MedImmune Inc.'s push to market what it hopes will be its next blockbuster drug got a key endorsement yesterday when an expert panel that advises the Food and Drug Administration gave what amounts to a recommendation for its approval, though for a smaller population than the company sought.
The Gaithersburg company previously had said it expected FluMist to generate as much as $1 billion in revenue within five years. But the company's estimate was based on the assumption that the vaccine would be approved for ages 1 through 64, not ages 5 through 49 as recommended by the panel.
The FDA usually follows the advice of such committees. If it wins approval, FluMist would become the first flu vaccine to be inhaled through the nose.
"I'm just thrilled with the significant step taken in getting a finished product out there," said David M. Mott, MedImmune's chief executive officer.
The company already is manufacturing supplies of the vaccine and plans to have it on the market in time for the fall and winter flu season next year, should the FDA approve it, he said.
MedImmune plans to market it with direct-to-consumer "education," using a budget far larger than used in the meager campaigns that market conventional flu shots.
The company plans to work with the FDA to find out what other tests are necessary to expand marketing of the vaccine to younger and older people, Mott said. He declined to discuss the vaccine's price.
Stefan D. Loren, an analyst at Legg Mason Wood Walker Inc., said many analysts would now be lowering revenue estimates for the product because of the smaller population group recommended by the FDA advisory panel.
He estimated that the drug would generate $80 million in revenue in its first year, if it were marketed for ages 5 through 49. He figures the vaccine would have peak sales of $500 million. The proceeds are to be split between MedImmune and marketing partner Wyeth Pharmaceuticals.
Loren said MedImmune will face a tough marketing challenge in getting healthy people to take a that's expected to cost more than a conventional flu shot.
"All the market research tells us there's an interest and a need," said MedImmune spokeswoman Lori Weiman, adding that many people would rather inhale a mist than get a shot.
It was MedImmune that decided to drop its request for approval in children under 5, a move advisory committee Chairman Robert S. Daum yesterday called "a masterstroke in terms of corporate strategy" to get the product to market.
The move was a bow to concerns that the live, though weakened, virus used in the vaccine might spur asthma symptoms and other illnesses in young children. The committee last considered FluMist in 2001 and backed its effectiveness but found the data then did not support its safety.
Yesterday, the committee voted that the vaccine was both safe and effective for people 5 through 49. The panel was closely divided on its safety for 50 to 64 years and found the data did not support the drug's effectiveness in that age range.
Some committee members said there may be initial public confusion about whether to take FluMist, a flu shot, or nothing at all.
Unlike FluMist, standard flu shots contain inactivated viruses generally considered safer for immune-compromised people.
A number of committee members therefore called for groups such as the Center of Disease Control and Prevention's Advisory Committee on Immunization Practices to make recommendations on who should take FluMist, if it is approved.
The CDC committee currently recommends the shots for people who are at increased risk for the flu, including senior citizens and health care workers. It recently encouraged flu shots to be given to healthy children ages 6 months to 23 months when feasible.