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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - INFarm (A unique, interferon-based veterinary therapy to minimize antimicrobial overuse in cattle and tackle the societal global problem of antimicrobial resistance)

Teaser

Summary

Infection management approaches highly rely on antibiotics, causing antimicrobial resistance (AMR). AMR is a serious threat to human and animal health, estimated to cause 700 000 human deaths annually, but predicted to rise to 10 million deaths by 2050. The increase of AMR is substantially impacted by overuse of antibiotics in animal health, with a shocking 80% being used in livestock. Furthermore, 70% of antibiotic drugs used in animal health are also of medical importance to human health, thus threatening our ability to treat even the most common infections. Due to absence of anti-viral medicines for animals, farmers use a massive amount of broad-spectrum antibiotics in the hope to treat the outbreaks in their animals cheap and fast, which is completely inefficient in virus-caused infections that are common in livestock and exacerbate the global problem of antibiotic resistance more each day. The emergence of AMR is recognized by the WHO as one of the greatest threats to global health leading to the inability to treat infections in human, and is strongly attributed to the overuse in animal farming. The major threat represented by AMR has resulted in several actions being undertaken to reduce the use of antimicrobials in food-producing animals. All these actions, combined with continuously increasing consumer awareness, is putting farmers under enormous pressure to reduce the use of antimicrobials. However, a shortage of effective alternatives is hindering farmers to change their current practices as their production output â€’ and thus their income â€’ is at serious risk due to diseased and dead animals. FarmPharma AB has the vision to be a game-changer in the development of sustainable, prophylactic and therapeutic veterinary products, by providing a solution to keep animals healthy without antibiotics, in order to satisfy a great unmet medical need for universal alternatives to antibiotics to break the infection cascade. FarmPharma is now focused on development of InterferOx, a first universal therapy that can both treat and prevent infections in cattle caused by either viruses or bacteria, helping to reduce antibiotics in cattle. The aim of this project is to perform a feasibility study, which includes conducting a market analysis, developing an optimal commercialization strategy, strengthening our IP position, expanding our value chain, and compile a consolidated business plan.

Work performed

The feasibility study has been performed to provide insights into the cattle health markets, to develop the commercialization and IP strategies as well as to expand value chain for FarmPharma. The consolidated and investor-ready business plan was compiled based on this study. The study revealed that FarmPharma will be targeting the cattle antimicrobials market segment of animal health market, which is currently worth of â‚¬1.7 billion and expected to further grow in the coming years. This growth is driven by a rising demand for animal protein products, a growing incidence of zoonotic diseases, regulations to prevent spread of animal diseases, and increasing R&D in animal health. On the other hand, further growth of the market is hampered by a lack of new antibiotics, rising antimicrobial resistance, expensive animal healthcare, and increasing consumer awareness. However, as a new and effective antimicrobial therapy, based on natural interferons and thus not causing any resistance, InterferOx is providing a solution to the first two restraining factors, meaning that these market-restraining factors are actually favourable for FarmPharma. The structure and conditions of the cattle antimicrobials market are also very favourable for FarmPharma as a company and InterferOx as a product (Fig.1). The competition within the industry is minimal, the bargaining power of customers and suppliers is restricted, the threat of substitute products is limited, and the threat of new entrants is moderate. Evaluation of freedom to operate reveals that InterferOx will be patentable. To launch InterferOx on the market all by themselves is very difficult for FarmPharma, instead FarmPharma follows the most successful approach by joining forces with a big pharma company, either via a licensing or co-development deal for InterferOx or a trade sale of the company. It is key to generate data on the efficacy, safety and cost-effectiveness of InterferOx against selected pathogens in preclinical and clinical trials. The target pathogens have been chosen based on the indication where InterferOx can have the most impact. Thereafter an interest for a licensing deal or acquisition from many animal health companies can be expected. The highest value and return on investment being expected after successful registration of InterferOx. FarmPharma has set up a collaboration with one of the leading European animal health regulatory agencies to advise on the best consecutive steps for approval, assess the optimal regulatory strategy for bringing InterferOx to the market and implement this as early on in the development process as possible. FarmPharma has established an international consortium with complementary expertise in immunology, drug development and agriculture consisting of three SMEs and two academic partners which together will develop, upscale and clinically validate our unique veterinary product InterferOx. FarmPharma represented this business idea to investors and local life science community in Uppsala innovation center, Connect Sverige (Uppsala investors network) and Invest in Green 2019 Svenska SolelmÃ¤ssan.

Final results

The lead candidates of InterferOx are now developing by FarmPharma and going to be tested against different selected pathogens in a range of in vitro assays. Established partnerships with academic partners will strengthen R&D to explore extension of the market indication of InterferOx in cattle, as well as spin-off potential for other farm animals. Upon completion of in vitro testing, FarmPharma and a leading veterinary CRO, who is an expert in development of veterinary products with extensive experience in veterinary preclinical and field trials, together will start small POC field studies of the product in cattle. FarmPharma along with the veterinary CRO, are able to provide essential resources, regulatory and clinical expertise, supported by clinical batch manufacturing of InterferOx by a CMO with specialist expertise in recombinant protein manufacturing. Meanwhile, the CMO will upscale the InterferOx manufacturing under GMP. This will place FarmPharma in an excellent position to start field studies in cattle and give FarmPharma a possibility to commercialize of InterferOx (Fig.2).
With InterferOx we will provide farmers a sustainable and effective new therapy with broad applicability for many infections thus reducing the number of diseased and deceased cattle thereby improving animal health and elevating farm production and consequently the profit of farmers in time when the usage of antibiotics is more and more regulated. InterferOx will have a potential to replace traditional antibiotics and thereby to stimulate its prudent use in animals, especially the ones of medical importance to human health, thus slowing down or even abolishing development of AMR. By minimizing the use of antimicrobial drugs, FarmPharma will improve the sustainability of effectively treating humans and animals with infectious diseases, also in the future. We Create a Sustainable Future: One Planet, One Health.