17th Dec 2007 07:00
GlaxoSmithKline PLC17 December 2007 Issued - December 17, 2007, London, UK & Philadelphia, US GLAXOSMITHKLINE RECEIVES FDA 'COMPLETE RESPONSE' LETTER FOR CERVICAL CANCER VACCINE GlaxoSmithKline (NYSE: GSK) announced today that it has received a completeresponse letter from the U.S. Food and Drug Administration related to itsapplication for the cervical cancer vaccine, CERVARIX(R). A complete responseletter 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 priorto approval. GSK will work closely with the FDA to prepare its response, whichit intends to submit to the agency as soon as possible. "We have already started addressing the questions and will be engaged indiscussions 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 andconstructive, and we are working diligently to resolve any outstanding questionsto 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 30,000females 10 to 55 years of age from ethnically and racially diverse populations. To date, CERVARIX(R) has been approved in 45 countries around the worldincluding the 27 member countries of the European Union, Mexico, Australia,Singapore and the Philippines. Licensing applications have been submitted inmore than 27 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007. S M BicknellCompany Secretary17th December 2007 Notes to Editors Burden of Cervical Cancer Worldwide, more than 500,000 women will be newly diagnosed with cervical cancerand over 280,000 women will die from it each year.1 In the United States, afterbreast cancer, cervical cancer is the second leading cause of cancer death inwomen ages 20 to 39.2 About GlaxoSmithKline GlaxoSmithKline-one of the world's leading research-based pharmaceutical andhealthcare companies-is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For companyinformation, please visit www.gsk.com/media. GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, isheadquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline'sactivities in the field of vaccine research, development and production areconducted. GSK Bio employs more than 1,500 scientists, who are devoted todiscovering new vaccines and developing more cost-effective and convenientcombination products to prevent infections that cause serious medical problemsworldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccinesto 169 countries in both the developed and the developing world - an average of3 million doses a day. Of those vaccine doses, approximately 136 million weredoses of combination pediatric vaccines which protect the world's children fromup 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 LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisAnnouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup'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 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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