Post by otherottawaguy on Mar 31, 2014 7:36:18 GMT -5
March 31, 2014
MannKind Corp. BUY
Company Update : Pharmaceuticals
Keith A. Markey, Ph.D., M.B.A.
FDA Issues a Balanced View of Afrezza
The FDA appears to have adopted a neutral assessment
of MannKind’s clinical trial data as revealed in the briefing
documents posted to the FDA website for the Endocrine and
Metabolic Drugs Advisory Committee on Friday.
The FDA concludes that Afrezza met the primary endpoint
for type 1 diabetes. Specifically, the drug was non-inferior to the
comparator, insulin aspart, after 24 weeks. In addition, the patients
who took Afrezza had a modest loss of weight (considered
a favorable outcome), while those on insulin aspart gained
weight. Also, the Afrezza group encountered fewer episodes of
hypoglycemia, despite taking a higher dose of insulin than the
comparator arm.
Statistical analyses point to less robust results with type 1
diabetics. While Afrezza was non-inferior compared with insulin
aspart, the change in HbA1c levels from baseline was inferior with
MannKind’s drug. This may have been due to a higher dropout
rate in the Afrezza arm than in the comparator arm (25% versus
11%), as supported by several statistical analyses, but not all.
Afrezza also met the primary endpoint for type 2 diabetes
by improving glycemic control when added to an oral drug
regimen that was not providing adequate control. The reduction in
HbA1c was considered modest, at -0.4%, but significant, and that
result may have been greater, if not for dropouts in the Afrezza
and placebo groups (21% and 30%, respectively). Indeed, all
sensitivity analyses supported the primary superiority outcome.
Weight gain and hypoglycemia were associated with Afrezza
in the type 2 study. But the weight gain was not huge (0.5 kg in
the 24 week study), and hypoglycemia was not unexpected as it
is a known side effect of insulin.
The Afrezza label will likely impose limitations. We note the
pulmonary division of the FDA recommended that Afrezza should
not be used by patients who smoke or have asthma or a chronic
lung disease. Also, a simple spirometry test is advised at baseline,
6 months, and then annually to monitor lung function.
Afrezza's unique pharmacokinetic profile may win the day.
The advisory committee may decide diabetics should have access
to a drug that more closely mimics the normal function of the
pancreas and is easier to take than today's therapies.
We are maintaining our BUY recommendation and price
target, though we recognize that the advisory committee vote and
FDA decision comprise a binary event that many investors may
prefer to avoid.
MannKind Corp. BUY
Company Update : Pharmaceuticals
Keith A. Markey, Ph.D., M.B.A.
FDA Issues a Balanced View of Afrezza
The FDA appears to have adopted a neutral assessment
of MannKind’s clinical trial data as revealed in the briefing
documents posted to the FDA website for the Endocrine and
Metabolic Drugs Advisory Committee on Friday.
The FDA concludes that Afrezza met the primary endpoint
for type 1 diabetes. Specifically, the drug was non-inferior to the
comparator, insulin aspart, after 24 weeks. In addition, the patients
who took Afrezza had a modest loss of weight (considered
a favorable outcome), while those on insulin aspart gained
weight. Also, the Afrezza group encountered fewer episodes of
hypoglycemia, despite taking a higher dose of insulin than the
comparator arm.
Statistical analyses point to less robust results with type 1
diabetics. While Afrezza was non-inferior compared with insulin
aspart, the change in HbA1c levels from baseline was inferior with
MannKind’s drug. This may have been due to a higher dropout
rate in the Afrezza arm than in the comparator arm (25% versus
11%), as supported by several statistical analyses, but not all.
Afrezza also met the primary endpoint for type 2 diabetes
by improving glycemic control when added to an oral drug
regimen that was not providing adequate control. The reduction in
HbA1c was considered modest, at -0.4%, but significant, and that
result may have been greater, if not for dropouts in the Afrezza
and placebo groups (21% and 30%, respectively). Indeed, all
sensitivity analyses supported the primary superiority outcome.
Weight gain and hypoglycemia were associated with Afrezza
in the type 2 study. But the weight gain was not huge (0.5 kg in
the 24 week study), and hypoglycemia was not unexpected as it
is a known side effect of insulin.
The Afrezza label will likely impose limitations. We note the
pulmonary division of the FDA recommended that Afrezza should
not be used by patients who smoke or have asthma or a chronic
lung disease. Also, a simple spirometry test is advised at baseline,
6 months, and then annually to monitor lung function.
Afrezza's unique pharmacokinetic profile may win the day.
The advisory committee may decide diabetics should have access
to a drug that more closely mimics the normal function of the
pancreas and is easier to take than today's therapies.
We are maintaining our BUY recommendation and price
target, though we recognize that the advisory committee vote and
FDA decision comprise a binary event that many investors may
prefer to avoid.
