Nasal-spray flu vaccine has significant success

By Luke Timmerman
Seattle Times business reporter

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A flu vaccine being developed into a nasal spray passed a key clinical test yesterday, showing that two doses can prevent healthy adults from getting the flu.

The vaccine, called FluInsure, still has to advance through larger tests and is projected to be three years away from the market as an alternative for people who would rather avoid needles.

Although the results were preliminary, they were significant. FluInsure's developer, ID Biomedical, a biotech company based in Vancouver, B.C., with operations in Bothell, said 100 percent of people in the study who got two doses were protected from fever, headache and muscle pain, while 86 percent were shielded from respiratory sickness.

That compared with about 48 percent of subjects on placebo medication who caught flulike symptoms. Side effects included a runny nose for a day or two. The trial enrolled 67 healthy adults ages who were directly exposed to the virus in London.

After the news, ID Biomedical stock rose 23 percent to close at $7.60 in after-hours trading on the Nasdaq.

"We set the bar pretty high, and we're thrilled we were able to leap over it," said Todd Patrick, ID Biomedical president.

The Food and Drug Administration has not yet approved a nasal-spray version of flu vaccine for the market, but the biotechnology industry is moving closer. FluMist, an experimental product from MedImmune and Wyeth, has been tested in more than 20,000 people and could be ready for the 2004 flu season.

MedImmune and ID Biomedical are taking different scientific approaches to making nasal-spray vaccines. ID Biomedical uses a key genetic piece of the virus that helps antibodies recognize and attack flu, without the ability to give people the illness.

MedImmune's FluMist is a live, weakened version of flu virus which builds up immunity, but in a few rare cases people in its tests have had respiratory illness. A advisory panel to the FDA recently recommended it for people ages 5 to 49, but the FDA has not yet ruled.

ID Biomedical has its sights for the vaccine in the pediatric market and for seniors. The company expects to test the effectiveness of its vaccine in 500 to 1,000 people during the 2003 flu season, and plans to do more broad studies before asking the FDA for approval, Patrick said.

The company is also seeking a drug-company partner to split development costs. If the next trials go well, analysts say it could be ready for the market in 2006.

David Miller, president of Biotech Monthly, said some investors may be disappointed that FluInsure didn't show effectiveness with a single dose. But he said ID Biomedical's product has an edge with safety.

"Some on Wall Street are fixated on the difference between one dose and two doses, but they're leaving out that FluInsure isn't a live virus, and it has a better safety profile," said Miller, who doesn't own the stock, but has at least one staff member who does.

Luke Timmerman: 206-515-5644 or ltimmerman@seattletimes.com