) recently announced encouraging results from the much awaited
phase III Affinity studies on its lead candidate Afrezza. Afrezza
is being developed for the treatment of type I or type II
diabetes. Afrezza met primary end points in both the studies.
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Results from the Study 171 (n= 518) revealed that non-inferior
decreases in A1c levels were observed in Afrezza treated patients
compared to the insulin aspart group. This was the primary
objective of the study. Afrezza was found to be well tolerated
during the study.
MannKind also issued a new press release to correct the
previously announced results from the Study 171 on Afrezza in
patients suffering from type I diabetes. Results in the new press
release revealed that the event rate of severe hypoglycemia was
lower in patients under the Afrezza group compared to those under
the insulin aspart group.
Meanwhile, MannKind's share price, which had shot up 7.1%
initially on the positive data, spiralled 12.5% following the
Results from the other phase III study on Afrezza (type II
diabetes), Study 175 (n=353), showed that the primary objective
of superior reductions in A1c levels from baseline was observed
in the Afrezza group compared to the comparator oral-therapy
group. Moreover, more patients under the Afrezza group reached
specified A1c target levels compared to those in the comparator
oral-therapy group. The candidate was generally well tolerated in
this study as well.
MannKind now plans to file the amended new drug application to
the U.S. Food and Drug Administration for the candidate in early
fourth quarter of 2013. The company will now enter into a formal
partnering process as the Affinity results have been declared.
The company will assess the opportunities of the candidate along
with multiple partners.
The positive results from the company's lead candidate are
encouraging. We expect investor focus to remain on Afrezza
going forward. However, we remain concerned about the company's
over dependence on Afrezza. Any setback related to the diabetes
candidate will be catastrophic for MannKind.
MannKind, a biopharma stock, presently carries a Zacks Rank #3
(Hold). Other biopharma stocks, such as
Alexion Pharmaceuticals, Inc.
) are comparatively well placed. While Actelion carries a Zacks
Rank #1 (Strong Buy), Alexion and Amarin carry a Zacks Rank #2