FDA Approves MedImmune, Inc.'s State-Of-The-Art Influenza Vaccine Manufacturing Facility
GAITHERSBURG, Md., Dec. 27 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that its newly constructed influenza vaccine manufacturing facility in Speke, England has been approved by the U.S. Food and Drug Administration (FDA). The facility allows MedImmune to produce up to 15 million bulk doses per month, or approximately 90 million bulk doses per influenza manufacturing season, of its trivalent, intranasal influenza vaccine, FluMist (Influenza Virus Vaccine Live, Attenuated).
"The approval of our new manufacturing facility demonstrates MedImmune's ongoing commitment to being a worldwide leader in the influenza vaccine market," said Bernardus N.M. Machielse, Drs., senior vice president, operations. "With this state-of-the-art facility, we can substantially ramp up production. It provides the capacity for manufacture of increased supply of FluMist and our investigational, next-generation influenza vaccine, known as CAIV-T (cold adapted influenza vaccine, trivalent). The facility could also be used to produce vaccine year round in the event of an influenza pandemic."
The square footage of the new facility is 10 times larger than MedImmune's existing bulk manufacturing facility in Speke, and features larger testing and storage facilities, as well as automated inoculation capabilities. The facility uses a new filtration process, which is expected to provide greater sterility assurance during bulk production. MedImmune plans to begin manufacturing FluMist at this site in 2006.
Recent Progress with Influenza Vaccine Franchise
In September 2005, MedImmune submitted a supplemental Biologics License Application (sBLA) to the FDA for approval to use CAIV-T, its refrigerator- stable liquid formulation of FluMist, in preventing influenza in healthy individuals 5 to 49 years of age. Included in the sBLA were data from a recently completed pivotal Phase 3 study comparing the immunogenicity of FluMist and CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations.
MedImmune also recently announced preliminary data from a Phase 3 study indicating that CAIV-T showed a statistically significant reduction (55 percent) in influenza illness caused by any influenza strain compared to the injectable influenza vaccine (TIV). The influenza attack rate was 8.6 percent for study participants receiving TIV compared to 3.9 percent for those who received CAIV-T (p less than 0.0001). The rates of serious adverse events and adverse events were similar in the two groups. As expected, runny/stuffy nose occurred more frequently in children receiving CAIV-T and site of injection events occurred more frequently among those receiving TIV. In the analyses of medically significant wheezing, the only statistically significant difference was observed in children not previously vaccinated who were under two years of age after the first dose. In this analysis, the rate in the CAIV-T arm was 3.2 percent versus 2.0 percent in TIV recipients. In this same population, no significant difference was observed beyond 42 days after the last vaccination. The goal of the study was to provide the pivotal data to seek regulatory approval for use of the intranasal vaccine in children down to six months of age. This prospective, controlled, Phase 3 trial included approximately 8,500 children between the ages of six months and 59 months, including those with a history of asthma and wheezing. It was conducted at approximately 250 sites in North America, Europe and Asia.
The company also announced this fall that it is working with the National Institutes of Health under a Cooperative Research and Development Agreement to produce and test attenuated, live intranasal influenza vaccines against pandemic influenza strains. This effort will use MedImmune's proprietary reverse genetics technology, which allows researchers to remove potentially pathogenic portions of a pandemic virus, thereby making the vaccine and its production safer. In the interest of public health, MedImmune has granted use of its reverse genetics technology to U.S. and international health authorities for clinical research, and is offering licenses to vaccine manufacturers developing pandemic influenza vaccines.
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.
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 2,000 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 manufacturing and development of influenza vaccines. 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 disclosed in MedImmune's filings with the U.S. Securities and Exchange Commission, MedImmune can provide no assurance that it will be able to maximize the projected capacity of the new facility or that product that is produced will be approved for release by the U.S. Food and Drug Administration or other regulatory authorities. 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.MedImmune, Inc.
CONTACT: Media: Jamie Lacey, +1-301-398-4035, Investors: Peter Vozzo,+1-301-398-4358, both of MedImmune, Inc.