FDA denies Glaxo's cancer vaccine fast track status; company defends diabetes drug

GlaxoSmithKline PLC revealed Thursday that the U.S. Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.

The FDA ruling means that Cervarix will have to go through a standard 10-month review, instead of a fast-track process that would have accelerated the approval and marketing of the vaccine in the key U.S. market.

Glaxo now expects to get the drug, which targets cervical cancer and is expected to become a multibillion-dollar product, to market in the United States sometime in 2008.

The company applied for U.S. marketing approval in March, hoping to receive a "priority review," which the FDA grants to medicines that represent a significant improvement compared with existing therapies.

Glaxo expects to launch the vaccine in Europe and several other markets in the second half of 2007. It was approved by health regulators in Australia earlier this month.

The decision on Cervarix comes as the company defends its diabetes drug Avandia after a study published in the New England Journal of Medicine last week said that people taking the drug are at greater risk of heart attacks.

The findings hit Avandia sales hard, with a report from market intelligence group Impact RX showing that the drug's share of the market for newly prescribed oral anti-diabetics fell to around zero from around 10 percent in the two days after the article was published.

The Avandia family of drugs, which includes combination treatments Avandamet and Avandaryl, last year posted sales of 1.6 billion pounds, making it GlaxoSmithKline's second best-selling drug after asthma treatment Advair.

In a letter to The Lancet medical journal published Wednesday, Ronald Krall, GlaxoSmithKline's medical director, said that data from long-term, large-scale trials of Avandia had indicated that the risk of heart attack associated with the drug was similar to two other commonly used generic diabetes medicines, metformin and sulfonylurea.

Krall attacked the methodology in The New England Journal of Medicine study and referred to two medical trials that had been published previously, known as ADOPT and DREAM, and findings from another as-yet unpublished study of more than 30,000 diabetic patients.

He said that those studies showed the incidence of hospitalizations for heart attack for patients on Avandia was the same as for other diabetes treatments.

Shares in Glaxo fell 1.36 percent to 1,310 pence ($25.91) Thursday on a broadly higher London Stock Exchange after losing around 13 percent since the New England Journal of Medicine report was published.