Roche Warns of Tight Supply of Its Promising HIV Drug

The Swiss pharmaceutical company Roche said Friday that tight supplies of its HIV drug candidate Fuzeon, known as T-20, mean only a limited number of patients will have access to it at first. Roche said the success in clinical trials of the drug, which awaits approval in the United States and European Union, together with increased resistance among patients to other HIV drugs, "will lead to a potentially faster and greater demand for Fuzeon than initially foreseen, with the potential for patient requirement for Fuzeon outstripping supply during its launch in 2003."

Roche, which expects to have Fuzeon commercially available in the first quarter of 2003, said it is on track with its manufacturing schedule and has already taken steps to boost production capacity for the drug.

Roche said it is instituting an early access program for the drug -- part of an effort by the Food and Drug Administration to make investigational drugs for serious illnesses available during late-stage clinical trials. Roche and partner Trimeris said they are in discussions with regulatory authorities, HIV-treatment physicians and HIV community advocates to establish fair criteria for early access and the allocation of Fuzeon during its launch.

Early access will begin in late September or early October and reach 1,200 patients worldwide by March 2003, Roche said. Combined with the current clinical program, this will give more than 3,000 patients access to the drug before its likely launch. David Reddy, head of Roche's HIV franchise, expects the company to have the capacity to supply some 25,000 patients by the end of 2003, with "significantly more" capacity thereafter.

Roche said it was on track to submit applications with US and European regulatory authorities in the current quarter. The FDA has already granted fast-track status, and there is an increased likelihood for a quick review in Europe. T-20's price -- more than the most expensive drugs currently on the market -- has created as much buzz as its effectiveness.

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