Thursday, April 29, 2004

AIDS drug encounters disappointing launch



By Theresa Agovino
The Associated Press

NEW YORK - When the new AIDS drug Fuzeon was launched last year, it was touted as a major breakthrough, with expectations so high it was feared the drug would be in short supply as patients clamored for it.

Instead, Fuzeon sales are below estimates and analysts are slashing revenue projections. Fuzeon's $20,000-a-year price tag, painful side effects and changing AIDS treatment strategies have made sales a disappointment.

Hoffmann-La Roche Inc., which markets Fuzeon for the drug's developer, Trimeris Inc., is expanding distribution and launching an advertising and public relations campaign. Nurses will visit patients to teach injection techniques to help avoid some of the drug's side effects.

But the outlook for Fuzeon remains uncertain.

Fuzeon works differently from other AIDS medicines; it prevents the HIV virus from entering a cell, while other drugs prevent the virus from replicating.

Yet Fuzeon is not intended to be a first or second line AIDS therapy - it is supposed to be used when patients are resistant to some AIDS drugs, but before all other drug options have been exhausted.

"I think Fuzeon is underutilized," said George Abercrombie, president and chief executive of Roche. "I think it is important to note we are still in the early stages of the launch. The learning curve is going to take a while."

Roche has been criticized for the drug's high price - Fuzeon costs three times more than any other AIDS drug.

And a recent policy change by Roche limiting the number of people who could get Fuzeon free has brought more complaints.

Free for some, not all

The change results from a dispute between Roche and government-funded AIDS Drug Assistance Programs, known as ADAPs. Nearly a third of AIDS patients receive their drugs through ADAPS, but only 37 of the country's 56 ADAPs pay for patients' Fuzeon.

Late last year, Roche stopped giving the drug to patients in states where ADAPs refused to cover the drug.

That decision has upset many patients.

In Texas, while the local ADAP plans to cover Fuzeon, John Willingham said he was rejected from the Roche free-drug program last December because the ADAP hadn't begun coverage yet.

"I was really upset. The ADAP program has nothing to do with me," said Willingham, who can't afford Fuzeon and has no private insurance. "It hit me as so unfair that drug companies are doing this to people with so few options."

Abercrombie said patients who live in states where ADAPS don't cover Fuzeon should lobby legislators for additional funds.

"We cannot afford to become a backup insurance plan," he said.

Physicians said some patients balk at the prospect of the injections, which can cause severe pain, welts and nodules.

A further challenge is a shift in AIDS treatment practices. AIDS patients take several medicines simultaneously, but the regimen must be changed as patients become resistant to the drugs.



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