August 15, 2013
Trials Show MannKind’s Inhaled Insulin More Effective Than Injected, Oral Treatments
redOrbit Staff & Wire Reports - Your Universe Online
The product, known as Afrezza, consists of a fast-acting insulin powder delivered via MannKind’s lightweight inhaler.
Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals.
Given its ease of use compared with conventional insulin shots, Afrezza has the potential to improve the quality of life for millions, and secure a significant share of the multi-billion dollar global insulin market.
According to Reuters reporter Esha Dey, preliminary results from MannKind’s two clinical studies included a reduction in fasting blood glucose levels and lower incidences of hypoglycemia – an insulin side-effect that leads to dangerously low blood sugar levels. MannKind said it expects to submit final data from the trials to the Food and Drug Administration (FDA) later this year.
The FDA had rejected Afrezza in early 2011, asking the Valencia, Calif.-based drug maker to conduct two clinical trials to prove the second-generation of the device was equivalent to its first-generation inhaler. MannKind had initially filed for approval based on data from its first-generation inhaler, before updating the application to the newer device.
The first trial, dubbed Study 171, compared Afrezza with Novo Nordisk's injected insulin NovoLog, and showed the second-generation device was comparable to the first-generation inhaler. The second trial, dubbed Study 175, showed Afrezza was better in reducing patients' A1C levels - a measure of blood glucose control - compared with oral therapy.
Afrezza is the flagship product for MannKind, whose stock price has risen nearly 50 percent over the past few months in anticipation of positive data from the two clinical trials. The company has another experimental diabetes therapy, known as MKC253, in development, along with two potential cancer treatments.
The inhaled insulin market has seen commercial failure in recent years. Pfizer withdrew its Exubera treatment in 2007 due to poor sales, primarily attributed to the large size of the device and its high price tag.
Shares of MannKind’s stock rose 27 percent on Wednesday morning following news of the clinical trials, before closing at $7.59, up 10.6 percent for the day.