Glaxo sticks with 'drug 381' despite Vioxx safety fears

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The Independent Online

Glaxosmithkline, the UK's largest drug maker, attempted to shore up confidence in its latest painkilling drug yesterday, saying it saw few similarities between it and Vioxx, the painkiller withdrawn by Merck in September.

Glaxosmithkline, the UK's largest drug maker, attempted to shore up confidence in its latest painkilling drug yesterday, saying it saw few similarities between it and Vioxx, the painkiller withdrawn by Merck in September.

The company said it had conducted an analysis of the public data on Vioxx and results from its own trials and concluded that its painkiller, codenamed 381, was as safe as similar drugs on the market.

Senior executives rallied to the defence of the US regulator, which has been criticised for failing to spot the possibility that Vioxx increases the risk of heart attacks.

The safety concerns over GSK's drug overshadowed the release of trial results showing that it could be more effective in relieving pain than the market leader in this class, Pfizer's Celebrex. The data on 381 had meant to form the centrepiece of GSK's "R&D day" for investors and analysts.

Analysts said GSK's presentations did not alleviate scepticism over the future prospects for the drug, and Tachi Yamada, the chairman of research and development at GSK, accepted that public concern had damaged the market for painkillers of this type, known as cox-2 inhibitors.

"I would agree that perceptions are poor at the moment, but there are differences between members of the family," he said. "We have a potential best-in-class pain medicine. I absolutely believe 381 can be a very, very big product."

The effect that Vioxx appears to have on blood pressure was not found in 381 or other cox-2s, GSK's data analysis found.

However, GSK has so far conducted only six-week trials, and it will not be until the new year that GSK gets a formal view from the US regulator, the Food and Drug Administration, on how to proceed with long-term trials that will decide the issue.

Max Herrmann, a pharmaceuticals analyst at ING, said: "There were not high expectations for the day, and they have delivered on those expectations. We have to wait for the FDA but I am sure they will have to do an 18-month study and that is going to delay the drug for up to a year."

In the meantime, Mr Yamada attempted to shift the focus to other drugs in the company's pipeline, and to the quantity of products coming through. GSK has 45 new drugs in the second stage of human trials, a 40 per cent increase on a year ago.

There was new data on several drugs which are already on the market and which, GSK believes, could be extended to treat a variety of other diseases. In particular, Avandia, which has sales of £100m a month as a diabetes drug, is now being trialled for Alzheimer's disease, on the theory that inflammation and brain metabolism contribute to the onset of the disease.

Mr Yamada expressed his opposition to calls for the FDA to be stripped of its role as safety monitor, which politicians in the US have argued conflicts with its responsibility for approving new drugs. He said: "You have to be able to weigh the balance of risks and benefits of a drug. Unless that can be viewed in its totality, you cannot make a sound decision on approval or removal of drugs from the market."

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