Glaxo seeks approval for cervical cancer vaccine

Glaxo submits cervical cancer vaccine to FDA for approval, challenging Merck's first-to-market Gardasil.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- GlaxoSmithKline said it submitted an application for its cervical cancer vaccine Cervarix to the Food and Drug Administration, bringing it one step closer to challenging Merck's now-dominant Gardasil.

Cervarix, if approved, would be used to prevent strains of the sexually-transmitted human papillomavirus, which can cause cervical cancer.

In an interview with CNNMoney.com, Glaxo (up $0.47 to $54.51, Charts) chief executive JP Garnier called Cervarix "the ultimate insurance for cervical cancer." Garnier said Cervarix could be on the market by the end of 2007, if the FDA grants the vaccine "fast track" review status and then approves it.

Merck's (up $0.76 to $43.99, Charts) Gardasil was launched in 2006 and is the only cervical cancer vaccine available on the market. Both Gardasil and Cervarix have been hailed by analysts as potential blockbusters, which the drug industry desperately needs to bolster pipelines as some of its top earners lose patent protection.

Gardasil has the early advantage since it came to market first. Gbola Amusa, analyst for Sanford C. Bernstein, projects $2.5 billion in peak annual sales for Gardasil and $1.5 billion for Cervarix.

About 10,000 women are diagnosed with cervical cancer every year, and 4,000 die from it, according to the Mayo Clinic, one of the most renowned cancer research centers.

London-based Glaxo is one of the largest drugmakers in Europe, along with the French company Sanofi-Aventis (up $0.44 to $43.37, Charts) and the Swiss company Novartis (up $0.62 to $56.89, Charts). New Jersey-based Merck is the No. 4 U.S. drugmaker, behind Pfizer (up $0.22 to $25.40, Charts), Johnson & Johnson (up $0.35 to $60.35, Charts) and Abbott Labs.

Amusa does not own shares of company stocks mentioned here and Bernstein does not conduct business with them.

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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer.

Morningstar: © 2014 Morningstar, Inc. All Rights Reserved.

Factset: FactSet Research Systems Inc. 2014. All rights reserved.

Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved.

Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor’s Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2014 and/or its affiliates.