U.S. Government Award Highlights Importance of MedImmune's Live, Attenuated Intranasal Vaccine Technology to Protect Nation Against Annual and Pandemic InfluenzaGAITHERSBURG, Md., May 4, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- MedImmune, Inc.
(Nasdaq: MEDI), 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(R) (Influenza Virus Vaccine Live,
Intranasal).
(Photo: http://www.newscom.com/cgi-bin/prnh/20060504/DCTH019 )
"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(R) (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
http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.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.
About Synagis
Synagis is indicated for the prevention of serious lower respiratory tract
disease caused by RSV in pediatric patients at high risk of RSV disease, which
is prominent in the Northern Hemisphere during the winter months. Synagis is
a humanized monoclonal antibody given by an intramuscular injection once a
month during the RSV season. Synagis was approved in 1998 by the FDA; in
1999, by the European Medicines Evaluation Agency; and in 2002, by the
Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded the
U.S. label for Synagis for use in young children with hemodynamically
significant congenital heart disease at risk of RSV disease. To date, Synagis
has been approved in 62 countries, including the United States. Synagis has
been used in more than half a million babies since 1998. Adverse events with
Synagis may include upper respiratory tract infection, ear infection, fever,
runny nose, rash, diarrhea, cough, vomiting, gastrointestinal upset and
wheezing. Very rare cases of severe allergic reactions such as anaphylaxis
(less than 1 case per 100,000 patients) have been reported following re-
exposure to Synagis. Rare severe, acute hypersensitivity reactions have also
been reported on initial exposure or re-exposure to Synagis. Synagis should
not be used in patients with a history of a severe prior reaction to Synagis
or its components. For full prescribing information for Synagis, see the
company's website at (http://www.medimmune.com/products/synagis/index.asp).
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 2,200 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. In addition, the amount of funding
actually available under a government contract may be affected by a number of
factors including, but not limited to, the funds available to HHS for this
purpose and the amounts actually expended by the company in performance of the
contract. As such, there can be no assurance that the full amount of expected
funding will be provided under the contract or that that the government will
not terminate the contract early.
SOURCE MedImmune, Inc.
Media: Clarencia Stephen, +1-301-398-4073, or Jamie Lacey, +1-301-398-4035;
Investors: Peter Vozzo, +1-301-398-4358, all of MedImmune, Inc.