UPDATE 3-MannKind Phase 3 inhaled insulin studies meet goal
(Adds analyst comment, updates stock)
CHICAGO Dec 4 (Reuters) - MannKind Corp (MNKD.O) said on Thursday that it had met the primary goal in its two final Phase 3 studies of Afresa, an ultra-rapid-acting, inhaled insulin product, sending the company's shares higher.
The success of the clinical trials comes after Pfizer Inc (PFE.N), Eli Lilly & Co (LLY.N) and Novo Nordisk A/S (NOVOb.CO) scrapped their plans for inhaled insulin earlier this year.
Valencia, California-based MannKind said it expected by mid-December to disclose more data from these studies in patients with type 1 and type 2 diabetes.
The next step is to finalize a New Drug Application for Afresa, which MannKind expects to submit to the U.S. Food and Drug Administration in early 2009.
"We assume 67 percent probability of regulatory approval and commercial success and would typically move to 85 percent upon (New Drug Application) filing," Robert W. Baird analyst Thomas Russo wrote in a research note. "Sensitivity analysis suggests this would correlate to $1 per share."
JPMorgan analyst Cory Kasimov said he remained cautious about the news.
"We are maintaining our more cautious (long-term) view given our general lack of confidence in the murky regulatory environment, and more importantly, our belief that investors will remain skeptical about the daunting commercial marketplace thanks to the Exubera experience," he wrote in a note.
Exubera, Pfizer's inhaled insulin product, was withdrawn from the U.S. market in 2007 due to weak demand.
MannKind shares were up 9 cents, or 3.1 percent, at $3 in midday Nasdaq trading as the broad market faltered. (Reporting by Debra Sherman; Editing by Lisa Von Ahn and Gerald E. McCormick)
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