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MOLECULON CHLORPHENIRAMINE PATCH SHOULD BEGIN CLINICALS LATE IN 1985

Executive Summary

MOLECULON CHLORPHENIRAMINE PATCH SHOULD BEGIN CLINICALS LATE IN 1985, company President George Goldenberg indicated in remarks made at a New York Society of Security Analysts meeting on June 12. "We are progressing very rapidly towards the first human clinical studies of this product sometime this year," he stated. Referring to the potential market for Moleculon's chlorpheniramine product, Goldenberg indicated that the substance, which has been on the market for about 40 years and is an ingredient in roughly 80-90% of OTC cold pills, produced sales of upward to $80 mil. last year." Goldenberg noted that in formulating the transdermal cold product, Moleculon has had to address the problem of chlorpheniramine's tendency to irritate the skin upon contact. The roughly one square inch patch is composed of the firm's patented Poroplastic polymer membrane. Described by the company as a "molecular sponge," the membrane, which can be 75% to 97% liquid, permits a drug to be continuously released at a controlled rate. The firm has indicated that it also expects to begin clinical testing of a controlled release dual antibiotic drug system in the fall. The system, which uses gentamicin and clindamycin, is being developed in conjunction with Walter Reed Army Hospital principally as a traumatic wound dressing. Goldenberg pointed out that the two antibiotics are also effective in the treatment of bed sores. "With the further development of this unique technology," he added, "we can foresee its application in the controlled release of combinations of drugs that can be used for many conditions such as the relief of coughs and colds." Off-patent drugs, according to Goldenberg, offer significant opportunities for adaptation to Moleculon's Poroplastic technology. "There are a large number of generic or multi-source drugs, all of which already enjoy significant markets and sales, that might benefit by virtue of a Poroplastic transdermal delivery system," he commented. "Their efficacy has been well chronicled in the scientific and medical literature." He added that the company would benefit from a one to two year approval process at FDA for these products, as it is only required to show bioavailability and bioequivalency. "Our independent research and development is designed to establish a series of studies with different drugs, bringing them through the development stage into the clinical testing stage and then licensing the marketing rights to pharmaceutical firms offering the requisite expertise for maximizing market coverage and sales," Goldenberg summarized.

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