Watch stocks you care about
The single, easiest way to keep track of all the stocks that matter...
Your own personalized stock watchlist!
It's a 100% FREE Motley Fool service...
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.
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.
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.
One event many people are holding their breath for, though, is the outcome of the November elections. Find out how to profit regardless of who prevails in The Motley Fool's special report "These Stocks Could Skyrocket After the 2012 Presidential Election." Get your free copy now by clicking here!