MedImmune Files Investigational New Drug Application for Cell Culture-Based Influenza Vaccine
Company Reaches Key Milestone in Commitment to HHS
and National Pandemic Preparedness
GAITHERSBURG, Md., Nov. 9 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has filed an investigational new drug
application (IND) with the U.S. Food and Drug Administration (FDA) to begin
human clinical testing of a cell culture-based seasonal influenza vaccine
using its proprietary live, attenuated, needle-free influenza vaccine
technology. The filing represents a milestone under the terms of a five-year,
$170-million contract with the U.S. Department of Health and Human Services
(HHS).(1)
MedImmune's currently marketed influenza vaccine, FluMist(R) (Influenza
Virus Vaccine Live, Intranasal), is now made using chicken eggs, as are all
other U.S.-approved influenza vaccines. Vaccine manufacturers have been using
eggs for production for decades; however, using chicken eggs as the production
medium limits scalability in manufacturing and increases the potential risk of
manufacturing delays or supply shortages. A severe outbreak of avian
influenza could kill the flocks used to produce the eggs that would be used
for vaccine production. To address these concerns, MedImmune will be applying
state-of-the-art cell culture-based manufacturing methods to produce influenza
vaccines without the need for chicken eggs. The success of this technology
will reduce production times and substantially increase MedImmune's U.S.-based
manufacturing capacity to provide influenza vaccine to the U.S. population.
After adding the cell culture-based production capability for its influenza
vaccine, MedImmune anticipates having the capacity to produce 300 million
monovalent bulk doses of a pandemic vaccine annually by 2012.
"MedImmune is pleased to reach this important step in our collaboration
with the U.S. government," said James F. Young, president, research and
development. "MedImmune's commitment to preparing the country to be protected
against influenza illness annually and in the event of a pandemic is stronger
than ever, and we are encouraged by the momentum of our research and
development efforts."
Under the terms of the contract awarded earlier this year, MedImmune
submitted a master product development plan to HHS on November 2, 2006
detailing the company's tactical approach from preclinical testing phases of
its cell culture-based vaccine through regulatory licensure. The plan sets
forth specific activities related to facility and manufacturing upgrade
compliance, as well as vaccine development milestones. The first study of a
cell culture- produced seasonal vaccine will characterize safety and
immunogenicity in a placebo-controlled trial.
MedImmune is playing an important role in contributing to the nation's
armamentarium against both annual seasonal and pandemic influenza. Each year,
influenza is responsible for up to 60 million infections,(2) resulting in
about 25 million doctors' office visits and hospital stays.(3) Between 1990
and 1999, about 36,000 Americans died from the flu and its complications each
year. There is increasing concern that a particularly virulent strain of flu
could create a national or worldwide pandemic, leading to high levels of
illness, death, social disruption, and economic loss, according to the Centers
for Disease Control and Prevention (CDC). MedImmune's research in the
influenza field seeks to continue to market and develop products for the very
real threats of existing seasonal influenza, while looking into the future at
ways to protect Americans against even more dangerous forms of the virus.
MedImmune's other recent influenza vaccine development activities include:
- The FDA is currently reviewing a supplemental biologics licensing
application (sBLA) to switch formulations from frozen FluMist, currently
approved in healthy individuals 5 to 49 years of age, to the
refrigerator-stable cold adapted influenza vaccine, trivalent (CAIV-T)
formulation of FluMist for the same population. Pending timely
approval, the company plans to launch the refrigerator-stable
formulation for the 2007-2008 flu season.
- MedImmune has also submitted a separate sBLA to the FDA seeking an
expanded label for CAIV-T for use in children between 12 months and 59
months of age who do not have a history of wheezing or asthma. A
response from the FDA for this sBLA is anticipated in the second quarter
of 2007 and pending positive outcome, MedImmune plans to commercially
provide CAIV-T for the expanded population for the 2007-2008 influenza
season. The company is hopeful that the FDA will review the sBLA for
CAIV-T label expansion expeditiously in order to prepare to vaccinate
the children identified by the CDC as being at the highest risk of
influenza disease as early as possible in the 2007-2008 season.
- MedImmune received approval from the FDA in July 2006 to utilize reverse
genetics technology in the development of seasonal and pandemic vaccines
and has offered to license key intellectual property for this technology
to governmental organizations and companies. For pandemic vaccines,
reverse genetics can be particularly important because the technology
allows vaccine manufacturers to work with a segment of the infectious
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.
- In June 2006, MedImmune, in collaboration with the National Institute of
Allergy and Infectious Diseases, initiated a Phase 1 study of a
monovalent, egg-based live, attenuated intranasal vaccine against the
avian H5N1 under a cooperative research and development agreement
(CRADA) with the National Institutes of Health (NIH). Under the CRADA,
MedImmune is developing a library of prototype vaccines representing
each HA subtype of pandemic potential and, in cooperation with the NIH,
evaluating prototype vaccines in phase 1 clinical trials.
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 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 (4.4 - 11.1 percent increase) and a
higher incidence of injection site reactions in those receiving the flu shot
(3.6 - 7.6 percent increase). A statistically significant increase in the
incidence of medically significant wheezing was seen in CAIV-T recipients 6
months to 23 months of age within 42 days following vaccination. Post-hoc
analyses showed higher all-cause hospitalizations occurring through 180 days
after vaccination in CAIV-T recipients 6 months to 11 months of age. Risk-
benefit analyses showed a favorable profile for CAIV-T as compared to TIV in
children 12 months to 59 months of age without a prior history of wheezing or
asthma.
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 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 2,500 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.
(1) This project has been funded in whole or in part with Federal funds
from the Office of Public Health Emergency Preparedness, Office of
Research and Development Coordination, under Contract No.
HHS0100200600010C.
(2) Centers for Disease Control and Prevention.
(3) Couch RB. Influenza: prospects for control. Annals of Internal
Medicine. 2000; 133:992-998
SOURCE MedImmune, Inc.
CONTACT: Media: Karen Lancaster, +1-301-398-5864 or Jamie Lacey,
+1-301-398-4035, or Investors: Peter Vozzo, +1-301-398-4358, all of MedImmune,
Inc.