UPDATE 2-FDA to review MannKind's inhaled insulin in six months

Tue Jul 20, 2010 11:44am EDT

* 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 (Reuters) - 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 months.

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 (NOVOb.CO) NovoLog.

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)