Aqua Bounty successfully completes key study for AquAdvantage Salmon

FDA accelerates review process
December 4, 2006

Aqua Bounty successfully completes key study for AquAdvantage Salmon

Aqua Bounty Technologies, Inc. (AIM: ABTX), a biotechnology company focused on enhancing productivity in the aquaculture market, announces today that it has satisfied a critical US Food and Drug Administration (“FDA”) requirement for its proprietary AquAdvantageTM gene.  This gene is used to halve the time required for salmon to grow to market size. 

The FDA has stated that “the data and information submitted adequately supports the molecular characterisation of the [gene] construct.”

Importantly, all other major studies required to gain approval for the transgenic salmon to be consumed in the US have been completed by the Company and are under review by the Agency.  These address all aspects of food safety, including allergenicity, nutrient content and genetic stability through inheritance. Other studies addressing animal health and product efficacy are being completed and will be submitted shortly.

Since the approval of the molecular studies, the company has been meeting regularly with the FDA to agree upon procedures and anticipates rapid progress in the review process

The company directors believe  the product will be ready for launch in 2009. 

The company expects AquAdvantage Salmon to be the first product of its kind to be approved by the FDA.  It is confident that the US approval will have a favourable impact on global markets and create downstream opportunities for other products which the Company is presently developing.

Dr Ron Stotish, VP of Regulatory Affairs of Aqua Bounty commented:

“While we do not predict regulatory outcomes, we are satisfied that the FDA has put into place mechanisms that facilitate an effective review process, allowing us to proceed with confidence and underlining our belief that we can achieve a successful outcome.”

Elliot Entis, Chief Executive Officer of Aqua Bounty commented: “We are extremely pleased with the progress made with the FDA and that we have passed this initial regulatory hurdle. We are actively engaged in a process that will result in a quality review and approval, meeting the needs of the public, the government and the biotechnology industry. Today’s endorsement is a clear indication for the marketable potential of our AquAdvantage gene.”