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GSK awarded $94 million BARDA contract
PALO ALTO, Calif.—Anacor Pharmaceuticals has announced that GlaxoSmithKline (GSK), its business partner, has been awarded a contract with the U.S. Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority (BARDA). The contract will support the continuing development of GSK2251052 (also known as GSK '052, formerly AN3665), a novel boron-based Gram-negative systemic antibiotic discovered by Anacor. The contract will provide GSK will up to $94 million in funding for up to four years as the company moves forward in studies to evaluate the compound's efficacy against bioterrorism threats, Phase II clinical trials of ventilator-associated pneumonia and Phase III trials for complicated intra-abdominal infections.
GSK will receive $38.5 million in the first two years, and the contract can be extended for a total of four years. BARDA will also provide technical support and will share the cost and drug development risk. If successful, the drug would represent the first new class of antibacterial agent to treat Gram-negative infections in 30 years.
"To help providers protect health and save lives in an emergency and every day, we will need to develop the next generation of antibiotics," BARDA Director Robin Robinson, Ph.D., said in a press release. "This commercial-plus-biodefense strategy creates a sustainable, cost-effective business model for private industry and taxpayers, and it promotes a warm base manufacturing capability for use in a public health emergency."
GSK '052 targets the bacterial enzyme leucyl-transfer RNA synthetase, or LeuRS, which is necessary for protein synthesis. Inhibiting protein synthesis terminates cell growth and leads to apoptosis. An added bonus is that since there are no commercially available antibiotics that target LeuRS, there is no known pre-existing bacterial resistance. Preclinical and Phase I studies have shown that NAME has potential as a treatment for infections caused by a broad range of Gram-negative bacteria, including E. coli, K. pneumoniae, S. marcescens, Citrobacter spp., Providencia spp., Proteus spp., Pseudomonas aeruginosa and Enterobacter spp. It also has displayed potential for treating pathogens responsible for complicated urinary tract infections, complicated intra-abdominal infections, ventilator-associated pneumonia and hospital-acquired pneumonia.
The compound was licensed to GSK by Anacor last July as part of the companies' ongoing research and development collaboration. Anacor received an option exercise fee of $15 million for the license and is eligible for future development milestones up to $75.5 million, commercial milestones of up to $175 million and double-digit tiered royalties with the potential to reach the high teens on annual net sales, according to a company press release. For its part, GSK is responsible for all further development and commercialization of the compound.
"BARDA's financial support for the development of GSK '052 will help ensure the rapid development of this compound toward its approval in all relevant indications," David Perry, Chief Executive Officer of Anacor, said in a press release. "With its novel mechanism of action, and potential to be administered both orally and intravenously, we believe GSK '052 has the potential to improve the lives of patients suffering from Gram-negative bacterial infections which have grown increasingly resistant to existing antibiotics."
BARDA's contract also supports initial lab testing to establish the drug's potential in providing protection against multi-drug resistant pathogens, including those containing the New Delhi Metallo-beta-lactamase-1 (NDM-1) resistance gene. The NDM-1 gene makes bacteria that carry it resistant to almost all routine antibiotics used for such infections.
The contract is part of a new approach to developing medical countermeasures, which was recommended last year in a review by Kathleen Sebelius, HHS Secretary. One facet is the development of broad-spectrum countermeasures for biological threat agents that can also treat regular public health threats, such as multi-drug resistant bacterial infections. It is the third contract funded under BARDA's new Broad Spectrum Antimicrobials Program.