Dallas, Texas 08/19/2013 (Financialstrend) – The MannKind Corporation (NASDAQ:MNKD) announced that in agreement to the facility contract dated july1, 2013 between the Deerfield Private Design Fund II. L.P and Mannkind, the terms or the conditions, which obligate Deerfield to purchase the second tranche worth $40 million of 9.75% senior secured Convertible Notes, have now been met.
The second tranche of Convertible Notes was a subject to the achievement of the 3rd phase from researches 171 and 175, which satisfied the primary efficiency endpoints of these studies and did not demonstrate any adverse security issues that would be anticipated to avert or prevent the approval of AFREZZA.
The Facility Agreement stated that Deerfield is obligated to buy as much as four equal tranches of Convertible Notes for total gross proceeds of $ 160 million. The closing of the second tranche will supposedly occur no later than 6th September, 2013.
Mannkind Proclaims Positive Clinical Data For Afrezza
The Mannkind Corporation held a conference call to discuss the preliminary results from study 171 and 175, two phase 3 clinical studies of AFREZZA. AFREZZA is related to INSULIN HUMAN rDNA ORIGIN. It is an investigational and ultra rapid acting mealtime insulin therapy which is administered using Mannkind’s next generation (GEN 2) inhaler also known as the Dreamboat inhaler.
Salient Features Of Clinical Study 171
Amongst patients affected by type 1 diabetes AFREZZA in contrast to insulin showed:
- Non-inferior decrease in A1c levels.
- Significantly less hypoglycaemia
- Significant weight advantage
- Essential decrease in fasting blood glucose levels
In addition, the transitions in the pulmonary function observed in the AFREZZA GEN-2 group were not at all distinct to those observed in an AFREZZA treatment group that utilised Mannkind’s first generation (MedTone) inhaler.
Highlights Of Study 175
Amongst the patients affected by type 2 diabetes which is treated by oral therapy, AFREZZA in comparison to oral therapy showed:
In patients with type 2 diabetes treated with oral therapy, AFREZZA, compared to oral therapy alone, showed:
- Paramount reductions in A1c levels
- Significantly more patients reaching the A1c target levels
- No substantial difference in the case of severe hypoglycaemia
- Reduced postprandial glucose excursions
These primary results are subject to further analysis.