March 8, 2006

MannKind has initiated patient enrollment in two pivotal 12-month Phase III clinical trials of its technosphere insulin in patients with Type 1 and Type 2 diabetes. The main objective of these studies is to evaluate the efficacy of technosphere insulin (TI) by assessing changes both in HbA1c levels as well as in blood glucose levels after a standardized meal.

The first of these new trials is a 12-month Phase III efficacy study in 500 Type 1 patients. In this study, TI will be compared to subcutaneous injections of a rapid-acting insulin analog. Patients in both arms of this study will also receive a basal insulin regimen.

The second of these trials was the subject of a special protocol assessment by the FDA in 2005. This trial will compare TI plus basal insulin to subcutaneous injections of premixed insulin (including a rapid-acting insulin analog) over a 12-month period in 500 Type 2 diabetes patients.