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(Alliance News) - OptiBiotix Health PLC on Wednesday said the US Food & Drug Administration has sent a letter affirming that the life science company's LPLDL product is "Generally Recognized As Safe".
Shares in OptiBiotix were up 7.4% at 47.00 pence in London in morning trade.
The affirmation follows OptiBiotix subsidiary ProBiotix Health Ltd's completion of process validation under US Pharmaceutical Good Manufacturing Practices. LPLDL is OptiBiotix's strain of probiotic bacteria lactobacillus plantarum. It is intended to lower cholesterol and blood pressure.
Gaining Good Manufacturing Process certification is tied to a US pharmaceutical deal between OptiBiotix and an undisclosed US company for use of LPLDL as a pharmaceutical drug product.
When the deal was announced in September 2018, OptiBiotix said it would "receive a six figure payment" from the undisclosed company at signing plus two more milestones with "amounts totalling a seven-figure sum". Another six-figure sum, plus royalties on future product sales will become due once the product is launched and there is another "seven-figure payment" should the US company opt to exercise its option for a worldwide licence - excluding India and Pakistan.
The completion of process validation under Good Manufacturing Practices means a drug substant, in this case LPLDL, "is produced consistently with pharmaceutical grade quality". Generally Recognized as Safe in the US means a substance is safe to add to food and is the highest food ingredient certification possible in the US. Obtaining this, OptiBiotix said, "ends an almost three year scientific and regulatory process".
ProBiotix Chief Executive Steve Prescott said: "Completing Pharmaceutical [Good Manufacturing Process] validation and receiving the [Generally Recognized as Safe] 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."
Prescott added: "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."
By Anna Farley; annafarley@alliancenews.com
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