With a focus on quality and consumer peace of mind, for a sixth consecutive year, Bioactive have successfully gained their Organic Certification for the Kimberley Plantation. Ensuring bio-security is what the discerning practitioner and natural health consumer expects from their listed medicines suppliers.
The certified organic status of its ‘farm fresh’ medicinal ingredients paves the way for a new generation of bio-secure listed medicines that are grown and made in Australia for local and export markets.
With the TGA approval of a new ingredient for use in Listed medicines, Bioactive is currently undergoing production trials and conducting clinical studies for a product release under the BioActive Natural Health banner in early 2019.
Bioactive has become the first Therapeutic Goods Administration (TGA) Sponsor to be granted exclusivity within the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2018.
Bioactive has exclusivity for a period of two years for both active and excipient forms of the new ingredient for use in Listed Medicines. This includes complementary medicines, sunscreens and oral health products.
TGA reforms, passed into law by the Federal Senate early in 2018, have made this possible. This reform was introduced to encourage innovation within the Listed Medicines sector and is intended to reward the resources invested by innovators who research and develop new ingredients.
Bioactive Laboratories’ Drug Discovery efforts were given a boost with an innovative collaborative funding model supported by the Federal Department of Agriculture and Water Resources.
The project was directed at investigating the use of bark extracts from tree harvesting to manufacture pharmaceutical products. Enhancing the non-wood benefits of tree plantation activity has commercial benefits as does research to identify and develop new pharmaceuticals to treat challenging medical conditions.
Principal researcher at Griffith University’s School of Environment, Professor Tony Carroll confirmed that the project demonstrated the potential of tree harvest residues as sources of compounds that can be used for a variety of applications, including pharmaceutical, veterinary, cosmetic, pest control and as a source of ‘rare’ fine chemicals for biotechnological research and development.
He said the lack of a sustainable supply of complex naturally derived compounds can stifle their development into pharmaceuticals, but harvesting them from plantation sources provides certainty that can aid in positive decision-making in the drug development pipeline.
Managing Director, Rick Ferdinands, reveals a New Pharmaceutical Disruption Model. This new model allows early revenue streams from ‘low risk’ listed plant based medicines, whilst drug discovery is advancing through collaborations.
Disruptive strategies such as these open the door to SMSF and sophisticated wholesale investors looking for early returns.
This presentation was delivered at the Wholesale Investor, Sydney event in June 2016.
Bioactive Laboratories welcomes its new investors, thanks existing shareholders & continues to invite SMSF investors to its register.
The Therapeutics subsidiary is powering ahead with the New Molecule Discovery project at the Griffith Institute for Drug Discovery. The significance of this project, in creating a compound library, will add to Bioactive’s IP register of patents for commercial licensing.
The Natural Health subsidiary, creating optimised extracts, submitted its TGA New Substance application in June. This important milestone firms up customer relationships and opens the door to an FDA submission in the near future.
Bioactive have discovered new plant sourced molecules creating first-in-class stomach friendly anti-inflammatory and anti-microbial agents. These collectively service the global market of 7 billion people.
An investor exit is planned looking towards either a listing or a trade sale.
Bioactive Managing Director Rick Ferdinands was invited by Trade and Investment Minister, The Hon Andrew Robb AO MP to attend the Northern Australia Investment Forum in Darwin from 8 to 10 November 2015.
The forum, a high-level event, brought together senior executives from leading international and Australian companies keen to pursue investment opportunities from a select group of Australian Tropical Medicine Research Projects. The company’s Infectious Diseases Platform was showcased to an array of international entities from pharmaceutical companies, philanthropic trusts and non-profit foundations.
“Meeting senior executive decision makers from around the globe, in one place, over three days, was a unique opportunity for Bioactive. My thanks goes to Paul Field and his team from the Australian Trade Commission for organising such a productive event.”, Rick Ferdinands.
Bioactive is now working with a number of these international interests.
Bioactive has brought forward its drug development pipeline by two years after significant infectious disease discoveries were confirmed by Professor Alan Cowman, Head of Infection and Immunity at the Walter and Eliza Hall Institute of Medical Research.
Bioactive Managing Director Rick Ferdinands, “The magnitude of these discoveries has not been seen since the early 1970’s for a major global infectious disease.”
Inside 8 weeks Bioactive & the Walter and Eliza Hall institute forged a collaboration and formed a new pharmaceutical company.
The new company’s aim is two fold, to conduct additional research into the unique active compounds using structure-based drug design & to continue to develop Bioactive’s patentable Optimised Extract towards a shorter term commercial outcome.
Bioactive are now finalising patents and relationships to take advantage of this extraordinary opportunity.
“With the right global partner we could see a commercial product launch of our optimised extract within 24 months post raising.” says Mr Ferdinands.
Three consecutive years of successful Certified Organic audits have solidified the Bioactive environmental credentials by approving Certified Organic status for the US & Australian markets. The US is currently the largest regulated global organic market for traditional medicine ingredients.
The US Department of Agriculture (USDA), after the third detailed on-site audit, granted Bioactive entry into the National Organic Program (NOP) and use of the coveted USDA Certified Organic seal.
The preparation and on-site audit of the Bioactive Plant Farms in the tropical North of Western Australia, was finalised in August 2013, July 2014, and again in Sept 2015. The process initially took over 2 years in the planning, but has now become an annual event.
The USDA standards require the integration of cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance and conserve biodiversity. This means that organic operations must maintain or enhance soil and water quality while also conserving wetlands, woodlands and wildlife.
Consumers globally choose to purchase organic products with the expectation that they are grown, processed and handled according to the USDA organic regulations.
This achievement adds another level of partner confidence in the Bioactive quality systems, flowing on to consumer peace of mind.
Bioactive Solutions, the Research and Development arm of the Bioactive Group are excited to announce the filing of their inaugural patent.
Managing Director Rick Ferdinands, “This patent, with research still in the discovery phase, represents a significant milestone in the short history of Bioactive.
The significance is in the non-synthetic plant based origins of the ‘herbal composition of an enriched extract’. As a proprietary formula, the patent abstract concentrates on ‘the treatment or prevention of inflammation’.
This early research indicates strong laboratory based results in four key areas: anti-inflammatory, anti-microbial, anti-oxidant and anti-cancer.
The flagship formula, Khapre®, based on this early discovery, is expected to be applied to many complementary medicine applications as an early commercial strategy to help fund the company’s drug development ambitions.