|This from Yahoo. I listened to the call and brh has it pretty much right. But the comments about the fda and approving for t2 but not t1 were more or less oblique and roundabout in that novo said in at least one conversation with the fda about insulin-affecting drugs--not specifically attributable, but inferred, to pulmonary--it wants to approve a drug not a regimen suggesting that if pulmonary insulin is not safe and effective for all insulin dependent diabetics then this could be a hurdle to approval. I don't know if I feel the same. How is approval for t2 a regimen and approval for t1 and t2 not a regimen?|
More interesting were the comments about pharmacoeconomics. Novo says basal insulin will never be delivered to lungs so if you are insulin dependent and getting at least one shot, what government coverage is going to pay 5x for pulmonary pre-prandial where there is no clinical improvement? He said this is especially a concern in EU where novo is getting plenty of heat on its analogues, priced 30% higher than human, which are demonstrably superior. Suggested more potential in US on this issue; 'but ask why our competition has not yet filed.'
Bottom line, this thing looks dead. So to me it appears the only reason for buying it was to lock away all the data from competitors and hibernate the project until perhaps some "ah-ha" moment arrives unlooked for.
Novo comments on ardm insulin
by: brheavy 02/10/05 06:10 pm
Msg: 24814 of 24845
from the webcast today. Novo's comments were
1. that it doesn't appear appropriate for type I diabetics.
2. that the costs don't look good for Europe where they even have a trouble getting a 30% premium for superior insulin analogs.
3. that they are just as far from a product today as when they started!!!
4. that the conversations with the fda indicate they would not approve a filing that did not cover both type I and type II ... (so remember number 1 above) Yikes...
One last comment. Novo's findings suggest T1s are not an appropriate population because, even though it is absorbed as insulin, it works in T1s as an intermediate. Lars continued to say that leaves T2, 'where an intermediate-acting would be appropriate' (presumably for the early stage patient requiring exogenous insulin, but not one with total dependency) but the economics don't look so good.
This is why ardm has lost 20% last 2 days.