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UPDATE 1-MannKind says FDA accepts inhaled-insulin NDA

Mon May 18, 2009 10:58pm IST
 
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* FDA accepts NDA for inhaled-insulin product

* Shares up as much as 24 pct to $7.24

May 18 (Reuters) - MannKind Corp (MNKD.O: Quote, Profile, Research) said the U.S. health regulators accepted the new drug application for its inhaled-insulin product, Afresa, sending its shares up as much as 24 percent.

The company is seeking approval of Afresa for use in adults with type 1 or type 2 diabetes mellitus for the treatment of hyperglycemia, or high blood sugar.

The U.S. Food and Drug Administration's acceptance of the Afresa application comes after several large drugmakers have exited the space due to weak demand and safety concerns.

Pfizer Inc (PFE.N: Quote, Profile, Research), which expected its inhaled insulin Exubera to be a $2 billion-a-year blockbuster, had to withdraw the product from the U.S. market in 2007 due to weak demand.

Exubera was also dogged by concerns about lung safety and the inconvenience of the bulky device used to administer it.

Other drugmakers like Eli Lilly & Co (LLY.N: Quote, Profile, Research) and Novo Nordisk A/S (NOVOb.CO: Quote, Profile, Research) scrapped their plans for inhaled insulin earlier last year.

MannKind shares were up more than 7 percent at $6.26 in afternoon trade Monday on Nasdaq. They earlier touched a high of $7.24.

For the alerts double-click [ID:nWNAB0989] . (Reporting by Anand Basu in Bangalore; Editing by Himani Sarkar)

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