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Push for new antibiotics.

WASHINGTON -- Federal health officials, pharmaceutical firms and medical experts are advocating quick approval of new medicines as the nation encounters outbreaks of antibiotic-resistant "superbugs."

Janet Woodcock, director of the Food and Drug Administration's center for drug evaluation and research, has described the need for new antibiotics as a crucial response to a worsening global crisis. Others believe that because the need for new antibiotics is so urgent, extensive studies involving hundreds or thousands of patients should be waived in favor of directly testing such drugs in extremely sick patients.

In a related matter, the Department of Health and Human Services (HHS) recently announced an agreement under which it will pay $40 million to GlaxoSmithKline PLC (GSK) to help it develop medications to combat antibiotic resistance and biological agents that terrorists might use. Under the plan the federal government could give the drug company as much as $200 million over the next five years.

"We are facing a huge crisis worldwide not having an antibiotics pipeline --it is bad now, and the infectious disease docs are frantic," warned Woodcock. "But what is worse is the thought of where we will be five to 10 years from now."

U.S. officials also hope to have new antibiotics available to battle lethal bugs that could be deployed in a bioterrorist attack. But many drug companies have halted efforts in the antibiotics arena because they consider the potential profits to be too low.

Under the deal with GSK (which still maintains an antibiotics research group) the pharmaceutical firm will receive an initial $40 million over 18 months from the Biomedical Advanced Research and Development Authority (BARDA), a unit of HI-IS that funds development of new medicines, vaccines and diagnostic tools for public health emergencies.

BARDA will contribute up to $200 million to GSK if the partnership continues over five years. A joint BARDA-GSK committee will decide which projects to invest in.

BARDA has spent $5 billion to $6 billion over the last decade to fund mostly private sector development of new medical tools, from bird flu and swine flu vaccines to antitoxins used to treat anthrax infections.

New carbapenem-resistant germs kill up to half of all hospital patients who get bloodstream infections from them, the Centers for Disease Control and Prevention said.

"There is an urgent need to address antibiotic resistance, and new models are needed to deal with this challenging area of drug development," said David Payne, head of GSK's antibacterial discovery performance unit. "We strongly believe that innovative public-private partnerships such as this are integral to solving this critical health care issue, and we are delighted to work with BARDA in a more strategic way."

The BARDA-GSK joint oversight committee will monitor progress, make decisions on the allocation of funds and decide on the addition or removal of drug candidates from the portfolio. GSK, considered an industry leader in government research collaborations, has had contracts with BARDA and other agencies for vaccines and antibiotics development.

As one of the few large pharmaceutical companies still pursuing antibacterial research, GSK also has creative collaborations and funding partnerships with other companies, academia and such funding bodies as the Innovative Medicines Initiative, Europe's largest public-private initiative, and the Defense Threat Reduction Agency, which is part of the U.S. Department of Defense.
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Title Annotation:Focus
Publication:Chain Drug Review
Geographic Code:9AZER
Date:Jul 8, 2013
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