Regulators are requesting two more studies to test the device's effectiveness in patients with type 1 and type 2 diabetes. MannKind says it will comply with the FDA's request. Afrezza's approval was previously denied in March pending additional safety data, and a decision delay was announced in December.
Other companies have tried and failed to get inhaled insulin products to market. If MannKind prevails, the company will make history -- and the resulting spike in its stock prices could make some investors very happy.
Surge Desk has the scoop on Alfred E. Mann, the billionaire entrepreneur behind MannKind and its breakthrough product.
1. He has a rags-to-riches story
With a net worth of $1.4 billion, Mann is the 721st richest man in the world, according to Forbes. Not bad for a guy who grew up selling magazines and lemonade in his hometown of Portland, Ore.
2. His companies are on the cutting edge
After earning degrees in physics, Mann founded Spectrolab, a company that provided optical filters for satellites and space equipment. He went on to establish a semiconductor company and then moved into the biotechnology industry, founding companies dedicated to insulin pumps, pacemakers and neuroprosthetics. Scientists at his company Pacesetter Systems invented the implantable insulin pump and created the first commercial rechargeable implantable pacemaker.
3. There are biomedical business incubators named for him
In 1998 the nonprofit Alfred E. Mann Institute for Biomedical Engineering was established at the University of Southern California. Its mission is to "bridge the gap between biomedical invention and the creation of commercially successful medical products that improve and save lives." Mann later established similar institutes at Purdue University and the Israel Institute of Technology.
4. Stars support his medical research foundation
Mann created the Alfred Mann Foundation in 1985 with a mandate "to develop medical technologies that might not be economically feasible for a for-profit corporation." Now it's a favorite cause of Hollywood luminaries.
Watch Debbie Allen, Bai Ling and Mann at the 2008 AMF Gala.
5. His company has struggled while Afreeza awaits FDA approval
Last year rumors swirled that MannKind had filed for bankruptcy. It hadn't, but the MannKind cash flow doesn't paint a pretty picture. Mann has made a line of credit available to the company, and in August MannKind sold 36.4 million shares in an effort to raise cash and pay down debt.
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