PURCHASE, N.Y. April 13, 2005 -- Nutrition 21, Inc. (Nasdaq:NXXI) announced today that the results of its Diachrome® clinical trial will be presented at three prestigious scientific conferences in Spring 2005. The study was conducted in collaboration with XL Health, a nationally recognized disease management firm. The 453 patient multi-center trial evaluated the effects of Diachrome, in conjunction with prescription anti-diabetics agents, on glycated hemoglobin (HbA1c), fasting plasma glucose, and cholesterol profiles in people with type 2 diabetes. The scientific conferences are: the American Heart Association’s 6th Annual Conference on Arteriosclerosis, Thrombosis and Vascular Biology; the Endocrine Society’s 87th Annual Meeting; and the American Diabetes Association 65th Annual Scientific Sessions.
The Diachrome study is the largest U.S. clinical trail to demonstrate the health benefits of chromium-based intervention for diabetes. “This is a major clinical milestone for Diachrome and further confirms its safety and benefits in managing blood sugar and cholesterol levels as an adjunct to pharmaceutical treatments for people with type 2 diabetes,” said Gail Montgomery, president and CEO, Nutrition 21. “We look forward to sharing the scientific data in an effort to gain adoption among the medical community of Diachrome for diabetes management.”
Additionally, Nutrition 21 announces it has agreed to the FDA’s request for an additional 60-day extension regarding the company’s applications for Qualified Health Claims (QHCs) for chromium picolinate. The FDA’s new decision date will be June 17, 2005. The Company applied for QHCs associating chromium picolinate with reduced risk of insulin resistance, type 2 diabetes and related conditions in December 2003.
“We understand the current resource constraints at the agency and will continue to cooperate with the FDA to move the process forward,” said Montgomery. “The health claims, if approved, will facilitate the Company’s marketing of chromium picolinate to healthcare professionals and consumers.”
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax® chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome®, which is available through diabetes educators or at www.diachrome.com. Nutrition 21 holds 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
Safe Harbor Provision
This press release may contain certain forward-looking statements. The words “believe,” “expect,” “anticipate” and other similar expressions generally identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based largely on the Company's current expectations and are subject to a number of risks and uncertainties, including without limitation: the effect of the expiration of patents; regulatory issues; uncertainty in the outcomes of clinical trials; changes in external market factors; changes in the Company's business or growth strategy or an inability to execute its strategy due to changes in its industry or the economy generally; the emergence of new or growing competitors; various other competitive factors; and other risks and uncertainties indicated from time to time in the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended June 30, 2004. Actual results could differ materially from the results referred to in the forward-looking statements. In light of these risks and uncertainties, there can be no assurance that the results referred to in the forward-looking statements contained in this press release will in fact occur. Additionally, the Company makes no commitment to disclose any revisions to forward-looking statements, or any facts, events or circumstances after the date hereof that may bear upon forward-looking statements.
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