Roche sets record price for Aids drug

South Africans have taken to the streets to demand cheaper Aids drugs Keystone

The Swiss pharmaceutical giant, Roche, has priced its new HIV drug Fuzeon at a record-breaking €18,980 (SFr27,870) a year.

The announcement has fuelled the debate surrounding the cost of Aids treatments and who can afford them.

Roche said the high price tag – more than double the cost of other HIV/Aids drugs on the market – reflected the complexity of manufacturing the revolutionary product, which involves more than 100 production steps.

The Basel-based company admitted that the high cost ruled out the use of the drug in developing countries.

Fuzeon is the first in a new class of drugs known as fusion inhibitors, designed for patients resistant to other Aids medicines. It is expected to win regulatory approval next month.

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

“It is the most complex drug in terms of manufacturing ever produced by the pharmaceutical industry,” Roche spokesman Horst Kramer told swissinfo.

“We have over 106 production steps. To produce 1kg of active substance, we need to have 45kgs of raw materials.

“The complexities of those raw materials and the high development costs result in this relatively high price.”

High cost

Fuzeon, also known as T-20, cost SFr840 million to develop, excluding marketing expenses.

More than half of this was accounted for by clinical trials, while most of the remainder reflected investment in specialist manufacturing.

Kramer declined to comment on the profit margin that Roche would enjoy on sales of Fuzeon, but said the company was hoping for peak annual sales between SFr500 million and SFr1 billion.

He indicated that the cost of the medicine would be similar in the United States.

Exclusive treatment

Reacting to the announcement, Christoph Schlatter, a spokesman for the Swiss Aids Federation, said: “We are not surprised because we knew it would not be cheap but we have to say that this drug will only be a good thing for a few people in rich countries.”

Meanwhile, financial analysts were taken aback by the cost. “This price is above our expectations,” said Patrick Burgermeister of Zurich Cantonal Bank.

“It shows that the limited amount that can be produced is supposed to be sold at the highest possible price in the industrialised countries.”

The twice-daily injection is given in combination with existing drugs and is expected to win marketing approval shortly from regulators in both Europe and the United States.

The drug has also been filed for approval in Canada, Switzerland and Australia.

In the meantime, Roche is launching a pre-licence special-access programme under which the drug will be available in certain European Union countries.

Kramer said it was not yet clear which countries would participate in the scheme or how many patients would be involved.

Aids pandemic

Kramer said he did not envisage Fuzeon ever being suitable for use in Africa – the epicentre of the global Aids pandemic – given its very high cost of production.

“In developed countries, we have a steeply increasing incidence of drug resistance and an increasing number of people who are running out of options for care, so for these people we urgently needed something completely new, something like Fuzeon,” he said.

“On the other hand, we have the challenge of HIV in developing countries, where access to basic care, access to the first steps of anti-HIV treatment need to be looked at.

“Here we have been active since the 90s in collaborating with UN organisations like WHO to improve access to care to people with need.”

Clinical trials

Including those already involved in clinical trials and an early free-access programme, some 3,500 people worldwide are likely to be receiving the drug by the end of March.

The total should rise to 12,000-15,000 by the end of 2003, and Roche expects to be able to supply about 40,000 people by the end of 2005.

With analysts estimating that as many as 50,000 patients in North America and Europe are resistant to other Aids therapies and are ready for Fuzeon, demand is expected to outstrip supply for the foreseeable future.

swisssinfo, Vincent Landon

Roche Aids drug

Roche has priced its new Aids drug at €52 (SFr76) a day.
Fuzeon targets people who are resistant to other Aids medicines.
Roche says the high cost reflects the complex manufacturing process.
Peak annual sales are estimated at up to SFr1 billion.