MannKind's Breathtaking News

MannKind (Nasdaq: MNKD  ) announced breathtaking news this week -- literally. The biotech completed patient recruitment for two phase 3 clinical trials for its insulin inhalant Afrezza. The "breathtaking" studies should begin soon and be completed in the second quarter of 2013.

Studying the studies
While both phase 3 studies involve Afrezza, they are quite different in nature. The first will include at least 471 patients with type 1 diabetes. Three arms will be used in the study -- a control arm, an arm using Afrezza with MannKind's older MedTone inhaler, and a third arm using Afrezza with the company's newer inhaler.

The second study will include at least 328 patients with type 2 diabetes. The patients will go through an initial run-in period using metformin, an oral antidiabetic medication.  The study will then compare patients using Afrezza versus a placebo inhalation powder.

MannKind likely feels a sense of deja vu in conducting these phase 3 studies. The company went down this road before a few years ago with Afrezza, the drug formerly known as Afresa. I guess marketing studies found that "zz" tops "s" in product naming. 

All went well until the company decided to switch inhalers. While the move resulted in a multi-year delay, it probably was the right thing to do.

Pfizer (NYSE: PFE  ) failed in its marketing of an insulin inhalant from Nektar Therapeutics (Nasdaq: NKTR  ) . Lilly (NYSE: LLY  ) and Novo Nordisk (NYSE: NVO  ) couldn't successfully launch their products either.MannKind saw improving its inhaler as the best opportunity to avoid a similar fate. 

Looking ahead
As MannKind CEO Alfred Mann pointed out in his public statements about the studies, completing patient recruitment often is the lengthiest part of conducting phase 3 clinical trials. Reaching this milestone is significant.

However, MannKind still has a long way to go to ultimately bring Afrezza to market. The company must raise some more cash to make it happen. And it needs a partner in a major way.

Afrezza holds great promise for many diabetics. My guess is that it will ultimately achieve success. However, until MannKind finds a well-heeled partner, I doubt the stock will be very successful. In the meantime, I'm not holding my breath.

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Fool contributor Keith Speights has no positions in the stocks mentioned above. The Motley Fool has no positions in the stocks mentioned above. Motley Fool newsletter services recommend MannKind. Try any of our Foolish newsletter services free for 30 days. 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 Motley Fool has a disclosure policy.


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  • Report this Comment On October 12, 2012, at 10:47 AM, WCoastGuynCA wrote:

    A new secondary that could results in an additional 100,000,000 share dilution (about 40%) is expected to be announced at any time.

    There's speculation that the share price could drop back to the $1.65 range.

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