Roche warns of Aids drug shortage

Roche says limited production capacity means not everyone will get their hands on the new Aids drug (picture: Roche) Roche blamed weak financial markets for the poor result (Roche)

Swiss pharmaceutical giant Roche has warned that due to excessive demand, it may not be able to supply a revolutionary AIDS drug to all those who need it.

Patient groups and AIDS activists have been clamouring for access to the new drug, T-20, which will be sold under the brand name Fuzeon. It is seen as an alternative treatment for tens of thousands of people who have become resistant to existing medicines.

Roche said, however, it would only be able to supply some 3,000 patients by March next year.

“In the short term, we do not have the flexibility to increase production beyond our current capacity to meet a potentially higher than initially anticipated demand,” said William Burns, head of Roche Pharmaceuticals.

New type of drug

The injectable drug, which Roche expects to reach the market in the first quarter of 2003, is the first in a novel class known as fusion inhibitors that work in a completely new way, by preventing HIV virus from entering cells.

All 16 of the currently approved AIDS medicines attack HIV only after it has entered a human cell. T-20 is currently undergoing a fast-track review at the United States Food and Drug Administration, and Roche said there was increased likelihood of a speedy approval in Europe as well.

Data released last month by Roche and its U.S. partner Trimeris Inc showed T-20 slashed the amount of virus in the blood of many patients running out of treatment options.

Furthermore, only three percent of those taking the drug gave up treatment as a result of injection site reactions. David Reddy, head of Roche’s HIV franchise, said this level of tolerance to the drug was far better than expected, which would further increase demand for T-20.

Roche and Trimeris are working at full speed to set up new production capacity at a plant in Colorado, but increased output will take time to build up. In the meantime, the companies have to rely on a small pilot plant.

“We are going to have to carefully monitor the allocation of T-20 throughout 2003,” said Reddy.

“Production will continue to ramp up as we proceed through the year. We expect that by the end of 2003 we will have enough capacity to supply drug to around 25,000 patients.”

Complex manufacturing process

Production is constrained by the complexity of the T-20 molecule. The product is the most complicated drug ever made, with the manufacturing process requiring 106 steps of chemical synthesis.

Roche and Trimeris plan to begin an early access programme in late September or early October to supply T-20 to 1,200 patients around the world at no cost.

Expanded access schemes allow drugs to be given to needy patients before a product is fully licensed and while clinical studies are continuing. Combined with the ongoing clinical programme, this will take the number of patients on T-20 to 3,000.

Roche and Trimeris have yet to disclose how much the drug will cost — but it will not be cheap. Industry analysts expect it be sold at a substantial premium to existing AIDS drugs at some $10,000 (SFr14,750) to $12,000 per patient a year.

Analysts expect the drug to achieve peak annual sales of $300 million to $600 million, according to independent consultancy Evaluate.

swissinfo with agencies