MedImmune, Inc.
(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has approved the company's new refrigerated formulation of FluMist(R)
(Influenza Virus Vaccine Live, Intranasal) for use in helping to prevent
influenza in healthy children and adults from 5 years to 49 years of age.
"Large and well-controlled clinical trials have shown FluMist to be an
effective and well-tolerated option to help prevent influenza disease in
healthy children and adults," stated Frank M. Malinoski, M.D., Ph.D.,
senior vice president, medical and scientific affairs. "We are confident
that the approval of our refrigerated formulation for FluMist will
encourage more healthcare providers to offer FluMist to their customers and
patients. The new formulation can be conveniently stored in a standard
refrigerator rather than frozen, as previously required. We recognize that
the frozen storage presented difficulties for some physician practices as
well as for providers who administer vaccine in places like schools,
pharmacies and grocery stores, and we are confident that this improvement
will enhance access to this important vaccine."
FluMist has been marketed in a frozen formulation since its original
FDA approval in 2003, and millions of doses have been distributed and
administered. The newly approved formulation of FluMist, known in clinical
studies as CAIV-T (cold adapted influenza vaccine-trivalent), will be
available for the 2007-2008 influenza season. Both formulations are free of
preservatives, including thimerosal.
Next MedImmune Goal for FluMist: Expanding the Pediatric Label
To date, 42 clinical trials involving approximately 60,000 individuals
have been conducted, including children as young as 6 weeks of age and
adults up to 98 years of age. In a recently completed pivotal Phase 3 study
involving approximately 8,500 children between 6 months and 59 months of
age, FluMist demonstrated a statistically significant 55 percent relative
reduction in the incidence of influenza illness caused by any influenza
strain including both matched and mismatched strains when compared to the
injectable influenza vaccine (TIV). This study was conducted during the
2004-2005 influenza season in the U.S., Europe and Asia and it was
submitted in July 2006 to the FDA as the basis of MedImmune's request to
expand the age indication for FluMist to include children as young as one
year of age who do not have a history of wheezing or asthma.
Pending the FDA's approval of an expanded age indication, MedImmune
plans to increase production of its new formulation of FluMist for the
2007-2008 season. MedImmune anticipates shipping its first doses in 2007 in
time for physicians to start vaccinating patients as early as August.
About FluMist
FluMist is currently 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. As with any vaccine, FluMist does not protect 100 percent of
individuals vaccinated and may not protect against viral strains not
contained in the vaccine.
Under no circumstances should FluMist be administered as an injection
(i.e. parenterally). FluMist is contraindicated in persons with
hypersensitivity to any component of the vaccine, including eggs; in
children and adolescents receiving aspirin therapy or aspirin-containing
therapy; in individuals with a history of Guillain-Barre syndrome; and in
individuals with known or suspected immune deficiency. The safety and
efficacy of FluMist have not been established in pregnant women or for
patients with chronic underlying medical conditions, including asthma or
reactive airways disease; the vaccine should not be administered to these
patients.
In randomized, placebo-controlled clinical trials of FluMist in its
refrigerated and frozen formulations, the most common solicited adverse
events in the indicated population (n=11,604) included runny nose/nasal
congestion, sore throat, cough, irritability, headache, chills, vomiting,
muscle aches, decreased appetite, abdominal pain, and decreased
activity/feeling of tiredness/weakness.
For information for indications and usage, dosage and administration,
and safety information, please see the current Prescribing Information at flumist/pdf/prescribinginfo.pdf, visit flumist, 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 medimmune/ .
This announcement contains, in addition to historical information,
certain "forward-looking statements" regarding the potential prospects of
FluMist and the results of clinical trials for 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, no assurance exists that FluMist will receive required
regulatory approval for children 12 months to 59 months of age or that,
even if regulatory approval is received, FluMist 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.
MedImmune, Inc.
medimmune/
View drug information on FluMist.