(Updates with safety review, share price)
By Toni Clarke
WASHINGTON, March 28 An initial review of
MannKind Corp's experimental inhaled insulin device by
U.S. Food and Drug Administration staff raised questions about
its safety and effectiveness but was less damning than some
investors had expected, sending the company's shares up as much
as 10.6 percent.
The reviewers issued their report before an April 1 meeting
of outside advisers to the FDA, who will discuss clinical trial
data and advise on whether the product, Afrezza, should be
Afrezza is a whistle-sized inhaler designed to deliver more
effective, rapid-acting insulin than injectable products offered
by Eli Lilly and Co and Denmark's Novo Nordisk
The FDA staff review raised questions about dosing, missing
data, bronchospasms, and Afrezza's effect on lung function.
In early 2011, the FDA rejected Afrezza and asked for two
more clinical trials, one in Type 1 diabetes and one in the more
common Type II form of the disease. The FDA wanted MannKind to
prove that a second-generation version of the device, known as
the Dreamboat, was equivalent to a first-generation inhaler
known as MedTone.
Inhaled insulin has a checkered history. In 2006, the FDA
approved Exubera, an inhaled insulin device made by Pfizer Inc
that had been expected to generate annual sales of $2
billion. But the inhaler was bulky and patients were put off by
the need for periodic lung function tests. Pfizer abandoned the
product after sales failed to take off.
Lilly and Novo Nordisk also dropped their inhaled insulin
products. Subsequently, clinical trials revealed a possible,
though unproven, link between Exubera and lung cancer.
The FDA's review of Afrezza found four cases of lung cancer
during the development program. In two of the cases the patients
had a prior history of heavy tobacco use. The other two did not,
but Dr. Lee Pai-Scherf, who is with the FDA's oncology products
division, examined the data and said "the available
characteristics are consistent with what would be expected in
Pai-Scherf added, however, that "the current available
evidence does not allow a meaningful analysis" regarding the
risk of lung cancer in patients exposed to Afrezza because of
small numbers and other confounding factors.
MannKind's shares rose 5 percent to $5.46 in morning trading
on Nasdaq. Earlier they rose as high as $5.75.
(Reporting by Toni Clarke; Editing by Doina Chiacu; and Peter