GAITHERSBURG, Md., March 21, 2007--MedImmune, Inc. (Nasdaq: MEDI) announced today that researchers will present data from three key studies involving the nasal-spray flu vaccine FluMist(R) (Influenza Virus Vaccine Live, Intranasal) during the National Association of Pediatric Nurse Practitioners' (NAPNAP) 28th Annual Conference on Pediatric Health Care in Lake Buena Vista, Florida. Results of two of the studies indicate that school-based influenza vaccination programs may represent an effective and feasible approach to help reduce influenza infection rates among vaccinated children and may also prove to be a valuable model to vaccinate large groups quickly. A third study of nearly 8,500 children six months to 5 years of age found that children vaccinated with FluMist experienced 55 percent fewer cases of influenza compared to those who received the flu shot. FluMist is currently indicated for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49 years of age. Based on the results of this pivotal Phase 3 study, MedImmune has filed with the U. S. Food & Drug Administration (FDA) for an expanded indication for FluMist to include children as young as one year of age without a history of wheezing or asthma.
Studies to be presented at the conference, which will be held here March 21-24, include:
-- Effectiveness of a School-Based Influenza
(Podium session presentation, "115: Clinical Papers," presented on
Wednesday, March 21 by Ginny Cummings, MS, CRNP, Clinical Research
Coordinator at the University of Maryland School of Medicine)
-- Implementing a Mass Influenza Vaccination
Program: The Carroll County
Experience (Poster session presentation on March 21-23 by Brigit
VanGraafeiland, MS, CRNP, of the University of Maryland School of
omparison of the Efficacy and Safety of
Vaccine-Trivalent (CAIV-T) With Trivalent Inactivated Influenza Vaccine
(TIV) in Children 6-59 Months of Age (Poster session presentation,
School-Based Vaccination with FluMist Lowers Rates of Flu Among School Children and Families
A study of more than 15,000 schoolchildren in four states conducted during the 2004-2005 influenza season found that school-based influenza vaccination programs may represent an effective and feasible strategy to help lessen the impact of seasonal influenza on households and communities. The study, which used FluMist and involved 28 schools in Maryland, Texas, Minnesota and Washington, was led by researchers from the University of Maryland School of Medicine and supported by a grant from MedImmune, Inc., and was published in the December 14, 2006 issue of The New England Journal of Medicine.
Investigators found in intervention-school households compared to control schools:
-- A 23 percent relative reduction in
influenza-like illness among
-- A 27 percent relative reduction in influenza-like illness among adults
-- A 38 percent relative reduction in the use
of prescription drugs to
treat flu-like illness and 31 percent relative reduction in the use of
over-the-counter medication during the peak flu week
County-wide Mass Influenza Vaccination Program Found Feasible and Effective: The Carroll County (Maryland) Experience
In the fall of 2005, the Carroll County Health Department and Public School System in Carroll County, Maryland conducted a public health initiative to provide influenza vaccine to eligible students and staff in all of the county's 22 public elementary schools using FluMist. Volunteers were recruited from the State Emergency Preparedness and Response Team, local health departments, medical centers, and nursing, medical and pharmacy schools. Licensed health professionals were trained to administer FluMist. Over the course of three days, more than 5,000 schoolchildren and nearly 450 staff members were vaccinated.
Cooperation between government, academic, and corporate partners enabled quick and effective design and implementation of a large-scale influenza vaccination campaign using predominantly local medical and lay volunteers. The outcome of this program is being used to create a curriculum to teach undergraduate and advanced practice students the skills needed to effectively participate in a rapid mass-immunization program.
Study Results Demonstrated 55 Percent Fewer Cases of Flu in Young Children Vaccinated with FluMist Compared with the Flu Shot
This Phase 3 study evaluated the incidence of influenza illness among young children vaccinated with FluMist compared to those vaccinated with the flu shot. The study of 8,475 children, between 6 months and 59 months of age, was conducted at 249 sites across the United States, Europe, Asia and the Middle East by MedImmune during the 2004-2005 influenza season. Children immunized with FluMist experienced 55 percent fewer cases of influenza compared to children who received the flu shot (153 vs. 338 cases, P<0.001). In the study, FluMist also demonstrated protection against influenza strains that were both matched and mismatched to the vaccine. The research was published in The New England Journal of Medicine on February 15, 2007.
Generally, both vaccines were well-tolerated. In children 6 months to 11 months of age, FluMist was associated with statistically significantly more hospitalizations for any cause. A non-significant trend toward more hospitalizations in the FluMist group was seen in children 12 months to 59 months of age with a past history of wheezing. These observations require additional study. Until further information is available, MedImmune is presently not seeking an indic ation for children under 12 months of age or for children 12 months to 59 months of age who have a past history of wheezing illness. In children 12 months to 59 months of age without a past history of wheezing, there was a trend (though not statistically significant) in the opposite direction in that there were fewer hospitalizations in children who received FluMist compared to the flu shot. In children 12 months to 59 months of age without a past history of wheezing, the rates of wheezing were not statistically different in children who received FluMist (4.7 percent) compared to the flu shot (4.9 percent).
FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.
Under no circumstances should FluMist be administered as an injection (i.e., parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.
In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irrita bility, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.
Please see the Prescribing Information for the currently available formulation of FluMist, which is attached, or visit http://www.flumist.com, or call 1-877-633-4411 for additional information.
On January 5, 2007, the FDA approved MedImmune's supplemental Biologics Licensing Application (sBLA) for a refrigerated version of FluMist, which will be manufactured for the 2007-2008 influenza season. Prior versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for next season's vaccine. However, preliminary prescribing information can be found by viewing the attachment.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain "forward-looking statements" regarding the potential prospects of and the results of clinical trials for FluMist. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change current expectations and could cause actual outcomes and results to differ materially from current expectation s. In addition to risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission, no assurance exists that FluMist will receive required regulatory approval for children 12 months to 59 months of age or that, even if regulatory approval is received, FluMist will be commercially successful. MedImmune undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law or regulation.
CONTACT: Media: Karen Lancaster, +1-301-398-5864, or Investors: Beatrice Pierre, +1-301-398-4905, both of MedImmune.