GlaxoSmithKline has requested a priority review of a BLA filed March 29 for its human papilloma virus vaccine Cervarix , the company told "The Pink Sheet" DAILY.

If FDA grants a priority review, Cervarix's action date will likely fall in late September. If the agency decides on a standard ten-month review, the date will fall in late January. Either way, "we're ready" for a launch "shortly after we get approval," the company said.

"What we're hoping gets communicated is how confident we are in the candidate vaccine," GSK said.

"We are proud of the data that has been published to date that has shown 100 percent efficacy against the cancer-causing virus types 16 and 18 and that we've shown preliminary evidence of cross-protection against other cancer-causing virus types."

The company said it would be making additional clinical trial data on Cervarix available in the near future. "We'll be presenting a follow-up to the four-and-a-half-year efficacy data that was presented last year, and we also will be presenting the results of our very large efficacy trial," GSK said.

The BLA contains data from clinical trials in almost 30,000 females ages 10 to 55 and reflects an ethnically diverse population, the company said. One of the trials showed that Cervarix induced higher antibody levels and more robust immune memory response when formulated with its proprietary AS04 adjuvant system - aluminum hydroxide plus MPL (monophosphoryl lipid A) - than with aluminum hydroxide alone.

GSK is looking to position Cervarix as superior to Merck's HPV vaccine Gardasil , formulated with aluminum hydroxide, based on the AS04 difference. The company launched a comparative study of the two vaccines in January (¹ Also see "GSK Wagers On Cervarix In Head-To-Head Trial Against Gardasil" - Pink Sheet, 18 January, 2007.).

In February, Merck said two Gardasil trials had been terminated because of positive results and the company expected about 4,000 subjects in placebo groups to be vaccinated by the end of 2007 (² Also see "Gardasil Trial Termination Is More Good News For Merck" - Pink Sheet, 27 February, 2007.).

Gardasil launched in June, with the company reporting $70 million in sales of the vaccine in its first full quarter on the market.

- Shirley Haley (s.haley@elsevir.com)

GlaxoSmithKline Submits Cervarix BLA

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