Jupiter, FL–(October 1, 2009–BUSINESS WIRE)—Dyadic International, Inc. (Pink Sheets: DYAI) (“Dyadic”) today announced that it has received acknowledgement from the U.S. Food and Drug Administration (“FDA”) that it has no questions at this time regarding Dyadic’s conclusion that the cellulase enzyme preparation derived from a genetically modified strain of its patented and proprietary C1 organism is generally recognized as safe (“GRAS”) under the intended conditions of use. The FDA based its notification (GRAS Notice No. GRN 000292) on information provided by Dyadic as well as other information available to the FDA.
Dyadic followed FDA-proposed procedures to establish that its C1-derived cellulase enzyme is GRAS. This process included convening an expert panel to review the necessary product safety data and then submitting a voluntary notification to the FDA of the expert opinion and the data supporting its conclusion.
With this positive development, Dyadic will immediately offer for sale a new liquid enzyme product produced from its C1 technology platform called, “CeluStar CL,” for use in the production of wine, beer and fruit juices. Now that Dyadic has successfully concluded this GRAS notification process, it also intends to identify co-development and licensing opportunities for the future production of additional C1-derived GRAS products.
“Receiving this positive acknowledgement from the FDA regarding our GRAS notification culminates a multi-year product development process and affirms Dyadic’s conclusion that its cellulase enzyme is safe for use by our customers. Dyadic intends to continue to utilize its C1 technology platform for the development of additional specialty enzyme products,” stated Richard Jundzil, Dyadic’s Director of Development & Quality.
Brian Murdoch, Dyadic’s Director of Sales, added, “the new CeluStar CL product further expands Dyadic’s innovative specialty enzyme solutions available for sale to our global customers. CeluStar CL is a value-added enzyme that provides enhanced performance over a wide range of application conditions.”
Dyadic International, Inc. is a global biotechnology company that uses its patented and proprietary technologies to conduct research and development activities for the discovery, development, and manufacture of products and enabling solutions to the bioenergy, industrial enzyme and pharmaceutical industries. Please visit Dyadic’s website atwww.dyadic.com.
CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS
Certain statements contained in this press release are forward- looking statements. These forward-looking statements involve risks and uncertainties that could cause Dyadic’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, Dyadic expressly disclaims any intent or obligation to update any forward-looking statements.
Dyadic International, Inc.
Brian Murdoch, Director of Sales