Glaxo's cancer vaccine Ok'd in Europe

Glaxo's cervical cancer vaccine approved by European authorities; Cervarix awaiting FDA decision; vaccine to compete against Merck's Gardasil.

By Aaron Smith, staff writer

NEW YORK ( -- Merck's cervical cancer vaccine Gardasil now faces direct competition from Glaxo's Cervarix, which was approved by European health authorities, said the vaccine's maker GlaxoSmithKline on Monday.

The British drugmaker GlaxoSmithKline (Charts) said the European Commission, which is Europe's version of the Food and Drug Administration, approved Cervarix for sale in the EU's 27 member states. Cervarix is already available in Australia.

Cervarix, approved for girls and women aged 10 to 25, protects against the sexually-transmitted human papillomavirus (HPV), which causes cervical cancer. Inoculation with the vaccine is considered most effective in girls before they become sexually active.

Cervarix is similar to the cervical cancer vaccine Gardasil from Merck & Co., Inc., (Charts, Fortune 500) the New Jersey-based drugmaker. Gardasil was launched last year, and is available in Europe and the U.S.

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Glaxo spokeswoman Liad Diamond said the vaccine would be launched in Europe in the next few weeks and the FDA is expected to complete its review of Gardasil in the first quarter of next year.

Gardasil has an advantage in being first to market, analysts say, though both vaccines are considered blockbusters-in-the-making.

Michael Krensavage, analyst for Raymond James & Associates, said that Gardasil has a competitive edge because it also guards against genital warts.

"It seems to me like the Glaxo vaccine will have a disadvantage to Gardasil because it doesn't protect against genital warts," said Krensavage, who projects that Gardasil sales will total $1.6 billion in 2007 and $2.3 billion in 2008.

Krensavage does not estimate Cervarix sales because he does not cover Glaxo, though analyst sales projections tend to run lower for the Glaxo vaccine.

About 10,000 women in the U.S. are diagnosed with cervical cancer each year, and 4,000 die from it, according to the Mayo Clinic, an esteemed healthcare research facility.

Krensavage does not own Merck stock and Raymond James does not conduct business with the company. Top of page