Exubera Success May Hinge on Usability

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At the recent annual scientific meeting of the American Diabetes Association, the Pfizer ( PFE) booth was jam-packed with doctors, nurses, academics and analysts angling for a firsthand look at the Exubera insulin inhaler.

"Change the diabetes experience," said one video display as a platoon of Pfizer representatives showed onlookers how to use the inhaler. To be sure, the New York-based drug giant hopes to vastly alter the way diabetics get their insulin by giving them the first option to injections to come on the market.

However, questions remain about just how easy the device is to use and whether a large number of insulin users will in fact make the switch.

"We still believe the device is a bit large, but we found it easy to use," Catherine Arnold of Credit Suisse wrote in research report after the June ADA meeting. She went on to say, though, that the "size and maintenance requirements of the device largely offset the convenience offered by inhaled administration."

The inhaler itself was developed by Nektar Therapeutics ( NKTR). Both that company and Pfizer are counting on Exubera to attract new patients and perhaps convert existing diabetics to what they say is an easier way to control blood-sugar levels, even if the drug costs more than injectable insulin.

Arnold for one is concerned that it will take Pfizer 12 to 18 months to educate patients and doctors about safety and device-management issues. She's neutral on Pfizer, and she doesn't cover Nektar. She doesn't own shares of the companies, but her firm says it does or seeks to do business with firms mentioned in its research reports.

"Most clinicians we spoke with indicated there is substantial patient interest in Exubera," Barbara Ryan of Deutsche Bank Securities said in a post-convention review. "They felt the device was certainly less than ideal, but it was generally viewed as easy to use."

Ryan, who has a buy rating on Pfizer, said "many doctors" believe some patients will have trouble gauging their ideal dose when inhaling Exubera. The best potential customers will be "motivated patients who were new to insulin therapy," she said. Ryan doesn't own shares, but her firm has provided services to Pfizer.

Several researchers at the ADA convention pointed out that technology improves over time, and that's been the case for insulin administration. Where once big needles were used for injections, now there are much smaller devices and pumps. The first insulin pump was the size of a backpack. Now, they're as small as cell phone or pagers.

As for insulin inhalers, Pfizer and Nektar will be pressed to improve Exubera not only for greater patient convenience, but also because of competition. Several companies are testing devices resembling anything from a cell phone to an asthma inhaler. Some potential competitors appear to offer "sleeker devices and more convenient administration," Arnold says.

The closest competitors are believed to be at least two to three years behind Exubera. Among the other hopefuls are Eli Lilly ( LLY), Alkermes ( ALKS) MannKind ( MNKD) and Novo Nordisk ( NVO).

Attempts at creating an inhaled insulin are nothing new. In 1925, German scientists reported on experiments that showed patients would need to inhale too much insulin for this approach to be effective, said Lutz Heinemann, CEO of business development at the Profil Institute for Metabolic Research in Neuss, Germany.

Speaking at the ADA meeting, he said each version of inhaled insulin will be different because of how the drug is formulated and how the delivery system works, and they can't be compared accurately without head-to-head tests. Heinemann has been a consultant to many diabetes-research companies.

Pfizer is supporting its Exubera launch with an extensive education campaign for doctors and patients, an effort it started soon after the Food and Drug Administration approved the drug on Jan. 27. Exubera is set to be available starting in mid-July.

The product comes with an instructional manual, details of which are posted at www.exubera.com in a PDF file with 44 pages of large type, photos and questions and answers.

Although an early prototype looks like it might have been a prop in a Cheech & Chong movie, the current device is much smaller. Still, patients may need to buy a carrying case because the device "is not pocket friendly," said one sales representative at the ADA meeting.

The inhaler is a canister with a triggering mechanism. To engage the device, patients pull a small handle on the bottom, allowing a plastic cone to slide on top of the triggering device. Then, they insert a blister pack containing the dry-powder insulin into the triggering device.

Next, they pull back on the trigger mechanism to gently pump-prime the device. Then, they press a button that releases the insulin into the plastic cone. On top of the plastic cone is a small mouthpiece, which patients use to take a slow, deep breath for five seconds.

Because people require different amounts of insulin, this process may need to be repeated more than once each time diabetics take their insulin.

Pfizer recommends that patients clean the plastic cone and the base once a week. The unit that releases the drug should be replaced every two weeks, and the whole device should be replaced once a year.

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