West Coast Editor

MedImmune Inc. said Monday it has completed enrollment in one pivotal Phase III study and started recruiting patients for another, each trial testing a separate compound that improves on a drug already on the market.

The company's stock (NASDAQ:MEDI) closed Monday at $27.36, down $1.06 cents.

Numax for respiratory syncytial virus (RSV) in high-risk infants is the subject of the new study, which will compare the drug's safety and efficacy with Synagis (palivizumab), MedImmune's monoclonal antibody approved in 1998 for RSV.

"There had been some question about the timing of when that trial was going to come, but in their earnings call they said they would start in time to catch this season," noted Alex Hittle, analyst with A.G. Edwards in St. Louis. Gaithersburg, Md.-based MedImmune disclosed earnings last month.

The study completing enrollment is in 8,500 children comparing the cold-adapted, trivalent intranasal flu vaccine with the injected product as a potential advance in the benefits of MedImmune's marketed intranasal vaccine, FluMist. (See BioWorld Today, Oct. 22, 2004.)

Hittle's firm, which makes a market in MedImmune securities, has a "hold" rating on the stock.

"At least recently, we've been wrong on that," he said, conceding that the company's share price has "come up quite nicely. It's basically profited from Chiron's disaster," Hittle added, referring to the shortage of flu vaccine brought about by Emeryville, Calif.-based Chiron Corp.'s overseas contamination snafu. (See BioWorld Today, Oct. 6, 2004.)

The Chiron situation "doesn't really help that much in terms of earnings, but it does get FluMist off the ropes," he said.

"MedImmune had last year what was the perfect storm - a year in which there was a sort of panic generated around flu vaccines - and they [still] failed to sell what was produced. This year they've got an even more perfect storm. They've sensibly stepped in and reduced pricing, and if they can't push out their 3 million doses at this halved price point, that doesn't bode too well for the future."

But Hittle said he was confident the doses would be sold.

As for Numax, the compound has proved more potent than Synagis in preclinical studies that targeted RSV replication in the lower and upper respiratory tract when given at the same dose monthly by intramuscular injection. The Phase III trial aims to find out whether those results will translate into better efficacy against lower respiratory tract illness in high-risk children, as well as to discover what effect Numax has on upper respiratory tract disease such as otitis media.

"The gist of it is that [Numax] binds better to the virus," Hittle told BioWorld Today. "A smaller amount of Numax would presumably have the same ability to provide passive immunity for premature infants. They're saying their hope is that by giving the same dose, there is more horsepower applied to the prevention of RSV, so they can conceivably prevent upper respiratory infections" brought about by the virus.

The Numax/Synagis Phase III will be conducted during two Northern Hemisphere RSV seasons in about 5,750 children, a group consisting of premature infants born at 35 weeks gestational age or less who are 6 months of age or younger at enrollment, along with children with chronic lung disease who are 24 months of age or less upon sign-up.

Last year, Synagis' label was expanded to include safety and efficacy data supporting its use in young children with hemodynamically significant congenital heart disease to prevent hospitalization caused by RSV.

MedImmune has "interesting stuff going on," Hittle said. His rating is due to the fact that "you have a fairly long wait here until things like Numax and FluMist Two' emerge on the market, and you have a bit of a long-term deficit in terms of R&D spend relative to [MedImmune's] peers," he said.