GSK to shut down antibiotic plants in the UK

The pharmaceutical company GlaxoSmithKline has agreed to sell three antibiotic brands to Novartis’ generic unit, Sandoz--Zinacef, Fortum, and Zinnat. As part of this sale, valued at US$500 million, GlaxoSmithKline will be closing plants in Ulverston, Cumbria, as well as those in Barnard Castle, County Durham. As a result of this shut-down, GSK has indicated that 300 employees will be laid off and that the company will place an emphasis on specialty drugs and vaccines, as well as “innovative antibiotics.” GSK will continue, however, to produce Augmentin, an amoxicillin and clavulanate potassium combination that has continued to generate significant profits for the company despite generic competition. For Novartis, this recent acquisition follows earlier commitments to expand antibiotic production in Austria. Of note, both Novartis and GSK are part of the AMR Action Fund, a $1 billion consortium created with the goal of bringing 2-4 novel antibiotics to market by 2030.

AMR Action Fund announces new partners and new CEO

Back in July, industry partners announced the AMR Action Fund, a 1 billion USD fund to invest in companies developing new antibiotics. This effort builds on an earlier concept by the World Health Organization and European Investment Bank to support development of novel antimicrobials. The AMR Action has recently announced that new partners have joined the Action Fund. The European Investment Bank, the Wellcome Trust, and the Boehringer Ingelheim Foundation will be joining and bringing additional capital of 140 million USD. The former head of Novartis’ Venture Funds, Henry Skinner, has also been selected to serve as the Fund’s CEO.

Review of five national antimicrobial reimburse-ment approaches assesses common limitations

A new review examines the antimicrobial reimbursement approaches undertaken or proposed in France, Germany, Sweden, the United States, and the United Kingdom. These reimbursement models have sought to address the market failure of antimicrobials at a national level. The review analyzes the magnitude, ability to incentivize novel research and development (R&D), capacity to ensure both affordability and antimicrobial stewardship, criteria used to evaluate novel antimicrobials, and suitability for scaling to other countries. The authors identified three common limitations amongst approaches. These include reimbursement plans proposing small changes that are exceptions to existing models, rather than integrating into these models; the nature of these approaches being unique to single markets; and difficulties predicting the financial impact that such approaches would have. The authors pointed out other common weaknesses including limitations to appropriately rewarding truly novel R&D over incremental improvements, ensuring sufficient sales volumes in reimbursement models without full delinkage of profits to volume of antimicrobials sold, and securing affordable prices for all end-users within the countries. This review also explored CivicaRx’s not-for-profit model to supply US hospitals with affordable generic antibiotics such as vancomycin and daptomycin.

While the authors assessed individual countries’ approaches, they also emphasized the need for a global coordinated effort to share costs and rewards and to better address market failures. They considered the full or partial delinkage approaches present in the UK and Swedish pilots, as well as the previously introduced PASTEUR Act in the US, to be the most innovative of the assessed approaches; emphasized the potential for other countries to learn from these pilots; and suggested that incorporation of standardized prioritization systems, such as the WHO’s Priority Pathogens List and AWaRe classification could help to harmonize how countries evaluate antibacterials for reimbursement mechanisms.

Potentially novel antibiotic developed for M. abscessus

Johns Hopkins University investigators have developed a novel antibiotic that could potentially be the first to treat Mycobacterium abscessus. M. abscessus remains one of the most dangerous members of the non-tuberculosis mycobacteria family, often presenting as a virulent drug-resistant infection. Currently, treatments for infections caused by this bacterium are limited to 12-18 months of multidrug therapy; even with these treatments, however, the current cure rate is only between thirty and fifty percent. The novel compound developed by researchers, named T405, is a beta-lactam within the penem subclass and has shown significant potency against M. abscessus. More importantly, however, T405 combined with avibactam has shown an ability to prevent M. abscessus from developing resistance. While the drug must progress to being tested in animal models next and the data is preliminary, researchers are hopeful that T405 could prove to be among the first approved antibacterials used to treat M. abscessus.