New authorisations for Cedroz and Mevalone

20 May 2020

Eden Research Plc

("Eden" or "Company")

New authorisations for Cedroz™ and Mevalone™

Eden Research plc (AIM: EDEN), the AIM-quoted company focused on sustainable biopesticides and plastic-free formulation technology for use in global crop protection, animal health and consumer products industries, announces that its commercial partner, Eastman Chemical Company ("Eastman"), has received a repeat of the emergency authorisation for Cedroz™ in the key territory of Italy and the full approval of Cedroz in the Netherlands. Separately, Eden has been notified that in Greece, the list of authorised uses for Mevalone™ has been expanded to include several minor diseases on olives and tomatoes.

Eden-developed Cedroz is a bionematicide that tackles root knot nematodes, a pest that causes severe damage to crops globally, both in open field and greenhouse situations.

After a successful summer harvest in 2019 applying Cedroz to crops in Italy under the initial "emergency use" authorisation, Eastman has been granted its second 120-day pass to coincide with the upcoming growing season. As the full authorisation continues to be assessed by the relevant authorities, this temporary solution highlights a sustained need for a suitable commercially available alternative for growers in the region. The grant of the emergency authorisation should not have any impact, positive or negative, on the chances of a full authorisation in Italy before the growing season.

The Netherlands has fully authorised the use of Cedroz in glasshouses on a wide range of crops.  This is the third full authorisation in the EU following the initial authorisation of Cedroz by the Rapporteur Member State, Malta, in 2019 and then Belgium later the same year. It should be noted that The Netherlands is not expected to be a key market initially.

The demand for Cedroz stems from it being residue-free and having a zero-day pre-harvest interval, which allows for applications right up to harvest. This stands Eden's product in good stead for inclusion in crop protection programmes that meet consumer demand for quality produce that is free from pesticide residues and intentionally added plastics. Heightened consumer awareness about the origins and standards of the food they purchase and the presence of microplastics in the environment are clear drivers for increasing regulatory scrutiny of crop protection products in today's market and in future years. Both active ingredients used in Cedroz, geraniol and thymol, also received approval as organic inputs across the EU earlier this year. 

We are pleased to also announce that the Greek authorities have now authorised the use of Mevlone on both olives and tomatoes for the treatment of several minor diseases affecting these crops.  As a part of its registration strategy, Eden's partner K&N Efthymiadis has sought authorisation to sell Eden's fungicide, Mevalone, for use on an expanding range of crops.  This serves to further expand the addressable market for Mevalone in Greece and reflects an ongoing effort to grow sales of Mevalone.

Sean Smith, Chief Executive Officer of Eden, said: "Following on from the glasshouse approval in Belgium, this approval in the Netherlands is a welcome addition to the growing portfolio of authorisations of Cedroz.  Whilst the Netherlands is not considered a priority market for the commercialisation of Cedroz, the authorisation in Belgium and the Netherlands both represent progress in securing regulatory clearances. We are pleased that the regulatory approval process continues in a number of important markets even whilst we have faced process and timing challenges in others. 

The importance of, and growing demand for, biopesticide products in Europe is further confirmed by Italy granting emergency use authorisation for the second consecutive year. Regulators recognise that biopesticides are a critical part of an integrated pest management strategy and are reacting accordingly. We anticipate more positive news for Cedroz in 2020 and beyond as a number of additional countries continue to review applications for full authorisation.

We are also pleased with the ongoing sales development of Mevalone in Greece as a result of the regulatory and commercial efforts of our partner, K&N Efthymiadis. We look forward to ongoing sales growth in Greece and throughout their territories as a consequence of these efforts and the resultant enlargement of the addressable market for Mevalone."

The information contained herein is not expected to have a significant impact on management's expectations of performance for the year.

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Notes:

Eden Research is an AIM quoted company that develops and supplies breakthrough biopesticide products and natural microencapsulation technologies to the global crop protection, animal health and consumer products industries

Eden's Sustaine encapsulation technology harnesses the biocidal efficacy of naturally occurring chemicals produced by plants (terpenes) and can 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 extract. They produce stabilised aqueous suspensions which, are easy to mix and apply, have phased release patterns, are safer for the environment and the crops themselves.

The European Chemicals Agency (ECHA) has proposed an EU-wide restriction on the placing on the market or use of "intentionally-added" microplastic particles. The proposed restriction includes the use of microplastics for agricultural and horticultural purposes, including polymers utilized for controlled-release fertilizers, encapsulated plant protection products (PPPs), seed coatings, and biocides.

By 2025 in the EU, pesticides containing synthetic polymer microplastics are likely to be banned and removed from the market. The only acceptable alternative is the substitution with biodegradable formulations. Reformulated products will need to be evaluated and registered within the five-year transition period.

Sustaine is one of the only viable, proven and immediately registerable solutions to the microplastics problem in formulations requiring encapsulation.

Historically, terpenes have had limited commercial use in the agrochemical sector due to their volatility, phytotoxicity and poor solubility. Sustaine provides a unique, environmentally friendly solution to these problems and enables terpenes to be used as effective, low-risk agrochemicals.

Eden is developing these technologies through innovative research and a series of commercial production, marketing and distribution partnerships.

The Company has a number of patents and a pipeline of products at differing stages of development targeting specific areas of the global agrochemicals industry. To date, the Company has invested in the region of 14m in developing and protecting its intellectual property and seeking regulatory approval for products that rely upon the Company's technologies. Revenues earned by the Company have been modest whilst the Company has concentrated on securing patent protection for its intellectual property, gaining regulatory approvals, identifying suitable industrial partners, and entering into commercial agreements. 

In May 2013, the three actives that comprise Eden's first commercial product, Mevalone, were approved as new ingredients for use in plant protection products by the European Commission ("EC"). This represented a major milestone in the commercialisation of Eden's technology and is a significant accomplishment for any company.  To illustrate this point, one should note that in 2013, Eden's approvals represented 3 of only 10 new active ingredients approved by the EC.

Mevalone is a foliar fungicide which has been authorised for sale in Kenya, Malta, Greece, Bulgaria, Spain, Italy, France, Cyprus, Albania, Portugal and Macedonia.

Cedroz is a nematicide which has been authorised for sale in Malta, Belgium and Mexico.

Eden was admitted to trading on AIM on 11 May 2012 and trades under the symbol EDEN.