AMOEBA (EPA:ALMIB) - AMOEBA HAS FILED THE APPLICATION FOR APPROVAL OF ITS BIOCONTROL SOLUTION IN EUROPE

Transparency directive : regulatory news

29/05/2020 08:00

PRESS RELEASE

AMOEBA HAS FILED THE APPLICATION FOR APPROVAL OF ITS BIOCONTROL SOLUTION IN
EUROPE

Chassieu (France), May 29, 2020 - AMOÉBA (FR0011051598 - AMEBA), producer of a
biological biocide, capable of eliminating bacterial risk in water and human
wounds, and a biocontrol product for plant protection, still in the testing
phase, informs that the application for approval of the biocontrol active
substance 'Willaertia magna C2c Maky lysate' was submitted on may 28 2020 to
the Austrian competent authority AGES (Agentur für Gesundheit und
Ernährungssicherheit, Agency for Health and Food Safety). The biocontrol
solution, developed by Amoéba, is intended for a fungicidal use in agriculture.

A file that meets regulatory requirements

This application for approval is the result of three years of work by Amoéba's
teams, which, between 2018 and 2020 and with the support of independent
laboratories, carried out all the required regulatory studies.

These studies included the assessment of :
1) the efficacy of the active substance "Willaertia magna C2c Maky lysate" in
crop protection,
2) its level of toxicity to humans,
3) its fate and behaviour in the environment,
4) its possible harmfulness to non-target organisms such as bees, earthworms,
fish or terrestrial and aquatic arthropods.

The results of all these studies, carried out in accordance with Good
Experimental and Laboratory Practices, have shown on the one hand a significant
efficacy of the active substance and on the other hand an absence of hazard for
humans and the environment. These characteristics, which will have to be
validated by the European Commission, could allow Amoeba's biocontrol solution,
once approved, to be classified as a "low risk" active substance.

One of the most active agencies in Europe for plant protection products

The Austrian competent authority, AGES (Agentur für Gesundheit und
Ernährungssicherheit, Agency for Health and Food Safety), that will assess the
dossier, is among the most active authorities in terms of risk assessment of
plant protection active substances. Austria is one of the four EU Member States
which have reviewed the largest number of plant protection active substances
over the last 20 years(1).

(1) Ranking of Member States in terms of number of active substances reviewed
and approved: Italy (56); Netherlands (51); France (46); Austria (40); Sweden
(35); Greece (30); Germany (26); Spain (23); 16 others (130). Source :
https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/
public/?event=activesubstance.selection&language=EN, (14 may 2020).

A possible approval mid-2023

The dossier submission is in line with Amoéba time schedule. The approval
procedure that is starting will take between 2.5 and 3.5 years, with an
expected decision in 2023.

The main steps are as follows:

* Evaluation phase by the rapporteur Member State (approximately 14 months): at
the end of which the draft report is submitted to the European Food Safety
Authority (EFSA).

* Risk assessment phase (7 to 11 months): EFSA carries out the risk assessment
and risk communication on food safety aspects and then organises an
consultation with experts and publishes a scientific report containing its
conclusions.

* Risk management phase (9 to 12 months): the European Commission presents a
draft regulation to the Standing Committee on the Food Chain and Animal Health,
which ultimately votes on the approval or non-approval of the active substance.
In general, an active substance is approved for a period of 10 years, or even
15 years if it is classified as "low risk".

These timeframes could be reduced depending on the deployment of the "Farm to
Fork Strategy" strategy of the European Commission (published on May 20th,
2020(2)) who "will also facilitate the placing on the market of pesticides
containing biological active substances and [...] will act to reduce the length
of the pesticide authorisation process by Member States".

A test and pre-marketing phase already under way with eight partners

The regulatory timetable could lead to a marketing authorisation for products
containing the active substance in 2024. However, in view of the positive
results of the tests carried out over the past two years, Amoéba has signed
research partnerships, which may lead to pre-marketing agreements, with eight
recognized players in the crop treatment field (BASF, Syngenta, Bayer, Philagro
Nichino, De Sangosse, Stähler Switzerland, Evergreen Garden Care and Certis
Europe). Through this unprecedented number of agreements, Amoeba's active
substance is supplied to the partners to be tested against different pathogens
affecting many types of crops.

The data from these tests will complement the regulatory data to support the
products registration and achieve optimal use of the amoeba lysate in all
intended applications.

"From the first laboratory results obtained in 2017 on the efficacy of our
amoeba lysate against downy mildew, we realized the true potential of our
discovery in biocontrol applications. We then set ourselves an ambitious
schedule with the specific goal of submitting our application for approval of
the biocontrol active substance within 3 years. The submission was made in line
with our expectations and in accordance with the deadlines agreed with the
competent authority AGES. In parallel with the regulatory process, Amoéba will
continue its new phase of technical evaluation of the amoeba lysate in 2020, on
3 continents and in 11 countries, representing a total of more than 145 tests,
including 75 for the company. This strategy is in line with the European Green
Pact's desire to reduce the use of plant protection products in order to
provide the agricultural world with new, healthy solutions with proven
efficacy," explains Fabrice PLASSON, Chairman and CEO of Amoéba.

(2) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/
?uri=CELEX:52020DC0381&from=EN

About AMOEBA:
Amoéba's ambition is to become a major player in the treatment of bacterial
risk in the fields of water, healthcare and plant protection. Our biological
solution is an alternative to chemical products widely used today. Amoéba is
currently focusing on the market of industrial cooling towers estimated at
EUR1.7Bn (1) on a global chemical biocide market for water treatment, evaluated
at EUR21Bn (2) and on the biocontrol market for plant protection estimated
globally at EUR1.6Bn (4). In the future, the Company is looking at developing
new applications such as chronic wound care, estimated at EUR 751 million (3)
in the USA. Sales of associated products with healthcare, biocides and crop
protection are subject to the Company being granted local regulatory market
authorizations. The Company is currently in a trial phase for biocidal and
plant protection applications and does not market any products.

Created in 2010, based in Chassieu (Lyon, France) with a subsidiary in Canada
and in the United States, Amoéba is quoted on the compartment C of Euronext
Paris. The Company is a member of the BPIfrance Excellence network and is
eligible for the PEA-PME SME equity savings plan setup. More information on
www.amoeba-biocide.com.

(1) : Amoéba data combined from sources: DRIRE 2013, Eurostat, ARHIA 2013
(2) : Sources combined by Amoéba from water treaters, Freedonia, Eurostat et
MarketsandMarkets
(3): BCC Research, "Markets for Advanced Wound Management Technologies,"
Wellesley, MA, 2017
(4): Biopesticides Worldwide Market 2013, CPL, Wallingford, UK

Contacts:

Amoéba
Valérie FILIATRE
General Manager
+33 (0)4 26 69 16 00
valerie.filiatre@amoeba-biocide.com

Investors and Media Relations
Grégory BOSSON / Mathieu CALLEUX
Agence Calyptus
+33(0)1 53 65 37 90
gregory.bosson@calyptus.net

Disclaimer

This press release contains certain forward-looking statements concerning
AMOEBA which are based on its own assumptions and hypothesis and on information
that are available to us. However, AMOEBA gives no assurance that the estimates
contained in such forward-looking statements will be verified, which estimates
are subject to numerous risks including the risks set forth in the Universal
Registration Document of AMOEBA filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) on April 30, 2020 under number
D20-0416 (a copy of which is available on www.amoeba-biocide.com). The forward-
looking statements contained in this press release are also subject to risks
not yet known to AMOEBA or not currently considered material by AMOEBA. The
occurrence of all or part of such risks could cause actual results, financial
conditions, performance or achievements of AMOEBA to be materially different
from such forward-looking statements.

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28/03/2024 18:30

AMOEBA (EPA:ALMIB) - AMOEBA HAS FILED THE APPLICATION FOR APPROVAL OF ITS BIOCONTROL SOLUTION IN EUROPE

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