Bridging the gap: Optibiotix signs US pharma deal for its probiotics range
12 Sep 2018 --- Life sciences company OptiBiotix Health has secured a deal with an unnamed US-based pharmaceutical company, enabling its Lactobacillus plantarum LPLDL probiotic to be developed as a biotherapeutic pharmaceutical product for the first time. The agreement grants the US partner exclusivity to the pharmaceutical market in the US with the option of expanding this worldwide in the future, totaling the milestone payments to seven-figures, as well as royalties on commercial sales, the company reports.
The deal is the company’s first licensing partnership for its blood pressure and cholesterol reducing bacterial strain, LPLDL, outside the food and food supplements market.
“This deal elevates the importance of our probiotic strain in the industry, demonstrating its true market value and closing the gap between the probiotic food supplements and pharma markets thanks to the scientific evidence backing its performance,” says Per Rehné, OptiBiotix Commercial Director.
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“This agreement sets LPLDL apart from other probiotics and demonstrates the interest and recognition that the pharmaceutical and medical world now place on the potential of microbiome activity modulation. Whilst OptiBiotix entered the market via food supplements, the scientific models used to develop LPLDL have been according to pharmaceutical protocols, unlike many other probiotic producers,” he says.
“This is a substantial investment by our US partner recognizing the real potential of our strain and the scale of the opportunity in one of the largest and fastest growing markets around the world.”
OptiBiotix was formed in March 2012 to develop compounds that modify the human microbiome – the collective genome of the microbes in the body – to prevent and manage human disease.
The aim of OptiBiotix is to discover and develop microbial strains, compounds and formulations, which modulate the human microbiome and can be used as food ingredients and supplements or active compounds for the prevention and management of human metabolic diseases, examples of which include obesity, cholesterol and lipid distribution and diabetes.
Together with Canada and Mexico, North America is home to the largest pharmaceutical market worldwide; the US alone making up more than 45 percent of the world’s pharmaceutical consumption.
LPLDL is a probiotic product using a naturally occurring bacterial strain, Lactobacillus plantarum, to aid elements of cardiovascular and physiological performance. Transforming the way physical health is approached, it leverages the microbiome-liver axis to modify an individual’s current bacterial community, addressing blood pressure and cholesterol issues in a holistic, scientifically founded manner. Independent human studies have shown LPLDL to be safe and effective and able to reduce LDL, total cholesterol and blood pressure.
The terms of the agreement allow the US company to remain anonymous to protect its commercial interests.
Although Rehné tells NutritionInsight that he doesn't believe there is a general shift in the probiotic industry towards looking into pharma options, he does see "a growing trend in the pharma industry to enter the probiotics/food nutrition market using strains that have been researched with an understood Mechanism of Action and with specific health benefits proven in human trials. The pharma industry is looking to enable self-intervention of the human microbiome.”
4,000 bacterialstrains for its outstanding capacity to hydrolyse bile salts.
This activity is potentially applicable to manage a range of health conditions
such as high cholesterol and high blood pressure.
There are two different approaches taken by pharma companies moving into the probiotics space, he explains.
1. They acquire/partner with food supplement companies in order to enter the market and operate according to the quality standard in the supplement industry.
2. To leverage their pharmaceutical brand and quality standards, they require the probiotic strain to be produced under GMP certified conditions and the finished supplement produced either in their own facilities or using contract manufactures.
“When it comes to biotherapeutic approaches, these are driven by the pharma companies looking for new ways to create drugs utilising live organisms such as probiotic strains. There are a number of products being developed and going through stage 2 and 3 for an FDA drug approval at the moment. This is a relatively new area and today, the FDA has not approved any probiotic as a live biotherapeutic product,” he notes. “However, the agency is building the legal framework for approvals with input from the industry and the FDA has released a guidance document in 2016 for early clinical trials.”
The FDA also released a statement last month recognizing the fast pace this field is developing and the need for advancing the work to put in place a suitable legal framework.
Looking to the future, OptiBiotix has established a pipeline of microbiome modulators that can impact on lipid and cholesterol management, energy harvest and appetite suppression.
The company reports that the development pipeline is fueled by its proprietary OptiScreen and OptiBiotic platform technologies designed to identify metabolic pathways and compounds that impact on human physiology and bring potential health benefits. These platforms are applicable across a wider range of other human diseases.
