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Exubera Education, Complicated Manufacturing Impacting Launch Timeline

Executive Summary

Pfizer's mid-year launch timeline for its inhaled insulin therapy Exubera is influenced by the need to educate physicians, complex supply chain issues and reimbursement discussions, Pfizer co-development partner Nektar suggested

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Pfizer breathes easy with Exubera data

Type 1 and type 2 diabetes patients do not experience greater reductions in lung function with long-term use of Pfizer's inhaled insulin Exubera, the firm says. Data from an eight-year extension study of 217 adults from the three Phase III Exubera trials show the average yearly reductions in lung function were similar between treatment and control groups, Pfizer says. Lung function tests are advised in product labeling for initiation of therapy and regular monitoring for the inhaled product (1"The Pink Sheet" Feb. 13, 2006, p. 23). The study, presented at the European Association for the Study of Diabetes Sept. 18, also shows that blood sugar levels were maintained with long-term Exubera use. Pfizer also presents data from an eight-day study comparing Exubera to Sanofi-Aventis' long-acting insulin Lantus in uncontrolled type 2 diabetics. The 40-patient study shows "no differences in the blood sugar variability endpoints between Exubera and Lantus," Pfizer says, adding that additional large-scale studies comparing the insulins are ongoing...

Pfizer breathes easy with Exubera data

Type 1 and type 2 diabetes patients do not experience greater reductions in lung function with long-term use of Pfizer's inhaled insulin Exubera, the firm says. Data from an eight-year extension study of 217 adults from the three Phase III Exubera trials show the average yearly reductions in lung function were similar between treatment and control groups, Pfizer says. Lung function tests are advised in product labeling for initiation of therapy and regular monitoring for the inhaled product (1"The Pink Sheet" Feb. 13, 2006, p. 23). The study, presented at the European Association for the Study of Diabetes Sept. 18, also shows that blood sugar levels were maintained with long-term Exubera use. Pfizer also presents data from an eight-day study comparing Exubera to Sanofi-Aventis' long-acting insulin Lantus in uncontrolled type 2 diabetics. The 40-patient study shows "no differences in the blood sugar variability endpoints between Exubera and Lantus," Pfizer says, adding that additional large-scale studies comparing the insulins are ongoing...

Pfizer Holding Its Breath On Exubera DTC Advertising To Focus On Education

Pfizer will begin direct-to-consumer advertising for its inhaled insulin therapy Exubera approximately one year after its approval, the company said at a June 10 briefing in Washington, D.C

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