who use insuslin, and ~ 15M T2s not using insulin - oral meds only. So if we include all of these in the potential label, the potential market size is 3 times that which we were looking at for the prior NDA.