Healthcare Industry News:  influenza 

Biopharmaceuticals FDA

 News Release - July 31, 2006

MedImmune Submits Refrigerator-Stable Formulation of FluMist(R) to FDA for Approval in Younger Children

Submission Marks Milestone in Company's Goal to Launch Improved Formulation of Intranasal influenza Vaccine with a Broader Pediatric Label in 2007

GAITHERSBURG, Md., July 31 (HSMN NewsFeed) -- MedImmune, Inc. (Nasdaq: MEDI ) announced today it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children 12 months to 59 months of age who do not have a history of wheezing or asthma. CAIV-T is the refrigerator-stable formulation of FluMist (influenza Virus Vaccine Live, Intranasal), a frozen vaccine approved in the U.S. to prevent influenza in individuals 5 to 49 years of age.

"This is a very satisfying moment for MedImmune as it represents the culmination of multi-year clinical, manufacturing and regulatory efforts to improve the profile of our influenza vaccine," said Edward M. Connor, Jr., M.D., executive vice president and chief medical officer. "Pending FDA review and approval, we believe that our live, attenuated influenza vaccine will be an important new vaccine for many children currently recommended for annual influenza vaccination by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP)."

The sBLA consists of data from more than 30,000 subjects in 15 clinical studies, including MedImmune's pivotal Phase 3 trial involving approximately 8,500 children between 6 months and 59 months of age. In this trial, efficacy of the vaccine was established across all age groups of children. Specifically, children vaccinated with CAIV-T had 55-percent fewer overall confirmed cases of influenza compared to the injectable vaccine. The study also showed that CAIV-T vaccination resulted in 89-percent fewer cases of matched H1N1 strains and 79-percent fewer cases of circulating mismatched H3N2 strains as compared to the flu shot. MedImmune's risk-benefit analysis of age subgroups of children within this trial indicated that CAIV-T is appropriate for use in children older than 12 months of age who do not have a history of wheezing or asthma.

influenza's Impact On The Community

The case for immunizing young children against influenza is well documented and continues to grow. During the 2003-2004 influenza season, 153 children died of influenza-related causes. Approximately 23 percent of those children were 2 to 4 years of age and nearly 50 percent of the deaths occurred among previously healthy children. Data from a study published in the New England Journal of Medicine in July 2006 indicated that influenza infections were missed in four out of five preschool-aged children who were treated for flu symptoms at a doctor's office or emergency room and in about three- quarters of those who were hospitalized.(1) The authors suggest that under- reporting/missed diagnoses of influenza may indicate that children can become infected with influenza at much higher rates than previously believed.(2) These statistics underscore the need to immunize children below the age of 5 to help reduce the burden of influenza disease.

"It is particularly important to vaccinate young children against influenza to help reduce hospitalizations and morbidity associated with influenza disease," said Kathryn Edwards, M.D., professor, pediatrics and vice chair, clinic research at Vanderbilt University Medical Center. "Recognizing the need to help reduce the influenza disease burden in children, the ACIP recently recommended influenza immunization for children 6 months to 59 months of age."

Experts have also long proposed that vaccinating school-aged children would considerably reduce influenza in the general population and help keep it from reaching epidemic levels. According to the CDC, influenza causes seasonal epidemics of disease resulting in approximately 36,000 deaths each year in the United States.

FluMist Now Available for 2006-2007 influenza Season

Last week, MedImmune announced that it was shipping commercial FluMist for the 2006-2007 influenza season. This early shipment enables physicians to immunize healthy individuals 5 to 49 years of age as soon as they receive doses of the vaccine. This year physicians have the opportunity to leverage the busy back-to-school season to accomplish immunization before influenza season begins. This should ease the burden in physicians' offices associated with fall and late-season immunization. The CDC's July 28 Morbidity and Mortality Weekly Report stated: "Administration of live, attenuated influenza vaccine is encouraged as soon as it is available and throughout the season."(3)

About FluMist

FluMist is 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. Like any vaccine, FluMist does not protect 100 percent of individuals vaccinated. In studies of people between the ages of 5 and 49 years, runny nose was the most commonly reported side effect. Other common side effects included various cold-like symptoms, such as headache, cough, sore throat, tiredness/weakness, irritability, and muscle aches.

FluMist should not be used, under any circumstances, in anyone with an allergy to any part of the vaccine, including eggs; in children and adolescents receiving aspirin therapy; in people who have a history of Guillain-Barre syndrome; and in people with known or suspected immune system problems. Pregnant women and people with certain medical conditions, asthma, or reactive airways disease should not get FluMist.

Please see the Prescribing Information at http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com, or call 1-877-633-4411 for additional information.

About CAIV-T

CAIV-T is an investigational intranasal, cold-adapted trivalent influenza vaccine. It is the refrigerator-stable formulation of FluMist, which is a frozen, live attenuated cold-adapted trivalent influenza vaccine. To date, the safety, tolerability and efficacy of CAIV-T has been studied in both healthy and at-risk populations between the ages of 6 weeks and 98 years.

On May 1, 2006 at the Pediatric Academic Societies' annual meeting, MedImmune presented its pivotal Phase 3 study for CAIV-T, entitled, "Comparison of the Efficacy and Safety of Cold-Adapted influenza Vaccine, Trivalent With Trivalent Inactivated influenza Vaccine in Young Children 6 to 59 Months of Age." The study included 8,475 children at 249 sites in 16 countries in North America, Europe, the Middle East and Asia. Study participants were randomized one-to-one to receive either CAIV-T or the flu shot during the 2004-2005 influenza season. Each participant also received a placebo nasal spray or placebo injection to preserve the double-blind design of the study. Participants were followed through the influenza season and evaluated to identify illnesses caused by influenza virus. The trial included more than 6,300 previously unvaccinated children and nearly 50 percent of the children enrolled were less than 2 years of age.

The results of this trial showed that CAIV-T was 55 percent more effective than the trivalent injectable inactivated influenza vaccine (TIV) in reducing influenza illness caused by any influenza strain in children 6 months to 59 months of age, including both matched and mismatched strains. The influenza attack rate was 8.6 percent for study participants receiving the flu shot compared to 3.9 percent for those who received CAIV-T (P <0.001). Against matched strains alone, CAIV-T was 45 percent more effective than the flu shot (attack rates: TIV = 2.4 percent, CAIV-T = 1.4 percent; P<0.001). In this study, CAIV-T also appeared to be 89 percent more effective than the flu shot in reducing influenza illness caused by the matched H1N1 A strain (attack rates: TIV = 0.7 percent, CAIV-T = 0.1 percent; P<0.001) and 79 percent more effective than the flu shot against the circulating mismatched H3N2 A strain (attack rates: TIV = 4.5 percent, CAIV-T = 0.9 percent; P<0.001). There were no cultures of mismatched H1N1 strains or matched H3N2 strains detected in the trial. While there were 16-percent fewer children with illnesses associated with B strains in the CAIV-T group compared to TIV (attack rates: TIV= 3.5 percent, CAIV-T = 2.9 percent), this difference was not statistically significant.

In the study, the overall incidence of adverse events and serious adverse events was similar in both groups except for a higher incidence of runny nose and nasal congestion in CAIV-T recipients (4.4 ~ 11.1 percent increase) and a higher incidence of injection site reactions in those receiving the flu shot (3.6 ~ 7.6 percent increase). A statistically significant increase in the incidence of medically significant wheezing was seen in CAIV-T recipients 6 months to 23 months of age within 42 days following vaccination. Post-hoc analyses showed higher all-cause hospitalizations occurring through 180 days after vaccination in CAIV-T recipients 6 months to 11 months of age. Risk- benefit analyses showed a favorable profile for CAIV-T as compared to TIV in children 12 months to 59 months of age without a prior history of wheezing or asthma.

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 2,300 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" relating to FluMist and CAIV-T. 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 expectations. In addition to risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission, no assurance exists that development efforts for CAIV-T will succeed, that CAIV-T will receive required regulatory approval or that, even if regulatory approval is received, CAIV-T 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.

(1) Poehling KA, et al. (for the CDC's "New Vaccine Surveillance Network"): The underrecognized burden of influenza in young children. New England Journal of Medicine. 2006/July 6; 355:37-40.

(2) Poehling KA, et al. (for the CDC's "New Vaccine Surveillance Network"): The underrecognized burden of influenza in young children. New England Journal of Medicine. 2006/July 6; 355:38-40.

(3) Smith, NM. Prevention and Control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report. 2006/July 28; 55: RR-10.


Source: MedImmune

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