MannKind - Biotech's Biggest Spenders

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Based: United States
R&D budget: $149 million (€109M)
Change from 08: +37.6%
Income spent on R&D: N/A

MannKind ($MKND) has had to maintain a picture of serene confidence as it continued to rack up heavy R&D expenses for a program for the inhaled insulin therapy Afrezza, which continues to inspire considerable skepticism among analysts. This year the NDA for the program faced a delay at the FDA and then found itself under attack from a former regulatory affairs exec who claimed in a lawsuit that the company had hidden serious "scientific misconduct" from clinical trials for the drug.

Back in 2008, MannKind spent $250.4 million on R&D, the bulk of that year's expenses. Since then, it's managed to carve a considerable amount out of its R&D budget.

MannKind has completed two early-stage studies of a cancer vaccine and has another preclinical program in the pipeline. A Phase II study for MKC1106-MT launched in mid-October. But virtually all of the attention at the company has been concentrated on the fate of Afrezza. The new deadline for an FDA decision is December 29. But even if it should get an approval, MannKind will face continued questions about its ability to make a market for an inhaled insulin therapy after Pfizer failed with Exubera. When Pfizer dumped Exubera, there were three other development programs underway for an inhaled insulin. MannKind's was the only one of the three to survive--so far.

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