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On October 16, 2009, the Food and Drug Administration (FDA) approved CERVARIX for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).
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"It's estimated that this year, ten women will die every day from cervical cancer in the U.S.," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "The ACIP recommendation for CERVARIX underscores how important it is for girls and young women to be vaccinated to help reduce the burden of this devastating cancer."
Additionally, the ACIP unanimously recommended to provide funding for CERVARIX from the Vaccines for Children (VFC) program. The federally funded program provides vaccines at no cost to children up through 18 years of age who might not otherwise be vaccinated because of inability to pay. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the ACIP.
CERVARIX is expected to be commercially available in the U.S. in late 2009.
About CERVARIX®( )
CERVARIX is administered to girls and young women between the ages of 10-25 in a three dose schedule with the second and third doses administered one and six months after the first dose. To date, CERVARIX has been approved in 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. GSK also received World Health Organization (WHO) prequalification in July 2009.
CERVARIX®( ) (Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) is a registered trademark of the GlaxoSmithKline group of companies.
Important Safety Information
About Cervical Cancer
Women are at risk of HPV infection and cervical cancer throughout their lives. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. While the majority of cervical cancers in North America are caused by HPV types 16 and 18, approximately 25 percent of all cervical cancers are caused by other oncogenic HPV types. Infection with cancer-causing virus types can lead to abnormal Pap tests, cervical pre-cancers and cervical cancer.
Cervical cancer is the second leading cause of cancer death in women in their twenties and thirties. ( )The American Cancer Society estimates that in 2009, in the U.S. approximately 11,000 women will be diagnosed with cervical cancer and 4,000 women will die from the disease, regardless of age. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year.
GlaxoSmithKline Biologicals - GSK Biologicals, GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world -- an average of 3 million doses a day.
Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.
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 further information please visit http://us.gsk.com
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 2008.
-- CERVARIX is contraindicated in patients with severe allergic reactions to any component of the vaccine. -- CERVARIX is not recommended for use in pregnant women. -- Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. -- The most common local adverse reactions and general adverse events in greater than or equal to 20% of subjects were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. -- Vaccination with CERVARIX may not result in protection in all vaccine recipients.
SOURCE GlaxoSmithKline
