Cervarix US Filing
GlaxoSmithKline PLC
29 March 2007
GLAXOSMITHKLINE SUBMITS BIOLOGICS LICENSE APPLICATION
TO U.S. FOOD AND DRUG ADMINISTRATION FOR CERVARIX(R)
New Vaccine Candidate Developed to Protect Against Cervical Cancer -
Filing Includes Data from Almost 30,000 Females
LONDON, March 29, 2007 - GlaxoSmithKline announced today that the company has
submitted a Biologics License Application (BLA) for CERVARIX(R) (human
papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidate
vaccine, to the U.S. Food and Drug Administration (FDA). If licensed, the
vaccine will be indicated for the prevention of cervical cancer and precancerous
lesions associated with the most common cancer-causing human papillomavirus
types. For this candidate vaccine, GSK selected a novel proprietary adjuvant
system called AS04, intended to enhance immune response and increase duration of
protection.
"Today's filing is an important milestone for GSK and reflects our commitment to
help prevent cervical cancer, the second most common cancer among younger women,
" said JP Garnier, CEO of GlaxoSmithKline, one of the world's leading vaccine
manufacturers. "We believe that the best possible protection against cervical
cancer will include routine screening together with a vaccine designed to
provide targeted, durable protection against the most common cancer-causing
virus types."
The BLA for the GSK cervical cancer candidate vaccine includes data from
clinical trials in almost 30,000 females 10 to 55 years of age and reflects an
ethnically diverse population. The submission also contains data from the
largest Phase III cervical cancer vaccine efficacy trial to date, which was
conducted around the world in more than 18,000 females 15 to 25 years of age.
"We are pleased to submit this file to the FDA," said Barbara Howe, MD, Vice
President and Director, North American Vaccine Development Organisation, at
GlaxoSmithKline. "It includes a considerable amount of data for virus types 16
and 18 that cause 70 percent of cervical cancer cases worldwide, as well as data
for other virus types that can lead to cervical cancer. We look forward to
presenting study results in the coming months."
The GSK cervical cancer candidate vaccine is formulated with a proprietary
adjuvant system called AS04, containing aluminum hydroxide and monophosphoryl
lipid A (MPL(R)). Published data have shown that the GSK cervical cancer
candidate vaccine formulated with AS04 provides a stronger and longer lasting
immune response compared to the same GSK vaccine composition formulated with a
traditional aluminum hydroxide adjuvant.
About Cervical Cancer
After breast cancer, cervical cancer is the second most frequently occurring
cancer in women between the ages of 20 to 39 in the United States. The American
Cancer Society estimates that in 2007 more than 11,000 women will be diagnosed
with cervical cancer and nearly 4,000 will die from this disease in the United
States. Furthermore, approximately 2 million precancerous lesions are diagnosed
each year in the United States.
The GSK Cervical Cancer Candidate Vaccine Around the World
In addition to the Biologics License Application submitted for CERVARIX(R) with
the U.S. Food and Drug Administration, GSK has submitted a marketing
authorisation application to the European Medicines Agency (EMEA), Australia,
Canada, and major countries in Asia and Latin America.
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 www.gsk.com.
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 with
up to six diseases in one vaccine.
Simon Bicknell
Company Secretary
29th March 2007
For further information please contact:
European Analyst/Investor enquiries: Anita Kidgell +44 20 8047 5542
Sally Ferguson +44 20 8047 5543
David Mawdsley +44 20 8047 5564
US Analyst/ Investor enquiries: Frank Murdolo +1 215 751 7002
Tom Curry +1 215 751 5419
UK Media enquiries: Philip Thomson +44 20 8047 5502
Alice Hunt +44 20 8047 5502
Gwenan White +44 20 8047 5502
U.S. Media inquiries: Nancy Pekarek +1 919 483 2839
Mary Anne Rhyne +1 919 483 2839
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
and Prospects' in the company's Annual Report on Form 20-F for 2006.
This information is provided by RNS
The company news service from the London Stock Exchange M