GlaxoSmithKline submits Biologics License Application (BLA) for CERVARIX

Apr 1 2007

GlaxoSmithKline has submitted a Biologics License Application (BLA) for CERVARIX (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 Organization, 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). 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.

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.

In addition to the Biologics License Application submitted for CERVARIX with the U.S. Food and Drug Administration, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and major countries in Asia and Latin America.