The Fate of Mannkind

Let's get one thing straight right up front: We're not talking about inhaled insulin. Sure, it comes out of an inhaler; yes, you breathe it in; and of course it's absorbed deep in the lungs. But please don't use those two unfortunate words. Inhaled insulin was a misguided idea—an attempt to replace needles and injections with something ostensibly more convenient. When Pfizer actually put that product on the market (the ill-fated Exubera in its giant bong of an inhaler), patients and doctors ignored it in droves. After that, Lilly and Novo Nordisk, big players in diabetes care, promptly folded their fast-acting inhaled insulin programs as well. No better than injected insulin, not all that convenient, and potentially dangerous. That was inhaled insulin.

Of course, if you could develop an insulin that worked better than injectable and was just as safe—and it just happened to be delivered by inhalation—that would be a completely different story. Wouldn't it? Patients and doctors would say, "That's different from Exubera." And they'd turn this drug—let's call it Afresa—into a blockbuster.

At least, that's what Al Mann is betting. And a hell of a bet it is. Mann, the legendary 82-year-old serial entrepreneur behind Afresa (also known as Technosphere insulin (TI)) has sunk $919 million of his own money into the project, and has signed a commitment to lend MannKind Corporation, his latest entrepreneurial venture, an additional $350 million to see Afresa through to market. MannKind filed Afresa's new drug application with FDA in mid-March, and though Mann and company are confident, the drug still has to clear some daunting hurdles. Will FDA approve another inhaled insulin in this safety-obsessed political climate, especially after the Exubera disaster? Will the agency weigh Afresa's label down with warnings that have less to do with MannKind's drug and more to do with Pfizer's? Will MannKind be able to find a partner that can set aside memories of the most dismal pharmaceutical launch in recent memory? And will physicians, payers, and patients see past the inhaler and recognize Afresa as an important step forward in diabetes control?