Mannkind Corp. (MM) (NASDAQ:MNKD)
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5 Years : From Apr 2012 to Apr 2017
MannKind Corp.'s (MNKD) chief executive said Tuesday the company still expects to launch its inhalable insulin product in 2011, despite Monday's decision by U.S. regulators not to approve the product at this time.
The U.S. Food and Drug Administration sent MannKind a so-called "complete response letter" Friday asking for more information about Alfrezza, which MannKind hopes will become an alternative for diabetics who don't like injecting insulin. The news sent MannKind shares tumbling nearly 25% Monday, on fears that the FDA might never approve the product.
But CEO Alfred Mann tried to reassure Wall Street in a conference call Tuesday morning, saying the agency asked for more information about how currently available data support the clinical utility of Afrezza in the marketplace.
"We interpret this request as a desire to understand the positioning of Afrezza within the range of available therapies, and a desire to know how, and in whom, and when in the course of therapy it should be used," Mann said.
MannKind shares rose 52 cents, or 6.6%, to $8.41 soon after the opening bell Tuesday.
Mann said the company would discuss with the agency the "extensive efficacy data" that has already been submitted, as well as further analysis.
Also, the FDA asked for information about the comparability of the commercial version of the MedTone inhaler device to the earlier version of this device that was used in clinical trials. Mann said the company plans to launch Afrezza with an even newer device, known as Dreamboat, and will seek FDA approval of that, which the company hopes will forestall significant delays.
"At this point, we have no reason to believe that our plans to launch in 2011 are adversely impacted by issues raised in the...letter," Mann said.
The FDA letter cited no safety concerns but requested updated safety data for the drug. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons.
Mann said the letter didn't require any additional pre-marketing clinical studies to be conducted for the FDA to complete its review of the application. MannKind will request a meeting with the agency to discuss its approach for resolving the remaining issues.
However, in cautionary language in MannKind's annual report filed Monday with the Securities and Exchange Commission, the company said the FDA could request that the company conduct additional clinical trials to provide sufficient data for approval.
Mann said the receipt of the FDA letter could clear the way for negotiations with other companies to potentially market the product.
The company is funded into early 2011 with "available financial resources," Mann said. An executive said this reflected existing cash and lines of credit.
-Peter Loftus; Dow Jones Newswires; 215-656-8289; email@example.com