Prospects Brighten for Maker of Nasal Flu Vaccine [NYT]
By ELIZABETH OLSON
Published: October 30, 2004
It would seem a drug executive's dream come true. A week ago Thursday, the secretary of health and human services summoned the top officials of MedImmune to his office in Washington to ask their help in dealing with the nation's flu vaccine shortage.
David M. Mott, MedImmune's chief executive, said that if the company scrambled it could triple its planned production and turn out more than three million doses of its vaccine, the nasal anti-flu spray FluMist. The spray sells for as much as $23.50 for a once-a-season dose, compared with about $10 for a flu shot.
FluMist got a further lift two days ago when the government said it would approve the vaccine next year as a treatment for people age 5 to 18 in the federal Vaccines for Children program aimed at low-income families. MedImmune's stock rose nearly 5 percent that day, closing at $28.38. Yesterday it rose 4 cents, closing at $28.42.
Even so, MedImmune may have little to celebrate yet. Such is the state of its business that the company will lose money on every dose of FluMist it sells. In the third quarter, it lost $65 million, or 26 cents a share, on revenue of $93 million.
The company now projects that its spray vaccines will not truly begin to pay off until the introduction of a new version being tested in clinical trials. MedImmune hopes this version will receive federal approval in time for the 2006-7 flu season. "We are operating without a net, but we are in a high-stakes, high-risk business," Mr. Mott, 38, said during an interview at the company's headquarters in Gaithersburg, Md., about 20 miles north of Washington. Before the current vaccine shortage began, MedImmune had planned to scale back sales efforts for FluMist this season, based on the disappointing reception when the product reached the market last year.
The company was able to sell only about 10 percent of the 4.5 million doses it produced for the 2003-4 flu season, as doctors and patients balked at its $46 price tag and at the need to keep it frozen until shortly before it is ready to use.
Another factor holding down sales is that the vaccine has federal approval for use only in people age 5 to 49; the people who suffer the most when they get the flu are infants and people older than 65.
Those obstacles could not be surmounted despite a $40 million marketing campaign and the work of 3,000 product representatives from MedImmune's partner, Wyeth Pharmaceuticals. Wyeth pulled out of the partnership in May.
"We relied too much on marketing muscle and brawn," said Mr. Mott, a former Salomon Brothers investment banker who became MedImmune's chief executive four years ago. "The launch plan missed the science and the medicine."
Going into the current flu season, the company had reduced the pricing to $23.50 and less and had planned to put only 1.1 million doses on the market. The idea was to ride out the market while finishing the clinical trials for its next version of a nasal-spray vaccine, which it calls CAIV-T. The improved spray requires refrigeration instead of freezing and can be administered to children younger than 5.
"We decided to bet on the biology," Mr. Mott said. MedImmune wanted a product that "makes sense for a pediatrician to use, and to prefer."
That meant a broad-based clinical trial that would compare the spray's effectiveness with that of injectable vaccines. But pulling that together in 18 countries was not easy.
Among the problems were enrolling 7,000 children, shipping the vaccine, making sure the trial coincided with this year's flu season and translating labels into nine languages. The trial, under way now, will end after this winter's flu season. The data will be analyzed next year, with the aim of using it for the 2006 flu season.
"We're taking two steps back," Mr. Mott admitted. "We really view the next couple of years as an extended pre-launch period. We are going back to classic biotech marketing, which is to rely on science and medicine."
nytimes.com |
