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Therapeutics


Tackling multi-drug resistant bacteria


Antibiotic resistance never should have become the public health crisis we are seeing today. As a society, we thought the problem of bacterial infections had been solved decades ago when more than 200 powerful antibiotics representing different classes such as -lactam, tetracyclines and macrolides were developed. Names such as amoxicillin, clindamycin and erythromycin have become well-known among consumers. Signs of resistance to antibiotics appeared almost immediately and continues to plague our healthcare systems.


T


he CDC estimates that every year, at least 2 million people are infected with drug resistant bacteria. Of these, 23,000 will die. The financial cost to the US is expected to range from $20 billion to $35 billion. On a global scale, the numbers are equally frightening. The World Health Organization estimates 700,000 people will die worldwide each year from multi- drug resistant micro-organisms. Premature deaths could reach 10 million annually by 2050, accord- ing to the United Kingdom’s Review on Antimicrobial Resistance. That could cost the global gross domestic product (GDP) $100 trillion in economic productivity. Today, the alarm bell about antibiotic resistance is sounding more loudly than ever, with several recent scares fresh in public officials’ minds (see Table 1). Looking ahead, the problem of antibiotic resistant bacteria shows no sign of abating unless new strate- gies for developing novel antibiotics take hold.


New approaches to battling resistance In 2016, world leaders gathered at the United Nations, committed to act on antimicrobial resis- tance, promising that individual nations would develop action plans to combat the problem. Earlier, the US Congress passed the Generating Antibiotic Incentives Now (GAIN) Act, creating special designations to speed up new-drug approvals and extending drug company patent


Drug Discovery World Summer 2017


exclusivity by five years. The 21st Century Cures Act of 2016 further clears the pathway to patients with new FDA approval schemes for serious or life- threatening infections. This provision is expected to speed approval of new antibiotics, especially for multi-drug resistant micro-organisms. Other government groups have acted more


directly, investing in early development of new antibiotic molecules and strategies. The US National Action Plan on Combatting Antibiotic- Resistant Bacteria (CARB) launched its accelerator, CARB-X, in 2016 with $500 million to jumpstart antibiotic development. CARB-X released its first tranche of $48 million to 11 biopharmaceutical companies in 2017. Similarly the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Welfare (DHHS), has committed up to $250 million over five years to support new antibi- otic development.


Acknowledging that there have been no new antibiotics developed in the past 30 years, the United Kingdom established the Antimicrobial Resistance Centre (AMR Centre) to support start- up work with $236 million with a goal of moving 20 new medicines into pre-clinical development by 2020 and advance 10 of those to clinical trials by 2022. The AMR Centre recently issued a call to action to the G20, an international forum for the governments and central bank governors from 20


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By Dr Ankit Mahadevia


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