Nestlé, Phosphagenics plan human trials
Nestle Nutrition for the use of Phospha-E in foods metabolic
syndrome, following the food giant's decision to exercise its
option this week.
Nestle took out the option on the form of vitamin E phosphate in April 2006, but realisation was dependent on the successful outcome of pre-clinical trials to confirm its effect on specific biomarkers associated with metabolic syndrome, inflammation and cardiovascular disease.
The results were made public in December, and Phosphagenics informed the Australian Stock Exchange on Monday of Nestle's decision to exercise its option, meaning that it now has the exclusive worldwide license for the use of Phospha-E in foods for the prevention and treatment of metabolic syndrome.
The Australian ingredients firm said today that the one or both parties will conduct human clinical trials, to enable health claims. A key aspect of the pre-clinicals was the determination of an appropriate dose for the human clinicals.
Where and when the human trials will take place is not known, but it is clear that neither company plans to rest on its laurels over bringing products to market. Nestle Nutrition has agreed that it will introduce a product to market within 12 months of regulatory approval.
Phosphagenics managing director Harry Rosen said: "Phosphagenics is looking forward to working closely with Nestle Nutrition to bring Phospha-E to market for this indication as quickly as possible".
He added that Nestle Nutrition is, in his view, "the world's most progressive specialised nutrition company".
Other key points relating to the structure of the agreement include the payment of an option fee (amount as yet undisclosed) by Nestle Nutrition, and that Phosphagenics will manufacture and sell Phospha-E to Nestle.
Indeed, Phosphagenics appears to have been preparing for an increase in demand for the ingredient; it is presently constructing a new A$500,000 (c €294,000) facility for the manufacture of tocopheryl phosphates in Melbourne, Australia.
Metabolic syndrome is characterised by a collection of factors, including overweight/obesity, high triglycerides, low HDL cholesterol, elevated blood pressure, and insulin resistance. It is a major risk factor for cardiovascular disease and diabetes.
An estimated 27 per cent of people having metabolic syndrome in the US, and as waist-lines are expanding across the Western world, other countries may not be far behind.
