OptiBiotix Health Regulatory News (OPTI)

16 May 2018

OptiBiotix Health plc

("OptiBiotix" or the "Company")

Exclusive manufacturing and supply agreement

OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high cholesterol, diabetes and skin care, announces it has entered into a five year agreement with Akums Drugs and Pharmaceuticals Ltd ("Akums") to exclusively manufacture and supply products containing OptiBiotix's cholesterol and blood pressure reducing strain LPLDL®, in India.

The agreement is a strategic step with the leading contract manufacturer in India to extend the opportunities offered by LPLDL® into India and Southern Asia.

Under the terms of the agreement, Akums will manufacture and supply products containing OptiBiotix's LPLDL® throughout India to maximise the financial return for both parties. In return for exclusivity, Akums will provide undisclosed and in-kind contributions and will explore the opportunities to utilise LPLDL® with OptiBiotix for biotherapeutics in India, including the authority registrations that would be required. Akums will contribute to human studies if required for product marketing purposes or by the Food Safety Standards Authority of India ("FSSAI") as part of product registration into food. The agreement does not have any minimum sales orders and the Company will update the market on sales in due course.

Akums is the largest contract manufacturing organisation in India, a manufacturing partner of choice to more than 600 companies, such as Abbott, Novartis, P&G, Sanofi and Sandoz, in the pharmaceutical and food supplement space. The company has 11 world class, WHO-GMP certified manufacturing facilities with US-NSF, NABL, FSSAI, HACCP and other accreditations, which cater for all major dosage forms (e.g tablets, capsules, syrups, suspensions, sterile parenterals, creams-ointments etc.). The company offers more than 3,500 supplement and pharmaceutical formulations across key health areas such as cardiovascular disease. Akums offers significant manufacturing capacity and supplies more than 12% of all food and drug supplements consumed in India.

India has a population of 1.3 billion people with cardiovascular disease accounting for up to 26% of all deaths, and 21% of the population suffering from hypertension (WHO). 80% of the population have abnormal lipid levels with 72% having low levels of 'HDL' or 'good cholesterol' (The Times of India June 8, 2014). Products containing LPLDL® have a unique ability to increase 'HDL' and reduce both bad cholesterol (LDL) and blood pressure, providing a clinically proven natural product to help reduce cardiovascular risk factors in countries with a high prevalence of these conditions.

Stephen O'Hara, CEO of OptiBiotix, commented: "We are excited to announce this agreement with Akums which expands manufacturing and sales of LPLDL® into Asia. We chose Akums as they are the largest contract manufacturing company in India for both food supplements and pharmaceuticals and have extensive experience in manufacturing products for some of the biggest food and pharmaceutical companies in the world. This agreement is a strategic step to add manufacturing to the supply chain in the Asian probiotic supplement and pharmaceutical market and extends the commercial reach of OptiBiotix's LPLDL® strain into Southern Asia. This allows OptiBiotix to offer multiple product solutions to consumer health and pharmaceutical companies within the region. This agreement is another step in a strategy designed to build multiple revenue streams from ingredient sales, white label and own label branded consumer and pharmaceutical products, across multiple channels, with leading industry partners from around the world."

For further information, please contact:

About OptiBiotix - www.optibiotix.com

OptiBiotix was formed in March 2012 to develop compounds which 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.

OptiBiotix has established a pipeline of microbiome modulators that can impact on lipid and cholesterol management, energy harvest and appetite suppression. The development pipeline is fuelled 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.