The FDA’s request for more information on Afrezza, the inhaled insulin made by MannKind Corp., knocked the wind out of the Valencia company’s stock price last week.
In the two days after the March 15 announcement that the Food and Drug Administration delayed a decision on approval, MannKind shares lost 29 percent of their value. Afrezza would be the pharmaceutical company’s first commercial drug to reach market and any uncertainty over the product’s promise isn’t good for investors.
The agency didn’t reject the company’s request for permission to market Afrezza outright, but asked for more information, including safety data. There was a bright spot in the approval process: The agency did not call for more testing.
The latest delay comes after a series of other setbacks for the diabetes treatment, including MannKind’s announcement in October that it couldn’t secure a major partner to market the drug – due to fears of more testing – that have made investors nervous. Meanwhile, large drugmakers such as Eli Lilly, Novo Nordisk and Pfizer have opted out of the inhaled insulin market, which raises the stakes: Either inhaled insulin lacks sales potential or MannKind locks it all up.
Matthew Pfeffer, chief financial officer at MannKind, told the Business Journal that the company will send the FDA additional information in the next few weeks. The company also will modify its original application to include a new inhaler, a whistle-size device that delivers the medication. He expects a final answer from the agency in about six months.
“That puts us pretty much on the same time line as we originally planned,” he said. “At the end of the day, it may not cause a material delay in the launch, but of course there’s some uncertainty there.”
The company plans to launch the drug, which it claims will be more effective than injected insulin treatment, in 2011.
But analyst Thomas Russo at Milwaukee-based Robert W. Baird & Co., believes the company is downplaying the uncertainty of getting FDA approval. He also noted that adding the new device into the approval process was a gamble.
“We view management’s current risk tolerance and potential swing-for-the-fences as an important consideration for investors,” Russo wrote in a March 16 report.
Russo maintained his “underperform” rating on MannKind stock with a target price of $5 a share.
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