ChromaDex advances in regulatory process for its patented nicotinamide riboside chloride (NR) ingredient in Australia; receives market exclusivity for two years
LOS ANGELES, Dec. 02, 2019 (GLOBE NEWSWIRE) -- ChromaDex Corp. (CDXC) today announced that it has received approval from the Australian Therapeutic Goods Administration (TGA) for its patented nicotinamide riboside chloride (NR) for use in listed complementary medicines. The listing indicates that ChromaDex has market exclusivity of NR through December 2, 2021.
With this approval, ChromaDex will be listing their final product as a complementary medicine on the Australian Register of Therapeutic Goods (ARTG).
“This is an important milestone as we expand our presence in the Asia-Pacific region,” says ChromaDex CEO Rob Fried. “We look forward to sharing the unparalleled science behind our ingredient with the people of Australia in 2020.”
Cells can use NR to create nicotinamide adenine dinucleotide (NAD), which is an essential molecule found in every living cell. NAD plays an essential role in cellular energy production and supporting cellular repair. Decreased NAD levels are associated with many age-related declines in overall health. Niagen® is the only commercially available NR which has twice been successfully reviewed under U.S. Food & Drug Association's (FDA) new dietary ingredient (NDI) notification requirement and has also been successfully notified to the FDA as generally recognized as safe (GRAS). In August, the European Food Safety Authority (EFSA) issued a positive opinion on Nicotinamide Riboside (NR) as a novel food ingredient for use in a food supplement; in November, the European Commission voted in favor of listing nicotinamide riboside chloride as a novel food.
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its patent-protected NR and has entered research agreements with more than 170 leading research institutions, including Dartmouth, the National Institutes of Health, University of Iowa, and the Scripps Research Institute.
For additional information on the science supporting Niagen visit www.chromadex.com.
ChromaDex Corp. is a science-based integrated nutraceutical company devoted to improving the way people age. ChromaDex scientists partner with leading universities and research institutions worldwide to uncover the full potential of NAD and identify and develop novel, science-based ingredients. Its flagship ingredient, NIAGEN® nicotinamide riboside chloride, is backed with clinical and scientific research, as well as extensive IP protection. ChromaDex maintains a website at www.chromadex.com to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.