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FluMist future lies with new formula of needle free vaccine

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GAITHERSBURG, Md. (AP) _ Last year, MedImmune Inc. and then partner Wyeth presented a study that suggested a new version of MedImmune's nasal spray influenza vaccine FluMist may be more effective at warding off the virus than the traditional needle jab in the arm.

The results, while preliminary, were encouraging for MedImmune. Its first attempts to sell FluMist had fizzled, bedeviled by a high price, storage problems, and limits on who could use the drug. Once thought to be a blockbuster product, the company even considered scrapping it.

MedImmune is now preparing to report the results of a much more comprehensive study of the retailored vaccine, meant to resolve the problems that saddled the original version and, the company hopes, prove it is better than the shot. It's a critical test for the drug that could become a widely used vaccine or be emblematic of a good idea that didn't work.

``If they want that franchise to be a winner for them, that trial really needs to work,'' Joel Sendek, an analyst with Lazard Capital Markets.

MedImmune expects the study to be ready sometime during the 2005 fourth quarter and plans to send the data to the Food and Drug Administration for review early next year. The company wants to market the new form of the vaccine for the 2007 flu season.

The study's goal is to prove a new formulation of FluMist, called CAIV-T, is as effective or better than the shot at protecting against the flu. MedImmune CEO David Mott said in an interview that the company does not want to produce a ``me too'' drug that only matches the power of vaccines already available to customers.

``That is less strategically interesting to us because it is really not our business,'' Mott said. ``If that were the outcome, we would evaluate our alternatives, including outlicensing the product or selling those assets.''

In an industry where companies struggle with the long and expensive road of turning science into drugs, MedImmune is one of the relatively few biotech successes. It posted $1.15 billion in revenue last year on several products, including the child respiratory drug Synagis. MedImmune forecasts $1 billion in Synagis sales this year. The company is expanding its suburban Washington headquarters and hiring about 20 new people per week.

However, MedImmune stumbled when it introduced FluMist two years ago. Acquired in 2001 through the $1 billion purchase of the California company Aviron, FluMist seemed like it would have broad appeal, especially among parents leery of giving shots to toddlers. MedImmune predicted it would eventually make $1 billion in annual sales on FluMist.

Flu vaccines build immunity against the virus that can cause serious illness, often in young children and the elderly. MedImmune uses weakened live viruses to foster that immunity while flu shots are made from killed flu virus.

But the FDA only approved FluMist for people from ages 5 to 49 on concerns over side effects. MedImmune's price per dose, originally about $46, was more than twice that of the shot, although it has since been reduced to around $20. Unfounded fears lingered in some patients and hospitals that the live virus in the vaccine could trigger the flu.

MedImmune's sales sagged, even with a severe shortage of flu shots last year. The company sold around 2 million doses and revised its outlook for FluMist, saying it would not be a major contributor to earnings. Mott now considers it like a drug in the final stages of clinical trials that happens to be already on the market.

CAIV-T is essentially the same as FluMist, but it has been slightly reformulated to allow it to be refrigerated. The original FluMist was frozen, a storage issue that made it hard for doctors to stock the drug.

The MedImmune study, conducted during last year's flu season, matched CAIV-T against the flu shot in 8,492 children between the ages of 6 months and 59 months at 250 sites worldwide.

During the original tests of FluMist, a small number of children suffered wheezing and asthma after taking the drug. That led the FDA to exclude young children from the drug's label. But Mott said the larger tests of CAIV-T will determine if those problems were just an anomaly, what he referred to as ``noise'' in the clinical results.

``Our hope and expectation is that it will turn out to be a better way to prevent the flu, particularly in kids,'' he said.

Mott downplays the overall effect of FluMist on the company, saying it accounts for just about 5 percent of its revenues. He won't reveal how much MedImmune has spent developing CAIV-T, but did say the trial comparing it to the flu shot cost at least $90 million.

The vaccine gets much of the attention, he asserts, because it is the company's only consumer product available without a prescription, Mott said. However, he predicted a failure of CAIV-T would not be a major blow to MedImmune.

Analysts are split on what impact the CAIV-T study will have on the company. Sendek said if it fails, MedImmune won't have to keep plowing money into developing a product that won't be profitable for several years. But Phil Nadeau of SG Cowen noted that the company's other products, such as Synagis, are nearing their limit of market reach. That means MedImmune needs a new drug to draw new sales.

``It (FluMist) is a small part of their current business,'' he said. ``However, topline growth will really come from the FluMist franchise.''

Pediatricians also are waiting to see whether the new version of the vaccine can eventually be used in young children. Many offices may now be reluctant to stock both FluMist and the shot because not all patients can use the nasal spray, said Dr. Julia McMillan, a professor of pediatrics at the Johns Hopkins Children's Center.

But a flu spray approved for young children may lead parents to pick it over the shot to spare youngsters the pain of an injection, she said.

``Pediatricians and parents would be more accepting,'' she said. ``Children in that age group get so many injections, to be able to avoid one would be a help.''
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