GSK denies Avandia risk as shares fall

The worldís second largest pharmaceutical company GlaxoSmithKline (GSK) says it strongly disagrees with claims in the New England Journal of Medicine (NEJM) that its blockbuster diabetes treatment Avandia (roseglitazone) could increase the risk of heart attacks.

Avandia is UK-based GSKís second best-selling drug after asthma treatment, Seratide (fluticasone/salmeterol), and is used to treat type 2 diabetes. The company posted a 19 per cent increase in Avandia sales to GBP 414m in Q1 FY07.

Doctors at the Cleveland clinic in the US analysed 42 historic clinical trials; they discovered that patients taking Avandia were 43 per cent more likely to have heart attacks, as well as being 64 per cent more likely to die from heart failure, than those taking a dummy pill.

GSK released a detailed statement refuting the NEJMís claims, stating: ìGSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks.î

GSK accuses the NEJM of combining conflicting studies, ìwhich is not the most rigorous way to reach definite conclusions about adverse events.

ìEach study is designed differently and looks at unique questions: for example, individual studies vary in size and length, in the type of patients who participated, and in the outcomes they investigate,î says GSK.

The company says a larger trial with 33,000 people with diabetes performed by independent investigators found there was no increased heart attack risk in people who took Avandia over other anti-diabetic medicines.

In response to the findings, the FDA is not asking GSK to take any action, but has issued a warning against Avandia.

ìThe FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia,î said Steven Galson, director of FDA's Center for Drug Evaluation and Research.

"We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened,î continued Galson.

GSKís shares suffered their biggest one day fall in four years this week. On 22 May they closed GBP 0.19 lower at GBP 13.71, having experienced a five per cent drop on the previous dayís trading.

Collins Stewart analysts said that the FDA has not yet published its findings into Avandia, adding: ìGSK itself has also conducted similar detailed analysis and has found no significant new issues. If any had been identified, then both the FDA and GSK would have withdrawn the drug from the market.î

Citigroup analysts said that the eight per cent drop on the New York exchange meant that investors believed Avandia would be withdrawn from sale, although adding this would be most unlikely.