) recently completed a phase III study (Study 175: n=353) on its
diabetes candidate Afrezza. MannKind completed all follow-up
visits for the enrolled patients in the study. The company
expects to publish data from the study later this summer.
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The open-label phase III study evaluated Afrezza inhalation
powder in patients suffering from type II diabetes. The study
assessed Afrezza using the next-generation inhaler in patients
whose disease is insufficiently controlled by metformin. Patients
enrolled in the study were randomized to either Afrezza or
We remind investors that in Jan 2011 MannKind had received a
second complete response letter (CRL) from the US Food and Drug
Administration (FDA) for Afrezza. The FDA had asked the company
to conduct two phase III trials with the next-generation inhaler.
Last month MannKind completed its first phase III study (Study
171) on Afrezza in patients suffering from type I diabetes. The
study evaluated Afrezza inhalation powder in patients suffering
from type I diabetes. The patients were randomized to one of
three arms: a control arm, in which patients utilize injected
rapid-acting insulin at mealtimes, or one of two Afrezza arms,
with patients either on MedTone or the next-generation inhalers.
Following the titration of the mealtime insulin, HbA1c levels
were assessed for an observation period of 12 weeks on the stable
doses of the mealtime insulin.
During its first quarter 2013 conference call, MannKind stated
that it plans to resubmit the New Drug Application to the FDA for
Afrezza in late September or early October this year. MannKind
intends to get Afrezza approved for treating adults suffering
from type 1 or type 2 diabetes. We expect investor focus to
remain on Afrezza going forward.
MannKind currently carries a Zacks Rank #3 (Hold). Other
biopharma stocks, such as
Jazz Pharmaceuticals Public Limited Company
Cubist Pharmaceuticals Inc.
), are comparatively well placed. While Jazz Pharma and Santarus
carry a Zacks Rank #1 (Strong Buy), Cubist Pharma carries a Zacks
Rank #2 (Buy).