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Pin to quick picksPlant Health Regulatory News (PHC)

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PHC279 Submitted for Regulatory Approval in Brazil

11 Mar 2020 07:00

RNS Number : 6870F
Plant Health Care PLC
10 March 2020
 

RNS Reach

 

10 March 2020

 

PLANT HEALTH CARE plc

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

 

PHC279 Submitted for Regulatory Approval in Brazil

 

Plant Health Care®, a leading provider of novel patent-protected biological products to global agriculture markets, is pleased to announce 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.

 

Plant Health Care'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.

 

Plant Health Care'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."

 

 

For further information, please contact:

Plant Health Care plc

Chris Richards, CEO Tel: +1 919 926 1600

Arden Partners plc - Nomad & Broker

John Llewellyn-Lloyd / Dan Gee-Summons Tel: +44 (0) 20 7614 5900

 Company website: www.planthealthcare.com

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Date   Source Headline
29th May 20207:00 amRNSHolding(s) in Company
27th May 20207:00 amRNSUpdate on PHC279 2019 Field Trials
6th May 20205:12 pmRNSAnnual Report & Accounts and AGM Notice Published
1st May 20203:21 pmRNSDirector/PDMR Shareholding
24th Apr 20207:00 amRNSResults for the year ended 31 December 2019
25th Mar 20207:00 amRNSHolding(s) in Company
23rd Mar 20203:45 pmRNSHolding(s) in Company
19th Mar 20203:09 pmRNSHolding(s) in Company
16th Mar 202011:53 amRNSResults of General Meeting
11th Mar 20207:00 amRNSPHC279 Submitted for Regulatory Approval in Brazil
24th Feb 20209:18 amRNSResults of Placing and Subscription
24th Feb 20207:00 amRNSProposed Placing and Subscription
19th Feb 20207:00 amRNSBlock listing Interim Review
5th Feb 20207:00 amRNSEmploy California Registration
23rd Jan 20207:00 amRNSFirst US patent issues for PREtec peptide products
9th Jan 20207:00 amRNSBrazil Update
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10th Apr 20197:00 amRNSResults for the year ended 31 December 2018
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28th Feb 20197:00 amRNSNew Technology Update
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28th Nov 20187:00 amRNSNew Technology Update
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19th Nov 20187:00 amRNSPlant Health Care to present at Mello London

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