Tibotec Gets AIDS - Pharmaceutical Executive


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

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 TB.

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."

Captured Alive

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 sense."

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."


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