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    Tuesday, May 14, 2024

    Researchers applaud antibiotics bill

    New Haven - A bill co-sponsored by U.S. Sen. Richard Blumenthal to promote antibiotics research that could reduce the nearly 100,000 worldwide deaths each year from drug-resistant infections received a warm welcome Thursday during a meeting of state biotech leaders at Yale University.

    Nobel Prize winner Thomas A. Steitz, a professor at Yale speaking in the Presidents Room at Woolsey Hall, called a provision in the bill to expand patent protection by five years for new antibiotics "very important ... given how long it takes to get through clinical trials."

    Only three new antibiotic drugs have been approved by the U.S. Food and Drug Administration since 2007, partially a reflection of companies bailing out of research in response to a low return on investment and partially an indication of the high barriers regulators have placed in the way of approval, speakers said. Pfizer Inc., which had an antibacterials research unit in Groton, disbanded the group last year, joining a growing list of major pharmaceutical companies that are no longer investigating new antibiotics.

    Blumenthal, speaking before about 75 people at a meeting of the drug-industry group Connecticut United for Research Excellence, said the bill he is co-sponsoring with U.S. Sen. Bob Corker, R-Tenn., contains provisions that could lead to speedier clinical trials of new antibiotics that are needed to combat a nearly five-fold increase over the past few years in U.S. deaths from drug-resistant bacteria. The Generating Antibiotics Incentives Now (GAIN) Act has gained bipartisan support and is expected to become law in the next few months, Blumenthal said, adding it could promote new research jobs in Connecticut.

    Paul Pescatello, president of CURE, said the bill would add about 40 percent more marketing time onto the typical 12 years that a pharmaceutical company has to sell an antibiotic after it has received regulatory approval. Given the sales numbers for established antibiotics, the extra time could add hundreds of millions of dollars to drug firms' bottom lines, encouraging more companies to enter the field.

    "We have made very good progress on this bill so far," Blumenthal said.

    Panelists at the meeting said the rise of such deadly organisms as MRSA and gram-negative bacteria is occurring because these pathogens are developing resistance to older antibiotics.

    "We need new tools to manage infection," said David Nicolau, director of the Center for Anti-Infective Research and Development at Hartford Hospital.

    But panelists said the days-long antibiotics regimes required to kill the organisms - as opposed to the years-long need for pills such as the cholesterol fighter Lipitor - don't give drug companies the ability to quickly recoup their investments.

    "Drug companies need incentives," Blumenthal said.

    Blumenthal said a vote on the GAIN Act is likely to be held in May. Because the bill has been included as part of a measure to reauthorize the Food and Drug Administration as a federal agency, he said, the act appears to have enough support for easy approval.

    "It's hooked to a train that's likely to reach a station," he said.

    l.howard@theday.com

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