MannKind Corporation, focused on discovering, developing and commercializing treatments for diabetes and cancer, has initiated patient enrolment in its pivotal phase 3 safety trial of inhaled Technosphere Insulin (TI) in the United States.

The open-label, randomized, prospective study will evaluate the pulmonary safety of TI in patients with type 1 and type 2 diabetes. This is the second phase 3 clinical trial of inhaled Technosphere Insulin following the commencement of MannKind's initial phase 3 efficacy study in Europe in late 2004.

"Our pharmacokinetic studies have shown that Technosphere Insulin is rapidly absorbed into the bloodstream, mimicking the first phase insulin release that has been lost in all patients with diabetes. This approximation of the first phase release significantly improves glucose control without increasing the risk of hypoglycemia. Earlier this month MannKind presented data at the American Diabetes Association Scientific Sessions from a recently completed phase 2b study, showing significant reductions in HbA1c levels over a three-month period with no increase in the risk of hypoglycemia. We hope to obtain further confirmation of these findings in our phase 3 studies, moving this important new treatment for diabetes closer to commercialization," said Hakan Edstrom, president of MannKind Corporation.

In addition to the initiation of the pivotal phase 3 safety trial, the Company is in the process of scaling up its manufacturing facilities in anticipation of regulatory filings and commercialization. With the current clinical package, the Company's data demonstrates that Technosphere Insulin is stable for at least 18 months under refrigerated conditions and for at least two months at room temperature, which is equivalent to or surpasses commercially available insulin products.

The MannKind inhaled insulin delivery system consists of a proprietary dry powder Technosphere formulation of insulin that is inhaled into the deep lung using MannKind Corporation's proprietary MedTone inhaler, which utilizes single-use, disposable, plastic cartridges containing Technosphere Insulin powder.