MannKind's Afrezza meets late-stage trial goals

AP News
Posted: Aug 14, 2013 8:14 AM

MannKind Corp. said Wednesday its inhaled insulin Afrezza met the main goals behind two late-stage studies, as the drug developer prepares for another push to get regulatory approval for its diabetes treatment.

Shares of the Valencia, Calif., company soared before markets opened and after the company made its announcement.

MannKind said preliminary results from the studies show that type 2 diabetes patients taking Afrezza and the widely used generic drug metformin saw better reductions in long-term blood sugar levels, called A1c levels, than those taking an oral medication.

Afrezza also produced reductions in blood sugar levels comparable to an insulin treatment in patients with type 1 diabetes.

MannKind Corp. has no drugs on the market and has been trying to win approval for Afrezza for years. Earlier this month, it said it lost $46.1 million in the second quarter.

The Food and Drug Administration told MannKind in early 2011 to run more clinical studies on the treatment.

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly and Co. ended its development program, citing regulatory uncertainty.

Afrezza is a fast-acting insulin powder delivered through an inhaler named Dreamboat. It comes in single-use cartridges and aims to deliver insulin quickly to the bloodstream by dissolving immediately upon inhalation.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can cause early death or serious complications like blindness, a stroke, kidney disease or heart disease when blood sugar climbs too high and damages organs and blood vessels.

Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly.

Demand for drugs that treat diabetes is climbing as rising instances of obesity are causing an explosion of diabetes cases globally.

MannKind shares climbed about 17 percent, or $1.15, to $8.01 Wednesday in premarket trading. The shares have ranged between $1.82 and $8.33 over the past year.