Pfizer: Exubera's Lung Side Effects Temporary

The drugmaker says patients who stop taking inhaled insulin see lung function return to normal in a month.
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Pfizer

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says patients experiencing small declines in lung functionafter using the company's Exubera inhaled insulin return to normal within one month of discontinuing use.

Lung problems are a major concern among doctors and patients, and onekey reason why Exubera has had a very slow start despite having beenapproved by the Food and Drug Administration in early 2006. After a problem-plagued launch last year, Pfizer recently stepped up marketing efforts.

Pfizer provided updated information Saturday on two ongoing clinicaltrials -- one for Type 1 diabetics, whose bodies can't produce insulin, andanother for Type 2 diabetics, who can't produce enough insulin or whosebodies can't process insulin adequately. Insulin helps the body convertsugar into energy.

Based on the third year of a seven-year research project, Pfizer saidlung function declines were "reversed" when patients stopped taking Exuberafor a month. When they started taking inhaled insulin again, "lung functionchanges similar to first-time users of Exubera were observed." The data waspresented in Chicago at the annual scientific conference of the AmericanDiabetes Association.

Saturday's interim analysis was similar to information Pfizer presentedafter these patients had been followed for two years. Earlier results alsofound that Exubera users had, on average, small declines in lung functionthat were reversed within a month of discontinuing Exubera. These patientsalso exhibited small reductions in lung function once they resumed takingExubera.

Exubera is a dry powder form of insulin that is inhaled through the mouth via a special device developed by Pfizer's partner

Nektar Therapeutics

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. The drug shouldn't be used by people with unstable or poorlycontrolled lung disease, by smokers or by people who have quit smoking for less thansix months.

The latest data also shows that Exubera patients maintained blood sugarlevels when compared to people taking injectable insulin, although there wasno statistically significant difference between the two groups. Exuberapatients "generally gained less weight" over the three-year period; butPfizer didn't say if the difference was statistically significant. Aspokeswoman was unable to immediately confirm if there was a significantdifference.

In a test of 627 adult Type 2 diabetics, researchers found that patientsin both groups had "similar improvement or maintained their blood sugarlevels" over three years. The average weight gain for an Exubera patient was7.7 pounds, vs. 9.1 pounds for a user of injectable insulin.

Side effects were similar, except the Exubera users showed morecoughing and shortness of breath. Pfizer said the coughing was"predominantly mild," decreased over time and "rarely" caused a patient toquit taking the drug.

In a test of 580 adult Type I diabetics, Exubera patients blood sugarscores rose slightly while injectable insulin users' scores declinedslightly. Pfizer said the difference wasn't statistically significant.Exubera users gained on average 3.5 pounds while injectable insulin usersgained 6.4 pounds. Side effects were similar, except for more coughing amongExubera patients. Coughing was "predominantly mild" and rarely caused apatient to discontinue treatment, Pfizer said.

Pfizer shares lost 54 cents to close at $25.38 Friday.