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MannKind readies for FDA approval

Posted: April 1, 2014 6:10 p.m.
Updated: April 1, 2014 6:10 p.m.

Matthew Pfeffer of MannKind Corporation displays the Afrezza inhaler in the company's Valencia office.

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In a matter of days, MannKind Corporation of Santa Clarita will learn the Food and Drug Administration’s decision regarding Afrezza - it’s one of a kind diabetes treatment.

If approved, the biopharmaceutical company’s revolutionary product is the first to deliver a rapid-acting, inhaled insulin powder for adults with Type 1 and Type 2 diabetes that goes right into the bloodstream within minutes.

The target date for the FDA to complete its review is April 15.

If MannKind gets the all clear signal from the FDA, Afrezza will immediately go into commercial production, said its Chief Financial Officer, Matthew Pfeffer.

The FDA will require that the company produce a couple qualification lots first to ensure the process is capable of delivering quality product on a full scale commercial basis.

But MannKind will ramp up production at its Danbury, CT facility to build up a good supply of the Afrezza, Pfeffer said.

“We want to build up a good supply of product in advance of the launch,” he said. “We don’t want to run out.”

The company has already tripled its manufacturing capacity, Pfeffer said.

While a FDA decision is expected by April 15, that date is not a given. The FDA could ask for more time, but as of March 24 Pfeffer says MannKind has “not been notified yet of any delay.”

A lot is riding on a green light from the FDA. If Afrezza’s inhalation device is approved, the technology lends itself to other projects that MannKind has in the pipeline.

“One is a pain product,” Peffer said. “It’s in a very early stage, but it lends itself to our technology to get something into the bloodstream very, very quickly to provide fast pain relief.”

But, more importantly, FDA approval would give the company the cash and chance to go after other applications.

In other words, the method of delivering medications directly into the bloodstream through an inhalation device could take off.

“This is the obvious direction, the one we have the most experience in,” Pfeffer said.

If approved, the next step is for MannKind to partner with a large worldwide pharmaceutical company that already has marketing and distribution infrastructure in place.

MannKind is confident in its product or it wouldn’t have made the application for the FDA review otherwise, he said.

MannKind’s stock began climbing a year ago, and as of publication date the company’s stock was were trading just below $6 a share.


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