AMOEBA (EPA:ALMIB) - Amoeba announces that Malta has agreed to be the reviewer of the new application for approval of its active substance for biocidal application in Europe.

Transparency directive : regulatory news

25/02/2019 17:40

PRESS RELEASE

   AMOEBA announces that Malta has agreed to be the reviewer of the new
application for approval of its active substance for biocidal application in
                                   Europe.
The start of the evaluation, formerly planned for the first quarter of 2021,
                          will take place in 2019.

Lyon (France), February 25th, 2019 - AMOEBA (FR0011051598 - AMEBA), producer of
a biological biocide capable of eliminating bacterial risk in water and human
wounds, and a biocontrol product for plant protection, announces that Malta has
agreed to be the Member State that will evaluate the new application for
approval of its biocidal active substance in Europe.

Following the non-approval of its biocidal active substance Willaertia magna
C2c Maky in 2018, Amoéba had expressed its willingness to submit a new
application for approval, on the basis of an updated dossier addressing the
safety and efficacy concerns raised during the first dossier examination (see
press release dated 26 April 2018). Although the French authority ANSES
accepted the submission of a new dossier from the first quarter of 2021, the
Company sought another Member State to initiate the evaluation of the active
substance within a shorter period (see press release dated 29 November 2018).

Malta Competition and Consumer Affairs Authority (MCCAA) has agreed to be the
evaluating competent authority for the new application for approval. The active
substance to be evaluated is the amoeba Willaertia magna C2c Maky in its living
form, intended for use in cooling towers to prevent legionella growth (Product
Type 11 - Preservatives for liquid-cooling and processing systems) and to
control the biofilm (Product Type 12 - Slimicides).

As part of the acceptance process by the evaluating competent authority, open
and constructive exchanges have already occurred between the MCCAA and Amoéba.
A meeting will be held in the 2nd quarter of 2019 between the MCCAA, its
non-governmental experts based in the Netherlands and Amoéba. The main
objectives of this pre-submission meeting prior to the application submission
are to discuss the technology and intended use of the biocide, to validate the
data required for this new submission and to agree on the submission date and
evaluation stages.

The MCCAA indicated that it was in favour of consulting the European Chemicals
Agency (ECHA) to ensure a harmonised view at European level on the type and
level of data required, and in particular on the non-sufficiently demonstrated
efficacy and the hypothetical risk associated with a 'Trojan Horse' effect.
Such a consultation, which should take place in 2019, had been proposed by the
European Commission during discussions with Amoéba. This proposal for a prior
consultation followed the issues Amoéba had faced during the previous
evaluation.

Amoéba is considering the submission of the application before the end of
2019. As soon as the date of submission and the estimated timetable are known,
Amoéba will publish 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 by the European Commission,
   following the evaluation by a Member State and the peer-review. The
   approval of the active substance is a necessary condition for its use in a
   biocidal product.

2) The authorisation to put the biocidal product on the market, issued either
   by the European Commission (EU authorisation) or by each Member State
  (national authorisation and mutual recognition), depending on the procedure
   chosen by the applicant.

Considering a submission of the application for the active substance approval
before the end of 2019, and subject to an assessment report by the MCCAA
recommending the active substance approval and issuance of provisional
authorisations (valid for 3 years, converted into definitive authorisations
once the active substance has been approved), the Company could consider the
first placing on the market of biocidal products containing the active
substance from the 2nd half of 2022 in Europe, for use in the prevention of
biofilm and legionella growth in cooling towers. Details of the procedure will
be specified in the future press release specifying the submission date and the
provisional timetable.

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
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 that Malta has agreed to be the reviewer of the new application for approval of its active substance for biocidal application in Europe.

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