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Pfizer scientists collaborating in new TB initiative

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Pfizer Inc. scientists in Groton are joining a worldwide collaboration to find a new drug regimen to battle tuberculosis, which kills an estimated 1.8 million people annually, the company said today.

The so-called Critical Path to TB Drug Regimens, an initiative that will bring together at least 10 pharmaceutical companies and the U.S. Food & Drug Administration, hopes to cut the time it might take to develop a new TB therapy from as much as a quarter century to as little as six years.

"A successful drug combination regimen to fight TB could save millions of lives," Dr. Tachi Yamada, president of the Bill & Melinda Gates Foundation's global health program, said in a statement. "This type of collaboration between the public and the private sector is exactly what's needed to help speed the availability of a shorter and more effective treatment for TB."

The Gates Foundation, along with the Global Alliance for TB Drug Development and the Critical Path Institute, helped get the initiative off the ground. The World Health Organization also is a backer of the initiative.

Other drug companies besides Pfizer involved in the initiative are Johnson & Johnson, Sanofi-Aventis, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals.

The lineup of drug companies could change over the coming months and years. "The collaboration will welcome participation from any company with a promising TB drug candidate in development," said a press release from the Critical Path initiative.

Nine promising antibiotics are currently being studied in earnest as part of a combination of drugs that could replace a nearly half-century-old regimen now being used. Because of the resilience of TB bacteria, an estimated half-million annual cases of tuberculosis globally are reported to involve drug-resistant strains of the disease, making the search for a combination of antibiotics essential, according to scientists.

The FDA, which will be joined by European regulatory authorities in trying to speed up the approval process for TB drug combinations, said the initiative is unusual, but not unprecedented.

"FDA is poised to repeat its creative regulatory approach to AIDS drugs in the 1990s, which helped save the lives of millions without compromising drug quality," said Mark Harrington, executive director of Treatment Action Group, which advocates for HIV-infected patients, who are more likely to be killed by TB than any other cause.



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