New AIDS drug out of patients' reach?

A new HIV drug that promises to help patients who have failed to respond to other medications carries a price tag more than double the most expensive treatments on the market. Roche said the drug, called Fuzeon (enfuvirtide), will cost Euro 52 a day, equivalent to around US$20,000 for a year's supply, to countries that elect to undertake a pre-licence special access programme before CPMP approval is granted

Though it isn't expected to receive marketing approval in the U.S. and Europe for several weeks, Roche says Fuzeon requires an extraordinarily difficult manufacturing process that makes its cost unusually high.

'This price reflects the structural complexity of th drug and its highly sophisticated manufacturing process,' said William M. Burns, head of Roche Pharmaceuticals. 'It is the most clinically advanced agent of the fusion inhibitors, a completely new class of drugs. With its unique mechanism of action, Fuzeon represents the first significant breakthrough in HIV therapy since 1996.'

The already steep cost of AIDS treatment has stirred controversy because of the limits it puts on access to these drugs in Africa and other developing regions. Now, the spiralling price of new medicine threatens to further restrict access to new AIDS treatments even in relatively wealthy countries.

Fuzeon is the front-runner in a new class of HIV medications known as fusion inhibitors. The drug's mechanism is not comparable to any existing HIV drugs. Unlike existing anti-HIV drugs that work inside the cell, it is designed to block HIV from entering healthy human immune cells and is active against strains of HIV that have become resistant to currently available medications.

Fuzeon was studied in two large, international phase III studies. These studies confirmed the activity of the drug against drug resistant forms of the virus and that treatment experienced patients receiving the new drug plus an individualised regimen of standard anti-HIV drugs were twice as likely to achieve undetectable levels of HIV in the blood (less than 400 copies/ml) as patients who received an individualised drug regimen without Fuzeon.

Fuzeon is one of the most complex and challenging molecules manufactured by the pharmaceutical industry at large scale, requiring 45kg of raw materials for 1kg of Fuzeon, and more than 100 production steps.

A total of 420 individual components are provided in each monthly treatment pack of Fuzeon. These comprise vials of Fuzeon, vials of sterile water for injection, alcohol swabs, syringes with retractable needles for reconstitution and syringes with retractable needles for injection.

'Fuzeon is unlike any of the existing HIV drugs in terms of complexity, cost of production and mode of administration,' said Dr Dani Bolognesi, ceo of Trimeris, co-developer of Fuzeon. 'For these reasons it is necessary to price Fuzeon differently from con-ventional HIV medications.'

Roche says it will be able to make enough of the drug for only 15,000 patients this year as it continues to increase production. Doctors and patient groups estimate as many as 50,000 patients in North America and Europe are resistant to some other AIDS therapies and could benefit from Fuzeon. Experts don't expect the drug to be marketed in developing countries, where resistance to existing AIDS drugs hasn't yet become a problem.