Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Wall Street Journal - September 30, 2002
Marilyn Chase Staff Reporter of The Wall Street Journal
The drug, called Fuzeon, is one of a class of medicines known as fusion inhibitors that scientists are racing to develop in a bid to outflank the swiftly mutating AIDS virus, which gradually renders the current cocktails of AIDS remedies ineffective for some patients.
New study data on Fuzeon indicate that the drug, originally billed as a solution for patients running out of treatment options, works even better for those with lesser degrees of viral resistance.
The drug is product of a collaboration between Trimeris Inc. of Durham, N.C., and Hoffmann-La Roche Inc. of Nutley, N.J., a unit of the Swiss drug maker Roche Holding AG. The companies this month applied to the Food and Drug Administration for permission to market the drug, formerly known as T-20.
The new study data, presented at a weekend session of the Interscience Conference on Antimicrobial Agents and Chemotherapy here, were drawn from 491 patients divided into four groups with varying levels of response to standard AIDS drugs. Patients with highly resistant viruses received either the best possible drug cocktail, individually tailored for them, or the optimized cocktail spiked with Fuzeon. The patients with less-resistant viruses also got the cocktail alone or the cocktail plus Fuzeon.
Virus levels declined in all four groups, which were followed for 24 weeks. But the greatest benefits came to patients with lesser degrees of resistance who got the cocktail plus Fuzeon. Some saw their virus levels plunge, for example, from 100,000 to 501 virus particles per milliliter of blood, the companies said.
Fuzeon's makers continued to sidestep the touchy question of price, however. Analysts have speculated that Fuzeon -- which takes 106 chemical steps to produce -- may cost as much as $12,000 to $15,000 a year. That would place the drug beyond the reach of all but the most affluent or well-insured patients. "We haven't set the price yet," a Roche spokeswoman said.
Roche and Trimeris already are planning to bring out a "son of Fuzeon," known only as T-1249, "designed to have more potency, a longer half-life in the blood, and more activity against different kinds of HIV, so that it can block viruses that become resistant to Fuzeon," said Dani Bolognesi, chief executive officer of Trimeris. Both drugs are given as injectionacs.
While Fuzeon's main side effect is skin irritation, three serious reactions arose during T-1249 treatment: fever; an allergiclike hypersensitivity reaction; and neutropenia, or a drop in white blood cells.
Write to Marilyn Chase at marilyn.chase@wsj.com
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