Positive results presented for new FluMist

MedImmune seeks OK for very young


If there's one thing parents of toddlers know, it's this: Vaccination shots are the pits.

They're scary, they leave a mark, and -- worst of all -- they hurt.

"The vast majority of kids would prefer not to have the pain," acknowledged Dr. Daniel Levy, an Owings Mills pediatrician and president of the Maryland chapter of the American Academy of Pediatrics.

That fact is among the chief motivating factors behind MedImmune Inc.'s quest to improve its inhaled flu vaccine called FluMist, which has thus far been a disappointment for the Gaithersburg company's investors.

The original formula, sanctioned for sale in 2003, is approved for use only in healthy people ages 5 to 49. Capturing the groups under and over that age range -- those most at risk from flu complications -- is critical to the vaccine's success.

At a meeting of the Pediatric Academic Societies in San Francisco yesterday, MedImmune presented data that showed the new-and-improved FluMist, called CAIV-T -- which is squirted into a patient's nostril -- trounced the standard flu shot when it came to preventing the illness in kids younger than 5.

Of those who received the injection, 8.6 percent came down with the flu, while fewer than half -- 3.9 percent -- of those given CAIV-T got sick.

The study results were first released in December, but MedImmune officially presented them yesterday. It's the latest move in the company's campaign to persuade the public, particularly federal officials, of the benefits of its new vaccine.

MedImmune also underscored findings yesterday that showed CAIV-T, short for cold adapted influenza vaccine-trivalent, to be better at preventing unanticipated strains of flu, the so-called "mismatched" kind that can be the basis for a pandemic.

"In the current environment of almost hysterical fear about the threat posed by `incurable' influenza, and accentuated by the current shortage of vaccines and antivirals, physicians and parents are likely to view this data as materially more important than in the past," analysts Geoffrey C. Porges and Neal A. Agar of Sanford C. Bernstein & Co. LLC in New York wrote in a report last winter.

MedImmune needs all the marketing edge it can get when it comes to FluMist, which has been something of an embarrassment for the Maryland biotech. Doctors have complained about its requirement for frozen storage, the public has worried about its use of a live -- though weakened -- version of the flu virus, and analysts have criticized the marketing and sales strategy.

The company is looking to CAIV-T for a second chance.

The new vaccine, which has yet to be approved for sale, requires refrigeration rather freezing, making it easier to store. MedImmune has made a concerted effort to demonstrate the safety of live viruses, which are also used in measles and mumps vaccines.

The company has significantly dropped its price for FluMist to about $25 this coming winter compared with $45 in 2003. A flu shot typically runs about $10 to $15.

"The biggest problem they had when they launched the product the first time seemed to be the price," said Philip Nadeau, a biotechnology analyst with S.G. Cowen & Co. LLC. "Most people aren't willing to pay a premium price for a flu vaccine."

In the study MedImmune highlighted yesterday, 8,500 children between the ages of 5 months and 59 months in 16 countries were given either the shot or the nasal spray during the 2004-2005 flu season. CAIV-T was shown to be 55 percent more effective than the shot, but almost just as important, the company was able to quantify a wheezing risk factor that had previously prevented the original FluMist from being approved for distribution in very young children.

The study showed 3.2 percent of children under 23 months who had never received a flu vaccination developed "medically significant wheezing" compared with 2 percent of kids who received the shot. This improves earlier estimates that suggested all recipients under age 5 could have "an increased rate of asthma and wheezing within 42 days of vaccination," according to a statement by the U.S. Food and Drug Administration..

"At the end of the day, we now have the information that will allow both the Food and Drug Administration and the pediatric practicing community to decide about the risk [versus] benefits," Edward M. Connor, MedImmune's executive vice president and chief medical officer, said from the California conference in a telephone interview yester- day.

The company plans to submit the recent findings to the FDA by the end of next month, in the hopes the results will influence the agency to approve the new version of the vaccine for the very young. Next, MedImmune will turn its attention to the other end of the spectrum, testing the vaccine on those over age 49. A lack of data kept the original FluMist from being approved for that group.

"It's incumbent on us to get both the data on the young kids and the other end of the population," said Connor, who expects that CAIV-T will be on the market by late 2007. But yesterday, his mind was on the kids.

"The biggest message from our perspective," he said, "is we're really happy with the results."


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