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.
"Mark Davis is a very experienced clinical development leader with a solid background in dermatology," said Greg Vontz, president and CEO of TOPICA. "Mark's understanding of the clinical development process, as well as his long-standing relationship with the FDA's Dermatology Division is vital to TOPICA's success and he will play a major role in our preparation for commercialization of luliconazole."
"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."
Mr. Davis has more than 27 years of experience in the biotechnology, pharmaceutical and medical device industry. Prior to joining TOPICA, he served in project leadership roles and as head of Clinical Operations at Onyx Pharmaceuticals developing oncology products. Prior to Onyx, he was Senior Director of Clinical Operations at Connetics Corporation, where he successfully led clinical programs for three dermatologic product approvals in the United States. Mr. Davis also spent more than 12 years in clinical development at Amgen. Mr. Davis earned his M.S. in biomedical engineering from the University of Utah and his B.S. in biomedical engineering from the University of California, San Diego.
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 is also developing luliconazole for the treatment of tinea pedis, the most common fungal infection of the skin, affecting about one in every 10 people. In the U.S. more than 22 million prescriptions are written annually for tinea infections. Currently approved products for the topical treatment of tinea pedis are only modestly effective, have a high reoccurrence rate and require a month of therapy. In 2009, TOPICA announced positive results from its Phase 2 clinical trial of luliconazole for tinea pedis. The results of TOPICA's Phase 2 trial demonstrated that luliconazole was substantially more effective than approved therapies and required half the treatment time. TOPICA expects to begin its pivotal Phase 3 trials in 2010 to support approval.
TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole in the Americas and Europe.
About TOPICA Pharmaceuticals
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.
SOURCE TOPICA Pharmaceuticals
|SOURCE TOPICA Pharmaceuticals|
Copyright©2010 PR Newswire.
All rights reserved