AMOEBA (EPA:ALMIB) - AMOEBA announces the result of the European vote on the non-approval and informs on the medium-term prospect of submitting an updated dossier.

Transparency directive : regulatory news

29/11/2018 16:39

PRESS RELEASE

AMOEBA announces the result of the European vote on the non-approval and
informs on the medium-term prospect of submitting an updated dossier.

Lyon (France), November 29, 2018 - AMOEBA (FR0011051598 - AMEBA), producer of a
biological biocide capable of eliminating bacterial risk in water, plant
protection and wound care applications, announces the publication of the result
of the vote on the non-approval of the biocidal active substance Willaertia
magna C2c Maky and informs on the medium-term prospect of submitting an updated
dossier.

1 - Results of the vote on the non-approval of the biocidal active substance

The vote took place during the session of the European Commission Standing
Committee on Biocidal Products on November 23rd, 2018 ; Amoéba became aware of
the result on November 28th, 2018.

Following the opinion adopted by the Biocidal Products Committee (see April
26th, 2018 press release), the 28 Member States have voted for the non-approval
of the biocidal active substance Willaertia magna C2c Maky for use as product
type 11 (TP 11 - Liquid protection products used in cooling and manufacturing
systems).

The Commission's implementing decision on non-approval will be published and
will enter into force in the coming weeks.

2 - Prospect of submitting an updated dossier

Following discussions between the European institutions and the Company on the
issues faced by Amoéba during the review of its dossier, the European
Commission's Directorate-General for Health and Food Safety (DG SANTE)
confirmed that it had "already encouraged ANSES to continue the dialogue in
case [Amoéba] would like to submit a new application for approval" and "if
needed, ANSES can also consult ECHA and the relevant working group(s) of the
Biocidal Products Committee (BPC) in order to ensure a harmonised view [at
European level] on the type or level of data needed".

On the basis of DG SANTE's recommendations, and following an official request
by Amoéba, ANSES has agreed to examine a new application dossier for approval
of the active substance Willaertia magna C2c Maky, completed with elements to
address the safety and efficacy concerns raised during the examination of the
first dossier.

However, in view of the Agency's current workload plan for examining dossiers
for biocidal and plant- protection substances and products, ANSES will only be
able to accept the submission of the dossier from the first quarter of 2021. As
such a deadline is not acceptable to the Company, Amoéba has requested that
ANSES reviews the proposed submission date. In parallel, Amoéba, in agreement
with ANSES, is looking for another evaluating Member State that could initiate
the evaluation in a shorter period of time.

As soon as the final schedule is known, Amoéba will transmit this information
by means of a Press Release. As a reminder, two regulatory steps are required
before any biocidal product can be marketed in the European Union:
1) The approval of the biocidal active substance: a necessary condition for its
use in a biocidal product.
2) The authorisation to place the biocidal product on the market, delivered
either by the European Commission (Union authorisation) or by each Member State
(national authorisation), depending on the procedure chosen by the applicant.
(See Chapter 6.8.1. of the 2017 company reference document filed with the
French Financial Markets Authority on April 27, 2018).

"We expected that the European Commission would follow Biocidal Products
Committee opinion. A constructive work with the European Commission and Member
States, including France, will allow an updated dossier to be resubmitted. One
of the important points to highlight is the European Commission's request to
guarantee a harmonized view of the data needed for the dossier. In this way,
the requirements will be clearly defined before the evaluation. We hope that
this clearly established roadmap can lead to the approval of our substance",
declares Fabrice PLASSON, Chairman of AMOEBA.

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. 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
Directeur administratif et Financier
04 26 69 16 00
valerie.filiatre@amoeba-biocide.com

Actifin
Ghislaine GASPARETTO
Communication financière
01 56 88 11 11
ggasparetto@actifin.fr

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 reference
document of AMOEBA filed with the French Financial Markets Authority (Autorité
des Marchés Financiers) on April 27, 2018 (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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AMOEBA (EPA:ALMIB) - AMOEBA announces the result of the European vote on the non-approval and informs on the medium-term prospect of submitting an updated dossier.

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