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MannKind Faces FDA Delay on Inhaled Insulin

From Associated Press (January 8, 2010)

VALENCIA, Calif._MannKind Corp. said Friday the Food and Drug Administration will take longer-than-expected to make a decision on the inhaled insulin because of a delay in inspecting a manufacturing site.

The drug's trade name is now Afrezza. It was formerly called Afresa.

MannKind said the FDA has not yet completed its inspection of the manufacturing facilities, operated by third-party supplier NV Organon.

The FDA was scheduled to make a regulatory decision on the drug by Jan. 16.

Shares of MannKind have been volatile over the last several days because of regulatory and potential market concerns on the inhaled insulin. Long-term, shares have doubled over the last 52 weeks.

On Friday, the stock fell 28 cents, or 3.4 percent, to close at $8.04.

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty. Meanwhile, MannKind has had difficulty finding a marketing partner for Afrezza.

Posted: January 2010