A new Aids treatment to be marketed by Glaxo Wellcome was recommended for approval last night by the US Food and Drug Administration.
The anti-viral drugs advisory committee of the federal Food and Drug Administration gave its recommendation to the new 3TC compound, now known under the trade name Epivir. Studies have shown it is one of the most effective treatments against Aids when used with AZT, another Glaxo Wellcome drug.
In London, the company's shares jumped 20p to 871p in expectation of the decision, while in New York, the company's American depository receipts gained $11/4 to $283/8 when the news was announced.
If the Administration follows the panel's advice, as it usually does, Epivir could win full approval before the end of the year. The drug helps doctors to combat the achilles heel of Aids treatment - resistance. Epivir appears to reactiviate AZT after HIV (the Aids virus) becomes resistant to it.
However, forecasters are divided about the potential for new anti-Aids drugs. Epivir is being reviewed alongside other anti-Aids treatments. Hoffman-La Roche's Invirase and Zerit, developed by Bristol-Myers Squibb, will be discussed today and tomorrow.
One view is that Invirase, and other so-called "proteinase inhibitors" that interfere with the reproduction of the virus, are the first of a new generation of anti-Aids drugs, and could double the market to over $1bn annually. By contrast, some analysts believe that, by 2000, Epivir, a similar compound to AZT, could only be worth around pounds 200m on its own to Glaxo, and perhaps pounds 250m when it reaches its peak. Even in combination with AZT, the potential might be only pounds 400m to pounds 500m, far less than last year's pounds 2.4bn sales of Glaxo's blockbuster Zantac anti-ulcer drug.
3TC was discovered in 1989 by BioChem Pharma, a Canadian company, with Glaxo, as it then was, taking licensing and development rights the following year. In September, results of the Delta trial involving medical research agencies in Europe and Australia showed substantial clinical benefits using 3TC with AZT, over using AZT on its own, although no evidence of improved mortality.
Glaxo Wellcome, headed by Sir Richard Sykes, believes that the AZT and Epivir combinaton may offer fewer side-effects than other so-called drug cocktails.Reuse content