Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Wall Street Journal - December 20, 2002
Vanessa Fuhrmans, Staff Reporter of The Wall Street Journal
The drug, called Fuzeon, has created much excitement among AIDS patients and doctors for the potent way it attacks super strains of the virus.
That's because resistance to existing therapies has grown at a troubling pace. As many as 78% of patients are believed to carry viruses resistant to at least one AIDS drug.
Fuzeon, expected to be approved before spring, is also extremely complicated and costly to make. Roche says it has managed to ramp up production to commercial scale. Still, the amount it will be able to make by the end of 2003 will be enough for only 15,000 patients, short of the 25,000 it originally projected. That means the company will allocate limited quantities to each country and work with health authorities and doctors to get it to the neediest patients.
"We're going to have to carefully manage the supply," said David Reddy, head of Roche's HIV products and disease strategy. Once a patient begins getting it, they will need enough to stay on it.
It's unclear just how great demand for Fuzeon will be. The drug isn't expected to be a standard therapy but instead a treatment for patients who don't respond to other drugs. Analysts estimate as many as 50,000 patients in North America and Europe are resistant to some other AIDS therapies and are ready for Fuzeon. Roche says it anticipates a rush for the drug once it hits the market.
Mr. Reddy said Roche will work with health authorities, doctors and patient groups to help determine how to best allocate the drug in each country. In many cases, he said, it probably will be handled much like a large-scale expanded-access program for unapproved drugs, in which patients may have to first meet certain criteria to determine their need.
The company says it has built in a six-month safety supply cushion in its projections for how many patients it can supply to make sure no one runs out of treatment. By 2004, the company said it expects it will be able to more than double capacity to enough for 32,000 patients. It projects enough drug for about 39,000 patients in 2005.
Price, however, also is expected to curb use of the drug. Roche and its partner, Trimeris Inc. of Durham, N.C., which discovered Fuzeon, won't announce a price until close to the drug's launch. But analysts and clinicians estimate it could cost between $12,000 and $17,000, more than any other drug on the market, reflecting the complicated manufacturing process. The high cost is likely to give strapped state and local AIDS public-assistance programs pause about covering Fuzeon in all but extreme cases of resistance.
In cases of patients who need public assistance, "what programs decide they can pay for will add another layer in deciding who will get the drug," said Bill Arnold, chairman of the ADAP working group, a coalition of AIDS groups and pharmaceutical companies that works on getting federal funds for AIDS drug assistance programs.
Unlike other AIDS therapies, Fuzeon is a synthetic peptide that works by stopping HIV from entering a cell. But it takes 106 steps -- more than 10 times the typical number of chemical reactions -- to make the lengthy peptide. Almost 100,000 pounds of specialized raw materials are needed to make little more than 2,200 pounds of the drug.
"Because it's a significantly complex drug to make, it's going to be significantly more costly," Mr. Reddy said.
Write to Vanessa Fuhrmans at vanessa.fuhrmans@wsj.com1
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