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
