Exubera Exuberance

Exubera won the race for approval of inhaled insulin. But three other inhaled insulins are in clinical trials.

Of these competitors the closest to market is probably an insulin and aerosol inhaler developed by Alkermes with Lilly. Their inhaler is reportedly smaller and easier to operate than the Exubera inhaler.

Novo Nordisk, along with Lilly, the other insulin giant, is in the race too. MannKind is also in Phase 3 clinical trials of its inhaled insulin, which is very fast acting and has higher bioavailability. Full disclosure: I own stock in MannKind.

The question of bioavailability might be a major one when it comes to cost and insurance reimbursement. Bioavailability means how much of the dose gets into circulation.

The bioavailability of Exubera is about 10 percent compared to regular insulin injections, Anne Cropp told the FDA’s advisory committee in its September 8 meeting. She is Pfizer’s global clinical leader for inhaled insulin.

This sounds to me like Exubera requires ten times as much insulin for the same effect. That’s not clear, because one analyst told The New York Times that when Exubera goes on sale, it will cost three times as much as regular insulin. That probably won’t be until this summer.

What does this mean for insurance reimbursement? I think that’s one of the biggest questions. It’s also one that we are not likely to find the answer to until we try to buy Exubera.