FDA approves new version of MedImmune flu vaccine

By Toni Clarke

BOSTON (Reuters) - U.S. regulators have approved an updated version of MedImmune Inc.'s nasal spray flu vaccine FluMist, the biotechnology company said on Monday.

Unlike the old version, the new one does not need to be kept frozen; it can simply be refrigerated, making it easier to handle and potentially boosting sales.

The U.S. Food and Drug Administration approved the new FluMist to help prevent influenza in healthy children and adults between the ages of 5 and 49. The company said it expects to begin shipping the first doses in time to start vaccinating patients as early as August.

FluMist, the first nasal spray flu vaccine, failed to catch on when it was introduced in 2003, partly because of the need to keep it frozen. The company expects to sell close to 3 million doses during the 2006-2007 season.

That figure could more than double in the 2007-2008 season with the new formulation, said Frank Malinoski, MedImmune's vice president of medical and scientific affairs.

"Over the next few months we will understand better what that demand will be," he said in an interview.

The new formulation of the vaccine will also be called FluMist and cost roughly the same as the old version -- between $16 and $20 per dose.

Whether it is successful will depend to a large extent on whether the company is able to get it approved for infants and the elderly, the groups most vulnerable to the flu, analysts have said.

The company has filed a separate application with U.S. regulators to market FluMist for children between the ages of 12 months and 59 months who do not have a history of wheezing or asthma. The FDA is expected to give a decision by the end of May.

One way MedImmune hopes to boost its market share is by pushing forward as much as possible the date that the vaccine is available - even, eventually, to early July. That could give physicians all summer to vaccinate children as they go in for pre-school physicals, said Malinoski.

The injectable flu vaccine was not available this season until the end of October 2006.

Gaithersburg, Maryland-based MedImmune has conducted trials of FluMist involving about 60,000 people, including children as young as six weeks of age and adults up to 98 years old.

MedImmune shares were down 2 cents at $34.30 in early afternoon trading on Nasdaq.