AMOEBA (EPA:ALMIB) - Amoéba submits its biocide application in the USA

Transparency directive : regulatory news

06/04/2021 17:45

PRESS RELEASE

               Amoéba submits its biocide application in the USA

        Information of the timetable for the other regulatory dossiers

Chassieu (France), April 6, 2021 - 5.45 pm- AMOEBA (FR0011051598 - ALMIB),
producer of a biological biocide capable of eliminating the risk in water and
human wounds, and of a biocontrol product for plant protection, still in a
development phase, has submitted today the application for approval of the
biocidal active substance, the living amoeba Willaertia magna C2c Maky, and the
biocidal products containing it, to the U.S. Environmental Protection Agency
(U.S. EPA).

Amoéba reminds that in August 2019, it had decided to voluntarily withdraw its
application for approval of the biocidal active substance, the living amoeba
Willaertia magna C2c Maky, and biocidal products containing it, and to submit a
new application for approval at a later stage.

During a pre-submission meeting in November 2019 between Amoéba and the U.S.
EPA, requests for clarification were raised about the scientific elements that
led to the withdrawal of the dossier and the way in which Amoéba planned to
respond.

Amoéba was therefore able to submit a new application today, with the
additional studies required by the U.S. EPA.

Once the active substance and biocidal product registrations are obtained,
expected by mid- 2022 subject to approval by the US EPA, registration
(notification and payment of fees) will be required at the state level, which
will take about two months (except for California, which requires a full
dossier evaluation of about 12 months). Once registration is obtained at the
local level, marketing may be possible in the State.

Amoéba thus envisages the first sales of its biocide product in the United
States from the second half of 2022, subject to a positive decision by the U.S.
EPA.

Information on the timetable for other biocidal and phytosanitary regulatory
dossiers:

Amoéba also provides information on the regulatory timetable for the various
regulatory dossiers:

  Biocide application (biocidal active substance, living Willaertia magna C2c
Maky):

- Europe: the application for approval of the active substance, submitted in
2019 (see Press Release of 12 August 2019), is currently being evaluated by the
Maltese authority. Amoéba considers that the evaluation report of the
authority could be available mid-2021.

- Canada: the application for registration of the active substance and biocidal
products containing it, submitted in 2019 (see Press Release of 1 February
2019) is currently being evaluated. The extension of the evaluation period
(initially estimated at 24 months) is due to a request for additional
information from the Canadian agency to which the company has responded.
Amoéba estimates that the decision of the Canadian agency could occur before
the end of 2021.

  Phytosanitary application (biocontrol active substance, lysate of
Willaertia magna C2c Maky):

- Europe: the application for approval of the active substance, submitted in
2020 (see Press Release of 29 May 2020), is currently being evaluated by the
Austrian authority. Amoéba considers that the evaluation report of the
authority could be available at the end of 2021.

- United States: the application for registration of the active substance and
products containing it, submitted in 2020 (see Press Release of 1 October 2020)
is currently being evaluated. The decision of the American agency should occur
during 2022.

- Brazil: an experimental permit was obtained in February 2021, allowing the
Company to initiate field trials on soybean, coffee and banana. Such trials in
Brazil are required for an application file.

Details of the procedures are available in the Universal Registration Document
(URD) filed with the French Financial Markets Authority (Autorité des Marchés
Financiers) on 30 April 2020 under number D20-0416, in particular in
sub-section 5.4.3. The URD is available on the company's website and its
update, including the above information, will be published in April 2021.

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 Euronext Growth. 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
Directeur Général Adjoint
+33 4 26 69 16 00
v.filiatre@amoeba-nature.com

Calyptus
Relations investisseurs & Presse
Grégory BOSSON / Mathieu CALLEUX
+33 1 53 65 37 90 /91
amoeba@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.

Adresse : 38 Avenue des Frères Montgolfier, 69680 CHASSIEU
Société Anonyme au capital de 311 578,38 EUR
RCS Lyon 523 877 215

Tel: +33 (0)4 26 69 16 00 ? Email: contact@amoeba-nature.com
Linkedin: @amoeba-nature ? Twitter: @AmoebaNature
www.amoeba-nature.com

AMOEBA's latest news

28/03/2024 18:30

AMOEBA (EPA:ALMIB) - Amoéba submits its biocide application in the USA

Transparency directive : regulatory news

AMOEBA's latest news

Other stories