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CDC director warns antibiotics pipeline 'nearly empty'

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Antimicrobial resistance is on the rise in the U.S. and elsewhere, and healthcare providers are running out of drugs in their arsenal to combat some pathogens, leaving patients vulnerable to dangerous infections, according to a new federal report.

In a telebriefing Monday, Centers for Disease Control and Prevention (CDC) Director Tom Frieden said, essentially, microbes have outsmarted current therapies available for bacterial infections.

"If we are not careful, we will soon be in a post-antibiotic era. In fact, with some microbes and bacteria, we are already there," Frieden said. He went on to say that the pipeline for new antibiotics is "nearly empty for the short-term" and that new, approved therapies could be nearly a decade away.

Annually, at least 2 million people in the U.S. acquire serious infections with bacteria that are resistant to one or more of the antibiotics designed to treat those infections, and at least 23,000 of those die as a result of infection, according to a report released Monday by the CDC. Most of these infections--including E. coli, salmonella, Shigella and C. difficile--are acquired in healthcare settings, such as hospitals or nursing homes.

Last year, Congress enacted the Generating Antibiotic Incentives Now (GAIN) Act, which provides drugmakers with an additional 5 years of exclusivity for qualifying new antibiotics, under the Food and Drug Administration Safety and Innovation Act (FDASIA). But some say more measures are needed to help overcome the economic and regulatory barriers to antibiotics development.

"The new CDC report highlights the serious threat that antibiotic resistant infections pose to patients and public health, and underscores the need for new drugs to treat these deadly infections," Amanda Jezek, vice president for public policy and government affairs at the Infectious Diseases Society of America (IDSA), told FierceBiotech in an email.

IDSA is calling for the FDA to establish a Limited Population Antibacterial Drug program (LPAD) to hasten approval of antibiotics to treat serious or life-threatening infections that have few or no adequate treatment options. The medical association also said it plans to propose new tax credits to spur more antibiotic R&D activity. 

In the wake of Big Pharma's withdrawal from the antibiotics arena, the biotech industry has stepped up. In the past few months alone, biotech companies have announced several new programs for antibiotics development, including a pact between Chapel Hill, NC-based Cempra ($CEMP) and Japanese FujiFilm subsidiary Toyama Chemical and a partnership between Germany's Evotec AG and Harvard University.

- read the CDC report

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