Boots' heart drug is cleared for sale

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THIRTEEN years of research and development costing dollars 100m ( pounds 53m) started to pay off for Boots yesterday when it was at last given clearance to sell its heart drug, Manoplax, in Britain.

The Department of Health gave Boots approval to market Manoplax for use in the treatment of congestive heart failure, the first green light from a national pharmaceuticals regulator.

The stock market welcomed the news, marking Boots shares 7p higher to 429p. Ian Smith, a pharmaceuticals analyst with Lehman Brothers, said the approval was a little sooner than expected.

It was also wider-ranging, he said. Whereas approval in the US may be limited to patients who cannot tolerate ACE-inhibitors, an alternative treatment, there is no such UK restriction.

Sir James Blyth, chief executive, said: 'This is indeed very welcome news. We confidently look forward to receiving further registration approvals in most major markets in the coming months.' Boots seeks licences in the US, France, Spain, Italy and Japan.

Boots believes Manoplax helps improve the quality of life for people with heart failure by reducing fatigue and breathlessness. It does not cure heart failure.

Dr Smith estimated Manoplax could produce sales of dollars 100m and operating profits of dollars 40m by 1995. By the late 1990s they could reach dollars 250m and dollars 100m respectively.

The drug is crucial for future growth at Boots' pharmaceuticals division, which has no other important products in the pipeline. In the year to March it made trading profits of pounds 121m. The key market is the US, where dollars 2.2bn is spent each year on heart treatments, compared with pounds 35m in the UK. Four million Americans suffer from chronic heart failure.

Last October an advisory committee to the US Food and Drug Administration recommended approval of Manoplax, subject to labelling and other restrictions. The FDA is expected to come to a decision before the end of the year.

Boots plans to spend pounds 15m- pounds 20m in the current year marketing the drug. Marketing to GPs and hospitals will begin in the early autumn, it said.

The success of Manoplax would help offset problems in Boots' specialist retail division. The core Boots The Chemist chain continues to lift profits, but Do It All, Halfords, AG Stanley and Children's World have all suffered.

Boots is planning to invite City analysts to visit Halfords, the motor parts retailer, next month, suggesting it has come to grips with that particular loss-maker.