Will the FDA Be Kind to MannKind?

MannKind (Nasdaq: MNKD  ) is scheduled to get a late present from the Food and Drug Administration on or before Dec. 29, when the agency decides whether to approve its inhaled insulin product, Afrezza. But the contents of the package -- an approval or a lump of coal -- remain to be seen.

Or perhaps I should say another lump of coal. The FDA already turned down the marketing application for Afrezza once. Before approving the drug, the agency wanted "data that support the clinical utility of Afrezza."

Has MannKind given the FDA what it needs to approve the drug? It's impossible for you or me to know, since we're not privy to the regulatory conversations. Clearly, management thinks so, but then it did the first time, too.

The bigger problem is that even if MannKind has fulfilled all the requirements, there's no guarantee of an approval. The FDA has had six more months to come up with a new issue to worry about. Perhaps the drug's lung cancer potential? A safety analysis of Pfizer's (NYSE: PFE  ) inhaled insulin, Exubera, showed a higher incidence of lung cancer among those patients taking the drug than in the study's control group.

And the FDA asking for another safety trial "just to be sure" isn't out of the question. Amylin Pharmaceuticals (Nasdaq: AMLN  ) and Eli Lilly (NYSE: LLY  ) know about that all too well, having been sent back to do more experiments on their diabetes drug Bydureon, a long-acting version of Byetta.

What investors need to remember is that neither Bydureon nor Afrezza are miracle drugs. Both have alternatives available: Byetta for Bydureon, and injected insulin for Afrezza. They're certainly more convenient, but the FDA is less concerned with the number of needle sticks and more concerned with making sure there aren't any problems with the new mode of delivery.

While I find it difficult to figure out whether the FDA will approve Afrezza, I can't fault investors for owning MannKind going into the FDA decision. The drugmaker has a market cap of only $1 billion and is clearly worth more if Afrezza is on the market -- and a heck of a lot more if MannKind can turn it into a blockbuster.

We can argue the merits of that last point at a later date -- like if it gets approved next week. For now, just take our Foolish poll then leave a comment lower on the page.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a Motley Fool Inside Value recommendation. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Fool has a disclosure policy.


Read/Post Comments (5) | Recommend This Article (8)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On December 22, 2010, at 4:42 PM, lisabetta wrote:

    the question of tumors in the lung was answered afrezza has not been ask to reinterate its safety findings it submitted the date required and no other questions were asked by the fda it is interesting that the fool keeps asking the sams questions and making the same comparisons with drugs whose only relationship with afrezza is they r all inhaleable.

  • Report this Comment On December 22, 2010, at 4:49 PM, TMFBiologyFool wrote:

    lisabetta,

    You and I (and MannKind) think the safety (lung cancer or otherwise) has been answered, but does the FDA. That's my point. It's impossible to know if the FDA will rehash something.

    -Brian

  • Report this Comment On December 22, 2010, at 7:39 PM, norman1066 wrote:

    Hi Brian,

    I think the bigger question we should be asking is why doesn't the FDA have to do a risk/reward analysis of their decisions. There is mounting evidence that they have lost their nerve and are taking the politically easy route of delaying new drug applications (NDAs). These delays will result in fewer new/improved therapies coming to market, cost increases for those drugs that do make it and the real suffering of countless patients.

    Uncertainty is a fact of life, but right now the FDA is making the perfect, the enemy of the good enough.

    Your point that there are alternatives to Afrezza is only partially correct. Afrezza will be the only ultra rapid acting insulin available to diabetics. This drug may make a new treatment regimen for Type 2 diabetes possible. This regimen will better control long term blood sugar levels in patients reducing their horrible long term symptoms (blindness, circulation disorders, and heart failure to name a few). Better treatment options promises reduced costs to the health care system saving everyone money.

    I guess I am a member of the Mannkind "cult" but I say innovation should be encouraged not discouraged by our government. Diabetes is at epidemic proportions in the USA we need all the help we can get.

    -Tim

  • Report this Comment On December 23, 2010, at 6:06 AM, goyocafe wrote:

    Brian,

    The FDA has NEVER raised the lung cancer issue for Exubera post approval. Pfizzler did, and much to their ill fated pleasure, the media and sell side analysts have capitalized on the mistated facts for almost three years.

    There is nothing for the FDA to rehash since the statistical significance of the original report was insignificant. They will, however, evaluate Afrezza on its own merit, and science, and all signs point to a superior product to Exubera.

  • Report this Comment On December 26, 2010, at 11:45 PM, ballhawker wrote:

    The trials were run, and no cancer safety signals were noted in those trials. Why do you keep perpetuating an "urban legend" about cancer when Afrezza has never shown a single safety issue in that area? I guess it makes for better copy, and that's what you are in the business of doing, attracting eyeballs. Fair and impartial journalism? I guess I need to lower my expectations when reading your website.

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