Penederm Announces New Drug Applications Accepted for Filing in U.S. and Canada.FOSTER CITY, Calif.--(BUSINESS WIRE)--June 6, 1995--Penederm 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 :DERM n. 1. The integument of animal; the skin. 2. (Anat.) See Dermis. ) today announced that new drug applications for a topical formulation containing Penederm's proprietary antifungal agent, KP363, have been accepted for filing by both the U.S. Food and Drug Administration and the Canadian Health Authority Health Protection Branch. Both applications are seeking approval to market KP363 for topical treatment of tinea pedis tinea ped·is n. See athlete's foot. Tinea pedis Fungal infection of the feet of the skin characterized by dry, scaly lesions. (athlete's foot athlete's foot: see ringworm. athlete's foot Form of ringworm that affects the feet. In the inflammatory type, the infection may lie inactive much of the time, with occasional acute episodes in which blisters develop, mostly between the toes. ). Later this year the company expects to submit two additional filings for KP363 in the United States and Canada for topical treatment of two other types of skin fungal disorders, tinea corporis tinea cor·po·ris n. A fungal infection of the body, characterized by a scaling macular eruption that frequently forms annular lesions on nonhairy parts of the body. and tinea cruris tinea cru·ris n. A fungal infection of the skin of the groin, occurring especially in males. Also called eczema marginatum, jock itch. tinea cruris Jock itch, see there . "KP363 has an excellent safety profile and has demonstrated high cure rates in clinical trials treating athlete's foot," said Penederm President and Chief Executive Officer, Lloyd Malchow. "This compound is already a successful topical antifungal prescription treatment in Japan that has generated sales of more than US$50 million in only its second full year after being approved. "The clinical results from the tinea pedis Phase III pivotal trials met or exceeded our expectations in all respects. Based upon these results, we are planning to conduct claim-support clinical studies this year which we believe will help us and our co-promotion partner, Schering-Plough HealthCare Products, differentiate the product in the market as a more effective topical treatment for certain fungal disorders," continued Malchow. Penederm is developing a variety of products for the treatment of dermatologic disorders based on its unique topical delivery technology. CONTACT: Penederm Inc. Edgar A. Luce, 415/358-0100 |
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