Bio-Gene and Rallis India Limited achieve key Flavocide^® production milestone

Highlights

• Successful pilot-scale production of Flavocide^® conducted by Rallis India Limited, one of India’s leading Agri-sciences companies and a subsidiary of Tata Chemicals Limited

• Demonstration that Flavocide^® can be produced at a consistent quality and yield at precommercial scale

• Flavocide^® produced by Rallis India Limited to be used in planned testing activities to advance the registration process for Flavocide^®

• Capacity to produce Flavocide^® in sufficient quantities for future supply to Bio-Gene’s commercial licensees

Bio-Gene Technology Limited (ASX:BGT or ‘Bio-Gene’ or ‘the Company’), an Australian company developing the next generation of novel insecticides derived from nature, and Rallis India Limited (‘Rallis’) announce the successful completion of pilot-scale production of pre-commercial quantities of Flavocide^®.

Appointment of Rallis for pilot-scale synthesis of Flavocide 

Bio-Gene appointed Rallis, a subsidiary of Tata Chemicals and part of the US$165 billion global Tata Group, to undertake process development and pilot-scale synthesis of Flavocide following a detailed evaluation of potential partners. Rallis was appointed based on its proven record of successful production of a wide range of agrochemical products meeting stringent standards and its capacity to produce Flavocide in sufficient quantities for potential future supply to Bio-Gene’s commercial licensees. Rallis is a predominant agrochemical company with over 75 years’ experience.

Achievement of key Flavocide scale-up production milestone

Rallis has produced several hundred kilograms of Flavocide from the pilot-scale batches, demonstrating high yield and consistent quality. This successful pilot-scale production is a critical milestone that validates the production process at a larger scale and establishes proven standard operating procedures for future large-scale manufacturing of Flavocide.

The completion of this pilot-scale production phase demonstrates robustness of Bio-Gene’s Flavocide production method and positions the Company to move forward with the remaining studies to be included in the dossier of data to support its application for regulatory approval of Flavocide for commercial use.

Tim Grogan, Managing Director & Chief Executive Officer for Bio-Gene said:

″We are extremely pleased to have achieved the successful pilot-scale production of multiple batches of Flavocide with high yield and consistency. Reaching this important milestone significantly reduces the technical risk associated with the production of Flavocide in commercial quantities. We are now well positioned to supply larger quantities to our commercial partners in the future.″

″Rallis has a global reputation of being a trusted solutions provider for the manufacture, development and distribution of agrochemical active ingredients. By engaging with Rallis, we have been able to access high quality manufacturing facilities and expertise, with the capacity to produce commercial scale quantities of Flavocide and to adjust production volumes in response to market demands.″

″It has been a real pleasure for our team to work closely with Rallis on this program. I congratulate all those involved from Bio-Gene and Rallis for achieving this important milestone.″

Dr Gyanendra Shukla, Managing Director & Chief Executive Officer for Rallis said:

″With a long-standing history of agrochemicals manufacturing and strategic partnerships with global customers, Rallis is committed to supporting the development and commercialisation of nextgen sustainable solutions for the Crop Protection and allied sectors. Our partnership with BioGene for the successful process development and scale-up of their patented nature-identical Flavocide insecticide is testament to that commitment. While Rallis does not expect the business to be material for Rallis until products containing Flavocide are launched, we look forward to continuing to work closely with Bio-Gene to enable the successful global commercialization of Flavocide-based solutions over the next few years.″

Flavocide is a nature-identical product based on Flavesone, a naturally occurring plant compound present in some eucalypts. Bio-Gene has developed a proprietary process to synthesise the molecule and produce it in commercial quantities. Bio-Gene owns all intellectual property created by its contractors relating to the synthesis of Flavocide.

Flavocide exhibits a new mode of action – that is, the way an insecticide controls or knocks down an insect - and is able to overcome insect resistance to current insecticidal products. Bio-Gene is developing Flavocide to address the worldwide problem of insecticide resistance in the areas of public health, crop protection, grain storage and consumer applications.

The Company’s business model involves entering into licensing arrangements with commercial partners internationally to formulate and develop insecticidal products that contain Flavocide. BioGene will then be entitled to receive up-front and milestone payments and then royalties from its commercial partners upon sale of these new products. Bio-Gene’s business model also includes the supply of Flavocide to these partners in commercial quantities under a commercial supply agreement.