Pfizer Applies to FDA for New Insulin Drug

Mar. 3–Pfizer Inc. and the French drug maker Sanofi-Aventis Group said Wednesday that the U.S. Food and Drug Administration has accepted their new drug application for Exubera, an inhaled dry-powder form of insulin.

The two global pharmaceutical companies are hoping to gain approval to market the new drug to adults who have Type 1 and Type 2 diabetes. The two already have agreed to globally co-develop, produce and manufacture Exubera. In addition, a small company called Nektar Therapeutics has collaborated with Pfizer to develop the inhalers used with Exubera. The proposed drug also is under review by European regulatory authorities.

New York-based Pfizer employs about 6,000 people at its research, development and manufacturing operations in Groton and New London.

Shares of Pfizer were little affected by the news Wednesday, closing the day’s trading on the New York Stock Exchange at $26.61 a share, unchanged from the prior day’s trading. Shares of Paris-based Sanofi-Aventis closed the day’s trading on the Big Board at $40.77 a share, up 7 cents from the prior day’s trading.

Exubera is inhaled into the lungs with the special device created by Nektar. Pfizer officials said it has been studied in more than 3,500 patients, some for more than seven years.

The potential market for the new pharmaceutical, if approved by federal regulators, would be huge. An estimated 180 million people worldwide are diabetic, and health officials estimate that number will swell to some 300 million over the next two decades.

Pfizer officials have said that in half of those with diabetes, the disease is uncontrolled or poorly controlled, putting them at risk for complications ranging from heart disease to kidney failure, nerve damage and blindness. Diabetes-related health care costs in this country alone total more than $100 billion.

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