Becker's Clinical Quality & Infection Control

35 ANTIBIOTIC RESISTANCE & STEWARDSHIP Big pharma backs off superbug: Why 5 drugmakers bailed on antibiotic research By Alia Paavola S everal major pharmaceutical compa- nies recently shut down their antibi- otic and antiviral research projects, backing away from the growing threat of superbugs, which may kill more than 10 million people a year by 2050. ere are several reasons big pharma is retreating from its promise to find cures for these antibiotic-resistant infections — the most prominent being a lack of profit. "e costs to develop a new antibiotic drug are no less expensive compared to develop- ment of drugs for other therapeutic areas, yet the commercial potential and return on investment for companies developing new antibiotics are significantly lower than drugs to treat chronic conditions such as diabetes or heart disease," Gary Disbrow, deputy di- rector of the Biomedical Advanced Research and Development Authority, which is part of HHS, told Business Insider. e lack of research poses a problem as at least 2 million people in the U.S. become infected with antibiotic-resistant bacteria per year and 23,000 people die each year as a result, according to the CDC. Antibiotics were once a lucrative business, but keeping up with new antibiotic-resistant strains became taxing. Since 2000, the FDA has only approved 12 antibiotics. Here is a breakdown of five drugmakers that shut down their antibiotics research programs in recent years: 1. Novartis. e Swiss pharmaceutical giant announced in July its intent to shut down its antibacterial and antiviral research programs in California, citing a company shi toward prioritizing therapies for cancer treatments, neuroscience and ophthalmology. e drugmaker had 32 antimicrobial research and development projects in its pipeline in 2018. 2. AstraZeneca. In December 2016, Astra- Zeneca sold its small molecule antibiotics business to Pfizer, effectively pulling out of antibiotic drug development. e drugmaker considered the business a "nonpriority" area. 3. Sanofi. Sanofi shed its anti-infection research and development unit in June, when it signed over the unit to Evotec AG. Sanofi wanted to focus on developing treatments for cancer, diabetes and cardiovascular disease. 4. Allergan. Aer a strategic review, Aller- gan decided in May to divest its $2 billion infectious disease unit to focus instead on its core businesses. 5. e Medicines Co. e drugmaker washed its hands of antibiotic research in November, when it sold off its infectious disease business to Melinta erapeutics. e deal was expected to strengthen e Medicines Co.'s financial profile. e pullback from big pharma revives concerns about a world in which common infections may be lethal as antibiotic resis- tance becomes increasingly problematic. While several pharma giants have backed out of antibiotic research, Merck, Roche, GlaxoSmithKline and Pfizer all have active antibiotic research programs. n Researchers develop 'smart antibiotics' to combat C. diff By Harrison Cook R esearchers at State College-based Pennsylvania State University and Tucson-based University of Arizona are developing smart an- tibiotics, which can target genes belonging to Clostridium difficile bacteria, according to a study published in The Journal of Antibiotics. Traditional antibiotics wipe out all forms of bacteria, including the good bacteria found in patients' stomachs, which can help fight C. diff infections. For the study, Arun Sharma, PhD, associate professor of pharmacology at the Penn State College of Medicine and David Stewart, MD, associate professor of surgery at the University of Arizona College of Medicine, cre- ated new forms of antibiotics called antisense treatments. These "smart antibiotics" work in a completely different manner than other antibiotics currently in use. "Our antisense antibiotics contain genetic material, which is complemen- tary to bacterial genetic material, so we designed our genetic material to target specific genes in C. diff," Dr. Stewart told Futurity. "And when our genetic material binds to the bacterial genetic material, it prevents the expression of bacterial genes. And that can cause C. diff to die." Researchers plan to conduct further studies to refine the antibiotic in preparation for animal testing. n "The commercial potential and return on investment for companies developing new antibiotics are significantly lower than drugs to treat chronic conditions." -Gary Disbrow, deputy director of the Biomedical Advanced Research and Development Authority

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