FDA Approves Cervarix, GlaxoSmithKline's Cervical Cancer Vaccine

PHILADELPHIA, Oct. 16 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK)
announced today that the U.S. Food and Drug Administration (FDA) has approved
CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine,
recombinant] 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).

"The approval of CERVARIX will bring an important new cervical cancer vaccine
to girls and young women," said Deirdre Connelly, President, North American
Pharmaceuticals, GlaxoSmithKline. "Immunization with a vaccine such as
CERVARIX -- along with annual doctor visits and Pap tests -- will help protect
women from cervical cancer, the second leading cause of cancer death in women
in their twenties and thirties."

CERVARIX was shown to be 93 percent efficacious in the prevention of cervical
pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma
in situ) associated with HPV 16 or 18, in women without evidence of current
infection with, or prior exposure to, the same HPV type at the time of
vaccination. The majority (approximately 75 percent) of cervical cancers in
North America are caused by HPV types 16 and 18.

The impact of CERVARIX against the overall burden of HPV-related cervical
disease results from a combination of efficacy against, and disease
contribution of, HPV-16, HPV-18, and oncogenic HPV types not included in the
vaccine. In a subgroup of clinical trial participants without oncogenic HPV
infection at the time of the first vaccination and without evidence of prior
exposure to HPV 16 and 18, the vaccine showed an overall efficacy of 70
percent against pre-cancerous lesions, regardless of HPV type. In an
additional analysis that assessed the impact of CERVARIX against specific HPV
types not included in the vaccine, in women without oncogenic HPV infection
with a specific type at the time of vaccination, approximately 89 percent
efficacy was observed in the prevention of precancerous lesions associated
with HPV type 31, the third most common cancer-causing virus type in North
America.

CERVARIX does not protect against disease caused by all HPV types.
Approximately 100 types of HPV have been identified to date and, of these,
approximately 15 virus types are known to cause cervical cancer.

"The FDA approval of a vaccine, such as CERVARIX, is an important development
in the prevention of cervical cancer," said Levi Downs, M.D., M.S.,
F.A.C.O.G., assistant professor in the Department of Obstetrics, Gynecology
and Women's Health, University of Minnesota, a clinical trial investigator and
consultant for GSK. "The treatment of cervical pre-cancers and cancer can be
devastating for women and their families. It's important for a vaccine to
help reduce the need for the invasive procedures often used to treat cervical
pre-cancers and cancers."

CERVARIX has a clinically acceptable safety profile. The most common local
adverse reactions and general adverse events in > or = 20 percent of clinical
trial participants were pain, redness and swelling at the injection site,
fatigue, headache, joint and muscle aching, and gastrointestinal symptoms.

The FDA's approval of CERVARIX was based on data from clinical trials in more
than 30 countries involving a diverse population of nearly 30,000 girls and
young women receiving CERVARIX.

CERVARIX is expected to be commercially available in the U.S. in late 2009.

About CERVARIX®
CERVARIX is administered to young women between the ages of 10-25 in a three
dose schedule that should be completed within six months of the initial 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
-- 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 vaccines 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
>
or = 20 percent 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.

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 www.gsk.com

Inquiries:

US Media inquiries: Jeff McLaughlin (919) 483 2839
Sarah Alspach (919) 483 2839
Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839

US Analyst/ Investor inquiries: Tom Curry (215) 751 5419
Jen Hill Baxter (215) 751 7002

UK Media inquiries: Philip Thomson (020) 8047 5502
Claire Brough (020) 8047 5502
Stephen Rea (020) 8047 5502
Alexandra Harrison (020) 8047 5502
Gwenan White (020) 8047 5502

European Analyst/Investor inquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503

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.

SOURCE GlaxoSmithKline

US Media: Jeff McLaughlin, or Sarah Alspach, or Mary Anne Rhyne, or Kevin
Colgan, all at +1-919-483-2839; or US Analysts/Investors: Tom Curry,
+1-215-751-5419; or Jen Hill Baxter, +1-215-751-7002; or UK Media: Philip
Thomson, or Claire Brough, or Stephen Rea, or Alexandra Harrison, or Gwenan
White, all at +44-020-8047-5502; or European Analysts/Investors: David
Mawdsley, +44-020-8047-5564; or Sally Ferguson, +44-020-8047-5543; or Gary
Davies, +44-020-8047-5503