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MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes
Date:9/16/2008

compared to the average gain of 1.4 kg (3.0 pounds) observed in the comparator group. This difference between groups was statistically significant (p=0.02).

At different times during the study (weeks 4, 26 and 52), postprandial blood glucose levels were measured over a six-hour period following the ingestion of a standardized meal. One hour after meal ingestion, patients in the TI group exhibited significantly (p<0.01) lower mean blood glucose levels (167.8 mg/dL; 167.9 mg/dL; and 165.7 mg/dL, respectively for each meal challenge) compared to the mean levels exhibited by the comparator group (210.9 mg/dL; 210.8 mg/dL; and 201.0 mg/dL, respectively). A full analysis of the meal challenge data has not yet been completed.

Fewer patients in the TI group experienced one or more hypoglycemic events (95.2%) compared to the proportion affected in the comparator group (98.9%). This difference in overall hypoglycemia in favor of Technosphere Insulin was statistically significant (odds ratio = 0.222; p<0.02).

Over the entire 52-week treatment period, Technosphere Insulin was generally well tolerated. No pulmonary neoplasms were reported. Consistent with the results from earlier studies of a shorter duration, after 52 weeks of treatment, there were no between-group differences in pulmonary function measures, including FEV1 (forced expiratory volume in one second), FVC (forced vital capacity), DLCO (carbon monoxide diffusing capacity) and TLC (total lung capacity). All safety data will be further analyzed along with data from the recently completed two-year pulmonary safety study.

About Technosphere Insulin

The pharmacokinetic profile of Technosphere(R) Insulin sets it apart from all other insulin products. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive Technosphere particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstre
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SOURCE MannKind Corporation
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