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Strong Partnerships are Helping Bring Next Generation Antibiotics to Market

Author: Melissa Stundick, PhD. Acting Branch Chief of BARDA’s Broad Spectrum Antimicrobials Program
Published Date: 2/18/2015 10:51:00 AM
Category: Medical Countermeasures;

BARDA and its partners are coming closer to bringing new drugs to market to help in the fight against antibiotic resistance.  Four of BARDA’s partners have met major milestones in the development of new antibiotics, and with increased funding, BARDA is poised to further strengthen the antibiotic pipeline.

Two of these drugs could be coming to market soon and both of them may be able to overcome antibiotic resistance that is threatening existing classes of drugs. The first new product is eravacycline, which was developed by Tetraphase Pharmaceutical to treat complicated intra-abdominal infections (cIAI).  The second is solithromycin, an experimental antibiotic by Cempra Inc. that would be used the treatment of patients with community acquired bacterial pneumonia (CABP).  Both of companies are working toward filing a new drug application (NDA) with the FDA in late-2015. If their applications are approved, they would become available for sale in the commercial market.

Two more BARDA-sponsored antibiotics to fight Gram negative infections also have met major milestones. BARDA is working with Rempex Pharmaceuticals on two global Phase 3 studies of Carbavace. One set of Phase 3 trials centers around its use in combatting complicated urinary tract infections and acute pyelonephritis, a common but serious kidney infection.

In addition, BARDA has been working with Achaogen Inc. since 2010 on the development of a novel aminoglycoside, plazomicin. Aminoglycosides are a group of bactericidal antibiotics that inhibit bacterial protein synthesis.  Achaogen has successfully moved this program into Phase 3 clinical development and has enrolled its first patient in clinical trials.

The President’s FY16 budget included a request for $1.2B in increased funding to address antimicrobial resistance. Several government agencies would be recipients of that increased funding, including BARDA. If approved, BARDA would use this funding to support new antibacterial therapeutics and diagnostics to combat bacteria that pose a threat to national security and public health - especially multi-drug resistant bacteria.

By working together, BARDA and its partners are poised to give hospitals and healthcare providers new options that can help them address a wide range of bacterial infections that are serious every day, but that can be particularly dangerous during an emergency when hospitals and healthcare systems are stressed.  We are very proud of our partnerships with these companies and excited by the milestones that they are meeting that could play an important role in protecting health. By continuing to work with our partners, we can fight antibiotic resistance with next-generation drugs during disasters and every day.

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