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More Delays on MannKind's Inhaled Insulin: The Pros and Cons

By Trista Morrison

Updated on: March 17, 2010 / 3:02 PM EDT / MoneyWatch

Biotech company MannKind (MNKD)'s tumultuous quest for approval of its inhaled insulin drug Afrezza has attracted outspoken supporters and detractors -- and this week's complete response letter from the FDA has them at each other's throats again.

Here's why the FDA didn't approve Afrezza and each camp's interpretation.

1. The FDA requested "currently available clinical data that support the clinical utility of Afrezza."

Bulls: FDA wants to discuss where Afrezza fits within the broad spectrum of available drugs for diabetes. Might limit patients but not the end of the world.
Bears: FDA doesn't see the usefulness of inhaled insulin given that there are so many other diabetes drugs available.

I have a hard time believing the bears on this one. The FDA tends to focus on whether or not drugs are safe and effective and lets the free market sort out whether or not people actually want to buy them. As the FDA approval and subsequent commercial implosion of Pfizer (PFE)'s inhaled insulin drug Exubera proved.

2. The FDA has questions about MannKind's MedTone inhaler.

Bulls: No big deal. MannKind never intended to launch Afrezza with the MedTone inhaler anyway; it was going to file for a supplemental approval of a newer device, Dreamboat, prior to launch. Most of the FDA's questions about MedTone were on issues Dreamboat addresses, so MannKind now plans to forge ahead with Dreamboat.
Bears: As TheStreet.com's Adam Feuerstein wrote: Asked by one analyst if there was a precedent in which FDA allowed a company to simply swap out one device for another in the middle of a review, MannKind said the company was operating in "entirely new territory."

Score one for the bears. New territory with the FDA is no territory I'd want to be in.

3. The letter cited no safety concerns, but requested updated safety data related to Afrezza.

Bulls: As Rodman & Renshaw analyst Simos Simeonidis noted, this is a big one because a primary concern about inhaled insulin has been cancer risk, and any concerns the FDA had about that would have been raised here. Instead the FDA just wants an update on any new data collected since MannKind filed for approval a year ago, and the company says there's nothing new of concern.
Bears: As far as I can tell, there's no bear argument here. But correct me if I'm wrong in the comments section below.

4. The letter did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA.

Bulls: Woo-hoo! No more clinical trials needed.
Bears: Quoting Feuerstein again: The company's statement says FDA didn't ask for new trials to "complete" its Afrezza review, but is that the same thing as saying FDA didn't ask for new trials in order to approve the device?

I have to go with the bulls here. If the bears are right, that's taking misrepresentation to an all new low.

Want More?

The Scoop on MannKind's Afresa Partnership Delay

Bull Bear photo courtesy of WikiCommons, GNU-FDL.