Patent Presents New Pharmaceutical Licensing Opportunities

PURCHASE, N.Y.–(BW HealthWire)–Nutrition 21, Inc. (Nasdaq: NXXI – news), a leading developer and marketer of clinically proven nutritional products, announced today that the United States Patent and Trademark Office has issued a patent to the company for the use of chromium picolinate in high doses to stabilize blood glucose levels and reduce hyperglycemia associated with Type 2 diabetes.

“We believe that human clinical studies will continue to demonstrate that chromium picolinate should be an integral component of nutritional therapy for Type 2 diabetes and insulin resistance,” said Gail Montgomery, president and chief executive officer of Nutrition 21. “To date, 10 clinical studies have shown chromium picolinate to significantly improve blood sugar control in people with diabetes, making it the most-studied form of chromium supplementation in this patient population.”

Nutrition 21 currently holds 31 patents for nutrition products, 21 of them for chromium compounds and their uses.

“This newly issued patent expands the potential for licensing the use of chromium picolinate for pharmaceutical applications,” added Montgomery. “As we move forward, we expect to leverage our entire patent portfolio as a key element of our business strategy. The breadth and depth of our patent protection is unique within the nutritional products industry, and provides us with a significant competitive advantage in the marketplace.”

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According to the American Diabetes Association, over 16 million Americans have diabetes. Patients with Type 2 diabetes represent 90% of the overall diabetic patient population. This disease is nearing epidemic proportions, due to an increasing number of older Americans, and a greater prevalence of obesity and non-active lifestyles. In Type 2 diabetes, the body’s ability to produce and use insulin to process carbohydrates, proteins and fats deteriorates, resulting over time in serious health complications.

Complications associated with diabetes include heart disease and stroke, kidney disease, blindness, nerve disease and amputations and impotence. More than half of the direct medical costs associated with diabetes arise from the treatment of complications. The direct and indirect cost of treating diabetes in the United States was $98 billion in 1997. The U.S. market for diabetes drugs was $9.3 billion in 2000.

In double-blind placebo-controlled studies Cefalu et al (1999) and Morris et al (2000) suggested that chromium picolinate increases insulin sensitivity (P less than 0.05) and glucose utilization (P less than 0.01), and helps maintain normal blood glucose levels. Cheng et al (1999) reported a randomized double-blind clinical trial of 180 individuals with Type 2 diabetes. One-third of the subjects received an oral daily dose of 1,000 micrograms of chromium in the form of chromium picolinate; one-third received 200 micrograms of chromium; and one-third received a placebo. The subjects receiving the 1,000 microgram dose of chromium as chromium picolinate exhibited an average reduction in glycosylated hemoglobin of 30% and a similar reduction in fasting and postprandial glucose levels (28% and 27%, respectively).

Chromium is a nutritionally essential trace element, as established in 1959 by Schwartz, as cited in Present Knowledge in Nutrition, page 571, fifth edition (1984, The Nutrition Foundation, Washington, D.C.). Chromium depletion is characterized by the disturbance of glucose, lipid and protein metabolism and by a shortened lifespan. Chromium is essential for optimal insulin activity in all known insulin-dependent systems (Boyle et al., Southern Med. J., 70:1449-1453, 1977). Insufficient dietary chromium has been linked to both adult-onset diabetes and to cardiovascular disease.

About Nutrition 21

Nutrition 21 develops and markets clinically substantiated products that make a significant contribution to the health and well-being of consumers. More information is available at

SOURCE: Nutrition 21