NFL BIOSCIENCES: Approval for its patent to be granted on NFL-101 in Europe and approval of the clinical development plan for NFL-101 by the EMA
21 Junho 2023 - 1:15PM
NFL BIOSCIENCES: Approval for its patent to be granted on NFL-101
in Europe and approval of the clinical development plan for NFL-101
by the EMA
NFL BIOSCIENCES: Approval for its patent to be granted
on NFL-101 in Europe and approval of the clinical development plan
for NFL-101 by the EMA
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company developing
botanical drugs for the treatment of addictions, is announcing that
it has received approval from the European Patent Office for
issuing its patent (17 716 853.1) for NFL-101, a nicotine-free
botanical drug candidate comprising natural proteins extracted from
tobacco leaves, focused primarily on smoking cessation. This patent
will protect the innovation that NFL-101 is based on through to
2036 in 17 European countries. Alongside this, the European
Medicines Agency (EMA), following the request for scientific advice
submitted by NFL Biosciences, approved the clinical development
plan for NFL-101.
Approval for its patent to be granted on
NFL-101 in Europe
NFL Biosciences has adopted a knowledge
management and protection strategy that led it to submit three
patent families granting it exclusive rights to its drug candidate
NFL-101. From the second patent family, this product patent,
initially registered and approved in France, China, South Korea and
the United States, concerns an “aqueous extract of tobacco leaves
and its use for the treatment of dependence”. The innovation that
NFL-101 is based on is therefore protected through to 2036 in 17
European countries (Austria, Belgium, Bulgaria, Denmark, Estonia,
Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Portugal, Slovenia and Sweden). National
registration applications based on this second patent family are
also in the review phase in the following regions and countries:
Japan, Canada, Australia, Brazil, India, Indonesia, Israel, Mexico,
Philippines, Eurasia, Saudi Arabia, United Arab Emirates and
Nigeria.
EMA approval of the clinical development
plan for NFL-101
In February 2023, NFL Biosciences submitted a
request for scientific advice to the EMA with a view to approving
the clinical development plan for NFL-101 through to its marketing
authorization. This scientific advice was issued on June 20, 2023,
approving NFL Biosciences’ proposed clinical development plan for
NFL-101. This plan includes provisions for the CESTO II study that
is underway, depending on its results, to be recognized as a first
phase 3 trial for a registration application. If this is approved,
there would be just one phase 3 study still to be carried out
before obtaining a marketing authorization.
NFL Biosciences is currently conducting two
clinical trials. PRECESTO is studying the effect of NFL-101 on the
desire to stop or reduce cigarette consumption and the sensations
triggered by cigarettes with 34 smokers who do not want to stop
smoking. The objective is to validate the complementarity of
NFL-101 with nicotine substitute treatments with a view to
potentially being used in combination. CESTO II is studying the
efficacy of NFL-101 as a cessation aid with 318 smokers who want to
stop smoking. The objective is to provide a demonstration of
efficacy to be part of a marketing authorization application. In
accordance with the business plan, the PRECESTO trial results are
expected to be available in the third quarter of 2023, followed by
the first results of the CESTO II trial in the fourth quarter of
2023.
About NFL Biosciences
NFL Biosciences is a biopharmaceutical company
based in the Montpellier area which develops botanical drug
candidates for the treatment of addictions. NFL Biosciences'
ambition is to bring new, natural, safer and more effective
therapeutic solutions to the entire world population, including
low- and middle-income countries. Its most advanced product, called
NFL-101, is a standardized, nicotine free tobacco leaf extract
protected by two patent families. NFL Biosciences intends to offer
smokers who want to quit a natural, safe, easy-to-administer and
personalized alternative. NFL Biosciences is also developing
NFL-301, a natural drug candidate for the reduction of alcohol
consumption and has a drug development project for the treatment of
cannabis use disorder.
The shares of NFL Biosciences are listed on
Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at
www.nflbiosciences.com
Contacts
Bruno Lafont – info@nflbiosciences.com - +33 4
11 93 76 67 Agence
Calyptus – nflbiosciences@calyptus.net - +33 1 53 65 68 68
- 20230621_NFLBioscience_brevet-Europe_Avis-EMA_EN_DEF (1)
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