OptiBiotix Health PLC LPLDL® Pharmaceutical GMP process validation (1911P)
09 October 2019 - 05:00PM
UK Regulatory
TIDMOPTI
RNS Number : 1911P
OptiBiotix Health PLC
09 October 2019
OptiBiotix Health plc
("OptiBiotix" or the "Company")
LP(LDL) (R) Pharmaceutical GMP process validation
Confirmation of GRAS letter received from FDA
OptiBiotix Health plc (AIM: OPTI), a life sciences business
developing compounds to tackle obesity, cardiovascular disease and
diabetes, announces that its fully-owned subsidiary ProBiotix
Health Ltd. ("ProBiotix"), has completed process validation under
Pharmaceutical Good Manufacturing Practices ("GMP") for LP(LDL) (R)
as a drug substance and received a letter from the United States
Food and Drug Administration (FDA) affirming LP(LDL) (R)'s
Generally Recognized As Safe ("GRAS") status. Obtaining GMP
certification is linked to a milestone payment under the
pharmaceutical deal in the US (RNS: 4 September 2018,
http://www.optibiotix-ir.com/content/news/archive/2018/04-09-18.asp).
Completing process validation under Pharmaceutical GMP's proves
that a drug substance (LP(LDL) (R)) is produced consistently with
pharmaceutical grade quality. GMP process validation is required by
customers and health authorities around the globe to commercialise
active ingredients as drugs. The validation of LP(LDL) (R)
Pharmaceutical GMP manufacture is a significant step in the
development of LP(LDL) (R) as a pharmaceutical drug product.
GRAS is an FDA designation that a substance added to food is
considered safe. ProBiotix had obtained a positive opinion from an
independent panel of experts earlier this year (RNS: 21 February
2019,
http://optibiotix-ir.com/content/news/archive/2019/21-02-19.asp),
and has now received a letter from the FDA affirming LP(LDL) (R)'s
status as GRAS. This is the highest level of safety certification
for a food ingredient in the US and ends an almost three year
scientific and regulatory process. LP(LDL) (R) (referred to as
Lactobacillus plantarum ECGC 13110402, its scientific name) has
been assigned the code GRN 000847 in the FDA register.
Steve Prescott, Chief Executive Officer of ProBiotix, commented:
"Completing Pharmaceutical GMP process validation and receiving the
GRAS notification letter from the US FDA is a significant
achievement for ProBiotix and LP(LDL) (R). Few marketed probiotics
have achieved this level of proven safety and efficacy and it has
triggered another milestone payment in the US Pharmaceutical
agreement we announced last year. GMP manufacturing is required to
commercialise a probiotic as a drug and is a de facto requirement
of many companies to include ingredients in their food supplement
formulations. Both GMP manufacturing and full GRAS status increases
LP(LDL) (R)'s market attractiveness and shows ProBiotix's
commitment to commercialising the highest quality products. I would
like to especially thank Dr. Luis Gosalbez who led both processes
internally."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
For further information, please contact:
OptiBiotix Health plc www.optibiotix.com
Stephen O'Hara, Chief Executive Contact via Walbrook
below
Cairn Financial Advisers LLP (NOMAD)
Liam Murray / Jo Turner / Ludovico Lazzaretti Tel: 020 7213 0880
finnCap (Broker)
Geoff Nash / Kate Bannatyne (Corporate Finance)
Camille Gochez (Corporate Broking) Tel: 020 7220 0500
Tel: 020 3859 7725
Goetz Partner Securities Limited
Ulrich Kinzel
Walbrook PR Ltd
Anna Dunphy Mob: 07876 741 001
About OptiBiotix - www.optibiotix.com
OptiBiotix Health plc (AIM: OPTI), which was formed in March
2012, brings science to the development of compounds which modify
the human microbiome - the collective genome of the microbes in the
body - in order to prevent and manage human disease and promote
wellness.
OptiBiotix has an extensive R&D program working with leading
academics in the development of microbial strains, compounds, and
formulations which are used as active ingredients and supplements.
More than twenty international food and healthcare supplement
companies have signed agreements with OptiBiotix to incorporate
their human microbiome modulators into a wide range of food
products and drinks.
OptiBiotix is also developing its own range of consumer
supplements and health products. The Company's current areas of
focus include obesity, cardiovascular health, and diabetes.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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