MedImmune Receives Complete Response Letter From FDA For New Formulation Of FluMist(R)

MedImmune, Inc.
(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has issued a Complete Response Letter (CRL) for a supplemental
biologics license application (sBLA) related to the new formulation of
FluMist (Influenza Virus Vaccine Live, Intranasal) for the current approved
indication. With the sBLA, MedImmune is seeking approval to use
refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) in
preventing influenza in healthy individuals 5 to 49 years of age. The FDA
is requesting clarification and additional information relating to data
previously submitted.


"Based on our review of the letter received, we expect to fully respond
to the agency within two to four weeks," said Linda J. Peters, senior vice
president, regulatory affairs. "We are confident that our continued
interaction with the FDA will result in approval of the new formulation of
our intranasal vaccine in advance of the 2007-2008 influenza season. CAIV-T
will bring an added level of convenience to administering the vaccine and
establish the basis upon which the company plans to expand the product's
label."


MedImmune plans to submit a separate sBLA to the FDA within the next
few weeks requesting an expanded label for FluMist. This sBLA will include
data from a Phase 3 study involving approximately 8,500 children between 6
months and 59 months of age.


Ms. Peters added, "We remain on track with our plans to launch in time
for the 2007-2008 influenza season an improved formulation of our
intranasal influenza vaccine with an expanded indication down to one year
of age."


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: flumist/pdf/prescribinginfo.pdf or visit
flumist


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.


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 2,300 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 regulatory approval
process and development plans 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 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.


MedImmune, Inc.

medimmune


View drug information on FluMist.

Buy Erythromycin Without Prescription