Westway Health (WWH) are an innovative Animal Health company based in Galway, Ireland. Our lead product in development is PanaMastTM LC (PanaMast), which represents a breakthrough in the treatment of bovine mastitis, the most economically important infectious disease affecting the dairy industry. PanaMast will dramatically change the way that dairy farmers treat and prevent mastitis and aims to be the world's first non-antibiotic medicine for mastitis treatment, offering a superior clinical outcome and delivering significant financial gains to end-users. This innovative, non-antibiotic technology is effective at killing all bacteria, including antibiotic-resistance bacteria, such as MRSA, whilst preventing the emergence of resistance bacteria. This innovation directly addresses the growing and major European and global problem of antibiotic resistance where novel, effective solutions are urgently required for this $40bn global market.
WWH's main focus is the development of veterinary therapeutics for the treatment of animal health diseases, however this application is part of the much larger societal problem of antibiotic overuse, and antibiotic-resistant bacteria. There is a global crisis looming regarding the emergence and spread of antibiotic-resistant bacteria. In the EU alone, 25,000 people die each year from antibiotic resistance. Overuse of antibiotics is a major factor in the development of resistant bacteria and consequently a rise in the number of human deaths. Reduced use of antibiotics in animal health and the development of alternatives has been advocated. Indeed, the One Health Approach advocated by governments globally views human, animal and environmental health together, where diseases can transmit from one species to another. In fact, the One Health Action Plan against Antimicrobial Resistance (AMR) has been cited in the new H2020 2018-2020 Health funding call with a focus on "the development of new antimicrobials and alternative products for humans and animals".
There needs to be more prudent use of antibiotics and preservation of antibiotics for human use, in a world where 80% of the world's antibiotics are used in animal health. Policies have been already enacted by governments in Denmark and the Netherlands to reduce such usage. The likelihood of future EU-wide action restricting or banning certain classes of antibiotics is high. Outside of the EU, the US FDA have issued a ban on the use of cephalosporins in animal health.
New concepts for novel anti-microbial therapeutics for human and animal health should deploy novel mechanisms of action and ideally, should not allow for a facile emergence of resistance following usage. At a national level, Ireland launched a National Action Plan (iNAP) on AMR for 2017-2020 in October 2017, which contains a range of strategic interventions and activities to reduce the spread of resistance while encouraging the development of novel solutions. Collectively given the aims of our research and the promising results to date, we feel that we are in a position to provide an excellent solution to address this major societal problem. By providing a means of reducing antibiotic usage in the sector which is the largest consumer of antibiotics, we shall conserve existing antibiotics for human usage. Prevention of bacterial resistance to our treatments shall prevent any potential zoonotic transfer of resistance from animals to humans, providing a glimpse into a safe 'post-antibiotic' era.
The overall aim of this H2020 SME Phase 2 project is to bring PanaMast to the point of EU commercial launch. This requires regulatory approval from the European Medicines Agency (EMA) through the submission of a product regulatory dossier requiring information under: Quality, Safety, Efficacy, themes. Thus, the first major project objective is to complete the remaining clinical and commercial aspects of product development to allow for completion and submission of a product regulatory dossier. This is ongoing, and the majority of the work packages (WPs) are involved with these aspects (see flow chart).
The second overall project objective is to ensure effective and efficient commercialisation of PanaMast. We are currently liaising with regulatory agencies and GMP manufacturing companies who will allow for immediate market launch and sale of the product, upon completion of the product regulatory dossier.
