With the zeal of a young entrepreneur, 82-year-old Los Angeles billionaire and philanthropist Alfred Mann has bet nearly half of his estimated $2.2-billion fortune that he can develop an inhaled version of insulin for the nation's 5 million diabetics.
But Mann's gamble is looking increasingly like a long shot, analysts and doctors say, and his huge personal investment may be in jeopardy.
The latest blow came Wednesday when Valencia-based MannKind Corp.'s stock lost almost 60% of its value after pharmaceutical giant Pfizer Inc. said a study showed that its failed version of inhaled insulin might increase the risk of lung cancer.
After dropping much of this year, MannKind shares lost an additional $3.50 on Wednesday, closing at $2.35.
Mann remains undeterred. In an interview, the chief executive was upbeat about his company's drug Technosphere, which combines a concentrated insulin powder with an inhalation device the size of a deck of playing cards. It is superior to rivals' efforts and will be a blockbuster when it arrives on the market as early as 2010, he said.
"By no means am I unsure of the scientific and clinical benefits of Technosphere. I have no reason to believe there is any safety issue with our drug," Mann said. "I admit the business environment has a lot of negativity around the sector right now, but that's just something we are going to have to reverse."
Drug companies have long sought new and lucrative ways to deliver insulin to patients but have hit roadblocks at every turn. The drugs have proved hard to develop, and research has shown that inhaled insulin causes slight declines in lung capacity.
Much is at stake. Insulin is a hormone that has traditionally been taken as a shot to help diabetics control their blood sugar. A significant number of diabetics inject themselves too infrequently, partly because the needle sticks are bothersome, research shows.
Despite questions about whether inhaled insulin caused lung problems after prolonged use, the Food and Drug Administration approved Pfizer's version of inhalable insulin in early 2006.
But in one of the biggest flops in modern pharmaceutical history, Pfizer pulled the drug, Exubera, late last year because of poor sales and took a nearly $3-billion charge.
MannKind has resisted comparisons and fought its own struggles.
Some skeptics have asked whether Mann, a former aerospace entrepreneur who made a fortune setting up and selling medical companies, is too blindly backing an idea whose day may never come.