FDA decision on inhaled diabetes drug still pending
Federal regulatory agency hasn't completed review of diabetes treatment, despite Pfizer CEO's comments on TV.
NEW YORK (CNNMoney.com) - Exubera, Pfizer's experimental inhalant for treating diabetes, has not been approved by the FDA, but a public relations blunder by the company's CEO had many believing otherwise Friday.
Hank McKinnell, chairman and chief executive officer of the world's biggest drug manufacturer, told CNBC that the Food and Drug Administration had approved Exubera. But the company issued a statement very soon after the TV appearance to say McKinnell's announcement wasn't accurate.
"[McKinnell] did make a mistake and I think it was just with everything going on," Pfizer spokeswoman Vanessa Aristide told CNNMoney.com.
The FDA has not completed its review of Exubera, which would become the first insulin inhalant on the market if the agency decides to the give the drug the green light. Exubera was approved by the European Commission for its member nations on Thursday. On that same day, Pfizer (up $0.63 to $25.68, Research) announced the FDA approval for another drug, its cancer treatment Sutent.
Exubera received a positive vote from an FDA advisory panel Sept. 8, and the FDA usually follows the advice of its panel.
Spokesmen for drug makers are generally very careful not to make statements that would be seen as second-guessing the FDA.
"You never want to front run the FDA," said Barbara Ryan, analyst for Deutsche Bank North America. "From my perspective, it was fairly obvious there was a miscommunication and it is what it is. By the same token, we expect Pfizer will get full approval on Exubera today or Monday."
Pfizer, a New York-based drug giant with $51.3 billion in 2005 sales, co-developed Exubera with Nektar Therapeutics (up $1.18 to $21.80, Research) and Sanofi-Aventis (up $0.22 to $45.92, Research). The French drug maker Sanofi-Aventis is no longer involved with the drug, because Pfizer recently bought their rights to Exubera.
Diabetes treatment is considered a lucrative industry in the United States, home to more than 20 million diabetics, according to estimates from the American Diabetes Association. Diabetics have difficulty producing their own insulin, which turns blood sugar into energy and is produced naturally by the pancreas in healthy individuals.
Diabetics have been injecting insulin since the 1920s, but an approved inhalant would allow them to put their needles away.
Ryan, the Deutsche Bank analyst, projects that Exubera sales will peak at $2 billion in 2010. Many other analysts consider the drug a potential blockbuster, but others doubt its effectiveness.
For more on the FDA and Exubera, click here.