Although production of chemical-based pharmaceuticals has long been outsourced to contract manufactu

Four new inhaled-insulin therapies are following Exubera (insulin) down the drug pipeline, and each one of them may eventually enjoy a significant advantage over Pfizer's groundbreaking new delivery system. But for now, Pfizer has the only drug in its class. The new inhalation system, originally developed by Nektar Therapeutics of San Carlos, California, shows a similar insulin profile to subcutaneously injected insulin, and has proven popular with patients during clinical trials. Although the drug's price had not been set at press time, strong patient uptake is fairly well assured. In part because the world's largest pharmaceutical company will put its marketing muscle behind it. But also because pulmonary delivery could boost compliance among patients who resist treatment because they fear needles or hate injections.

No one is rooting harder for Exubera than manufacturers of inhaled-insulin therapies in late-stage clinical trials: Kos Pharmaceuticals, Mannkind Corporation, Novo Nordisk (which partners with Aradigm, based in Hayward, California), and Eli Lilly (which teamed up with Boston-base Alkermes). Nothing would have been worse for these companies than FDA's failure to approve Pfizer's drug. And now that Exubera is launched, few outcomes could derail the new products faster than a major setback for their biggest competitor. If Exubera puts physicians and patients at ease about the new insulin delivery system—and satisfies FDA that the new technology is safe—it will create a new market, for which all future inhaled-insulin products will compete.

"I think it's good to have somebody like Pfizer coming first with all their power," says Ralf Rosskamp, MD, executive vice president, research and development at Kos Pharmaceuticals, based in Cranbury, New Jersey. "They will make sure people understand how inhaled insulins are used, how good they are for patients. They pave the way. And in the end, it's the patient's decision, then, if he sees different kinds of devices and makes a change later."

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