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CELLEGY COMPOUND DESIGNATED ORPHAN DRUG BY FDA; MONOLAURIN UNDER DEVELOPMENT TO TREAT CONGENITAL ICHTHYOSIS

 NOVATO, Calif., May 13 /PRNewswire/ -- Cellegy Pharmaceuticals Inc. today announced it received Orphan Drug designation from the Food and Drug Administration (FDA) for the company's lead compound, monolaurin. Upon approval by the FDA, the company will market the compound under the name Glylorin(TM). The designation grants Cellegy seven years of market exclusivity for the treatment of congenital primary ichthyosis, a debilitating dermatologic disease. Monolaurin is in phase II clinical trials and the company hopes to file a new drug application with the FDA in the latter half of 1994.
 Approximately 100,000 people in the United States suffer from congenital ichthyosis, a rare, disfiguring skin disorder characterized by dry, thickened, scaling skin. No prescription drug is approved currently to treat this disease.
 "Cellegy is encouraged by early trials with monolaurin. Upon approval, we believe it will be a very powerful tool for the physician to use with patients suffering from this seriously disfiguring disease," said Gerald Simmons, the company's president and chief executive officer.
 Cellegy embraces a unique scientific approach to treating ichthyosis and other skin diseases based on its understanding that the stratum corneum (or top layer of skin) is active metabolically and possesses the ability to stimulate the release of biological response modifiers. Cellegy believes it is the first company to focus on the role the epidermis plays in regulating processes that create the disease.
 Cellegy Pharmaceuticals Inc. is a privately held biopharmaceutical company developing novel dermatological products to treat and prevent skin disorders and chronic skin diseases, minimize the effects of aging and deliver drugs.
 -0- 5/13/93
 /CONTACT: Gerald Simmons, president and CEO of Cellegy Pharmaceuticals, 415-382-6770; or Mark Brand or Kimberly Kraemer of Pondel Parsons & Wilkinson, 310-207-9300, for Cellegy Pharmaceuticals/


CO: Cellegy Pharmaceuticals Inc. ST: California IN: MTC SU:

MS-JL -- LA032 -- 8267 05/13/93 16:01 EDT
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Publication:PR Newswire
Date:May 13, 1993
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