Wall Street Journal - July 16, 2003
Gautam Naik, Staff Reporter of The Wall Street Journal

Fuzeon caused a stir about a year ago when a 24-week study showed that patients who took it, in combination with standard drugs, were twice as likely to achieve undetectable levels of HIV virus in their blood, as well as double the increase in their immune cell count, compared with patients whose therapy didn't include Fuzeon. Roche said those results have now been sustained when the drug is taken over a 48-week period.

"The treatment benefit we saw early on is maintained in longer-term therapy," said David Reddy, head of Roche's HIV/AIDS business. "At that time, it was treated with cautious optimism, but [the longer-term results] are really meaningful for doctors and patients."

Fuzeon is the first of a new class of drugs that blocks the HIV virus from entering the human immune cell. It was developed by Roche and Trimeris Inc., a U.S. biotechnology firm. Doctors hope the medicine will stem the growing problem of drug resistance among people carrying the HIV virus.

Roche said the latest results were drawn from two trials that included 1,000 patients in 112 centers in various countries. The study found that the greatest magnitude of benefit is seen when Fuzeon is used earlier in treatment rather than later. Another key result: The length of time that the HIV virus was undetectable in the blood was three times longer for patients given a cocktail containing Fuzeon than those whose medication excluded the Roche drug.

Despite its potency in fighting HIV, Fuzeon's high price tag -- about $20,000 (€17,730) for a year's supply -- could put it out of reach for many patients. One reason for the high cost is the complex manufacturing process, which involves 100 separate steps, according to Roche. The drug is already available in the U.S. and several European countries.

Roche had previously hoped to supply medicine to between 12,000 and 15,000 patients by year end but has now revised that estimate upward to 18,000 patients. This would let it boost production forecasts for future years.

Roche currently expects to supply the drug to 39,000 people by the end of 2005, according to Reuters. Roche has said in the past that Fuzeon could have peak annual sales of as much as one billion Swiss francs ($720.84 million, €644.7 million).

Robert Gallo, an American scientist who co-discovered HIV in 1983, said Tuesday at the International AIDS Society conference in Paris that he believed Fuzeon-type drugs would be the most attractive new approach to fighting the virus in the years ahead, according to Reuters. A number of other pharmaceutical and biotech companies are also working on different approaches to preventing the virus from locking on to human immune cells.

In Zurich trading, Roche shares rose 1.1% to end at 111.25 Swiss francs.

In afternoon Nasdaq Stock Market trading, Trimeris shares were up 9.1% at $54.14.

Write to Gautam Naik at gautam.naik@wsj.com

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