65 -- Solicitation for the Creation of Formulations of Vitamins and Minerals for the Treatment of Age-Related Macular Degeneration

The National Eye Institute of the National Institutes of Health is seeking proposals from pharmaceutical companies to create 4 formulations to be tested in a clinical trial of participants at risk of developing age-related macular degeneration in one or both eyes. The formulations will be as follows: Formulation 1 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 2 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 3 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 4 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. The company must demonstrate the ability to make these formulations with previous products that have similar components. The company must demonstrate the willingness to produce these formulations for a large multi-centered trial involving 4000 subjects for at least 7 years. The formulation should be produced with the minimal number of tablets or gel capsules possible to enhance compliance of the study subjects. The company must produce these formulations in a timely fashion to begin the clinical trial by June 2005 and have the ability to remain solvent throughout the next 7 years. Responses to this synopsis are due September 30, 2004. Electronic submission is preferred. Send all submissions directly to: Emily Y. Chew, MD [email protected] NIH Building 31, Room 6A52 31 Center Drive, MSC-2510 Bethesda, MD 20892-2510 310 496 6583 (tel) 301 496 2297 (fax) Please note that this is not a solicitation for contract proposals and no contract award is planned from the submissions received.