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MannKind Announces Positive Clinical Data For AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints

MannKind Corporation (Nasdaq:MNKD) today announced that it will hold a conference call at 4:00 pm (EDT) today to discuss preliminary results from Study 171 and Study 175, two Phase 3 clinical studies of AFREZZA ® (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy administered using MannKind’s next-generation (Gen2) inhaler (also known as the Dreamboat™ inhaler).

Highlights of Study 171

In patients with type 1 diabetes, AFREZZA, compared to insulin aspart, showed:

  • Non-inferior decreases in A1c levels;
  • Significantly less hypoglycemia;
  • Significant decreases in fasting blood glucose levels; and
  • Significant weight advantage.

In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind’s first-generation (MedTone) inhaler.

Highlights of Study 175

In patients with type 2 diabetes treated with oral therapy, AFREZZA, compared to oral therapy alone, showed:

  • Superior reductions in A1c levels;
  • Significantly more patients reached A1c target levels;
  • Reduced postprandial glucose excursions; and
  • No significant difference in the incidence of severe hypoglycemia.

These preliminary results are subject to further analysis. More detailed preliminary results are included in separate releases that accompany this announcement.

“We are pleased that both Phase 3 studies met their primary efficacy endpoints and that Study 171 also achieved its other main objective of demonstrating comparability between the Gen2 and MedTone inhalers,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “The positive results of Study 171 and Study 175 will form the basis of an amendment to our new drug application for AFREZZA, which we expect to submit to the Food and Drug Administration early in the fourth quarter of this year.”

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