2008 Should Make or Break MannKind

With only one compound in late-stage testing and that compound's study results coming out in the next few months, 2008 will be a make-it-or-break-it year for MannKind (Nasdaq: MNKD).

MannKind's only potential near-term revenue-generating drug is its inhaled insulin Technosphere, which is in multiple phase 3 studies as a treatment for both type 1 and type 2 diabetes. This year, we'll get to see a multitude of data from those phase 3 trials. If the data is good enough, an FDA marketing application for Technosphere may follow.

Top-line data from one of the upcoming pivotal efficacy studies in type 1 diabetes should be released in the third quarter, and data from a phase 3 trial testing the drug in type 2 diabetes patients is guided to be out before year's end, according to MannKind. The last of the three crucial studies MannKind needs to successfully get Technosphere onto the market is its two-year safety study, the results of which will be publicly announced either prior to MannKind's Technosphere marketing application or in conjunction with it.

Speaking of marketing application, if everything goes according to plan, MannKind is also projecting filing for approval with the FDA in 2008. This timeline puts the earliest chance for possible approval of Technosphere in the second half of 2009.

In its fourth-quarter conference call yesterday, MannKind's wonderfully successful founder and CEO Alfred Mann gave a spirited denunciation of the other inhaled insulin products like Eli Lilly's (NYSE: LLY) and Alkermes' (Nasdaq: ALKS) AIR insulin drug. We won't find out in 2008 if Technosphere is more marketable than these other inhaled insulins, but the numerous data results that will be out this year will be a good start in outlining Technosphere's potential.