MannKind Wins Big

MannKind Wins Big

There are days when Diabetic Investor is convinced that the FDA does the opposite of what everyone thinks they’ll do just to prove the agency is as wacky as the diabetes world. Going into the FDA panel meeting for Afrezza everyone was convinced the panel would come up with a no vote, based strictly on the briefing documents the FDA released before the meeting. Yet in a stunning turn of events the panel not only voted to approve the drug but did so in resounding fashion, 13 to 1 for Type 1 patients and 14 to 0 for Type 2 patients.

Needless to say shares of MannKind skyrocketed after the vote became public and everyone is expecting shares to rise even further today. Although the full FDA is not required to follow the panels’ advice with such a resounding vote Afrezza’s approval is a virtual certainty. All the company needs now is to find a partner, a task which just became much easier and we’ll finally find out if Afrezza is the greatest thing to hit the market since soft soap and sliced bread.

Diabetic Investor remains unconvinced that Afrezza will ever live up to its hype and not because it’s not a good drug.  MannKind is expecting premium reimbursement for Afrezza at a time when premium reimbursement just isn’t happening.  Quite frankly the company needs premium reimbursement as Afrezza is more expensive to manufacturer than conventional insulin.

The company and/or their partner will also have to spend a small fortune building a sales team while at the same time ramping up a marketing plan. Now some might assume that Afrezza being the only FDA approved inhaled insulin will sell itself but this also assumes that physicians haven’t heard of another FDA approved inhaled insulin, Exubera. The fact is Afrezza won’t sell itself and actually could find a tough road once on the market.

The simple fact is Afrezza is rather average insulin which happens to be inhaled rather than injected. The data on Afrezza isn’t all the compelling, not that Afrezza is inferior rather it’s on par with what’s already on the market. The main difference comes down to cost and delivery system. Afrezza will likely cost more because of its delivery system which to Diabetic Investor provides cause for concern as we just don’t see payors anxious to dish out big bucks for a rather average drug when there is a perfectly good and cheaper alternative available.

That’s the truly odd thing about Afrezza as for years the company has been stating that it’s better insulin which happens to be inhaled rather than injected. The company for years did their best to distance themselves from the long shadow of Exubera. Yet today the best thing they have going for them just might be the fact the drug is inhaled rather than injected. Quite frankly this is likely what the company wanted all along to be the last man standing so to speak, to have the only FDA approved insulin on the market.

Still Diabetic Investor remains unconvinced Afrezza will ever live up to its lofty expectations; this is not a billion dollar drug by any stretch of the imagination. The drug has its place in the therapy regimen and will likely find its niche over time.  Time will tell of course but given the history of MannKind wise investors should enjoy the ride as it won’t last forever.