GlaxoSmithKline Receives FDA 'Complete Response' Letter; Cervical Cancer Vaccine Hit by Delay
PHILADELPHIA, Dec. 17 -- GlaxoSmithKline announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX(R). A complete response letter 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 prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.
"We have already started addressing the questions and will be engaged in discussions 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 and constructive, and we are working diligently to resolve any outstanding questions to 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 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.
To date, CERVARIX(R) has been approved in 45 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 27 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007.
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)
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/media.
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 from up 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 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 2006.