A Peek in the Pipeline
Not all the action at Tibotec centers on HIV. Its pipeline contains compounds for hepatitis C and extensively drug-resistant
tuberculosis (XDR-TB), both of which happen to be common coinfections and killers of people with HIV worldwide. Although the
hepatitis virus shares many molecular similarities with HIV, HCV research has lagged until recently. As for TB, treatment
for this neglected developing-world plague has scarcely advanced in 40 years.
In April, the first protease inhibitor to treat HCV, telepravir, which Tibotec is codeveloping with Vertex, made news because
in a large Phase IIb trial it cut treatment time in half when taken with the standard of care. This promises a critical advance
because hep C requires a 48-week course of treatment, and the often-brutal side effects make compliance difficult. The company
is also working on a polymerase inhibitor that could be taken in combination with telepravir, on the HIV regimen model. In
July, Tibotec signed two new license agreements with Medivir for a Phase I polymerase inhibitor for HIV and hepatitis B as
well as a preclinical HIV protease inhibitor.
Tibotec also just started a Phase II trial of TMC 207, a novel molecule that has shown potency against a slew of resistant
TB strains, including XDR bacteria—the "untreatable" type (mis)diagnosed in the globe-trotting young Atlanta attorney in June.
If TMC 207 pans out, it could save a million lives in the developing world and put the brakes on the runaway epidemic of resistant
On the drawing board is a novel trial design to treat patients with both hep C and HIV using new Tibotec drugs for both viruses
that have shown minimal interactions. Since coinfected patients currently must choose between treating their HCV or their
HIV, a combo targeting both that was both safe and effective might erase hepatitis C's dubious distinction as the number-one
killer of US HIV patients.
Says Julie McHugh, J&J's company group chair of virology: "We place a high priority on early collaboration between the R&D
and commercial sides, strategizing around not only how to bring a product to market but what are the data sets that make
a difference to physicians and patients."
AIDS, of course, remains the mission. Tibotec is currently conducting the largest-ever trial of HIV treatment in women. "The
typical industry-sponsored study is at least 80 percent male, and most are white, so there's a need to know how the drugs
perform in women," says Tennenberg. "When talking with the community about how we could study Prezista in a way that would
both meet people's needs and help us understand how it worked best, we all agreed that a study in women and minorities makes
And the company's relationship with activists and patients continues to deepen. In a sign of the trust the community has invested
in Tibotec, the National Association of People With AIDS invited Glen Mattes to become only the second member from pharma
to join its board. Like many activists, Mattes fears for the future. Will our nation continue to budget the billions of dollars
necessary for adequate HIV treatment and care? Will the movement, founded and largely fueled by gay white men but increasingly
peopled by African-American women, transcend its many differences to fight another day? "We have to be careful that all the
hard work that's been put into distinguishing the needs of this population continues to have a champion," Mattes says. "And
I think there's an opportunity—whether for the industry or our company—to be an integral partner in that."
One recent development, however, threatens to complicate, if not scuttle, the hard-won relationship between activists and
pharma. The Office of Inspector General is stepping up enforcement of regulations against direct communication between drug
makers and patient groups. Nass notes, "A few companies that have been receptive to us in the past are now telling us that
their lawyers are telling them that they can't meet with us because the government will look at it as the company trying to
improperly influence the patients."