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MannKind says FDA wants two new clinical trials of its insulin inhaler

The latest delay in the approval of Afrezza sends the biotech firm's shares tumbling.

January 19, 2011|By Nathan Olivarez-Giles, Los Angeles Times

MannKind Corp. divulged that the Food and Drug Administration has asked for more testing of its key, long-delayed product — an insulin inhaler for people with diabetes.

The Valencia biotech firm said in a statement that Afrezza will require two new clinical trials before U.S. regulators again consider approving the device.

Trading of MannKind shares was halted on the Nasdaq exchange before the announcement Wednesday morning. But in after-hours trading, the stock fell more than 40% to $5.25.

According to the company, the FDA has also requested more information regarding Afrezza's usage, handling, shipment, storage, labeling and packaging.

The FDA action will delay possible approval for about a year and a half, said Simos Simeonidis, a biotech analyst with Rodman & Renshaw in New York.

The setback isn't the first for MannKind — the FDA twice declined to approve Afrezza in 2010. Simeonidis said the company can survive this latest delay, even though Afrezza is its most prominent prospect.

"Financing isn't a problem. They have cash. The company isn't going to go away," he said. "And the data has been strong for efficacy and safety for Afrezza. But this approval is extremely important. It's 90% of the company. They have some cancer vaccines, but they're in earlier stages, and this has to be approved for them to be profitable."

Alfred Mann, a billionaire inventor who founded MannKind, said he was disappointed by the FDA's action but remained optimistic about Afrezza's long-term prospects.

"We are encouraged that the FDA is asking for clinical studies," said Mann, 87, in the statement released by the company. "We remain committed to working with the FDA to make Afrezza available to people with diabetes."

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