PHC.L Regulatory News (PHC)

25 September 2023

PLANT HEALTH CARE plc

("Plant Health Care" or the "Company")

New PREtec Products Submitted for Regulatory Approval

PHC25279 and PHC68949 submitted for approval in Mexico

Plant Health Care® (AIM: PHC.L), a leading provider of novel patent-protected biological products to global agriculture markets, is pleased to announce it has submitted applications to the Mexican regulatory agency for approval to commercialize the newest products derived from the Company's PREtec technology platform (Vaccines for PlantsTM), PHC25279 and PHC68949, for use on major crops. 

PHC25279 helps control a broad spectrum of plant diseases when used as part of an integrated disease control program and is expected to find immediate application for the control of Gray Mold (Botrytis cinerea) in berries, Downy Mildew (Pseudoperonospora cubensis) in cucurbits such as cucumbers and Late Blight (Phytothphora infestans) in tomatoes and other Solanaceae crops. The current planted area in Mexico for berries totals 55,000 hectares. The production of cucumbers in Mexico is expected to reach 1.02 million metric tons by 2026. Additional PHC25279 product label claims against various other plant pathogens will be added in the future. 

PHC68949 is a novel product that amplifies a plant's natural defense pathways to provide protection against plant parasitic nematodes which damage plant roots and limit crop yield. As a next generation bionematicide, PHC68949 increases plant health and yield across a wide range of commercial crops. Results from field studies confirm the efficacy from foliar applications of PHC68949 is comparable to synthetic chemical nematicides and superior to current biological products. PHC68949 is expected to find immediate use in tomatoes, eggplants, peppers and other crops within the Solanaceae family and in cucurbits to protect against yield and quality losses caused by root knot nematodes (Meloidogyne spp.) and other pathogenic nematode species. Mexico's 2023 fresh tomato production is forecasted to reach 3.4 million metric tons (MMT). Additional PHC68949 product label claims against plant parasitic nematodes will be added in the future. 

Both products are based on the Company's PREtec technology platform (Vaccines for PlantsTM). Derived from natural proteins, PREtec is an environmentally friendly technology which stimulates plant defense and pathogen resistance mechanisms within plants, resulting in improved crop growth and quality along with the ability to withstand a variety of abiotic stresses. PHC25279 and PHC68949 represent unique products from this platform which provide specific benefits of improved disease and nematode control, plant health and yield. PREtec peptides are compatible with mainstream agricultural practices and common IPM (Integrated Pest Management) and resistance management practices.

The regulatory process in Mexico for agricultural products involves a detailed and comprehensive review of standard data requirements. Upon approval, the Federal Committee for Protection from Sanitary Risks (COFEPRIS) will issue Federal Registration. Although COFEPRIS does not commit to a specific timeline for granting regulatory licenses, the Company expects the review to start soon and to receive regulatory approvals within 1-2 years.

Plant Health Care continues to expand into new markets around the world and is growing its relationships with major global distribution partners. The Company is on track to achieve revenue of $30 million by 2025 through the launch of new products and continued organic business growth through current and future distributor relationships.

Jeff Tweedy, CEO of Plant Health Care, said: ‟Ranking 11th in global food production, Mexico provides a tremendous opportunity for the adoption of these new products to support sustainable agriculture. Building on the current success of our ProAct biostimulant, our dedicated team in Mexico is already laying the groundwork for the commercial launch of these two new products once the regulatory licenses are granted. These registration submissions are key steps for Plant Health Care in meeting our $30 million revenue target by 2025."

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About Plant Health Care

Plant Health Care offers products to improve the health, vigour and yield of major field crops such as corn, soybeans, potatoes and rice, as well as specialty crops such as fruits and vegetables. We operate globally through subsidiaries, distributors and supply agreements with major industry partners. Our innovative, patent-protected biological products help growers to protect their crops from stress and diseases, and to produce higher quality fruit and vegetables, with a favourable environmental profile.

Find out more at www.planthealthcare.com