When J&J eyed an acquisition of Tibotec, it saw a company with three promising compounds in early-stage development. And tracked
as they were toward "salvage patients"—those with extreme resistance who had exhausted all their options—they did not at first
glance look like blockbuster material. But crunch the numbers and two trends leap out.
Lew Silbert
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First, the number of salvage patients was (and is) growing at a disturbingly fast clip. Last year, some 40,000 patients in
the United States were not responding to even the latest high-power combos, and "20,000 are in dire need," Nelson Vergel,
an HIV-positive treatment activist, told the Wall Street Journal last year. "I call them the invisibles because they are too tired and too sick to fight for their rights."
Second, any new HIV drug able to lay claim to the market's highest "genetic barrier" (the ability to prevent the virus from
escaping the drug's action by mutating) and back it up with proof of competitive potency and durability could deliver a knockout
punch to the first-line market leaders: Abbott's Kaletra (lopinavir/ritonavir) and BMS's Reyataz (atazanavir sulfate) in the
protease-inhibitor category; BMS's Sustiva (efavirenz) among the non-nucleosides.
So far, drugs used for salvage have tended to be disappointing also-rans. But if J&J won its bet, it would grab a major share
of the market in two of the three top HIV classes, while triggering a great leap forward for the treatment paradigm. By combining
the diagnostic test with "resistant to resistance" drugs, the far-flung drug empire that was entirely lacking an HIV pipeline
could, in one fell swoop, advance personalized medicine as here-and-now, state-of-the-art care in HIV.
But another unpredictable variable quickly came into play in the development of Tibotec's pipeline: the AIDS activists.
A Listening Tour
The medical transformation of AIDS into HIV disease led to the decline of AIDS activism as a mass movement. Gone were the
mass demonstrations, the theatrics, the rage, and much of the original wildly anti-pharma attitude. What endured was a network
of sophisticated treatment activists who had forged ties with FDA, NIH, and industry's heavy hitters in HIV. Their mastery
of the scientific, R&D, and clinical realities of the disease earned them not only respect but considerable clout. By the
time the national coalition called ATAC (AIDS Treatment Action Coalition) formed in 2000, every drugmaker had its own history
and strategy to deal with the activists.
Tibotec had neither, which proved to be an advantage. Starting from scratch, J&J, with Stoffels' guidance, immediately set
about preparing to launch three HIV drugs in as many years. "J&J realized that this was a new space for us—a very interesting,
perhaps challenging, space with a lot of opportunity," says Tibotec president Glenn Mattes. "It gave us the beautiful luxury
of time to find the right staff and to talk and listen to the community."
Mattes was tapped to build Tibotec after his successful start-over of J&J acquisition Centocor and a long run marketing specialty
products in oncology and cardiology. Yet nothing in his experience quite prepared him for this most special of specialties.
"None of us who initially thought about this assignment realized the diversity of stakeholders critical to our success," he
says.
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