WIXOM, Mich., Jan 18, 2006 /PRNewswire-FirstCall via COMTEX/ -- Rockwell Medical Technologies, Inc. (RMTI), a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported today that it has obtained an exclusive license for the U.S. patent for a proprietary, water-soluble vitamin and carnitine mixture for dialysis patients to be delivered via the Company's Dialysate. The license agreement gives the Company the exclusive right to manufacture and market this novel vitamin/drug delivery product.
Rockwell has entered into a license agreement with Charak, LLC, based in Cerritos, CA, founded by nephrologist Dr. Ajay Gupta who serves as its CEO. The agreement grants the Company the exclusive worldwide rights to manufacture and market liquid and dry dialysate compositions containing a proprietary, water-soluble vitamin and carnitine mixture for which Charak LLC has obtained a U.S. patent. The mixture contains vitamin C, vitamin B.sub.6, thiamine, vitamin B.sub.12, folic acid and carnitine. The patent covers the method for preventing and correcting vitamin deficiency in both hemodialysis and peritoneal dialysis patients with renal failure. Prior to marketing the product, Rockwell will have to obtain US Food & Drug Administration (FDA) approval. Rockwell estimates that the potential U.S. dialysis market for vitamins and carnitine could be as much as $200 million.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell said, "We are very pleased to secure the rights to this proprietary product and to further develop our work with Dr. Gupta. There is a definite need for improved methods and compositions for the prevention and treatment of vitamin and carnitine deficiency due to high expense, poor patient compliance, and inadequate bioavailability of vitamins. We believe this innovative delivery method will greatly benefit the dialysis patient and greatly improve the quality of treatment the dialysis provider can offer." Mr. Chioini further stated, "This water-soluble vitamin and carnitine mixture together with our Soluble FePPi Iron-delivery therapy would give Rockwell two exclusive products that strengthen our product offering and have potential to capture substantial markets. We believe that dialysate is the ideal delivery vehicle for the therapies that are necessary and required to sustain and improve the quality of life for dialysis patients."
Patients with chronic renal failure are at an increased risk for multiple vitamin and nutrient deficiencies. Vitamin intake is often decreased in uremic patients because of anorexia and reduced food intake. Also, the diets prescribed for these patients frequently contain less than the recommended daily allowances of certain water soluble vitamins. The metabolism of folate and pyridoxine is abnormal in renal failure. Furthermore, because water soluble vitamins are removed by dialysis they are routinely prescribed for dialysis patients in the United States. Vitamin deficiency is associated with a 15% increase in mortality as per the results of the Dialysis Outcomes and Practice Patterns Study (DOPPS).
Carnitine, an amino acid derivative, is essential for the transport of long-chain fatty acids across the mitochondria, where fatty acids are oxidized to provide energy for muscle tissue and other cells. Carnitine, however, is water soluble and not highly bound to any large molecule and therefore is cleared by dialysis. Signs of carnitine deficiency include muscle weakness, cardiac dysfunction, hypoglycemia, and changes in lipid profile such as elevated triglycerides. Clinical studies have demonstrated that carnitine replenishment results in improvement in intradialytic hypotension, muscle cramps, muscle strength, exercise capacity, a sense of well being, and possibly an increase in muscle mass. Furthermore, L-carnitine deficiency in dialysis patients may promote resistance to erythropoietin action, which is corrected by L-carnitine supplementation.
Dr. Ajay Gupta, CEO of Charak, LLC stated, "Because carnitine and water- soluble vitamins are removed by the process of dialysis their deficiencies are widely prevalent in the hemodialysis patient population. Carnitine deficiency is associated with cardiomyopathy and dialysis hypotension. Dialysis hypotension prevents adequate dialysis or fluid removal during dialysis, thereby leading to congestive heart failure and hospitalizations. Furthermore, deficiencies of carnitine and vitamin C contribute to anemia and a resistance to action of erythropoietin thereby increasing the requirements for erythropoietin to achieve the target hemoglobin. Carnitine and vitamins supplemented via dialysis solution is designed to achieve normal plasma levels of carnitine and water-soluble vitamins by physiological replacement of these vital nutrients, thereby reducing morbidity, mortality and the requirement for erythropoietin."
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate(R) Dry Acid Concentrate Mixing System, RenalPure(R) Liquid Acid Concentrate, SteriLyte(R) Liquid Bicarbonate Concentrate, RenalPure(R) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at http://www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding the potential of Rockwell's proprietary water-soluble vitamin and carnitine mixture and Soluble FePPi, statements regarding the efficacy of these products and statements regarding the market potential for Rockwell's proprietary products, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to a significant delay in gaining FDA approval, failure to obtain FDA approval or inability to obtain adequate Medicare reimbursement, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.