Zeneca's asthma drug cleared in US

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The Independent Online
Shares in the big drugs groups soared yesterday on a raft of good news for the industry and strong demand from US investors. Zeneca revealed that its Accolate respiratory drug, said to be the first new asthma treatment for 20 years, had been cleared by the Food and Drug Administration for use in the US market after an earlier hitch.

Glaxo Wellcome, meantime, hit a new all-time high after its best-selling Zantac ulcer treatment was approved in low-dosage form for sale over the counter in six Continental countries. Sentiment was further boosted by news that drug sales in the world's top 10 markets had grown by 6 per cent to $70.7bn in the first half of 1996.

US buying on Thursday night spilled over into the London market yesterday. Zeneca was 33p higher at pounds 15.80, helping to reverse some of the previous day's fall, when Bayer of Germany said it would not bid for the British group. Glaxo Wellcome leapt to within an ace of pounds 10, ending 18p up at 994p and SmithKline Beecham put on 16.5p to 771p, after its US pension fund revealed an increased holding.

The FDA approval came as a relief to Zeneca, which suffered a set-back in March when Accolate was rejected by a key advisory committee of the powerful US licensing agency, citing a possible adverse reaction when used with two other drugs.

However, a Zeneca representative in the US said a clinical study of its effects when taken with the allergy drug Seldane was already under way and found no significant problems. Another study, with the blood-thinning drug Coumadin, was conducted after the panel meeting and found a potential effect on bleeding. As a result, doctors and patients would be warned about mixing the two drugs on the Accolate label, the Zeneca spokeswoman said.

Accolate is the first oral drug for asthma, providing long-term prevention, rather than acute treatment, of mild to moderate asthma in children and adults from 12 years old.

It is also Zeneca's first drug in this field. Dr Alan Boyd, head of medical research at the group, said it worked by blocking leukotrienes, which stimulate the symptoms of asthma after being triggered by certain stimuli as yet unknown to scientists. As a tablet, Zeneca believes that Accolate represents an advance on steroid treatments, given the stigma and difficulties associated with the inhaler devices.

Dr Boyd rejected suggestions from some analysts that Accolate was no more effective than Intal, a long-standing treatment for asthma now off- patent. The US market for the new drug is estimated at around $1.6bn, but one City estimate suggests that sales are only likely to reach pounds 50m by 1998.

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