Adeona Gets Manufacturing Agreement For reaZin
Ann Arbor-based Adeona Pharmaceuticals Inc. (NYSE Amex: AEN), a developer of medicines for central nervous system diseases, announced today that it has executed an agreement with TG United Inc. of Brooksville, Fla., to provide commercial-scale manufacturing capabilities for reaZin.
Adeona is developing reaZin, its product candidate for the dietary management of Alzheimer's disease and mild cognitive impairment, as a prescription medical food.
Top-line results from Adeona's clinical study evaluating reaZin for the dietary management of Alzheimer's disease and mild cognitive impairment were presented last week at the 63rd Annual Meeting of the American Academy of Neurology.
In the patients administered reaZin, the primary outcome of increasing serum zinc and decreasing serum free copper was effectively demonstrated. In addition, the average cognitive function of the placebo group declined over 6 months in comparison to patients managed with reaZin. The cognitive function trends favoring the patients administered reaZin were observed in all three standardized cognitive tests and suggest that reaZin may provide an important dietary benefit to Alzheimer's disease patients.
"Executing this agreement for the manufacturing of our product candidate, reaZin, is an important step for commercialization," said James S. Kuo, M.D., Adeona's CEO. "With the recent news that revised guidelines for diagnosing Alzheimer's disease could double the population size, we are excited that reaZin may be of benefit to this growing population, particularly in the earlier stages."
A medical food is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
In general, to be considered a medical food, a product must, at a minimum, meet the following criteria (according to the Food & Drug Administration (FDA) and the U.S. Congress, as part of the Orphan Drug Act):
* The product must be a food for oral or tube feeding
* The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements
* The product must be intended to be used under medical supervision
Ingredients of the product must have GRAS (Generally Recognized As Safe) status or be FDA-approved as food additives
* The product must comply with FDA regulations that pertain to labeling, product claims, and manufacturing
ReaZin, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. reaZin was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high oral bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) the ability to minimize gastrointestinal side effects of oral zinc therapy.
More at www.adeonapharma.com.
