OptiBiotix Health PLC (LON:OPTI) is close to completing the processes required to meet US regulatory compliance standards for the manufacture of its LPLDL strain.
OptiBiotix, which is responsible for the manufacture of the cholesterol-reducing Lactobacillus Plantarum LPLDL strain, said it has been working with its manufacturing partner to invest in and develop the necessary pharmaceutical processes, supporting documentation, and production batches to confirm regulatory compliance. It anticipates this work will be completed by the end of July 2019 with certification following shortly afterwards.
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In a scientific and commercial update, the life sciences firm noted that receiving certification would trigger a second milestone payment and allow it to market LPLDL as a product manufactured to pharmaceutical standards, thus opening up further opportunities with pharmaceutical companies.
The company is developing a number of products based on SweetBiotix, the company’s low-calorie alternative to sugar, and these are now undergoing manufacturing scale-up with a US corporate partner.
On the commercial side, the company said it continued to see revenue growth in early 2019 and is expecting further growth in the second half of the year, while various product launches are scheduled to occur in 2020.
“With current products winning awards for their science and product innovation and growing deal flow across international markets, the company is continuing to grow revenue streams across a broad deal pipeline,” declared Stephen O’Hara, the chief executive officer of OptiBiotix.
“If most of these partners deliver on their forecasts, revenues will continue to grow in the months and years ahead. We are particularly pleased that, as the value of our brands increase internationally, we are seeing increased retail interest and a number of our larger corporate partners committing to product launches," he added.