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MannKind is up Big But What is Afrezza?


Shares of MannKind (NASDAQ: MNKD) are soaring on Wednesday after positive data related to its inhaled insulin product, Afrezza, was very positive. There’s more to this data than meets the eye, though. Afrezza has been, pardon the cliche, a labor of love for MannKind.

Borrowing another cliche, if you don’t succeed, try, try again. Afrezza was turned down by the FDA. It first filed for FDA approval in March 2009 but the FDA told the company in 2011 to run more trials, specifically comparing a new inhaler for administering the drug to a previous device used in earlier studies. The company said that today’s positive data will be used to submit another application to the FDA sometime in the fourth quarter of this year.

You would think that inhaled insulin would be popular among diabetics since it requires no needles but Pfizer (NYSE: PFE) proved that theory to be wrong–at least at the time.

Read More: MannKind up 15 Percent Wednesday- Why?

Pfizer’s inhaled insulin product, Exubera, was pulled from the market because of poor sales. Doctors didn’t prescribe it, in part, because it proved no better at managing the disease than traditional injections but it came at a much higher price. Eli Lilly (NYSE: LLY) tried to develop an inhaled insulin product as well but ended the program saying that there was regulatory uncertainty.

MannKind has certainly found that to be true. Afrezza has fought the comparison to Exubera for years along with the idea that inhaled insulin might cause a decrease in lung function. Data doesn’t appear to support any meaningful decrease.

But MannKind might have it right this time and if it does, that can mean big money. As the world gets fatter (sorry, “percentage of people who are obese rises”), so does the incidence of diabetes. Statistics show no signs of the world slimming down any time soon so MannKind might just be in the perfect spot. It currently has no drugs on the market. This would be a blockbuster way to make an entrance–if doctors will buy in.

 

[stock-tools exchange="NASDAQ" symbol="MNKD" image_height="230" image_width="350"]

Disclosure: At the time of this writing, the author had no position in the company mentioned.

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One Comment

  1. Henry Hill

    August 15, 2013 at 3:05 pm

    $MNKD saw a clear hypoglycemia advantage for the AFREZZA -Gen2 group. More from their latest CC @ http://stks.co/bf78