* FDA accepts resubmission; classifies as class 2 response
* FDA sets Dec 29 as review date
* Shares up as much as 12 pct
(Adds analyst comments, details; updates stock movement)
BANGALORE, July 20 MannKind Corp (MNKD.O) said
U.S. health regulators accepted the resubmission on its inhaled
insulin product and classified it as a class 2 response, which
typically means the treatment will be reviewed within six
The U.S. Food and Drug Administration has set Dec. 29 as
the review date for Afrezza -- a drug-device combination
insulin therapy being developed for the treatment of diabetes,
the company said in a statement.
In March, MannKind received a complete response letter from
the FDA requesting additional information on the new drug
application for Afrezza. [ID:nN15189840]
While an acceptance of the resubmission does not guarantee
an approval, investors and analysts cheered the
earlier-than-expected submission, which shows that MannKind was
able to address the issues efficiently.
MannKind submitted clinical data from a recently completed
efficacy study in patients with type 1 diabetes as well as
updated pooled safety data related to Afrezza, in response to
the complete response letter.
It also submitted information on the comparability of its
delivery system to the device that was used in the clinical
studies, as requested by the FDA.
"The favorable regulatory developments and prelaunch
preparations put Afrezza's commercialization on schedule for
the first half of 2011," Griffin Securities analyst Keith
Markey said in a note.
"Only a global partner and a possible financing are needed
to complete the picture," Markey, who maintained his "buy"
rating and $26 price target on the stock, added.
In February, MannKind had said it opened partnership talks
with a few new parties on Afrezza. [ID:nSGE6102MW] Tuesday's
news can reduce the risk for potential partners.
"We expect that the company will re-engage in partnership
discussions and we continue to believe that it will be
successful in finding a partner for Afrezza," Rodman and
Renshaw analyst Simos Simeonidis said.
He reiterated his "market outperform" rating and $18 price
target on the stock.
Afrezza, previously known as Afresa, is designed to deliver
a more effective rapid-acting insulin than injectable products
such as Eli Lilly & Co's (LLY.N) Humalog and Novo Nordisk's
Exubera, another inhaled insulin developed by Pfizer Inc
(PFE.N) and approved in 2006, had failed to see commercial
success and was abandoned after it generated sales of just $12
million in the first nine months of 2007.
Insulin, a hormone produced by the pancreas, regulates the
body's glucose levels. Without proper levels of the hormone,
the body is unable to break down and use sugar. If untreated,
blood vessels and nerves can be destroyed, leading to organ
failure and death.
Shares of the company were up 9 percent at $6.77 in
late-morning trade Tuesday on Nasdaq. They reached a high of
$6.94 earlier in the day.
(Reporting by Esha Dey in Bangalore; Editing by Jarshad
Kakkrakandy and Maju Samuel)