New Roche HIV drug out of Africa's reach

(Reuters, London) - Switzerland's Roche Holding priced its new HIV drug Fuzeon at a record-breaking €18 980 (R165 000) a year yesterday, fuelling controversy about the cost of Aids treatments. Roche said the high cost - more than double that of other HIV/Aids drugs on the market - reflected the complexity of manufacturing the revolutionary product, involving more than 100 production steps.

Fuzeon is expected to be approved by regulators in Europe in the coming weeks.

David Reddy, the head of Roche's HIV business, did not envisage Fuzeon ever being suitable for use in Africa, given its very high cost of production.

"Even if we were to price this drug at cost, it is not going to be the type of drug that is suitable for the developing world," he said.

Fuzeon is the first in a new class of drugs known as fusion inhibitors designed for people resistant to other Aids medicines.

Unlike existing drugs that work inside the cell, it blocks HIV from entering healthy human immune cells.

"This drug is 10 times more complex to manufacture than the next most complex class of drug in the HIV arena - the protease inhibitors," Reddy said.

The high price took industry analysts by surprise. Lehman Brothers, which had expected a cost of $15 000, said the higher figure might trigger upgrades to Fuzeon sales forecasts.

Patrick Burgermeister of Zuercher Kantonalbank added: "This price is clearly above our expectations and shows that the limited amount that can be produced is supposed to be sold at the highest possible price in the industrialised countries."

Reddy said Fuzeon, which is also known as T-20, had cost Sf840 million (R4.9 billion) to develop, excluding marketing expenses. More than half of the cost was accounted for by clinical trials and most of the rest reflected investment in specialist manufacturing. Pure research costs were only about 1 percent.

Reddy declined to comment on the profit margin that Roche would enjoy on sales of Fuzeon, which it believed could eventually have peak annual sales of up to Sf1 billion. The cost of the medicine would be similar in the US.

The twice-daily injection is given in combination with existing drugs and is expected to win marketing approval in the US by March 16.