Topica Pharmaceuticals Names Mark W. Davis Vice President of Clinical Development
PALO ALTO, Calif., Feb. 18 /PRNewswire/ -- TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced the appointment of Mark W. Davis as Vice President of Clinical Development. In this position, Mr. Davis will lead TOPICA's clinical development activities for luliconazole, its lead product candidate, for the treatment of onychomycosis (nail and nail bed fungal infections) and tinea pedis (athlete's foot). The company expects to initiate a Phase 1/2a trial of luliconazole in the U.S. for onychomycosis during the first quarter of 2010 and to advance luliconazole into a Phase 3 clinical development program for tinea pedis this year.
"Based on luliconazole's strong clinical profile, clinical development programs and previous approval in Japan, as well as TOPICA's robust Phase 2 study in tinea pedis, I believe the compound is poised for terrific success," said Mr. Davis. "I will be working diligently to advance all of the clinical development programs for luliconazole with a specific near-term focus on leading development efforts in onychomycosis where this anti-fungal therapy could become the first truly effective and safe topical therapy for patients."
Luliconazole is one of the most potent and broad-spectrum topical antifungal agents. TOPICA is developing luliconazole for onychomycosis, which affects approximately 35 million people in the U.S. Currently approved therapies for onychomycosis are either ineffective or are complicated by the potential of liver toxicity and require hepatic monitoring. In numerous rigorous preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration and therapeutically effectively levels in the nail bed. This preclinical profile suggests luliconazole has the potential to be the first highly effective and safe topical therapy for onychomycosis. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion.
TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole in the Americas and Europe.
TOPICA is a privately-held specialty pharmaceutical company focused on licensing, developing and commercializing topical prescription products to treat the needs of patients with serious nail and skin conditions. Taking advantage of its established trans-Pacific network of scientific and industry contacts, TOPICA has in-licensed its lead product candidate, luliconazole, a topical antifungal agent that is already on the market in Japan. TOPICA is developing luliconazole for the treatment of tinea pedis (athlete's foot) and onychomycosis (fungal infections of the nail). For more information, please visit http://www.topicapharma.com.
CONTACT: Joey Fleury of WCG, +1-415-946-1090, [email protected], for
Web site: http://www.topicapharma.com/