Tibotec Gets AIDS - Pharmaceutical Executive

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Tibotec Gets AIDS
With a new wave of "resistant to resistance" HIV drugs, a record of consistent innovation, and a dynamic partnership with AIDS activists, J&J's little company is in it to win it. And end it.


Pharmaceutical Executive


Mattes faced the challenge head-on. "I decided that it would be very, very important for me to do an awful lot of listening," he says. He took J&J and Tibotec managers to hospitals, public clinics, and AIDS service organizations in and around Newark. The trip was just half an hour's drive from the company's Bridgewater office, but it took them to another planet, populated as it was by the nation's highest proportion of women with HIV, most of them poor, black, and dependent on public funds for treatment and care. "We were staggered by the demographics and the breadth of the disease," Mattes recalls. "It was a quiet ride back to the office."


Alan Tennenberg
If Mattes was new to AIDS, two of his big hires were veterans. Alan Tennenberg, MD, Tibotec's vice president of clinical affairs, had started his own public clinic for 1,400 AIDS patients in Jacksonville, FA, where his first order of business was to broker a cease-fire between the department of health and the HIV community. "During my time at the clinic," he recalls, "we brought the two together, and they went from being antagonistic to a nice partnership." Lew Silbert, Tibotec's global vice president of professional affairs, boasted similar stripes. He was at Burroughs-Wellcome when activists campaigned to lower the $8,000 price of AZT. "We realized after four people from ACT UP came in and made themselves comfortable with handcuffs that there was a better way of communicating," he recalls. "I took my cue from that and said, 'Well, why should this be any different than any other human interaction?'"

In fact, over two decades, the pharmaceutical industry and AIDS activists have alternately fought, exploited, and befriended each other. And when they join forces, as on such issues as streamlining FDA drug approval and targeting public funds for AIDS programs, they make an unbeatable team. "We both want to get the drugs out as fast as possible," says Rob Camp, cochair of ATAC's drug development committee. "Once they realize that, they see that all of our other concerns about patient needs might be worth serious consideration."

Doing Well and Doing Good

This realization was crucial when ATAC and Tibotec sat down to discuss the design of Phase III trials of Prezista and etravarine. The activists proposed that the company step up and conduct the first-ever two-experimental-agent study, a huge boon to salvage patients because it would deliver a double-barreled shot at HIV, while substandard single-drug therapy can be outwitted by the virus with as little as a single genetic mutation.

ATAC had been pushing drugmakers for years to collaborate with each other on such a study, but even pressure from FDA failed to get anyone to bite. Adding a second experimental drug would only double the unknowns and risks; patients would be less safe, trials would take longer, each compound's effects would be harder to clarify—and who needed the headache of sharing proprietary information and other resources with a competitor?

"Here was Tibotec, a company that had two agents of their own that could be tested together," says Heidi Nass, who heads ATAC's drug-development projects with Rob Camp and, like Camp, is HIV-positive. "We thought, If not them, then who?"

Tibotec signed on to the idea not only to serve salvage patients but also to test its two drugs' viability as a marketable combo. Dubbed DUET-1 (Prezista with etravarine) and DUET-2 (etravarine alone), the studies were up and running with 1,200 patients in record time. The typical DUETer had burned through 12 HIV drugs, had extreme resistance, severe immune damage, and was too sick to qualify for most other industry-sponsored trials.


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