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MannKind Reports Successful Completion of Device Bioequivalence Trial
Date:1/13/2009

VALENCIA, Calif., Jan. 13 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today announced successful completion of its trial to demonstrate equivalence of its commercial inhaler to the version of the device that was used in clinical trials to deliver AFRESA(TM), MannKind's ultra rapid acting insulin that recently completed Phase 3 clinical trials.

Study 138 - Bioequivalence of Clinical and Commercial Scale Inhalers

Study 138 compared the bioequivalence of MannKind's inhalation device, which underwent some design changes after the initiation of Phase 3 clinical trials in order to make the device more rugged and less costly to manufacture. Clinical trial subjects were administered AFRESA Inhalation Powder from the same bulk lot, according to a randomized two-way crossover protocol, consistent with the standard requirements of bioequivalence testing. As previously announced, this study was requested by FDA at AFRESA's pre-NDA meeting held in July 2008.

Dr. Peter Richardson, MannKind's Chief Scientific Officer, commented, "We were confident from bench testing that the improvements we made with the device had preserved all critical air-flow parameters, but we recognized at our pre-NDA meeting the FDA's desire to validate this fact with in-vivo data. We collaborated with the agency in the design of the study and now have an extensive body of in vitro and in vivo evidence to demonstrate equivalence of the two device versions against a range of measures. Together with the recent announcement that we met the primary end-points of our pivotal Phase 3 program, we now have a clear path to submission of the AFRESA NDA. With study 138 complete, there are no longer any outstanding elements of the NDA and we expect to have the complete NDA submitted to FDA within the next few weeks."'/>"/>

SOURCE MannKind Corporation
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