PURCHASE, N.Y. & BALTIMORE, Jan 25, 2005 -- Nutrition 21, Inc. (NXXI: NASDAQ) and XL Health Corporation announced today positive results from a pivotal randomized, double-blinded, placebo-controlled clinical trial evaluating the effects of Diachrome(R), a combination of chromium picolinate and biotin, on glycated hemoglobin (HbA1c), fasting plasma glucose, cholesterol and triglyceride profiles in patients with type 2 diabetes. The 453 patient multi-center trial was conducted by Nutrition 21 in collaboration with XL Health, a nationally recognized disease management firm managing chronically ill patients for the Centers for Medicare and Medicaid Services (CMS) and private Medicare Advantage markets. It is the largest U.S. study to demonstrate the health benefits of a chromium-based intervention for diabetes.
"The detailed findings from the trial are being shared with a number of clinical outcomes groups at both XL Health and Nutrition 21," said Paul Serini, executive vice president of XL Health. "Based on the positive trial results we have seen thus far and the apparent benefits to our diabetic patients' health and medical spending, XL Health is investigating ways the Diachrome product can be incorporated on a broad scale into the work we do with CMS and Medicare Advantage patients."
"This major clinical milestone for Diachrome further confirms its safety and benefits in uniquely managing both blood sugar and cholesterol levels in conjunction with pharmaceutical treatments for people with diabetes," commented Gail Montgomery, president and CEO of Nutrition 21. "We are currently sharing the data with strategic business partners and key medical experts to enlist their support in accelerating our efforts to move Diachrome into clinical practice as a nutritional therapy for people with diabetes and at risk for heart disease."
According to the American Diabetes Association, there are 18.2 million people in the United States, or 6.3% of the population, who have diabetes. Heart disease is the leading cause of diabetes-related deaths and adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes. The cost of diabetes, both direct medical expenditures and the costs of foregone productivity, is estimated to have been $132 billion in 2002.
"Given the increasing public health burden associated with the escalating incidence of diabetes, we believe the market potential for Diachrome, as a safe, effective and inexpensive adjunct therapy to diabetes disease management is significant. We eagerly await the opportunity to present the data at key scientific meetings in the months ahead," added Montgomery.
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(R) chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome(R), 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.
About XLHealth Corporation
XLHealth (www.xlhealth.com) is a privately held company owned by a combination of founders, management and Goldman Sachs Private Equity Funds. It has been at the forefront of disease management innovations since its inception. Founded by physicians, many of whom were affiliated with Johns Hopkins, XLHealth replaces the more customary remote telephone "call-center" or direct mail support with ongoing, face-to-face meetings with patients and physicians. XLHealth also uses tight coordination of care, behavior modification, and in-depth patient profiling integrated with claims, pharmacy, and lab information to generate sophisticated, predictive modeling. The firm emphasizes preventing avoidable and expensive disease complications and hospitalizations. XLHealth was recently awarded the Disease Management Association of America's (DMAA) Recognizing Excellence Award for "Best Disease Management Program: Medicare."
The statements contained in this release which are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, certain delays beyond the company's control with respect to market acceptance of new technologies and products, delays in testing and evaluation of products, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission.