Word: viracept
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Still, a little de-reg can go a long way, as it has for Peter Johnson, president and CEO of Agouron Pharmaceuticals in La Jolla, Calif. Earlier this year the FDA, using a streamlined process specifically developed for life-threatening diseases like AIDS, gave a green light to Viracept, the firm's new anti-HIV drug...
...appropriate drugs based on clinical trials that are smaller and faster than normal. The agency also allows "rolling submissions," meaning it will accept and release initial reviews of drug components that are prepared earlier than the rest. For Agouron the difference was startling: the FDA's review of the Viracept application took a total of only 83 days; in 1992 the average length of time for FDA drug approval was 19 months...
...took 38 months from the time we first decided to commence development to the time Viracept was approved, and that's strikingly short," says Johnson. Drug development took "basically three years, as opposed to an average in the industry that's closer to eight years or more...
...newly greased skids can improve not only the health of waiting patients but also the firm's bottom line. Agouron spent the past 12 years pumping all its income--$56 million last year--into research on the technology and procedures later used to bring Viracept to market. Agouron's net loss last year was $19.5 million, and under normal FDA review, Viracept would still not have been able to earn money for several more years. Under the new rules, however, Agouron can profit immediately from sales of Viracept, which, as one of only four protease inhibitors currently revolutionizing AIDS treatments...
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