MannKind’s Inhaled Insulin Fails to Win U.S. Approval

(Corrects reference to inhaled insulin in third paragraph.)

MannKind Corp., the biotechnology company founded by billionaire inventor Alfred Mann, failed to win approval from U.S. regulators to market its first product, an inhaled insulin called Afrezza, for diabetes.

The Food and Drug Administration asked for two new studies of the device in patients with Type 1 and Type 2 diabetes, Valencia, California-based MannKind said today in a statement.

MannKind said it has already started the new studies and will meet with the FDA soon to make sure they satisfy the agency’s requirements. MannKind, an unprofitable biotechnology company, is trying to a product that would be the only inhaled insulin device to treat the 170 million people worldwide with diabetes.

“We are disappointed” with the FDA’s decision, Mann said in the statement. Still, he said, “we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program. We remain committed to working with the FDA to make Afrezza available to people with diabetes.”

MannKind fell 7.3 percent to $9.11 before a trading halt at 11:57 a.m. New York time on the Nasdaq Stock Market. Before today, the shares had surged 22 percent in 2011.

Photographer: Jamie Rector/Bloomberg

Alfred E. Mann, chief executive officer of MannKind Corp. Close

Alfred E. Mann, chief executive officer of MannKind Corp.

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Photographer: Jamie Rector/Bloomberg

Alfred E. Mann, chief executive officer of MannKind Corp.

The FDA last month delayed a decision on MannKind’s device that was set for Dec. 29. Afrezza also failed to win FDA approval March 15 when the agency asked for updated safety data.

Type 1 diabetes is an inherited disorder which occurs when people don’t have sufficient amounts of the hormone insulin, or are resistant to it, limiting their ability to convert blood sugar into energy. Type 2 diabetes typically occurs later in life, often resulting from obesity and a sedentary lifestyle.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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