GAITHERSBURG, Md., Oct 21, 2004 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it is increasing its planned delivery of
FluMist (Influenza Virus Vaccine Live, Intranasal) up to a total of three
million doses. Originally the company had completed production of 1.1 million
doses. In recent days and in response to the shortage of the injectable
influenza vaccine, MedImmune had discussed the feasibility of completing
production of additional doses at its Philadelphia facility from its bulk
vaccine material. In discussions this evening with Tommy Thompson, Secretary
of Health and Human Services (HHS), and Dr. Lester Crawford, Acting
Commissioner of the U.S. Food & Drug Administration (FDA), MedImmune described
the actions required to allow the delivery of FluMist expeditiously to U.S.
citizens in its attempt to help alleviate the current injectable vaccine
"Due to the extraordinary efforts of the FDA and HHS, we believe we can
increase our expected delivery of FluMist to a total of 3 million doses this
flu season," said David M. Mott, president and chief executive officer. "To
succeed in these efforts, we will need to work closely with the FDA to produce
and release 400,000 doses of FluMist per week for five consecutive weeks
beginning in early November."
The October 8, 2004 Morbidity and Mortality Weekly Report distributed by
the U.S. Centers for Disease Control and Prevention (CDC) stated that FluMist,
if available, should be encouraged for healthy persons who are aged 5-49 years
and are not pregnant, including health-care workers (except those who care for
severely immunocompromised patients in special care units) and persons caring
for children aged <6 months.
MedImmune also discussed with HHS and FDA its production plans for 2005
and beyond. In these discussions the company described what actions would be
needed before the end of this year to enable the company to increase its
production plan for 2005 from two to three million doses to eight to 10
million doses. The company currently has the capacity to produce up to 20
million doses of FluMist, and expects to be able to double that capacity to 40
million doses by 2007.
"We remain committed to continuing to work with Secretary Thompson and
public heath officials in doing everything that is reasonable and feasible to
increase our production," continued Mott. "We are also committed to
developing our next-generation, refrigerator-stable FluMist formulation, known
as CAIV-T, to demonstrate that it is the product of choice, particularly for
children. Toward this goal, we have already completed 42 clinical trials
involving more than 64,000 subjects for both FluMist and CAIV-T. We also have
eight more clinical trials currently underway involving an additional 70,000
subjects for these vaccines."
The company did not change its financial guidance issued earlier in the
day as a result of the late-breaking collaborative discussions with health
authorities as it is too early to know how many, if any, of the additional
doses produced will actually be sold. MedImmune's financial guidance released
earlier today assumed that one to two million doses of FluMist would be sold
during the 2004 influenza season.
In a typical year, influenza is responsible for an average of 36,000
deaths (primarily in the elderly) and 200,000 hospitalizations in the United
States. Children have the highest rates of influenza infection of any age
group during the flu season and are important disseminators of the influenza
virus into communities. According to the Centers for Disease Control and
Prevention (CDC), 152 children younger than 18 years of age died in the United
States from influenza and its complications during the 2003-2004 flu season.
Seventy-one percent of these children had no high-risk medical conditions, as
defined by the CDC. Influenza vaccination of all healthy children 6-23 months
of age and their close contacts is now routinely recommended by the CDC's
Advisory Committee on Immunization Practices.
FluMist was approved by the FDA in June 2003. It is the first live,
attenuated influenza vaccine 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
There are risks associated with all vaccines, including FluMist. FluMist
does not protect 100-percent of individuals vaccinated, or may not protect
against viral strains not represented in the vaccine. 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-Barri
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. See Prescribing Information for indications and usage, dosage and
administration and safety 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 pediatric infectious
diseases, cancer and inflammatory diseases. With approximately 1,900
employees worldwide, MedImmune is headquartered in Maryland. For more
information, visit the company's website at http://www.medimmune.com.
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties. 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. The company is developing several products for potential
future marketing. 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.
SOURCE MedImmune, Inc.
Media, Jamie Lacey, +1-301-398-4035, or Investors, Peter Vozzo,
+1-301-398-4358 or John Filler, +1-301-398-4086, all of MedImmune