To: Arthur Radley who wrote (25 ) 1/27/2006 11:22:10 AM From: tuck Respond to of 507 I hear the FDA decision is expected today. Here's an article that gives brief mention of the European label. Common wisdom is that the FDA label will be similar: >>Thu Jan 26, 2006 03:00 PM ET By Deena Beasley LOS ANGELES, Jan 26 (Reuters) - Pfizer Inc. ( PFE ) , the world's largest drug maker, on Thursday said European regulators approved its inhaled insulin treatment for diabetes. Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, Pfizer said. The U.S. Food and Drug Administration is slated to make its decision on the dry powder form of human insulin, by Friday. Industry analysts have predicted that sales will top $1 billion a year. The European approval "suggests that Pfizer has been able to address any labeling issues, including comments on safety and dosing, which. bodes well for a formal FDA final approval," WR Hambrecht & Co. analyst Andrew Forman said in a report. Exubera was approved for use in adult Type 2 diabetics who are no longer responding to oral drugs and in Type 1 diabetics in combination with long-acting injected insulin. Diabetics use insulin to control their blood sugar and prevent complications such as heart disease, blindness and limb amputations. Nektar Therapeutics Inc. ( NKTR ) invented the insulin formulation used in Exubera and the inhaler for delivering it to the lungs. Nektar will receive royalty payments on sales. Several other companies are developing inhaled insulin products, including Eli Lilly & Co. ( LLY ) and Alkermes Inc. ( ALKS ) , which are partners in one project, and Mannkind Corp ( MNKD ) , Kos Pharmaceuticals Inc. ( KOSP ) and Novo Nordisk ( NVO ) . Shares of Pfizer rose 29 cents, or 1 percent, to $25.12 in afternoon trade on the New York Stock Exchange. Nektar shares were up $1.04, or 5.4 percent, at $20.34 on the Nasdaq.<< emphasis mine Cheers, Tuck