Healthcare Industry News: H1N1
News Release - July 6, 2006
MedImmune Receives FDA Approval to Use Reverse Genetics Technology for FluMist(R) Vaccine ProductionProcess Enhances Efficiency and Reliability in Producing Seasonal and Pandemic Influenza Vaccines
GAITHERSBURG, Md., July 6 (HSMN NewsFeed) -- MedImmune, Inc. (Nasdaq: MEDI ) announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines, including FluMist (Influenza Virus Vaccine Live, Intranasal) and the next-generation, refrigerator-stable formulation, CAIV-T (cold adapted intranasal vaccine -- trivalent). Creation of new vaccine strains is the first step (and often a production-limiting one) in the influenza vaccine manufacturing process. Use of reverse genetics (also known as "plasmid rescue") technology enhances the safety, specificity, reliability and efficiency with which new vaccine strains can be produced.
"Reverse genetics represents an important breakthrough in commercial influenza vaccine processes by improving the efficiency of producing new influenza vaccine strains on an annual basis," said George W. Kemble, Ph.D., vice president, research and development, vaccines. "This technology enables scientists to replace cumbersome seasonal vaccine strain development methods that were created in the 1960s with modern techniques, which should allow us to accelerate the availability of influenza vaccines to the public.
"For producing pandemic influenza vaccine seeds, reverse genetics has the added benefit of allowing scientists to remove potentially pathogenic portions of the virus, thereby creating a safer production process for the vaccines," Dr. Kemble commented further.
Toward this end, MedImmune has already begun applying its plasmid rescue technology to pandemic research efforts. Last month, the National Institutes of Health (NIH) began enrolling participants in a Phase 1 study of an intranasal H5N1 influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology, which also utilized reverse genetics technology. Investigators at MedImmune and Johns Hopkins Bloomberg School of Public Health Center for Immunization Research, where the study is being conducted, are hopeful that a live, attenuated intranasal influenza vaccine would be as effective against potential pandemic A strains as it has been shown to be against seasonal matched and mismatched A strains of influenza.
Most influenza vaccine manufacturing companies and governmental agencies are now using reverse genetics technology in their development of pandemic vaccine candidates because it allows them to avoid working directly with the infectious, circulating pandemic strains. As the owner or exclusive licensee of the key patent estates for use of the reverse genetics technology in human influenza vaccines, MedImmune remains committed to making sure that the technology is accessible to government institutions and industry manufacturers. As such, the company has offered other influenza vaccine manufacturers non-exclusive licenses to this intellectual property estate for use in manufacturing seasonal or pandemic vaccines.
MedImmune's Commitment to Delivering Influenza Vaccines to the Public As the manufacturer of FluMist, the first major innovation in influenza vaccine technology in more than 50 years, MedImmune continues to expand upon its commitment to ensure the nation is adequately protected against seasonal and pandemic influenza by using the latest in scientific and medical advancements. In addition to the activities described above, the company also recently received a $170-million contract from the U.S. Health and Human Services Department to expedite the development of cell culture-based production of its influenza vaccine. Further, the company also recently submitted its first lots of commercial FluMist for the 2006-2007 influenza season to the FDA for approval and release. The company expects to have all lots approved and released for commercial sale by the first week in September. Should all things continue on track, MedImmune anticipates shipping its first doses of FluMist for the upcoming season to customers by the end of July 2006.
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.
CAIV-T is an investigational intranasal, cold-adapted trivalent influenza vaccine. It is the next-generation, 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 5 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 with nearly 50 percent of those children 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 44 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 = 1.0 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 = 3.0 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 (2.5 - 5.6 percent increase) and a higher incidence of injection site reactions in those receiving the flu shot (3.6 - 7.6 percent increase). There were no significant differences through the whole study period for all reported wheezing or for medically significant wheezing (MSW), a pre-specified safety endpoint. Previously unvaccinated children between 6 and 23 months of age had a small but statistically significant increase in MSW at 42 days following their first dose (2.0 percent for TIV vs. 3.2 percent for CAIV-T). Statistically significant differences were not seen beyond 42 days after this first dose nor at any time after the second dose.
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 that involve risks and uncertainties, in particular, related to the research and development of potential influenza vaccines. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.
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