[rusty]

Pfizer to Seek Approval for Inhaled Insulin in '05
Tue Nov 30, 2004 06:24 PM ET

LOS ANGELES (Reuters) - Pfizer Inc. on Tuesday said it expects by early next year to seek U.S. approval for its long-delayed inhaled insulin drug, which it is developing with French drugmaker Sanofi-Aventis and drug delivery company Nektar Therapeutics .
Pfizer Chief Executive Hank McKinnell disclosed the company's plans for the drug, called Exubera, during a meeting in Groton, Connecticut, with industry analysts. The medicine would be the first inhaled form of insulin, and reduce the number of insulin injections diabetics need to give themselves daily to control their blood sugar.

Shares of San Carlos, California-based Nektar, which developed the inhaled insulin and the device to deliver the fine powder to the lungs, rose almost 24 percent on the Nasdaq after the announcement.

The companies filed earlier this year for European approval of Exubera, which analysts have estimated could reach worldwide annual sales of $2 billion.

Deutsche Bank Securities on Tuesday raised its rating on Nektar to "buy" from "hold," citing the Pfizer comments as well as information from industry contacts that a European pre-approval inspection of Nektar's San Carlos manufacturing plant went well.

The report also said European regulatory inspections of Pfizer's Terra Haute packaging facility and the Frankfurt-based insulin plant went well.

Concerns about Exubera's effect on lung function have dogged the drug for years, necessitating additional clinical trials.

In September, the companies unveiled data showing that Exubera is effective in controlling blood sugar levels in diabetics over prolonged periods of time.

The trial -- designed to compare the effectiveness of Exubera when added to other diabetes drugs versus use of the drugs alone -- showed a slight reduction in lung function for both groups.

Shares of Nektar surged $3.60, or 23.8 percent, to close at $18.69 on Nasdaq, while Pfizer rose 44 cents, or 1.6 percent, to $27.77 on the New York Stock Exchange.

(Additional reporting by Deena Beasley in Los Angeles)