LONDON and PHILADELPHIA, June 30 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE: GSK) today provided the following update regarding
its application to the U.S. Food and Drug Administration (FDA) for approval
of CERVARIX(R), its vaccine to prevent cervical cancer.
GSK has submitted its response to questions raised by the FDA in their
Complete Response Letter, received in December, 2007. In addition, given
that final data from GSK's Phase III pivotal efficacy study, HPV-008, are
expected to be available later this year, GSK has decided to augment its
application for approval with these data to ensure they are included in the
U.S. label. GSK anticipates submitting these data in the first half of
2009. The timing depends on reaching a certain number of cases in order to
conduct the final analysis. An FDA action on the application is expected to
take up to six months following this submission. Interim data from this
study were filed in the original application for the vaccine in March,
2007. The company does not expect that new clinical studies will be
required for approval.
"Study 008 is a key study that will be completing later this year, and
we expect the final results will strengthen the U.S. label for
CERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, North
American Vaccine Development, GlaxoSmithKline. "We continue to have
positive and productive discussions with the FDA and remain confident in
the vaccine's safety and efficacy profile. We look forward to bringing this
important new cervical cancer vaccine to girls and women in the U.S."
To date, GSK's cervical cancer vaccine has been approved in 67
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 35 additional countries
including Japan. GSK also submitted the vaccine 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.
GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global
vaccine manufacturer committed to preventing disease in people of all ages
with innovative vaccines and delivery systems. The division, headquartered
in Belgium, is active in vaccine research, development and production with
more than 30 vaccines currently available globally and 20 more in
development. In 2007 GSK Biologicals distributed 1.1 billion doses of
vaccines -- an average of 3 million doses a day.
CERVARIX(R) is a registered trademark of the GlaxoSmithKline group of
companies.
GSK cautionary statement regarding forward-looking statements
Under the safe harbour 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 2007.
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
SOURCE GlaxoSmithKline
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http://www.who.int/vaccine_research/diseases/hpv/en
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