New collaboration aims to speed TB drugs to market

WASHINGTON Thu Mar 18, 2010 6:21pm EDT

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WASHINGTON (Reuters) - U.S. regulators, drug companies, philanthropists and advocates announced a new alliance on Thursday to speed tuberculosis drugs to market, a day after cancer researchers and drugmakers launched a similar initiative.

The U.S. Food and Drug Administration said it will work with drug developers to help them through some of the requirements for testing drugs before they can win approval, with the goal of speeding trials and saving money.

"FDA is absolutely committed to working with partners to speed access to new, safe and highly effective treatments for TB, which continues to mutate and spread," FDA Commissioner Dr. Margaret Hamburg said in a statement.

The alliance, called the Critical Path to TB Drug Regimens or CPTR, will test potential combinations of new TB drugs from different companies as they are being developed -- an almost radical approach.

Companies rarely cooperate on having their drugs tested together and usually such combinations are devised by doctors in the field long after drugs are approved. The alliance said it can take as long as 24 years to get approval for new TB drug cocktails under this system.

The new approach echoes initiatives in the 1990s to help speed AIDS drugs to market. AIDS and TB must both be treated with combinations of drugs taken every day -- for months in the case of TB and for life in the case of AIDS.

Partners include the Global Alliance for TB Drug Development, the Critical Path Institute, the Bill & Melinda Gates Foundation, Johnson & Johnson, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Japan's Otsuka, Novartis, Sequella and Anacor Pharmaceuticals Inc.

"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," said Dr. Tachi Yamada, president of the global health program at the Gates Foundation.

"A successful drug combination regimen to fight TB could save millions of lives."

MILLIONS OF DEATHS

Tuberculosis killed 1.8 million people in 2008, or nearly 5,000 people a day. It is caused by the Mycobacterium tuberculosis bacteria. More than 2 billion people are infected.

TB can be cured with antibiotics but they must be taken daily for months to be effective. Because people do not always take the drugs as directed, multiple drug-resistant strains called MDR-TB have emerged.

The World Health Organization reported that MDR-TB killed 150,000 people in 2008 and infected 440,000 globally. The WHO said the numbers suggest the hard-to-treat infection is spreading and there is an urgent need for countries to set up labs to fight it.

"I've seen first hand the public health impact and personal tragedy of drug-resistant TB," Hamburg said.

"This creative approach mirrors FDA's own investments in innovative regulatory science that ensures the best new medical technologies -- including combination therapies -- reach patients as soon as possible."

"The CPTR initiative has the commitment of the FDA and regulatory authorities in Europe to help develop and validate improved, safe, and accurate regulatory pathways to test and register combination TB treatments," the group said.

"No single company or institution can do it alone," said Dr. Paul Stoffels of Johnson & Johnson.

(Editing by Chris Wilson)

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