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GSK Begins Shipments of Fluarix(R) and FluLaval(R) to U.S. Customers for 2008-2009 Influenza Season
2008-08-11 13:27:00
GSK Begins Shipments of Fluarix(R) and FluLaval(R) to U.S. Customers for 2008-2009 Influenza Season
GSK anticipates delivery of at least half of shipments by the end of August
PHILADELPHIA, Aug. 11 /EMWNews/ -- GlaxoSmithKline (NYSE:
GSK) today announced that it will begin shipment of FLULAVAL(R) [Influenza
Virus Vaccine] and FLUARIX(R) [Influenza Virus Vaccine] to U.S. customers
for the 2008-2009 influenza season. The U.S. Food and Drug Administration's
(FDA) Center for Biologics Evaluation and Research (CBER) released the
first lots of FLULAVAL and FLUARIX, allowing distribution to begin. GSK
plans to supply the U.S. market with approximately 35 million doses of the
two products combined -- an increase from last year, when GSK contributed
approximately 33 million doses.
GSK anticipates delivery of at least half of its influenza vaccines by
the end of August and the vast majority to be shipped to customers by the
end of September.
"GSK is committed to continually raising awareness of the role of
influenza vaccination in helping to keep people healthy," said David
Pernock, Senior Vice President, GlaxoSmithKline. "We are excited to play an
integral part in helping adults protect themselves against this serious
infection."
FLUARIX is available for purchase on GSKVaccinesDirect.com. FLULAVAL is
available for purchase on GSKVaccinesDirect.com or through three
distributors -- Henry Schein, Inc., McKesson Medical-Surgical and ASD
Specialty Healthcare.
About Influenza
Influenza, or the flu, is primarily passed from one person to another
through the air by droplets released when an infected individual coughs or
sneezes, but may also be spread by direct contact with flu
virus-contaminated surfaces.
According to the U.S. Centers for Disease Control and Prevention (CDC),
annual flu vaccination is the most effective method for preventing flu
virus infection and its complications. The CDC recommends an annual flu
vaccination for anyone who wishes to reduce their risk of contracting the
flu -- especially adults over 50 years of age, women who will be pregnant
during the flu season and anyone with chronic health conditions, such as
heart disease, asthma, chronic obstructive pulmonary disease (COPD) and
diabetes. The CDC also recommends annual vaccination for caregivers and
household contacts of these high-risk groups, such as relatives and
healthcare workers. In fact, approximately 83 percent of the U.S.
population is included in one or more of the target groups that the CDC
recommends to receive the vaccination; however, less than 40 percent of the
U.S. population received a flu vaccination during 2007-2008.
The beginning, severity and length of the flu season can vary widely
from year to year. According to CDC data, the peak in flu activity between
the years 1976 and 2008 frequently occurs after December, most commonly in
February. In general, healthcare providers should begin offering
vaccination soon after the vaccine becomes available and if possible by
October. The CDC recommends an extended vaccination effort, with
vaccination offered at every opportunity throughout the flu season.
About FLUARIX and FLULAVAL
FLUARIX and FLULAVAL are indicated for active immunization of adults
(18 years of age and older) against influenza disease caused by influenza
virus subtypes A and type B contained in the vaccines. These indications
are based on immune response, and there have been no controlled trials
demonstrating a decrease in influenza disease after vaccination with these
products. FLUARIX and FLULAVAL are not indicated for use in children.
Important Safety Information
FLUARIX and FLULAVAL should not be administered to anyone with known
systemic hypersensitivity reactions to eggs, egg products, egg or chicken
proteins, or any component of the vaccines. FLUARIX and FLULAVAL should not
be administered to anyone who has had a life-threatening reaction to
previous administration of any influenza vaccine. Immunization should be
delayed in anyone with an acute evolving neurologic disorder, but should be
considered when the disease process has been stabilized.
In a clinical trial with FLUARIX, adverse events included pain and
redness at the injection site, muscle aches and fatigue. In clinical trials
with FLULAVAL, the most common adverse events were pain, redness, and/or
swelling at the injection site and headache, fatigue, myalgia, fever and
malaise. Most adverse events in clinical trials were mild and self-limited.
(See adverse reactions section of the Prescribing Information for each
product for other potential adverse events.)
Vaccination with FLUARIX or FLULAVAL may not protect 100 percent of
susceptible individuals. If Guillain-Barre syndrome has occurred within six
weeks of receipt of prior influenza vaccine, the decision to give FLUARIX
or FLULAVAL should be based on careful consideration of the potential
benefits and risks.
GlaxoSmithKline: A Leader in Flu
GlaxoSmithKline has an active research and development program targeted
at both seasonal and pandemic flu and has recently invested more than $2
billion to expand capacity for manufacturing its flu vaccines FLUARIX and
FLULAVAL and its antiviral flu medication Relenza(R) (zanamivir for
inhalation). GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research
Triangle Park, NC, is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. GSK Biologicals (GSK Bio), one of the world's leading vaccine
manufacturers, is headquartered in Rixensart, Belgium, where the majority
of GlaxoSmithKline's activities in the field of vaccine research,
development and production are conducted. GSK Bio employs more than 1,500
scientists, who are devoted to discovering new vaccines and developing more
cost-effective and convenient combination products to prevent infections
that cause serious medical problems worldwide. In 2006, GSK Bio distributed
more than 1.1 billion doses of vaccines to 169 countries in both the
developed and the developing world -- an average of three million doses a
day. Of those vaccine doses, approximately 136 million were doses of
combination pediatric vaccines which protect the world's children from up
to six diseases in one vaccine.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
Enquiries:
Media enquiries: Jeff McLaughlin (215) 751 4890
Nancy Pekarek (215) 751 7709
Mary Ann Rhyne (919) 483 2839
Sarah Alspach (215) 751 7709
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors that may
affect GSK's operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2007.
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Registered Office:
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Brentford, Middlesex
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