So close, and yet so far. It looks like there will be no marketing partnership for MannKind’s ultra rapid-acting insulin product Afresa anytime soon. The company had planned to enter into a deal with a large pharmaceutical company by the end of this year, but now approval from the Food and Drug Administration (FDA) for their inhaled insulin won’t be until January 2010, at the earliest.
“We believe that we and our potential partners will be better able to address appropriate deal terms and structure once the label for AFRESA is clarified. Since we do not expect a response from the FDA before January 2010, we believe that we will not conclude a deal before the end of 2009″, says MannKind Corp in a regulatory filing dated Tuesday October 6, 2009.
Shares of the company’s stock have taken a nosedive.
Considering the first FDA-approved inhaled insulin, Exubera, was pulled from the market because of poor sales, it will be very interesting to see just how successful Afresa may be. MannKind believes that their product’s unique formulation, which alters the pharmacokinetics and pharmacodynamics of the drug as compared to previous attempts at inhaled insulin, puts them in a different category altogether. But for now, don’t hold your breath.
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Securities and Exchange Commission Regulatory Filing