(Bloomberg) -- 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, Valencia, California-based MannKind said today in a statement. While the regulators didn’t cite any safety concerns, they did request updated safety data, the company said.
More than 20 million Americans have diabetes, which occurs when a patient doesn’t have enough of the hormone insulin used to convert blood sugar to energy. Many of these patients take insulin and the company is betting that an inhalable product will have greater appeal to diabetic patients than injections.
“We think the issues raised by the letter are completely addressable,” said Matthew Pfeffer, chief financial officer, in a telephone call after the equity markets opened in New York.
Mannkind shares fell 90 cents, or 8.6 percent to $9.58 at 10:06 a.m. New York time in Nasdaq composite trading. Trading was initially halted on the stock, as the shares tumbled as much as 37 percent. That was the biggest percentage decline since April 9, 2008, after Eli Lilly & Co. dropped development of an inhaled insulin product.
Medtone Inhaler
The FDA raised issues about whether the inhaler used by Mannkind was comparable to the Medtone inhaler, Pfeffer said. Mannkind had planned to submit a new drug application for a “next-generation” inhaler in the second quarter, he said.
The FDA raised issues about whether the inhaler used by Mannkind was comparable to the 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,” the CFO said. He said both the timetable for the FDA to respond to the new information the company would submit or to a new application would 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, due to 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’s Pfeffer said the company is in ongoing discussions with pharmaceutical companies that could partner with the company to market the drug.
Analysts are split on the company’s prospects. Four of 10 analysts who cover MannKind recommend selling its shares and five urge buying, according to data compiled by Bloomberg. The one-year target price for the shares ranges from $1 to $26.
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