Mist

WASHINGTON -- MedImmune Inc. said yesterday that U.S. regulators approved its new British manufacturing plant for making the FluMist influenza vaccine in 2006, when the company expects an easier-to-use version to be approved for sale. MedImmune, which is supplying 3 million doses of FluMist this year, will be able to produce up to 15 million doses a month with the new plant in Speke, England, the company said. MedImmune will start making FluMist in 2006 at the plant, which also might be used to make a version now under regulatory review and to produce vaccine for a potential flu pandemic, the company said in a statement.

MedImmune Inc. said yesterday that a new version of its FluMist influenza vaccine, which is given as a nasal spray, was more effective than standard flu shots in a study of small children. The company's stock gained 4.54 percent. In a clinical trial of 8,492 children, ages 6 months to 5 years, the influenza infection rate of those who received MedImmune's CAIV-T nasal spray was 3.9 percent, compared with 8.6 percent among children who got a standard flu shot, Medimmune said in a statement on its Web site.

MedImmune Inc. said it expects to receive information within the next few weeks that will help the Gaithersburg drugmaker determine whether to continue its nasal flu-vaccine program. During a conference call yesterday morning to discuss the company's third-quarter loss, MedImmune Chief Executive Officer David M. Mott said he expects to receive data from a clinical trial of CAIV-T, a second-generation of its FluMist nasal influenza vaccine. If the vaccine is not shown superior to the traditional flu shot or the Food and Drug Administration declines to approve its use in very small children, MedImmune might look to unload the product.

With the threat of a large-scale avian influenza epidemic looming, the federal government has enlisted Maryland-based MedImmune Inc. to help it prepare for such a possibility. The Gaithersburg company announced yesterday that it would collaborate with the National Institute of Allergy and Infectious Diseases to develop a library of vaccines -- based on its seasonal FluMist nasal spray -- that could be rapidly manufactured in the event of a widespread flu outbreak. MedImmune will provide the prototype vaccines, and the institute will run them through clinical trials.

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."

Water Power Tourists love a close-up visit to Niagara Falls Capt. Gary English powered the Maid of the Mist away from its dock and headed toward Niagara Falls and its walls of rushing water looming more than 17 stories high. He had 300 people aboard the boat for its first run of the year last month. By the season's close in October, more than 2 million tourists will have been showered by mist from the famous waterfall aboard one of the double-decker boats in the Maid of the Mist fleet.

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.

Though flu season is not over, a report by one Wall Street analyst suggests sales of FluMist, the nasal spray flu vaccine made by Gaithersburg-based MedImmune Inc., will again be dismal this year. Survey results released this week by the New York investment house Lazard Freres & Co. estimate that about 1 million doses of FluMist have been sold by doctors and pharmacies this season. That is a third of the 3 million doses produced at the urging of public health officials. The officials feared a flu epidemic after flu vaccine-producer Chiron Corp.

U.S. health officials voted yesterday to include MedImmune Inc.'s FluMist in the federal Vaccines for Children program for the flu season next year, the latest development that could boost the nasal spray's future sales. The influential and closely watched Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention in Atlanta added FluMist to the program as an alternative to conventional flu shots. As a result, children eligible for the program will be able to receive the FluMist vaccine free of charge.

MedImmune Inc. is bumping up production of its FluMist vaccine for a second time, and now expects to make 3 million doses for this winter's flu season, the Department of Health and Human Services announced yesterday. MedImmune, based in Gaithersburg, originally made 1.1 million doses for this winter. When flu shot supplies were interrupted by production problems - blocking nearly half of the 100 million doses designated for the United States - MedImmune said this month that it would increase production to 2 million doses.