GlaxoSmithKline in US setback

GlaxoSmithKline’s cervical cancer vaccine, Cervarix, faces a delay in the US as the federal Food and Drug Administration (FDA) has not issued approval for marketing but is requesting further information.

Glaxo is not disclosing what the outstanding questions are or how long they will take to answer.

Cervarix is one of Glaxo’s biggest new drug hopes but will face a major setback if not approved in the United States, the world’s biggest drugs market.

The FDA’s ‘complete response letter’ means Glaxo are further behind Merck & Co’s rival product, Gardasil which is already being marketed in US as well as in Europe. Cervarix gained EU approval in September and has already been approved in 45 countries globally including the 27 member states of the EU.

Gardasil is already a major product, with third-quarter sales of £208 million for Merck. Both Cervarix and Gardasil protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV) and are designed to be given to girls and young women.

However, the two vaccines are not identical, Gardasil targets four strains of HPV (two responsible for cervical cancer and two causing the less serious condition of genital warts). Glaxo’s product addresses only the two cancer strains.

Analysts have anticipating a decision on Cervarix by January 2008 said the setback would delay approval by at least a few months and possibly over a year.

In a statement, GlaxoSmithKline said it will work closely with the FDA to prepare its response, which it intends to submit as soon as possible.

Analysts at Cazenove said this unexpected delay to US approval increases the doubt over Glaxo’s top line growth. Without any real clarity of the potential delay to US approval, this setback will have a significant impact on investor sentiment in our opinion.

A Glaxo spokesman declined to comment on when a final US decision on Cervarix might now be made. Shares in the group fell 1.4% to £13.04 in early trading today.

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