NUTRITION 21 LAUNCHES NITROSIGINE™, A NOVEL PATENTED SOURCE OF INOSITOL-STABILIZED ARGININE SILICATE, ACCEPTED BY THE FDA AS A NEW DIETARY INGREDIENT

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PURCHASE, N.Y. May 16, 2013Nutrition 21, LLC, a leading developer and marketer of nutritional ingredients whose health benefits are substantiated by extensive clinical research, proudly announced today the launch of Nitrosigine™, a novel patented source of inositol-stabilized arginine silicate accepted by the United States Food and Drug Administration (FDA) as a New Dietary Ingredient (NDI). In pre-clinical studies, Nitrosigine™ has been shown to demonstrate superiority over arginine in blood flow markers and has been shown to positively affect silicon absorption, providing evidence of health benefits applicable to many market categories.

“Nitrosigine™ is an exciting addition to our ingredient division and we anticipate it will allow our customers to impact consumers in the sports nutrition, cardiovascular health and men’s health categories. Nitrosigine™ also validates our ability to develop patent-protected NDIs,” explained Michael Satow, President and CEO of Nutrition 21.

Primary investigator, Dr. James C. Russell, Professor Emeritus, Department of Surgery, Metabolic and Cardiovascular Diseases Laboratory at the Alberta Institute for Human Nutrition, University of Alberta, Canada and his colleagues conducted one of the preclinical studies, entitled “Metabolic Effects of a Novel Silicate Inositol Complex of the Nitric Oxide Precursor Arginine in the Obese Insulin-resistant JCR:LA-cp Rat.”  Their research concluded that the arginine silicate inositol complex is absorbed efficiently; raising plasma arginine levels, and is more biologically effective than arginine hydrochloride. Dr. Russell stated, “Our research has shown significant protective effects of the novel amino acid compound arginine silicate in an animal model of the Metabolic Syndrome with treatment reversing impaired function of the coronary arteries.”

“The benefits seen with Nitrosigine™ in enhancing coronary blood flow can also be applied to other categories, including sports nutrition and men’s health. Arginine has been studied extensively since 1998 as a natural metabolic donor of nitric oxide. There is also accumulated evidence over the past 35 years suggesting an important role for silicon in connective tissue and for bone health. Nitrosigine™ provides the benefits of arginine and silicon, with additional benefits from the unique combination,” said James Komorowski, MS, CNS, Vice President Scientific and Regulatory Affairs at Nutrition 21.

Nitrosigine™ Science Highlights:
Research has shown dramatic protective effects of the novel amino acid compound arginine silicate in pre-clinical studies. Results with human subjects are anticipated for Q3 2013.

  • Nitrosigine™ almost doubles maximum blood flow compared to Arginine HCI and is 4x greater than Control
  • Nitrosigine™ blood vessel relaxation is almost 5x greater than Arginine HCI
  • Nitrosigine™ supplementation significantly increased silicon blood levels compared to normal dietary intake

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“Nutrition 21 is thrilled to begin selling our NDI accepted, Nitrosigine™. Based on pre-clinical results, Nitrosigine™ demonstrated superiority over arginine as shown by increases in blood flow markers and silicon absorption.  We anticipate significant market interest with strong customer sales,” said Michael Quinn, Executive Director, National Sales at Nutrition 21.

About Nutrition 21

Nutrition 21 is a leader in the nutritional supplement industry. The Company is a developer and marketer of efficacious, high-value, clinically substantiated ingredients for dietary supplements, medical foods and beverages, with Chromax® chromium picolinate being a flagship product. With many years of biotechnology and pharmaceutical experience, it has the scientific platform and processes in place to create unique, patentable products that are safe and clinically effective. Rigorous preclinical and clinical trials are a key part of its product development strategy to ensure product safety and consumer trust.

Nutrition 21 currently holds over 100 domestic and international issued and pending patents for products. Many support unique claims associated with, among others, glucose metabolism, weight management, brain health, and cardiovascular health. For more information please visit: www.Nutrition21.com.

The assets of Nutrition 21, Inc., were acquired in November 2011 by an investment group led by Phillip Satow and Michael Satow, and are now part of Nutrition 21, LLC.  Michael Satow serves as President and Chief Executive Officer and Phillip Satow as Chairman of the Board. Phillip and Michael together have almost 50 years of healthcare experience. Most recently, they founded and built JDS Pharmaceuticals, LLC, a specialty pharmaceutical company focused on the psychiatric and women’s health markets. JDS was sold in 2007 to Noven Pharmaceuticals, Inc., for $125 million.

Contact Information:

Bill Levi
Nutrition 21
VP, Strategy and Business Development
914 701-4549
blevi@Nutrition21.com

Michael Quinn
Executive Director, National Sales
914-701-4506
mquinn@Nutrition21.com

James Komorowski, MS, CNS
Nutrition 21
Vice President, Scientific & Regulatory Affairs
Nutrition 21 LLC
914-701-4519
jkomorowski@nutrition21.com

Dr. James C. Russell
Professor Emeritus, Department of Surgery
Metabolic and Cardiovascular Diseases Laboratory
Alberta Institute for Human Nutrition
4-002 Li Ka Shing Centre for Health Research Innovation
University of Alberta
Edmonton, AB T6G 2P5 Canada
780-945-9140
Jim.Russell@ualberta.ca

Metabolism Clinical and Experimental 56 (2007) 1318–1325
Metabolic Effects Of A Novel Silicate Inositol Complex Of The Nitric Oxide Precursor Arginine In The Obese Insulin-Resistant, JCR: LA-cp rat; Spencer D. Proctor, Sandra E. Kelly, Donna F. Vine, James C. Russell