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LPLDL® Pharmaceutical GMP process validation
09 October 2019
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 LPLDL® as a drug substance and received a letter from the United States Food and Drug Administration (FDA) affirming LPLDL®'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 (LPLDL®) 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 LPLDL® Pharmaceutical GMP manufacture is a significant step in the development of LPLDL® 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 LPLDL®'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. LPLDL® (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 LPLDL®. 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 LPLDL®'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
Stephen O'Hara, Chief Executive
Contact via Walbrook below
|Cairn Financial Advisers LLP (NOMAD)||Tel: 020 7213 0880|
|Liam Murray / Jo Turner / Ludovico Lazzaretti|
|finnCap (Broker)||Tel: 020 7220 0500|
|Geoff Nash / Kate Bannatyne (Corporate Finance)
Camille Gochez (Corporate Broking)
|goetzpartners securities Limited||Tel: 0203 859 7725|
|Walbrook PR Ltd
|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.
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