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Growing political and media pressure risks skewing the judgment of the US medicines regulator towards excessive caution at the cost of innovative treatments, the head of AstraZeneca, the Anglo-Swedish pharmaceutical group, warned recently.
Speaking at the presentation of his company's 2004 results, Sir Tom McKillop, chief executive, said there was a danger that the US Food and Drugs Administration would be "push[ed] ... away from their traditionally very well judged sense of benefit and risk" and that "their ability to take a balanced view" could be jeopardised.
Despite regulatory setbacks with its Exanta and Iressa drugs last year, strong performance by older drugs, including Nexium for ulcers, helped push AstraZeneca's 2004 earnings per share up 28 per cent to $2.28 for 2004.
Pre-tax profit was up 20 per cent to $5.09bn (£2.83) on sales of $21.4bn. The company lifted its earnings per share target for this year to between $2.35 and $2.50, and said it had up to $2.2bn in cash for share buy-backs.
Sir Tom warned: "If we lead people to believe that there can be new medicines without risks, that will stop innovation in its tracks."
However, he stressed that AstraZeneca had no intention of abandoning more innovative research into ground-breaking new medicines.
Sir Tom said he was an optimist that the peak in fear over health risks had been reached and a new balance would soon be restored.
He also vigorously defended Crestor, the company's intended "blockbuster" anti-cholesterol drug, hit by reports of health risks, which he dismissed.
"It is the right product at the right time and we are determined it will win its rightful share of the market," he said.
John Patterson, whom he appointed last month to overhaul AstraZeneca's research and development, hinted at the need for inter, nal change when he stressed that in future "quality outcomes" on new drugs should be more important than "speed to submission" with the regulators.
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Source: Internet, exclusive to FE
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