Rockford Coscia submits:
This December, Afrezza, MannKind’s (MNKD) inhalable insulin therapy for prandial (meal-time) management of blood glucose in diabetics, faces FDA decision. Afrezza’s path to approval is well worn and bloodied, most notably by an approval and subsequent market withdrawal of Pfizer’s (PFE) Exubera. Other inhalable therapies have also been attempted by such high-powered partnerships as Alkermes/Eli Lilly (LLY) and Aradigm/Novo Nordisk (NVGN); all abandoned in the wake of Exubera’s withdrawal. Currently Afrezza is the only form of inhaled insulin still under FDA review.
With the market failure of Pfizer’s Exubera, potential investors in MannKind’s endeavor must address why Afrezza will not suffer the same market setbacks assuming a favorable decision by the FDA in December. MannKind has, of course, amassed a number of reasons to convince investors that Afrezza will become a market blockbuster with varying degrees of substance.