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Executive Summary

Allergan will sponsor development of Nelson R&D's dopamine receptor agonist, N-0437, when the compound begins clinical trials for treatment of glaucoma in 1986, Nelson R&D disclosed in a recent 10K annual report with the Securities & Exchange Commission. "The use of such a dopamine agonist represents a novel approach to glaucoma therapy," Nelson noted. The agreement with SmithKline subsidiary Allergan includes worldwide marketing rights for the product's ophthalmic uses. Nelson's CEO, Peter Upton, at one time headed Allergan's internal. operation. At the same time, Nelson R&D will begin clinical trials with N-0437 for Parkinson's disease. "The compound's selective action should result in fewer side effects than are produced by the dopamine agonists currently available for the treatment of Parkinson's disease," the company said. As one compound moves into clinicals in 1986, another should reach the NDA filing stage. Nelson R&D said it anticipates filing an NDA "late in 1986" for triamcinolone acetonide formulated with Azone, the company's proprietary compound that enhances transdermal penetration of active substances. The topical corticosteroid is intended for treatment of psoriasis and atopic dermatitis. "Development of this product is, in part, a strategic move by the company intended to establish Azone's credibility and to further facilitate regulatory approvals of [other] Azone products," Nelson explained. "Although Azone generally is considered an excipient not subject to regulatory approval as such, product formulations containing Azone do require FDA approval on a case-by-case basis." The company currently has a number of Azone and Tranzone drug development projects underway for several larger pharmaceutical houses including Upjohn, Schering-Plough, Burroughs Wellcome and Lilly. Tranzone, a transdermal patch, can be used in conjunction with Azone to allow delivery of a potentially greater number of drugs than is current possible, the 10K says. Approximately 18% of the firm's 1985 revenues of $3.1 mil. came from Sandoz under an agreement for the development and licensing of Dexan, a dextromethorphan product aimed at treatment of irritable bowel syndrome. "Expanded clinical trials to define the optimum dosage will be completed in 1986," Nelson said. "The final stage of clinical testing to further establish the product's safety and efficacy will continue into 1987." Nelson R&D also has two other products in the late stages of clinical development. While an NDA for Griseoderm, a topical antifungal, was filed in 1981, FDA told the company in 1984 that an additional study would be necessary. Now in the process of reviewing the data from that study, Nelson indicated that yet another trial may be required for approval. Tranylol, an antidepressant developed by the firm through Phase II, "is being reviewed by potential licensees." The 10K notes that Nelson is currently receiving royalties from one licensed product, the acne treatment Cleocin T, which has been manufactured and marketed by Upjohn since 1980. At the more basic research level, Nelson said it is exploring compounds active on GABA receptors, for possible therapeutic uses in the treatment of schizophrenia and Huntington's chorea, and on melatonin receptors, for potential treatment of depression, insomnia and jet lag. In the cardiovascular area, the company is focusing on the discovery and development of a new class of calcium channel blockers.

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