30th Mar 2007 07:00
GlaxoSmithKline PLC29 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 hassubmitted a Biologics License Application (BLA) for CERVARIX(R) (humanpapillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidatevaccine, to the U.S. Food and Drug Administration (FDA). If licensed, thevaccine will be indicated for the prevention of cervical cancer and precancerouslesions associated with the most common cancer-causing human papillomavirustypes. For this candidate vaccine, GSK selected a novel proprietary adjuvantsystem called AS04, intended to enhance immune response and increase duration ofprotection. "Today's filing is an important milestone for GSK and reflects our commitment tohelp prevent cervical cancer, the second most common cancer among younger women," said JP Garnier, CEO of GlaxoSmithKline, one of the world's leading vaccinemanufacturers. "We believe that the best possible protection against cervicalcancer will include routine screening together with a vaccine designed toprovide targeted, durable protection against the most common cancer-causingvirus types." The BLA for the GSK cervical cancer candidate vaccine includes data fromclinical trials in almost 30,000 females 10 to 55 years of age and reflects anethnically diverse population. The submission also contains data from thelargest Phase III cervical cancer vaccine efficacy trial to date, which wasconducted 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, VicePresident and Director, North American Vaccine Development Organisation, atGlaxoSmithKline. "It includes a considerable amount of data for virus types 16and 18 that cause 70 percent of cervical cancer cases worldwide, as well as datafor other virus types that can lead to cervical cancer. We look forward topresenting study results in the coming months." The GSK cervical cancer candidate vaccine is formulated with a proprietaryadjuvant system called AS04, containing aluminum hydroxide and monophosphoryllipid A (MPL(R)). Published data have shown that the GSK cervical cancercandidate vaccine formulated with AS04 provides a stronger and longer lastingimmune response compared to the same GSK vaccine composition formulated with atraditional aluminum hydroxide adjuvant. About Cervical Cancer After breast cancer, cervical cancer is the second most frequently occurringcancer in women between the ages of 20 to 39 in the United States. The AmericanCancer Society estimates that in 2007 more than 11,000 women will be diagnosedwith cervical cancer and nearly 4,000 will die from this disease in the UnitedStates. Furthermore, approximately 2 million precancerous lesions are diagnosedeach 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) withthe U.S. Food and Drug Administration, GSK has submitted a marketingauthorisation 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 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. 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 withup to six diseases in one vaccine. Simon BicknellCompany Secretary29th 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 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 Reviewand 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 ExchangeRelated Shares:
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