MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type ...( Pivotal efficacy and safety studies m...),Health

Pivotal efficacy and safety studies meet primary endpoints

VALENCIA, Calif., Dec. 4/PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today announced that it has met the primary endpoints of its final two pivotal Phase 3 studies of AFRESATM, the company's ultra rapid acting, inhaled insulin product. The company expects to disclose more details of the top-line data from these studies in patients with type 1 and type 2 diabetes (studies 030 and 102) by mid-December.

"We are very pleased to announce the positive outcome of these, the last of our three pivotal Phase 3 studies. We look forward to presenting more complete data, including analyses of secondary endpoints, as soon as they are available, which are expected before the end of this year. AFRESA promises to be an important additional option for the treatment of patients with diabetes. Our next step is to finalize a new drug application for AFRESA, which we expect to submit to the FDA in early 2009," commented Dr. Peter Richardson, MannKind's chief scientific officer.

About Study 030

Study 030 compared the pulmonary safety of meal-time inhalation of AFRESA versus usual care in over 2000 patients with type 1 and type 2 diabetes. The study met its primary endpoint: after two years of treatment, no adverse effects were observed on patients' lungs in the AFRESA-treated group.

About Study 102

Study 102 compared the efficacy of meal-time AFRESA in combination with a long-acting basal insulin versus twice daily injections of pre-mixed insulin (a mixture of a rapid-acting insulin analog and intermediate-acting insulin). Study 102 met its primary endpoint, showing comparable improvements in HbA1c levels over 52 weeks between the two treatment groups.