FluMist Flop Dogs MedImmune

Mott said Wyeth has a "different focus" on FluMist than Medimmune. "The equation for them is much more challenging," he added, because FluMist won't contribute meaningfully to sales or earnings growth until the 2007-2008 flu season and because Wyeth's marketing deal expires in mid-2014 (when the FluMist U.S. rights return to Medimmune).Wyeth made the original FluMist deal in 1999 with the tiny vaccine-maker Aviron, which was acquired by Medimmune in 2002. The deal was later revised.

Mott also said Monday that if Wyeth bowed out, Medimmune would have to write off $75 million relating to the marketing and promotional agreements as well as take an annual hit to earnings per share of 10 cents to 20 cents through 2007. But EPS would rise by 20 cents during 2009, the company said

Medimmune said Wyeth has completed a preliminary analysis of two clinical trials comparing the second-generation FluMist to injectable flu shots. "In each trial, [the revised version] showed statistically superior efficacy against culture-confirmed influenza with no statistically significant increase in wheezing episodes," the company said.

The results are especially encouraging, Mott said, because the wheezing side effects issue will play an important role when the FDA considers if the vaccine can be used by young children and people over 49.

One of the tests surveyed 2,200 infants and children from ages six months to 71 months with a history of recurring respiratory infections. They had a 53% lower incidence of flu than did children receiving standard flu shots.

Another test examined 2,200 children ages six years to 17 years who had a history of asthma. Those receiving the revised FluMist had a 35% lower incidence of flu versus those who received flu shots.

These tests represent the third -- and final -- phase of human testing before a drug is submitted for approval to the FDA. Medimmune also is excited about the drug called CAIV-T because it is refrigerator-stable. The current FluMist must be frozen.