GRAS Status Opens Door to U.S. Food Industry

    MELBOURNE, Australia, March 18 /PRNewswire-FirstCall/ -- Phosphagenics
 Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today
 announced that an independent panel ("the panel") of food safety experts
 unanimously concluded that Phosphagenics' patented Phospha E(R) is
 Generally Recognized As Safe (GRAS). This comes as a result of the panel
 critically evaluating data and information pertinent to the use of Phospha
 E(R) in breakfast cereals, juice beverages and table fats.
 
     Phospha E(R) is a patented derivative of vitamin E with superior
 qualities, such as greater absorption and activity. In pre-clinical
 studies, Phospha E(R), when given orally, has been shown to lower blood
 cholesterol and triglyceride levels, inhibit the formation of arterial
 plaques and suppress the main inflammatory pathways involved in metabolic
 syndrome (a condition which markedly increases the risk of heart attacks,
 strokes and diabetes).
 
     The Company is preparing a GRAS notification to inform the U.S. Food
 and Drug Administration ("FDA") of the expert panel's conclusion that
 Phosphagenics' Phospha E(R) is GRAS. If the FDA has no further comment,
 GRAS designation allows manufacturers to produce and sell foods that
 include Phospha E(R) in the U.S. food industry.
 
     "GRAS status extends the permitted use of Phospha E(R) beyond the
 nutritional supplement market and into the substantial U.S. food industry,
 and represents a tremendous commercial opportunity for Phosphagenics," said
 Harry Rosen, Phosphagenics' President and CEO.
 
     APPENDIX AND NOTES TO EDITORS
 
     About GRAS
 
     Generally Recognized as Safe (GRAS) is an FDA designation that a
 chemical or substance added to food is considered safe by experts, and so
 is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA)
 food additive tolerance requirements.
 
     GRAS exemptions are granted for substances that are generally
 recognized, among experts qualified by scientific training and experience
 to evaluate their safety, as having been adequately shown through
 scientific procedures (or, in the case of a substance used in food prior to
 January 1, 1958, through either scientific procedures or through experience
 based on common use in food) to be safe under the conditions of their
 intended use.
 
     The substance must be shown to be "generally recognized" as safe under
 the conditions of its intended use. The proponent of the exemption has the
 burden of proving that the use of the substance is "generally recognized"
 as safe. To establish such recognition, the proponent must show that there
 is a consensus of expert opinion regarding the safety of the use of the
 substance.
 
     About Phosphagenics Limited
 
     Phosphagenics is a Melbourne-based, globally driven biotechnology
 company focused on the discovery of new and cost effective ways to enhance
 the bioavailability, activity, safety and delivery of proven pharmaceutical
 and nutraceutical products.
 
     Phosphagenics' core technology is built around the science and
 application of phosphorylation, a process where the addition of a phosphate
 group has been found to enhance the bioavailability, activity and safety of
 existing pharmaceuticals and nutraceuticals, as well as to assist in the
 production of drug delivery platforms.
 
     Phosphagenics' shares are listed on the Australian Stock Exchange (POH)
 and the London Stock Exchange's Alternative Investment Market (PSG). An ADR
 - Level 1 program was established in the U.S. with The Bank of New York
 Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the
 'over-the-counter' market. In July 2007, this was upgraded to the
 International OTCQX, a new premium market tier in the U.S. for
 international exchange-listed companies, operated by Pink Sheets, LLC.
 
     For more information, please visit Phosphagenics' web site at
 www.phosphagenics.com
 
     Safe Harbor Statement
 
     This press release contains forward-looking statements based on current
 expectations of future events. If underlying assumptions prove inaccurate
 or unknown risks or uncertainties materialise, actual results could vary
 materially from the Phosphagenics' expectations and projections. Risks and
 uncertainties include general industry conditions and competition; economic
 conditions, such as interest rate and currency exchange rate fluctuations;
 technological advances and patents attained by competitors; challenges
 inherent in new product development, including obtaining regulatory
 approvals; domestic and foreign health care reforms and governmental laws
 and regulations.
 
 
 

SOURCE Phosphagenics Limited

More by this Source


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

 

PR Newswire Membership

Fill out a PR Newswire membership form or contact us at (888) 776-0942.

Learn about PR Newswire services

Request more information about PR Newswire products and services or call us at (888) 776-0942.