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U.K. rejects Glaxo drug
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October 1, 1999: 10:55 a.m. ET
But final decision pending on state funding for Relenza flu therapy
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LONDON (CNNfn) - Glaxo Wellcome appeared poised for a major showdown with British health regulators Friday after reports that the U.K.'s new pharmaceutical watchdog had ruled out Glaxo's controversial anti-flu drug, Relenza, for state funding.
The National Institute for Clinical Excellence, or NICE, a newly created committee that advises the government on how to ration resources for the budget-conscious National Health Service, is said to have concluded that Relenza shouldn't be prescribed by the NHS.
The institute found insufficient evidence that Relenza, a twice-daily inhalation drug therapy that costs 24 pounds for a full course, is effective in elderly, asthmatic or high-risk patients, the Financial Times reported.
Relenza is part of a new class of compounds known formally as neuraminidase inhibitors, which aim to prevent the spread of infection from one cell to another within the respiratory tract.
The FT said NICE believes more information must be gathered about the drug before it can feel comfortable recommending its inclusion on the NHS prescription list.
Glaxo (GLXO) acknowledged Friday that a "rapid assessment" committee charged with evaluating Relenza had, in fact, recommended that NICE reject the drug for prescription by the NHS.
But Nancy Pekarek, a company spokeswoman, said discussions continue between Glaxo and NICE and that the agency has yet to reach a final decision.
Pekarek dismissed suggestions of insufficient testing, noting that the company conducted "large-scale" clinical trials among 6,000 patients before the drug went on sale in Australia and New Zealand. Relenza also was approved by the U.S. Food and Drug Administration in July and hit Germany pharmacies Friday.
"I think we have a product here that clearly is the first anti-viral treatment ever for…influenza," Pekarek said. "In addition to being an innovative treatment it has been shown in clinical trials to reduce the severity of the symptoms and also the duration of the flu by up to two and a half days."
She said the patients participating in the clinical trials included a "broad cross-section" of high-risk patients.
In Britain, a medical industry magazine recently suggested that prescribing Relenza in a year of flu epidemics could end up costing the NHS 100 million pounds ($164 million). Doctors reportedly are concerned they'll be bombarded with demands for Relenza prescriptions, which Glaxo said could cost British taxpayers about 10 to 15 million pounds a year.
Glaxo said Friday a negative ruling on Relenza, should it materialize, likely would have little impact on the company's overall financial results.
Britain accounted for only 6 percent of Glaxo's $13.25 billion in sales last year, while its largest market, the United States, contributed 40 percent of sales.
The final decision on Relenza now is expected to pass to U.K. Health Secretary Frank Dobson.
Shares of Glaxo were off 2.34 percent at 1,547 pence in London Friday afternoon. 
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Glaxo Wellcome
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