FluMist Gets a Needed Boost

Refrigerated Version Cleared

MedImmune said yesterday that it had won federal approval for a new refrigerated version of its nasal flu vaccine FluMist, giving the Gaithersburg company an important victory in its efforts to achieve more widespread adoption of a product that has not caught on in the marketplace.

The current version of FluMist must be kept frozen, a deterrence for many doctors, pharmacists and vaccine administrators in schools because they stock standard flu shots in refrigerators and typically do not have freezers available. Also, international distribution channels are unable to support frozen vaccine.

"A frozen formulation is just a non-starter for many of these groups," said Frank J. Malinoski, senior vice president of medical and scientific affairs for MedImmune. "You don't even get in the door with the frozen formulation with a lot of groups."

Besides reducing storage problems, federal approval for the new formulation is essential to helping MedImmune clear another crucial hurdle: winning approval for the vaccine in children under 5 years old. FluMist is only approved for ages 5 to 49, limiting the vaccine's use in an age group that is generally averse to needles.

But that is not the primary advantage the company and many public health officials see in FluMist. MedImmune thinks FluMist is better at preventing the flu in children than the flu shot, and in 2005 the firm released results of a large study demonstrating that FluMist was 55 percent better than the standard flu shot at preventing infection in children under 5. MedImmune used the refrigerated version in the study, and the results have been submitted to federal regulators as part of the company's application to expand the product approval label to children as young as 1. A decision is expected by the end of May.

"I believe that the current version, because of its narrow label and requirement for being frozen, is a small product," said Phil Nadeau, an analyst for Cowen. "In order for this to be a meaningful product for the company, they need to expand the label and get it out of the freezer. This is a step in the right direction."

FluMist has, so far, has been a blemish for executives at the region's most successful biotech company. MedImmune acquired the product by buying a company called Aviron for $1.5 billion in 2002. Analysts had forecast sales of $800 million worldwide for FluMist, and in 2003, MedImmune and Wyeth, its corporate partner at the time, launched the vaccine with a $25 million advertising campaign.

It didn't take. MedImmune chief executive David M. Mott called the launch a "debacle of the first order" and set out to rebuild the FluMist franchise by creating a refrigerated version and obtaining approval for children under 5. Now, Mott and his executive team are hoping for vindication.

"It was their idea to buy this company," Nadeau said. "They put a lot of their reputation on the line for it. They haven't been able to have a second shot at making it a success. They've been waiting for several years to change the record on it. It's something they really want to go well."

This flu season, MedImmune has sold about 2.5 million doses of FluMist, and the company expects to hit its target of 3 million doses by the end of the season. That would more than double the amount of FluMist doses sold in the 2005-2006 season.

However, the sales figures may not reflect a true picture of public demand because the Department of Defense has a contract to buy up to 1.2 million doses. And as part of an effort to vaccinate 250,000 children in Maryland schools, MedImmune is contributing 83,000 doses of FluMist, the state is buying 77,000, and the Centers for Disease Control and Prevention is providing 90,000 more.

Ed Danoff, a pharmacist at the Medicine Chest Pharmacy in McLean, said he has sold about 40 doses of FluMist compared with 2,500 flu shots. He said he has had better luck with FluMist during times of vaccine shortages. This flu season, traditional shots are plentiful around the country. In fact, Danoff has 400 more shots available.

Public health officials say it's not too late to get vaccinated. The peak of flu season can extend until March, according to the CDC.

"If someone appears nervous, then we suggest the FluMist," said Danoff, whose pharmacy bought a $700 freezer in order to carry the vaccine.

John Eklund, the owner of Preston's Pharmacy in Arlington, said he has been pushing FluMist because he thinks "it's a great product."

"I am a FluMist proponent," he said. He has sold about 130 doses.

Nadeau thinks MedImmune can sell 15 million doses -- for $300 million -- in 2009. That's $500 million less worldwide than what had been originally projected.

Geoff Porges, an analyst with Sanford C. Bernstein and Co., said: "Will it be a product that attains some measure of profitability and carries its weight in the portfolio? I think so. Will it ever be the blockbuster that management suggested it would be? No."