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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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Blake Masterson

Freelance Writer, Journalist and Father of 5

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