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.
Exubera by Pfizer/Nektar has the inhaled insulin market all to itself—for the next two or three years. With peak sales of
$3 billion worldwide by 2013, says Wolters Kluwer, it's a "new delivery" blockbuster. The insulin is the same. But the compact
inhaler allows patients to draw the drug into their blood through the lungs—without ever touching a needle.
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."
But even as the new companies hope for Pfizer's early success, they have begun to measure themselves against each other and,
ultimately, against the market leader. So far, there are several major points of difference: the formulation of the drug,
the size and convenience of the inhaler, the precision and ease of dosing, the safety of the product, and in the case of one
product, the bioavailability of the insulin itself. No one company has the advantage in all of these areas, and since many
patients may find one or another quality most important, it is unclear which product besides Exubera will gain the upper hand.
Every New Product Has Its Edge.