MannKind fails to win approval for inhaled diabetes drug

MannKind Corp., the biotechnology company run by billionaire inventor Alfred Mann, failed to win approval from U.S. regulators to market its inhaled insulin drug, Afrezza, for people with diabetes.

The Food and Drug Administration asked for more information about the medication, the Valencia company said Monday. While regulators didn’t cite any safety concerns, they did request updated safety data, MannKind said.

More than 20 million Americans have diabetes, which occurs when someone doesn’t have enough of the hormone insulin used to convert blood sugar to energy.

Many of these people take insulin, and the company is betting that an inhalable product will have greater appeal to those with diabetes than injections.

“We think the issues raised by the letter are completely addressable,” said Matthew Pfeffer, chief financial officer.

The FDA raised issues about whether the inhaler used by MannKind was comparable to its Medtone inhaler, Pfeffer said.

MannKind had planned to submit a new drug application for a “next-generation” inhaler in the second quarter, he said.

“If we are allowed to incorporate this information on the inhaler in our response, we can stay on schedule for the commercial launch,” he said. He said the timetables for the FDA to respond to the new information the company would submit or to a new application would both be six months.

Mann formed MannKind from three other companies in 2001 and has lent the company almost $1 billion to finance clinical trials and make Afrezza the company’s first marketed product.

His efforts to gain approval and find a marketing partner for the drug have been complicated by the failure of other companies to develop viable inhaled insulin products.

New York-based Pfizer Inc., the world’s largest drug company, abandoned its inhaled insulin, Exubera, because of lackluster sales and later disclosed that some patients developed lung cancer in clinical trials.

Novo Nordisk of Bagsvaerd, Denmark, the world’s biggest insulin producer, dropped its effort in January 2008, saying its inhaled insulin didn’t offer significant advantages over new forms of injected insulin and had limited sales prospects. Eli Lilly & Co. of Indianapolis followed suit, abandoning its product two months later.

MannKind shares fell $2.59, or 25%, to $7.89.