The purpose of this document is to outline Fulhold Pharma’s current and planned scientific and commercial status in order to inform both current and potential investors.

  1. What is the nature and status of Fulhold Pharma’s business ?

Fulhold Pharma Plc (‘Fulhold’) is a UK registered biotechnology company. Fulhold Pharma develops and commercialises the worldwide use of its patented active ingredient Carbohydrate Derived Fulvic Acid (CHD-FA) in Human and Animal Healthcare. CHD-FA is a type of Fulvic Acid that is pure, safe and manufactured to exacting reference standards. CHD-FA does not suffer from the variable quality and contamination that prevent environmental sources of Fulvic Acid being used in human medicine. It is a broad-spectrum anti-microbial and has anti-viral, anti-bacterial, anti-fungal and anti-inflammatory properties. CHD-FA can be used in many formulations and shows synergistic activity with other active ingredients that are no longer effective against drug-resistant organisms. It is also thought that it is highly unlikely that bacterial and fungal pathogens will develop any drug resistance to CHD-FA.

Fulhold Pharma owns international  patents for the production and use of fulvic acid in the areas of human and animal health and agriculture. CHD-FA is the only known pharmaceutical grade fulvic acid available. There is a strong and growing evidence base for its efficacy and this is supported by a comprehensive  safety and toxicity profile. We have 13 years of research, a CHD-FA patent portfolio and ongoing R&D projects that are highly promising.

Fulhold Pharma aims to add and secure value for shareholders as it engages with projects at all stages of the pharmaceutical value chain in realising the potential of CHD-FA.

Fulhold Pharma was until recently listed on the Danish GXG market but, as this exchange has been closed down, the business is again privately owned.

Although we may seek a future listing, we are now seeking to raise funds from third party investors directly.

  1. Current Activities
  2. Research & Development Pipeline
  1. i) Wound Treatment

Recent research has shown that CHD-FA is a promising topical agent for drug-resistant wound infection. Funded by the U.S. Department of Defense (DoD), scientists at the New Jersey Medical School’s Public Health Research Institute (PHRI), led by Professor David Perlin, found that CarboHydrate Derived Fulvic Acid (CHD-FA) showed strong activity against a variety of bacterial and fungal pathogens and demonstrates reliable anti-inflammatory properties that promotes robust healing.  Fulhold is currently devising the strategy and funding necessary to achieve Regulatory approval from the FDA and EMA for a drug-resistant wound infection product. In addition, discussions are taking place with the DoD to fund further research into the use of CHD-FA on burn wounds.

  1. ii) Oral Healthcare

Over the past five years Fulhold has commissioned research into the use of CHD-FA in human and animal oral health from both Glasgow University Dental School and Blu Test Laboratories Ltd, a leading microbiology contract research organization. The results of this work, in conjunction with their own research over the past year has resulted in a leading, global, innovation-driven pharmaceutical organisation to enter commercial discussions with Fulhold over the potential use of CHD-FA in human and animal oral health. We have been working with their Global Innovations screening team and CHD-FA has now been approved for patent review and product development with their specialist oral health division.

  • iii) Inflammation & Infectious Diseases

A large, U.S.-based pharmaceutical  organisation is performing and sponsoring a range of research initiatives into the use of CHD-FA in general inflammation and specific infectious diseases. Results of this research is expected in the coming months.

  1. iv) Over The Counter (OTC) Sales & Marketing

The current trading operations sell approximately USD 2 million of CHD-FA product per annum. Fulhold manufactures and formulates around twenty CHD-FA-based products for companies such as ATKA in Africa and Secuvie in Europe. We are planning to expand our OTC activities internationally through the introduction of our own brand, Oticine.

  1. v) HIV Trial

Due to legislative changes in India, the Phase 3 human HIV trial had to be halted earlier than planned and the results are therefore inconclusive. However, as part of this project, we have gathered extensive safety data for the ingestion of CHD-FA over a prolonged period and this can be used as part of our evidence base.

  1. vi) Other
  • We are also working with other organisations to investigate the use of CHD-FA in areas which include :
  • Eczema – We are in discussions with a European organisation over the development and marketing of an eczema product
  • Female Personal Hygiene – we are in the process of developing a female personal hygiene business, Femicine. We believe that CHD-FA’s anti-inflammatory, anti-viral, anti-bacterial and anti-fungal properties are a compelling proposition in this market.
  • Personal Hygiene – Collaborative testing continues for the use of CHD-FA in soaps, shampoos and deodorants and we are researching methods of producing a pure CHD-FA powder for use in the formulation of products for this market
  • Agriculture – researching the use of CHD-FA against Xylella, a pathogen affecting the olive industry
  • Animal Health – testing CHD-FA for use in combating bacterial and fungal infections in commercial shrimp farming and bee colonies
  • Sports Nutrition – mineral uptake studies and food additive regulation activities are planned for this market

 

  1. Manufacturing

The primary manufacturing  operations of Fulhold are currently based in Stellenbosch, South Africa. The manufacturing and packaging processes have been assessed and certified as compliant with Food Safety System Certification (FSSC) 22000. The current production facility is awaiting Good Manufacturing Practices (GMP) inspection accreditation.

We have built a new Active Pharmaceutical Ingredient (API) production facility in Mauritius and are currently developing  its operational capability. This facility has been set up to meet  future demand resulting from a series of discussions and negotiations with potential partners.

  1. Corporate & Administrative
  1. i) Repository of Scientific Evidence & Documentation

Over the last year we have collated, indexed and centralised our documentation and evidence base into a single, secure ‘repository’. This has already proved a valuable asset in enhancing our ability to produce marketing materials, answer questions and support commercial discussions.

  1. ii) Patent Portfolio

Although an expensive part of our business to maintain, our patent portfolio is as comprehensive as it is valuable. We maintain and enhance this on an ongoing basis.

  • iii) Regulatory Activities

In late 2014/early 2015 we commissioned a Regulatory Review, Gap Analysis and Regulatory Strategy from  Jenson R+, a specialist Pharmaceutical Regulatory Consultancy.

Jenson assessed our Repository of Scientific Evidence and Documentation from a Regulatory viewpoint and identified what is valid, what needs to be enhanced or replaced and what the gaps are that need to be filled (and at what estimated costs).

In addition, Jenson confirmed what data can be (re)used across different applications which is important when considering both cost- and speed-to-market.

We now understand the Regulatory environment more fully and the specific,  immediate steps and costs necessary to achieve our Regulatory goals in wound treatment and oral healthcare with both the FDA (U.S.) and EMA (EU).

Author : David Squire, September 2015