The companies in this group were selected for having at least one investigational product in Phase II or beyond, which targets bacteria and/or fungi identified by WHO and/or US Centers for Disease Control (CDC) as threats to human health.* They are evaluated exclusively on their R&D activities, which means only 20 points are available to these companies. Entasis delivers the strongest performance, followed closely by Wockhardt. Summit follows in third, just ahead of Melinta (filed for bankruptcy in December 2019) and Tetraphase in joint fourth place.
Entasis’ R&D pipeline of four medicines exclusively targets bacteria in the highest threat category defined by WHO and CDC. For example, its most advanced project targets A. baumannii, which can cause severe drug-resistant infections including pneumonia and urinary tract infections (UTIs). Entasis stands out for supporting its two late-stage projects with plans to ensure better access and good stewardship soon after launch. This includes zoliflodacin, a novel Phase II candidate targeting gonorrhoea, which is estimated to cause 78 million infections globally.1 As a novel medicine, zoliflodacin has important differences from existing medicines, which may help to preserve its effectiveness.
Within this group, Wockhardt has one of the largest pipelines: four projects in clinical development, and five in pre-clinical stages. It has multiple projects that target bacteria in the highest threat category. For example, its medicine cefepime/zidebactam, in Phase I, targets carbapenem-resistant Enterobacteriaceae, which causes diverse diseases including lower respiratory tract infections. Wockhardt is planning ahead to ensure rapid access to its four late-stage candidates: it commits to simultaneously filing the successful products for registration in India and other high-need countries. Although Wockhardt has a substantial generic medicine division, it was evaluated by the Benchmark alongside the small- and medium-sized enterprises. This enables a comparative analysis of its R&D activities.
Summit is developing three antibacterial medicines, including one in Phase III that is considered novel: ridinilazole, for C. difficile infections. Ridinilazole meets all criteria for novelty: it belongs to a new chemical class, and has a new target, mode of action and no cross-resistance. In terms of access planning, Summit has already entered into a regional licensing agreement for the medicine with Eurofarma Laboratorios, one of the largest pharmaceutical companies in Brazil and present in more than 20 countries in Latin America.
Melinta and Tetraphase are tied in fourth place, having performed well in different areas. Melinta filed for bankruptcy in December 2019. During the period of analysis, it had the largest pipeline in this group, with 11 projects, including eight in clinical development. It also reported access plans in place for its late-stage projects, but not stewardship plans. Tetraphase has a smaller pipeline, but it does have both access and stewardship plans in place to support its approved product, eravacycline. This includes a licensing agreement and plans to develop a surveillance network.