- Primary Endpoint Achieved Demonstrating Equivalent Immune Response -
GAITHERSBURG, Md., June 16 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that the primary objective was met in a Phase 3
study evaluating the immunogenicity of two different formulations of its live,
attenuated intranasal influenza vaccine. Preliminary results indicate that the
currently approved frozen formulation, known as FluMist (Influenza Vaccine
Live, Intranasal), and the investigational, next-generation refrigerator
stable formulation, CAIV-T (cold adapted influenza vaccine, trivalent),
produced similar immune responses. Additional analyses of primary and
secondary endpoints are ongoing and final results are expected to be submitted
to the U.S. Food and Drug Administration later this year for review.
"We are pleased that this bridging study has met its primary objective
demonstrating comparable immunogenicity between FluMist and CAIV-T," said
Edward M. Connor, M.D., executive vice president and chief medical officer.
"Completing this Phase 3 study is the key step in our plan to seek U.S.
regulatory approval for CAIV-T in healthy individuals 5 to 49 years of age and
replace the frozen formulation of FluMist in the marketplace. Additional
studies are ongoing to assess CAIV-T compared to the injectable flu vaccine in
children from 6 months to 5 years of age."
The Phase 3 double-blind study was designed to demonstrate equivalent
immunogenicity (using strain-specific geometric mean titers) of CAIV-T and
FluMist in healthy individuals between the ages of 5 and 49 years. The study
randomized 980 participants at 26 sites in the United States to receive either
CAIV-T or FluMist. Children between the ages of 5 and 8 years of age (n=414)
received two doses of vaccine, while participants 9 years of age and older (n=
566) received one dose of vaccine. Immunogenicity was evaluated by measuring
antibody levels in blood serum (specifically, serum HAI antibodies) to each of
the three influenza strains contained in the vaccines. Serum samples were
obtained from all participants prior to receipt of the first dose and then
again 28 to 35 days after the last dose of the vaccine. Study results
indicated that CAIV-T and FluMist showed equivalent post-vaccination HAI
antibody titers for all three vaccine strains.
FluMist was approved by the FDA in June 2003. It is the first live,
attenuated influenza vaccine in the U.S. that 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 placebo-controlled clinical trials, the most
common solicited adverse events in the indicated population (n=2,762) included
runny nose/nasal congestion, headache, cough, sore throat, tiredness/weakness,
irritability, decreased activity and muscle aches. For full prescribing
information for FluMist, see the company's website at
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 approximately 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 results of clinical trials for
FluMist and CAIV-T. 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 discussed in MedImmune's filings with the
U.S. Securities and Exchange Commission, MedImmune can provide no assurance
that FluMist will be commercially successful. In addition, no assurance
exists that development efforts for CAIV-T will succeed, that CAIV-T will
receive required regulatory approval or that, even if regulatory approval is
received, CAIV-T will be commercially successful. 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
all of MedImmune, Inc.