The long promise of insulin that diabetics can inhale appears to be moving closer to the market. An inhalable insulin powder called Afrezza showed positive results for controlling diabetes in a late-stage clinical trial, the drug’s maker, MannKind (MNKD), reported today.
Pharmaceutical companies have been working on inhalable insulin for a long time on the theory that diabetics would prefer to puff on an inhaler than give themselves a shot. In 2007, Pfizer (PFE) stopped selling its Exubera insulin powder because of weak sales after less than two years on the market. Exubera never gained traction, largely because insurers wouldn’t pay for it, saying it was too expensive and didn’t work for many patients. Eli Lilly & Co. (LLY) and Novo Nordisk (NVO) both ended inhaled insulin research programs in 2008.
MannKind has been trading testing data with the U.S. Food and Drug Administration since March 2009 in hopes of getting approval for Afrezza, which it says is more effective than the prior drugs and could cost about the same as the current injectable insulin “pens”—about $2,000 annually. It is taken before a meal with a small inhaler the company calls “Dreamboat,” causing peak insulin levels to be reached in 12 minutes to 14 minutes, matching the insulin release in non-diabetics when they eat. The drug is also expected to be used by those suffering from Type 1 diabetes, in which the body produces no insulin. The latest study, involving 518 patients with Type 2 diabetes, showed that Afrezza helped to reduce long-term blood sugar levels.
The market for diabetes treatment is “so immense and it’s growing so rapidly,” says MannKind’s chief financial officer, Matthew Pfeffer. “While we think of our country as having an obesity and diabetes epidemic, we’re not even in the top 10 of incidence of diabetes. But it is a bad problem here and we’re going to start with the U.S.” More than 8 percent of Americans have type 2 diabetes, which occurs when blood sugar levels rise too high, a condition called hyperglycemia.
California-based MannKind plans to file this latest trial data with the FDA in the fall and expects a decision on approval in the second quarter of 2014. News of the trial sent company shares soaring more than 25 percent in early trading. The stock was up 18 percent, to 8.10 at midday.
MannKind’s chairman and chief executive officer, Alfred Mann, has spent about $930 million of his own money to pursue the company’s signature product. He is also MannKind’s largest shareholder. MannKind has booked losses of more than $2.1 billion since its 1991 founding, including a $169 million loss in 2012.