Cellegy receives FDA grant to test skin disease treatment.FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 3, 1996--Cellegy Pharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CLGY; Warrants:CLGYW), with headquarters in Foster City, Thursday said it had received from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) a $400,000 Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the grant for its Phase III study to evaluate the safety and efficacy of the topical drug Topical drug Drug or medication applied to a specific area of the skin and affecting only the area to which it is applied. Mentioned in: Minoxidil Glylorin for the treatment of congenital ichthyosiform erythroderma congenital ichthyosiform erythroderma or ichthyosiform erythroderma n. A hereditary skin disease characterized by diffuse chronic erythema and the formation of thickened, scaly skin on the palms and soles, sometimes associated with ocular and , a disfiguring skin disease. This particular grant is awarded by the FDA to those companies displaying the most promising results with Orphan Drugs in pre-clinical research or clinical trials. Upon FDA approval, Cellegy would have seven years exclusive domestic marketing rights on the treatment. Cellegy initiated a Phase III clinical study using Glylorin in January 1996. Phase III is the last testing phase prior to filing for marketing approval with the FDA. The company said its Phase II clinical study using Glylorin achieved statistically significant results in the treatment of congenital ichthyosis Ichthyosis Definition Derived from two Greek words meaning "fish" and "disease," ichthyosis is a congenital (meaning present at birth) dermatological (skin) disease that is represented by thick, scaly skin. . The company also said that it is currently in advanced stages of discussion with a major pharmaceutical company regarding a worldwide development and marketing agreement for Glylorin. Congenital ichthyosiform erythroderma is one of the severe ichthyoses for which no therapy is commercially available. People who suffer from this disease can experience severe scaling of the skin over the entire body; it is a lifelong condition that is complicated by inflammation and hyperproliferation. Some 100,000 persons in the United States are afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, with the most serious forms of these diseases. Up to another 2 million individuals suffer from milder forms of ichthyoses and treatment-resistant severe dry skin. Cellegy is a pharmaceutical company developing and bringing to market, through corporate collaborations and marketing arrangements, a new generation of drug delivery products as well as consumer and prescription products based upon manipulation of the skin barrier. CONTACT: Cellegy Pharmaceuticals Inc., Foster City Richard Juelis, 415/524-1600 or Market Makers, Santa Barbara Jimmy Caplan, 805/569-0076 or Eisenberg Communications Rick Eisenberg, 212/496-6828 |
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