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July 22, 2010

J&J AIDS drug shows promise, raises questions

Reuters: "Two pivotal trials of a Johnson & Johnson (JNJ.N) experimental HIV drug found it worked as well as an existing drug, with fewer side effects but also with nearly twice as many patients failing to respond to treatment.

"The drug, rilpivirine or TMC278, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS.

"J&J already has a deal with U.S. biotech company Gilead Sciences (GILD.O) to develop a single pill combining rilpivirine with Truvada, a drug containing Gilead's tenofovir and emtricitabine.

"Gilead currently sells a once-daily pill, Atripla, that combines Truvada with Sustiva, an older NNRTI made by Bristol-Myers Squibb (BMY.N). But it earns no profit on the Bristol drug, known generically as efavirenz, and all of the Atripla components lose patent protection in the next few years. ...

"Fewer TMC278 patients, 2 percent, dropped out of the trials due to side effects versus 7.2 percent of the Sustiva group, according to results presented at the International AIDS Conference in Vienna on Thursday.

"Serious side effects, including psychiatric and neurologic problems, were seen in 16 percent of the TMC278 group versus 31 percent of the Sustiva group.

"But the data also showed 9 percent of TMC278 patients experienced virologic failure compared to 4.8 percent of Sustiva-treated patients."