Provexis Regulatory News (PXS)

28 Feb 2007 07:00

Provexis PLC28 February 2007 28 February 2007 Provexis plc ("Provexis") Fruitflow(R) Clears FDA GRAS Review Process Provexis, the nutraceutical company that develops scientifically-provenfunctional and medical foods, is delighted to announce that the US Food and DrugAdministration ("FDA") has no objection to the conclusion that the Fruitflow(R)heart-health technology is Generally Recognized As Safe ("GRAS"), clearing theway for its use in the USA. On 9 March 2006, Provexis announced that an independent Expert Panel affirmedthat in their view Fruitflow(R) was safe for consumption in the United States.On 9 August 2006, Provexis served a comprehensive safety notice to the FDA,together with the aforementioned Expert Panel report in accordance with USregulation governing Substances Generally Recognized As Safe. Provexis can nowconfirm that it has received the formal response from the FDA which confirmsthat they have no objection to the conclusion that Fruitflow(R) is GRAS underthe intended conditions of use. These conditions, as detailed in the Provexisnotice to the FDA, include the addition of Fruitflow(R) to fruit juices,fruit-flavoured drinks and yoghurt drinks. Commenting on this positive development Provexis CEO Stephen Moon said: "The clearance of this regulatory hurdle is an important step in the developmentof our Fruitflow licensing strategy and one which further strengthens thefirst-class scientific and regulatory platform underpinning our heart-healthtechnology. I am delighted that we have received the best possible response fromthe FDA and I expect it to be an important catalyst for our licensing activityin the USA." For further information please contact: Stephen Moon, CEO Tel: 020 8392 6634Provexis plc END This information is provided by RNS The company news service from the London Stock Exchange