PHILADELPHIA, Dec. 17 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) announced today that it has received a complete response letter from
the U.S. Food and Drug Administration related to its application for the
cervical cancer vaccine, CERVARIX(R). A complete response letter is issued
by FDA's Center for Biologics Evaluation and Research (CBER) when the
review of a file is completed and questions remain to be answered prior to
approval. GSK will work closely with the FDA to prepare its response, which
it intends to submit to the agency as soon as possible.
"We have already started addressing the questions and will be engaged
in discussions with the FDA to finalize our responses," said Barbara Howe,
M.D., Vice President and Director, North American Vaccine Development,
GlaxoSmithKline. "Our discussions with the agency continue to be positive
and constructive, and we are working diligently to resolve any outstanding
questions to bring CERVARIX(R) to the U.S. market."
The application filed for the GSK cervical cancer vaccine included
safety, efficacy and immune response data from clinical trials involving
almost 30,000 females 10 to 55 years of age from ethnically and racially
diverse populations.
To date, CERVARIX(R) has been approved in 45 countries around the world
including the 27 member countries of the European Union, Mexico, Australia,
Singapore and the Philippines. Licensing applications have been submitted
in more than 27 additional countries including Japan. GSK also submitted
CERVARIX(R) to the World Health Organization (WHO) for prequalification in
September 2007.
Notes to Editors
Burden of Cervical Cancer
Worldwide, more than 500,000 women will be newly diagnosed with
cervical cancer and over 280,000 women will die from it each year.(1) In
the United States, after breast cancer, cervical cancer is the second
leading cause of cancer death in women ages 20 to 39.(2)
About GlaxoSmithKline
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, please visit http://www.gsk.com/media.
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 3 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.
CERVARIX(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk
Factors' in the 'Business Review' in the company's Annual Report on Form
20-F for 2006.
References:
1. World Health Organization. Initiative for Vaccine Research.
http://www.who.int/vaccine_research/diseases/hpv/en/ Accessed on May
2, 2007.
2. Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005.
Cancer Journal for Clinicians 2005; 55; 10-30
Enquiries:
UK Media enquiries: Philip Thomson (020) 8047 5502
Alice Hunt (020) 8047 5502
Joss Mathieson (020) 8047 5502
Claire Brough (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Liad Diamond (919) 483 2839
European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Biologicals: Stella Gu +32 2 656 3533
Alice Grasset +32 2 656 8774
SOURCE GlaxoSmithKline
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CONTACT:
UK Media enquiries: Philip Thomson, Alice
Hunt, Joss Mathieson, or Claire Brough, (020)-8047-5502, US Media
enquiries: Nancy Pekarek, +1-215-751-7709, Mary Anne Rhyne, or
Liad Diamond, +1-919-483-2839, European Analyst/Investor
enquiries: David Mawdsley, (020)-8047-5564, or Sally Ferguson
(020)-8047-5543, US Analyst/ Investor enquiries: Frank Murdolo,
+1-215-751 7002, Tom Curry, +1-215-751-5419, Biologicals: Stella
Gu, +32-2-656-3533, or Alice Grasset, +32-2-656-8774, all of
GlaxoSmithKline
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