Roche announced today that 1200 individuals will receive early access to its new fusion inhibitor T-20 (Fuzeon) ahead of a likely marketing approval in the second quarter of 2003. Expanded access criteria are still being discussed, says the company. However, the company also flagged up concerns about its ability to meet demand for the drug despite scaling up production facilities. In an interview with Reuters, Roche HIV boss David Reddy said that the company will be able to supply no more than 25,000 patients by the end of 2003.
T-20 will be used predominantly in treatment-experienced patients, who have difficulty assembling a drug combination that keeps viral load suppressed. For further information on T-20 click here.
Roche has been strongly criticised for failing to meet demands for compassionate access to T-20, also known as enfuvirtide. The company says that it has been impossible to produce large quantities of the drug because the manufacturing process is so complicated, and because it requires significant investment in factory capacity.
Cost likely to take T-20 into new league
The cost of producing T-20 means that Roche will need to charge more for the drug than any other antiretroviral, increasing the likelihood that the drug will be reviewed carefully by funding authorities in some European countries. In an interview with Thestreet.com last month, investment analyst Sharon Seiler predicted that T-20 will have to be priced at around $12,000 in the USA in order to achieve a gross margin of 60% to 70%. This implies a European price above €8,000 (£5,300) per year, given that European prices generally lie 20-30% below US prices.