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Drugs giant GSK unveils breast cancer breakthrough

Stephen Foley,William Kay
Monday 07 June 2004 00:00 BST
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GlaxoSmithKline, the UK's biggest drug maker, has unveiled more details of its pipeline of forthcoming drugs, saying its new cancer treatment could halt the growth of breast cancer. The news emerged as GSK attempts to fend off allegations of fraud and withholding information about Seroxat, known in the US as Paxil, an anti-depressant for children.

GlaxoSmithKline, the UK's biggest drug maker, has unveiled more details of its pipeline of forthcoming drugs, saying its new cancer treatment could halt the growth of breast cancer. The news emerged as GSK attempts to fend off allegations of fraud and withholding information about Seroxat, known in the US as Paxil, an anti-depressant for children.

GSK presented new trial data on its cancer treatment at the American Society of Clinical Oncology meeting in New Orleans, Louisiana, one of the most important scientific events of the pharmaceutical industry calendar. Both the UK's giant drug companies, GSK and AstraZeneca, are showcasing new data this year.

But the Seroxat scandal took another twist yesterday when it emerged that the Government's Medicines and Healthcare Products Regulatory Agency (MHRA) had begun an investigation into suggestions that GSK had held back important information from clinical trials. This indicated that Seroxat may cause a greater risk of suicide and "self-harm" if given to depressed teenagers.

A spokeswoman for the MHRA said: "We take very seriously any failure to comply with the law. Last year MHRA announced that it would investigate GSK to establish whether it hadcomplied with its legal obligations under UK and European law. The investigation will report shortly." GSK declined to comment.

The New York State attorney-general, Eliot Spitzer, has accused GSK of fraud over its presentation of information about Seroxat. Jean-Pierre Garnier, GSK's chief executive, said: "Our reputation is attacked and we are not getting a fair chance to rebut. There is a certain amount of bullying in those tactics."

GSK's new cancer pill, to be called lapatinib, shrunk or halted the growth of tumours in almost half of women where previous drugs had failed, the study showed. The company has already began a new, bigger human trial of lapatinib in breast cancer and expects to file for approval to launch the product next year.

It is one of the most advanced of a new generation of drugs developed by GSK, which needs additional products to plug the hole in sales since previous blockbusters lost patent protection and succumbed to copycat competition. M. Garnier has named the product as one of 20 potential new blockbusters.

When Kimberly Blackwell presented the lapatinib study, she said: "Research into new treatment options for women with metastatic breast cancer is bringing us closer to a day when we can halt the progress of this cancer and manage it like other chronic diseases."

Oncology, the treatment of cancer, is one of the few therapeutic areas in which Europe's pharmaceuticals companies dominate, generating £7bn of sales last year. AstraZeneca will this afternoon present new data on Iressa, its already-launched lung cancer product.

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