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This article was originally published in The Tan Sheet

Executive Summary

ELAN NUTRAPHARMA LAUNCHING HEARTY BALANCE PARKINSON'S DISEASE PRODUCT LINE of nutritionals as ethically marketed medical foods, parent company Elan Corp. plc said Oct. 18. The Hearty Balance food line will not be available over-the-counter and will be promoted to physicians and Parkinson's disease societies, the company announced. Elan NutraPharma is currently marketing the Hearty Balance beverages for $ 2 each in "very vanilla," "zesty strawberry" and "dutch chocolate" flavors, and anticipates that a full food line including entrees, soups, snacks and dessert items will follow shortly, the company said. Elan NutraPharma expects Hearty Balance food prices to be comparable to average food expenditures. Although Elan NutraPharma does not recommend a suggested daily dosage because it believes that use of Hearty Balance products should be directed by patients' doctors, the firm said that four servings per day would meet the Recommended Dietary Allowance for essential nutrients. Elan NutraPharma said that Hearty Balance products did not require FDA approval, but meet agency requirements for medical foods. In conjunction with marketing the Hearty Balance products, Elan NutraPharma has initiated a program called "Quality of Life Through Balanced Nutrition," which was developed to provide "the most current information on the role of nutrition in Parkinson's disease," the company stated. The program, which instructs patients on how to incorporate Hearty Balance products into daily meal planning, is based on research that found that patients taking Parkinson's drugs levodopa or carbidopa-levodopa have special nutritional requirements. Parkinson's patients must enroll in the program to obtain Hearty Balance products. Patients can join the Quality of Life program through physicians and Parkinson's disease societies as well as by calling a toll-free number staffed by registered dieticians. Orders for the Hearty Balance line can be placed through the "1-800" number and will be delivered to patients' homes within two days. The program also entitles members to a quarterly newsletter on Parkinson's and a resource book that provides information on Parkinson's disease and nutrition. Elan NutraPharma bought the rights to manufacture and market the Hearty Balance food products from Lexington, Mass.-based Interneuron Pharmaceuticals, which developed the 7:1 carbohydrates-to-protein formula used in Hearty Balance products. Under terms of that agreement, Elan agreed to pay $ 5.4 mil. in advance royalties for exclusive rights to the products, Interneuron said. Additional royalties will be paid according to future sales. Interneuron President and CEO Glenn Cooper, MD, stated at an Oct. 25 session of the Montgomery Securities Health Care Conference in New York City that he anticipates the Hearty Balance products will capture a $ 100 mil.-plus market. The Hearty Balance products were developed based on two clinical trials comparing the 7:1 carbohydrates-to-protein formula of Hearty Balance to two other diets. One study evaluated 12 patients on three different diets, with each diet lasting one week: a balance of 7:1 carbohydrates to protein; a ratio of 1.5:1 carbohydrates to protein; and a ratio of 30:1 carbohydrates to protein. Results of the study revealed that patients consuming the 7:1 carbohydrate-to-protein-diet had "better overall muscle movement," Elan said. Another study tested 100 patients on the same three diets for six weeks (two weeks per diet) and found similar results, particularly that motor performance was best on the Hearty Balance diet. Based in Cambridge, Mass., Elan NutraPharma was founded in the spring. Mike Sember, executive vice president of market development for Elan Corp., is heading the division until a permanent director is appointed. Elan NutraPharma manufactures and markets nutritional and medical food products for a variety of chronic medical conditions, including Fiberlain, a high-fiber, high-protein formula suitable for long-term tube feeding, and Nitrolan, a high-nitrogen, high-protein formula developed for post-operative patients, septic patients and patients with thermal injury, pressure sores or other conditions requiring a high- nitrogen solution.

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