Flumist

Gaithersburg-based MedImmune announced Tuesday evening a voluntary recall of early batches of its nasal spray vaccine against swine flu after tests revealed that the doses lost strength within months of being shipped. The recall affects 4.7 million doses of FluMist, though most were distributed in October and early November when tests showed that the vaccine was at full strength, said officials at the Food and Drug Administration. Because of that, people who got vaccinated should be protected from the H1N1 virus and do not need to worry about getting vaccinated again, officials said.

WASHINGTON - MedImmune Inc. must stop using a marketing brochure for FluMist, its nasal-spray influenza vaccine, because the document lacks directions for use and details on potential risks, federal regulators said. "This consumer-directed flier is misleading because it fails to reveal material facts regarding the risks associated with the use of FluMist," the Food and Drug Administration said in a warning letter dated June 21 and posted yesterday on the agency's Web site. "More specific information is necessary."

MedImmune Inc. said yesterday that the Food and Drug Administration has approved a refrigerated version of its FluMist vaccine to soon replace the current frozen formulation, which has been criticized for having difficult storage requirements. Wall Street reaction to the news was tepid. MedImmune shares closed down 7 cents, or 0.2 percent, to $34.25 in moderate trading on the Nasdaq yesterday. Securing the approval means the Gaithersburg company has cleared the first of at least three significant hurdles analysts say are hampering the nasally inhaled vaccine's success.

MedImmune Inc. expects to reap an extra $10 million from sales of its FluMist vaccine over the next three months as a result of the flu shot shortage and believes it could increase production to sell millions more next year, company officials said yesterday. The Gaithersburg company now expects to sell 1 million to 2 million doses of FluMist this winter. And it could make as many as 20 million doses of FluMist for next winter, and 40 million by 2007 or 2008, Chief Executive Officer David M. Mott told analysts in a conference call after the company released third-quarter earnings.

MedImmune Inc.'s FluMist was approved yesterday by the Food and Drug Administration, paving the way for the Gaithersburg biopharmaceutical company to make available by the winter flu season the first nasal-spray flu vaccine to be sold in the United States. The FDA said it would allow FluMist to be given to healthy children and adults between the ages of 5 and 49. Children ages 5 to 8 need two doses of the vaccine, six or more weeks apart. All others need one dose. The vaccine is expected to cost $46 per dose, according to MedImmune.

A flu spray made by Gaithersburg-based MedImmune Inc. is effective for young children, the Food and Drug Administration said yesterday, signaling that the company might soon win approval to market the vaccine for use in children younger than 5. Some health experts say FluMist would be a welcome tool in combating the flu because it would help immunize children who could otherwise get the illness and spread it to others. An FDA advisory panel will take up the issue tomorrow, with the expectation that the agency will make a decision before the end of May. Approval could greatly increase sales of the nasal spray vaccine by MedImmune, which agreed last month to be purchased by London-based AstraZeneca PLC for $15.6 billion.

A top executive of MedImmune Inc. told analysts at a health care stocks conference yesterday that the company needs to slash the price of its beleaguered FluMist influenza vaccine by more than half to boost sales for the next flu season, again sparking questions about that firm's marketing strategy for a product it has characterized as important to its future. James Young, the research and development president of Gaithersburg-based MedImmune, said the company would be looking to slash the per-dose price of FluMist from last year's $46 "probably down into the low 20s" as it repositions the product for the flu season to come.

With a high number of flu cases reported in Maryland, the Baltimore County Health Department has scheduled clinics to administer FluMist, a newly developed nasal spray, to help meet the increased demand for protection against influenza. Dr. Michelle Gourdine, the county health officer, said that with only a small amount of injection vaccine available, the county is focusing on the FluMist clinic. The first is scheduled Dec. 30. Additional clinic dates will be scheduled after Jan. 1. Gourdine said people interested in receiving the nasal spray must call for an appointment.

MedImmune Inc., the Gaithersburg-based maker of the FluMist nasal spray vaccine, reported a drop in fourth-quarter earnings and a loss for the year yesterday, despite increased sales of its most popular product. Annual revenue was $1.14 billion, up 9 percent from 1.05 billion in 2003. But rising expenses, which grew to $1.2 billion from $813 million for 2003, more than offset the gain. Among the expenses were research and development costs, which tripled last year to $120 million, and charges associated with the breakup of a partnership with drug company Wyeth.

MedImmune Inc. said yesterday that it will stick with its FluMist flu vaccine despite the nasal spray's dismal first season's sales but warned that its profit for the next several years would fall short until an improved version and other new drugs come onto the market in 2007. The Gaithersburg drug maker cut its outlook for 2004, projecting earnings of 50 cents to 60 cents a share for the full year, well below analysts' consensus estimate of 95 cents per share, according to Zacks Investment Research.