MedImmune Awarded $170 Million, Five-Year Contract From U.S. Health and Human Services to Develop Cell-Based Influenza Vaccines
Thursday May 4, 11:01 am ET
U.S. Government Award Highlights Importance of MedImmune's Live, Attenuated Intranasal Vaccine Technology to Protect Nation Against Annual and Pandemic Influenza
GAITHERSBURG, Md., May 4 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News), manufacturer of the first innovation in influenza vaccine technology in more than 50 years, announced today that it has been awarded a $170 million, five-year contract from the U.S. Health and Human Services Department (HHS) to develop cell-based seasonal and pandemic vaccines using its proprietary live, attenuated, needle-free influenza vaccine technology. Receiving this fully funded contract from HHS further emphasizes the potential importance of the Phase 3 clinical trial results MedImmune presented earlier this week showing that CAIV-T (cold adapted influenza vaccine, trivalent) was statistically significantly more effective than the flu shot in reducing influenza illness caused by any influenza strain in children 6 months to 59 months of age. CAIV-T is the investigational, next-generation of MedImmune's currently marketed vaccine, FluMist® (Influenza Virus Vaccine Live, Intranasal).
"This fully funded HHS contract bolsters MedImmune's commitment to preparing the U.S. to be protected against influenza illness annually and in the event of a pandemic," said David M. Mott, president and chief executive officer. "By leveraging both our innovative influenza vaccine technology and our expertise in cell-based manufacturing, we believe we are well positioned to become the premier U.S.-based supplier of highly effective influenza vaccines. We plan to expand our domestic manufacturing capacity by establishing a cell-based facility in the United States that can produce at least 150 million doses within six months of notification of an influenza pandemic. We also plan to initiate our first Phase 1 study against the avian H5N1 strain this coming June under a cooperative research and development agreement with the National Institutes of Health to determine if our technology can be as effective against potential pandemic A strains as it is against seasonal A strains of influenza."
Mott continued, "The best way for MedImmune to play a role in protecting people against a pandemic is to increase its participation in the seasonal influenza business. Toward that goal, we expect to hear back from the U.S. Food and Drug Administration (FDA) in July on the data included in our supplemental Biologic License Application (sBLA) showing that the refrigerator-stable CAIV-T is equivalent to frozen FluMist. This will allow us to be in a position to produce CAIV-T for commercial use for the 2007-2008 influenza season.
"Further, in June, we plan to submit our sBLA for CAIV-T, requesting that the label for our influenza vaccine be expanded to include children from 6 months to five years of age," Mott stated. "In addition to the data from our large, pivotal Phase 3 trial, this sBLA will include immunogenicity results from a recently completed clinical trial that showed one dose of CAIV-T produced significantly higher serum HAI titers in young, immunologically naive children than two doses of the flu shot, particularly against A strains. If we are successful in expediting the review on this sBLA, we will be able to make this important vaccine available for these children for the 2007-2008 season."
MedImmune's Manufacturing Expertise
MedImmune's influenza vaccine, FluMist, is currently made using chicken eggs, as are all other U.S.-approved influenza vaccines. MedImmune's manufacturing process requires far fewer eggs than other manufacturers because its vaccine technology has dose yields that can be as much as 100-fold higher than the flu shot. As such, MedImmune currently has the capacity to scale up to 45 million bulk doses per month upon development of monovalent pandemic vaccine using egg-based production methods. However, by applying cell-based manufacturing methods, MedImmune believes that it could further reduce its production times and substantially increase its U.S.-based manufacturing capacity in preparation for a pandemic. After adding the cell-based production capability for its influenza vaccine, MedImmune anticipates having the capacity to produce 300-400 million monovalent doses of a pandemic vaccine annually.
Bernardus N. M. Machielse, Drs., MedImmune's senior vice president, operations, commented: "For the last 10 years, we have used our extensive experience with cell-based technology to manufacture Synagis® (palivizumab), a monoclonal antibody that is the standard of care in high-risk infants for preventing respiratory syncytial virus -- the leading cause of viral pneumonia. Through this experience, we have discovered innovative steps to continually increase production yields, which we are now applying to our influenza vaccine manufacturing plans."
The awarding of the U.S. government cell-culture manufacturing contract advances MedImmune's ongoing commitment to ensure the nation is adequately protected against seasonal influenza and prepared for a potential influenza pandemic by using the latest in scientific and medical advancements. Toward this end, MedImmune has notified the World Health Organization and other governmental agencies of its intent to license the key intellectual property for reverse genetics technology, which the company either owns or exclusively licenses, to governmental organizations and companies developing pandemic influenza vaccines for public health purposes. For pandemic vaccines, reverse genetics is important because the technology allows vaccine manufacturers to work with a segment of the infectious, circulating pandemic virus strain's genome rather than directly with the infectious strain itself. Using this technology, it is also possible to make changes to the virus to make it less virulent.
About CAIV-T
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 effect 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 prespecified 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 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 flumist.com, visit flumist.com, or call 1-877-633-4411 for additional information.
About vaccine production methods
Egg-based vaccine production involves injecting fertilized eggs with a single influenza strain, where it infects the embryo and is released into the egg's fluid. The vaccine virus is collected after several days of incubation and processed further. For traditional, inactivated vaccines, up to two eggs may be required to produce a single dose of vaccine whereas FluMist may give rise to 100 times or more of this vaccine for each egg. Cell-based vaccine production is similar to fermentation in that massive quantities of the virus are collected in a single process. MedImmune researchers introduce the virus into a sterile container of mammalian cells, the vaccine virus replicates in these infected cells and it is then released into the culture fluid. As such, the cell culture process is much more efficient than egg-based production. |
