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J&J's Prezista wallops Abbott's Kaletra

Johnson & Johnson's Prezista beats Abbott's protease inhibitor Kaletra in controlling HIV replication in a head-to-head clinical trial

US-headquartered Johnson & Johnson's Prezista (darunavir) has beaten Abbott's Kaletra (lopinavir) in controlling HIV replication in a head-to-head clinical trial.

In the trial, both protease-inhibitor drugs were boosted with doses of ritonavir and taken by patients who had previously been using other drugs to control HIV infection, which leads to AIDS.

The data was presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Sydney. The team, led by Jose Valdez-Madruga, demonstrated that after 48 weeks of treatment, 71 per cent of HIV-infected participants who took darunavir had undetectable viral loads. Only 60 per cent of patients on lopinavir achieved undetectable levels of the virus.

The primary endpoint of the trial was to show there were no differences in outcomes, but Valdez-Madruga said he found superiority with darunavir, developed by J&J's Belgium-based subsidiary Tibotec.

Valdez-Madruga, who is director of clinical trials for the Sao Paulo AIDS Programme in Brazil was reported as saying: "This is the first time that any drug has been shown to be superior to lopinavir. Patients with experienced HIV infection now have an option for treatment."

He added that his team also found that darunavir appears to protect the other drugs classes better than lopinavir. Also, fewer resistance mutations in the nucleoside reverse transcriptase class and in the protease inhibitor class appeared while patients were being treated with darunavir.

In Q2 FY07, Abbott posted global Kaletra sales of USD 315m, up 18.9 per cent on Q2 FY06 revenues. For H1 FY07, sales of Kaletra were USD 615m, up 12.9 per cent on H1 FY06.

Analysts have estimated that peak sales of Prezista may reach USD 900m a year. The drug currently has a wholesale cost of USD 25 per day.

26th July 2007

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