The U.S. Food and Drug Administration's (FDA) Endocrinologic
and Metabolic Drugs Advisory Committee will be reviewing
) New Drug Application (NDA) for its lead candidate, Afrezza
(inhaled insulin), tentatively on Apr 1, 2014. MannKind's shares
dropped 16.4% on the news.
MannKind is looking to get Afrezza approved for the improvement
of glycemic control in adult patients suffering from type I or
type II diabetes. We note that MannKind has already received two
complete response letters (CRL) for Afrezza from the FDA. While
issuing the second CRL in Jan 2011, the FDA asked the company to
conduct two phase III trials (study 171 and study 175) with the
In Oct 2013, MannKind resubmitted the NDA for Afrezza on the back
of positive results from the phase III studies. Although a final
decision from the U.S. regulatory body is expected by Apr 15,
2014, a further delay in approval or even a third CRL cannot be
entirely ruled out. MannKind is dependent on the success of
Afrezza and an additional delay in gaining approval will weigh
heavily on the stock.
The track record of previously approved inhaled insulin drugs
) Exubera (the first inhaled insulin to be approved in the U.S.
in 2006) has been pretty disappointing. Pfizer was forced to stop
market the drug after disappointing sales of the drug. Exubera
accounted for a mere $12 million in the first three quarters
after launch. Pfizer also faced severe safety issues while
marketing the drug.
Following the failure of Exubera, other big players including
Eli Lilly and Company
) discontinued their inhaled insulin programs citing lack of
confidence in the regulatory environment and market prospects of
an inhaled insulin product.
Currently, we have low visibility on the questions that will be
raised at the FDA advisory panel meeting - we expect investor
focus to remain on the outcome of this meeting.
MannKind, a biopharmaceutical company, presently carries a Zacks
Rank #3 (Hold). Some better-ranked stocks in the
biopharmaceutical sector include
) with a Zacks Rank #1 (Strong Buy).
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