From Pfizer, Irrational Exubera?

Its insulin inhaler may not be as big a diabetes blockbuster as expected

Janet Ruhl may be Pfizer Inc.'s (PFE ) worst nightmare. Ruhl, who injects a small amount of insulin each day to control her diabetes, has been dissing Pfizer's soon-to-debut diabetes remedy on her new blog and on a Web discussion group. The treatment, Exubera, is the first product that lets diabetics inhale insulin powder rather than inject the drug. But Ruhl, a 57-year-old software developer and author from Gill, Mass., says she thinks Exubera will be hard to use and could cause lung damage. "It looks like a terrible idea," Ruhl says.

Pfizer executives have told Wall Street analysts Exubera could ultimately bring in $2 billion a year in sales. But amid mounting resistance from patients and physicians, some analysts now wonder if it will be worth even half that much. "We feel they will fail to gain traction," says Sanford C. Bernstein & Co. analyst Richard T. Evans. Dr. Michael Berelowitz, a senior vice-president at Pfizer, responds that there is "quite a lot of pent-up interest" in the drug.

Pfizer could use a new blockbuster. In the month of June alone, its $12 billion cholesterol-buster Lipitor came under attack when a competing drug went generic; it pulled out of a partnership to develop a promising insomnia treatment; and its blockbuster antidepressant Zoloft lost its patent protection. With the loss of such gold mines, the pressure on Exubera only increases.

Exubera's big virtue was supposed to be that it's inhalable, but even that could prove to be a liability. Some patients in the clinical trials suffered lung problems. Pfizer recommends that physicians withhold the drug from patients who perform poorly on a lung-function test. Those who get the drug will need to have their lungs retested periodically. With such hassles, "there's not a lot of enthusiasm," says Dr. Joel Zonszein, director of the clinical diabetes program at Montefiore Medical Center in New York.

Pfizer's pricing plan could also be a turnoff. The list price of $122 to $140 a month is at least 33% higher than that of injected insulin, according to a June 22 report from Cowen & Co. That means most health insurers will charge their highest co-pays for the drug, and they could impose limits on who can get it, dooming prescribers to endless paperwork and phone calls.

Then there are the clumsy qualities of the inhaler. Exubera's insulin doses come in only two sizes, making it hard for patients to tweak their intake based on their meal or exercise plan for the day, warns Dr. Richard A. Jackson, a senior physician at the Boston-based Joslin Diabetes Center. Plus, when the device is unfolded, it's about the size of a can of tennis balls. Some patients may be embarrassed to use it in public. Pfizer executives have been talking up Exubera as the pain-free alternative for patients who are afraid of syringes. But the runaway success of a new drug called Byetta -- which patients inject twice a day -- has sent the whole idea of the needle-phobic patient right out the window, physicians say.

Pfizer considers Exubera a revolutionary new choice, and Berelowitz says the company has launched "a hugely extensive education campaign" to train physicians and nurses how to incorporate the device into a complete diabetes care regimen. To ease lung-safety fears, the company has launched a trial of 5,000 Exubera users. "We'll study them for as long as it takes" to ensure the drug is safe, Berelowitz says.

With Exubera doubts on the rise, Pfizer is on the offensive. Its sales machine is gearing up to target diabetes specialists and general practitioners. Pfizer has not revealed its advertising plans, but Bernstein's Evans estimates the company will spend more than $50 million a year pitching Exubera directly to consumers. With competitors racing to develop inhalers that are less clunky than Exubera, Pfizer is hard at work on version 2.0. "We're not going to sit back," Berelowitz says.

By Arlene Weintraub

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