On November 2, 2017 Mannkind (MNKD) announced that the FDA has approved an update to its inhaled insulin product Afrezza prescribing information to include new clinical data that were presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. Afrezza (human insulin) inhaled powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. Since the announcement, the firm’s stock price more than doubled from $2.34 on Nov. 2 to $4.91 on Nov. 5, i.e., today.
The FDA decision came as a surprise, but the doubling of the stock was not of any surprise because Afreeza is the only inhaled rapid-acting mealtime insulin available in the United States. It is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute.
The label update:
– Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
– Clarity on “Starting” and “Adjusting” mealtime dose.
– Updated pregnancy and lactation section to conform to current FDA label guidance.
In conjunction with the approved labeling revision, MannKind received a letter of Fulfillment of Post-Marketing Requirements for PMR 2166-2 and PMR 2166-3, satisfying two of the four post- marketing requirements for Afrezza as described in the 2014 FDA approval letter.
Afrezza® (insulin human) inhalation powder is prescription rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza was studied in over 60 different clinical trials evaluating >3,000 people living with type 1 and type 2 diabetes. The product is covered by many national and regional insurance plans and MannKind offers a savings card that reduces the copay for most commercially insured patients to as little as $15.
Afrezza is the only inhaled rapid-acting insulin available today. The inhaled route of delivery is a unique feature that can spare patients from multiple daily mealtime injections, but the true benefit of Afrezza is defined by its rapid time-to-measurable-effect, time-to-peak, and return-to- baseline, all of which allow patients the ability to experience the management of their disease in a different way.
Satish Garg, MD, MBBS, DM Barbara Davis Center for Diabetes (BDC), University of Colorado explains: “These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels.”
Having the only fast-acting inhaled insulin, and in light of the FDA approval of an update to Mannkind inhaled insulin product Afrezza prescribing information. And the fact that the update includes new clinical data that were Mannkind presented presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016, we believe that Mannkind stock price will continue to rally until it reflects a fair value of Mannkind’s worth.
Mannkind market cap is now around $519 million a value that cannot be fair for Mannkind now after the FDA’s new update of Afrezza prescribing information as described. We believe that a fair market cap. for Mannkind would be $1.5 billion, i.e., around 2,5 times its current market cap.
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