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Plant Health Care Submits PHC279 for Regulatory Approval in Brazil

Plant Health Care plc (LON:PHC), a leading provider of novel patent-protected biological products to global agriculture markets, has today announced it has successfully submitted its application to the regulatory agencies in Brazil for approval to commercialize the Company’s first peptide product, PHC279, for the control of Asian soybean rust.

Highlights:

  • Plant Health Care’s application for approval to sell novel peptide product PHC279, to treat Asian soybean rust has been submitted to the authorities in Brazil.
  • Review of the application is expected to commence shortly and the Federal regulatory licence is expected in 1-2 years.

As announced on 15 August 2019, the 2018/19 Field trials of PHC279 as a seed treatment in Brazil soybeans, showed up to 45% improved control of Asian soybean rust (ASR) and up to 16% yield increase when compared with foliar fungicide programs alone. Based on these results, the Company intends to move forward to commercialise PHC279 in Brazil, with regulatory approval expected by the end of this year at the earliest.

Brazil is the world’s largest exporter of soybeans, with some 36 million hectares (89 million acres) planted in 2019. One of the challenges of producing soybeans in Brazil is ASR, which is a potentially devastating disease. Growers spent $2.1 billion in 2017 on soybean fungicides in Brazil.

The company’s PREtec peptides stimulate the plant to defend itself. Derived from natural proteins, this is a novel, environmentally friendly approach to protecting crops and increasing yields, compatible with mainstream agricultural practice. PHC279 may allow farmers to reduce applications of toxic fungicides or to achieve better control of disease.

PHC’s submission for registration of PHC279 for the control of ASR has been accepted by the three responsible Brazilian agencies: the Ministry of Agriculture, Livestock and Food Supply (MAPA), the National Health Surveillance Agency (ANVISA), and the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA). The Brazilian authorities do not commit to a specific timeline for granting regulatory licences. However, the Company expects the review to start soon and given PHC279’s environmentally friendly profile and unique mode of action compared with conventional agrochemical products anticipates a regulatory licence will be granted in 1-2 years.

The Company expects to be in a position to launch the product soon after regulatory licences have been obtained. Low cost production methods are progressing to scale-up and will be in place before launch.

Chris Richards, CEO of Plant Health Care said, “PHC279 is the first of many peptides from the Company’s PREtec platform. Submitting our application for regulatory approval in Brazil is the first step towards regulatory approval in Brazil and an important milestone towards commercialising this product. Outside of Brazil, we are preparing to launch this novel technology directly to markets in the U.S. and other countries, initially targeting markets with an opportunity of $5 billion.”

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