Pfizer scraps drug trial after deaths

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The Independent Online

The world's biggest pharmaceuticals company, Pfizer, has suffered a devastating blow after being forced to abandon the development of a new blockbuster cholesterol drug because of the high number of patients who have died during trials.

Pfizer had hoped Torcetrapib would take over as one of its main revenue earners when the patent on its existing cholesterol drug Lipitor expires in three years time. Lipitor currently generates some $13bn (£6.5bn) a year for the company - about half of its annual profits. Analysts had predicted the new drug could be even bigger, contributing some $20bn a year in profits.

But the US drug giant announced on Saturday it had scrapped the Torcetrapib trials after the US Data Safety Monitoring Board (DSMB) warned the company that the number of deaths in the trials had been too high. Some 82 patients who were taking both Torcetrapib and Lipitor died during the drug trials, compared with only 51 who were taking just Lipitor.

In a statement issued at the weekend, Pfizer said it was in the process of contacting all those who were conducting the trial - known as the Illuminate trial - to inform them that all patients taking the medication should stop immediately.

Shares in the company are likely to fall sharply today, as investors come to terms with the news. Pfizer admitted it had been surprised and disappointed by the results.

Pfizer had spent $1bn on the Torcetrapib trials and hoped to start marketing the drug next year. The failure of the drug could cast doubt on similar cholesterol drugs being developed by the rival pharmaceuticals companies Roche and Merck.

Dr Philip Barter, the director of the Heart Research Institute in Australia, and chairman of the steering committee which oversaw the Torcetrapib study, said: "Based on all the evidence we have seen regarding Torcetrapib, and in light of prior study results, we were very surprised by the information received from the DSMB, the only body with access to the unblinded safety data. We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug."

Only on Friday, the group had issued an upbeat trading statement, including some reassurance that the Torcetrapib trials were on track. The group also announced plans to cut 20 per cent of its sales force, as part of a cost-cutting plan.

Pfizer's chief executive Jeffrey B Kindler moved to reassure investors the company was still in good shape. He said yesterday: "While the DSMB information we received was both surprising and disappointing, our focus is on the best interests of patients and making sure this information is communicated to appropriate medical and regulatory authorities as quickly as possible.

"With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it. It is important to put this information in the context of both our commitment to transform Pfizer and our overall product and financial strength."

Mr Kindler stressed that the group still had a diverse in-line and new product portfolio, adding that the end of the Torcetrapib trials would have no effect on the company's profits in the current year.

He said Pfizer would accelerate previously announced plans to transform the business. In particular, the group would focus on its core research and development, manufacturing and commercial operations. The company remains committed to introducing at least six new products every year as of 2010.

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