Eden Research Regulatory News (EDEN)

10 May 2022

Eden Research Plc

("Eden" or "Company")

Regulatory update: Progress towards EPA approval and further authorisation in Italy

Eden Research plc (AIM: EDEN), the AIM-quoted company focused on sustainable biopesticides and a plastic-free formulation technology for use in global crop protection, animal health and consumer products industries, announces that it has passed a key milestone in the US for the approval of its products, Mevalone® and CedrozÔ. In addition, Eden's biofungicide, Mevalone®, has received authorisation for use on new crops in Italy for the control of the disease Botrytis cinerea, a destructive fungal pathogen affecting many plant species, as well as authorisation for use against additional fungal pathogens Powdery Mildew and Sclerotinia.

Progress towards EPA approval

The United States Environmental Protection Agency (EPA) has confirmed that it has granted Eden's plastic-free, microencapsulation technology, Sustaine®, an exemption from the requirement of a tolerance for residues in pesticide formulations in pre-harvest applications to crops. This is a key milestone with Eden now in the final stages of a process which should result in its three active ingredients (eugenol, geraniol and thymol) and two formulated products (Mevalone and Cedroz) receiving authorisation in the US in 2022.

The addressable markets in the US, based on the products' current labels, are approximately €94m for Mevalone and €189m for Cedroz. With the demand for biopesticides such as these increasing significantly in the US due to rising regulatory restrictions for conventional chemicals, the tolerance exemption and subsequent approvals will present a significant opportunity for Eden.

Further Mevalone authorisation in Italy

Mevalone is sold exclusively in Italy by Eden's commercial partner, Sipcam Oxon SpA ("Sipcam"), under the brand name "3logy®".

Eden announces that it has been granted a label extension for 3logy in Italy, which authorises 3logy to be used against two new fungal pathogens and adds a number of new crop types to the label including berry fruits, tomato, watermelon, salad leaves, herbs, aubergines, cucumbers and peppers.

Product applications are permitted close to the point of harvest, with most new uses having a pre-harvest interval of just one day. 3logy affords growers maximum flexibility in their crop protection programmes as it is free from residues and provides the important benefit of avoiding product rejections by wholesalers and food retailers which can result from higher-than-allowed pesticide residue levels.

Sipcam has extensive experience with 3logy and has recently supported significant label extensions in Spain and Portugal as well as in Italy. This approval in Italy will enable Sipcam to expand the market for 3logy across thousands of hectares of new high value crops, such as strawberries where over 14,000 tonnes are exported from Italy alone on an annual basis.

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Notes to Editors:

Eden Research is the only UK-listed company focused on biopesticides for sustainable agriculture. It develops and supplies innovative biopesticide products and natural microencapsulation technologies to the global crop protection, animal health and consumer products industries. 

Eden's products are formulated with terpene active ingredients, based on natural plant defence metabolites. To date, they have been primarily used on high-value fruits and vegetables, improving crop yields and marketability, with equal or better performance when compared with conventional pesticides. Eden has two products currently on the market: 

Based on plant-derived active ingredients, Mevalone® is a foliar biofungicide which initially targets a key disease affecting grapes and other high-value fruit and vegetable crops.  It is a useful tool in crop defence programmes and is aligned with the requirements of integrated pest management programmes. It is approved for sale in a number of key countries whilst Eden and its partners pursue regulatory clearance in new territories thereby growing Eden's addressable market globally.

Cedroz™ is a bionematicide that targets free living nematodes which are parasitic worms that affect a wide range of high-value fruit and vegetable crops globally. Cedroz is registered for sale on two continents and Eden's commercial collaborator, Eastman Chemical, is pursuing registration and commercialisation of this important new product in numerous countries globally.

Eden's Sustaine® encapsulation technology is used to harness the biocidal efficacy of naturally occurring chemicals produced by plants (terpenes) and can also be used with both natural and synthetic compounds to enhance their performance and ease-of-use. Sustaine microcapsules are naturally-derived, plastic-free, biodegradable micro-spheres derived from yeast. It is one of the only viable, proven and immediately registerable solutions to the microplastics problem in formulations requiring encapsulation.

Eden was admitted to trading on AIM on 11 May 2012 and trades under the symbol EDEN. It was awarded the London Stock Exchange Green Economy Mark in January 2021, which recognises London-listed companies that derive over 50% of their total annual revenue from products and services that contribute to the global green economy. Eden derives 100% of its total annual revenues from sustainable products and services. 

For more information about Eden, please visit: www.edenresearch.com .