- Bulk Production Capacity Expanded to Up to 90 Million Doses of FluMist(R)
GAITHERSBURG, Md., Dec. 27 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) 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
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 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.
SOURCE MedImmune, Inc.
CONTACT: Media: Jamie Lacey, +1-301-398-4035, Investors: Peter Vozzo,
+1-301-398-4358, both of MedImmune, Inc.