Glaxo Moves Ahead With Cervarix

Yesterday, GlaxoSmithKline (GSK - Analyst Report) received a favorable recommendation from the US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its cervical cancer vaccine, Cervarix.

While the advisory committee voted 12-1 in favor of the efficacy of the vaccine, its safety profile got 11-1 in support from the panel. While the FDA is not bound by the advisory committee’s recommendation, it generally follows the suggestion.

Cervarix was found to be highly effective and was well tolerated in the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, in girls and young women. Types 16 and 18 are the two most common virus types known to cause cervical cancer.

The vaccine is currently approved in nearly 100 countries around the world, including the 27 member states of the European Union, Australia, Brazil, South Korea, Mexico and Taiwan. Glaxo is seeking approval in more than 20 additional countries including the U.S. and Japan.

Approval in the U.S. would open up a very large market for the product, which recorded £125 million in global sales in 2008. Once approved, Glaxo will compete directly with Merck’s (MRK - Analyst Report) Gardasil. Although Merck beat Glaxo to the market, we believe Cervarix comparatively offers a broader base, has more potent protection and could achieve peak sales of approximately £1.5 billion.

Glaxo has presented very encouraging data against genotypes that account for 70% of cervical cancer cases and management believes that Cervarix may offer protection against several other genotypes that could increase this figure to 80% of cervical cancer cases.

The American Cancer Society estimates that about 11,000 women will be diagnosed with cervical cancer and 4,000 women will die from the disease in 2009 in the U.S. Globally, more than 500,000 more women are expected to be diagnosed with cervical cancer and 280,000 women to die from it every year.

A response from the US FDA on Cervarix should be out shortly. We believe that US approval of Cervarix will significantly boost Glaxo’s vaccine segment revenue, which came in at £2.5 billion in 2008.

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