PALO ALTO, CA--(Marketwire - March 28, 2011) - TOPICA Pharmaceuticals, Inc., a privately-held biotechnology company, today announced the election of David E. Cohen, M.D., M.P.H., to the company’s Board of Directors. Dr. Cohen is a renowned expert in dermatology with more than 20 years of clinical experience.
“Dr. Cohen’s addition to the board comes at an important juncture as TOPICA moves luliconazole from Phase 1/2a into a Phase 2 trial,” said G. Kirk Raab, chairman of TOPICA’s Board of Directors. “Based on my experience serving with him on the board of Connetics Corporation, I am certain that he will bring valuable clinical insights that will assist in the development of one of the most promising molecules to be studied in onychomycosis.”
Results of the Phase 1/2a luliconazole trial evaluating the safety, tolerability, and pharmacokinetics of a 10 percent concentration of luliconazole solution after maximal use topical application in adults with moderate-to-severe distal subungual onychomycosis of the toenails are expected in the second quarter of 2011. Following results of this trial, TOPICA will enter into a Phase 2 trial. The Phase 2 trial will enroll patients with mild-to-moderate distal subungual onychomycosis and will evaluate the impact of two different dosing regimens of luliconazole on clear nail growth and fungal eradication.
“Being able to work with Kirk Raab and TOPICA’s CEO, Greg Vontz, again, especially during a transformative point in the company’s history, is exciting,” said Dr. Cohen(*). “I’m encouraged by luliconazole’s preclinical results and believe the molecule provides TOPICA with the opportunity to bring the first highly effective and safe topical therapy to market for the 35 million Americans that suffer from onychomycosis.”
Dr. Cohen is currently Associate Professor of Dermatology, vice chairman of Clinical Affairs, and Director, Occupational and Environmental Dermatology and chief of Allergy and Contact Dermatitis in the Department of Dermatology at the New York University School of Medicine. He is also lecturer of Environmental Sciences in the Columbia University School of Public Health.
He serves as a clinical consultant to numerous companies and is a former member of the Board of Directors of Connetics Corporation, a dermatology company acquired by Stiefel Laboratories. Dr. Cohen has published widely in the field of clinical dermatology and is a frequent lecturer at national and international meetings. He was recently Program Chairman for the 130th Annual Meeting of the American Dermatological Association. Dr. Cohen is a member of the editorial board of Journal of Drugs in Dermatology and the editorial advisory boards of Dermatitis and Skin and Allergy News.
A Summa Cum Laude graduate of City University of New York, Dr. Cohen received his medical degree from the State University of New York at Stony Brook School of Medicine in Stony Brook, New York, and earned a Master of Public Health from the Columbia University School of Public Health in New York. He has been honored by election to Alpha Omega Alpha, the medical honor society, and has received the Merck Sharp Dohme Award for Academic Excellence.
About Luliconazole
Luliconazole is one of the most potent and broad-spectrum topical antifungal agents. In numerous, rigorous preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration and therapeutic levels sufficient for fungal eradication in the nail bed. This preclinical profile suggests that luliconazole has the potential to be an 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 for onychomycosis in the Americas and Europe.
Luliconazole was approved in Japan in 2005 for the treatment of tinea infections of the skin. To date more than 8 million patients have been treated with the product in Japan where luliconazole is one of the leading topical anti-fungal prescription products for tinea infections.
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately-held specialty pharmaceutical company focused on developing topical prescription products to treat the needs of patients with serious nail and skin conditions. In September 2010, Tinea Pharmaceuticals, formerly Topica Pharmaceuticals, Inc. announced that it had entered into a sublicense and purchase option agreement with an undisclosed partner to develop luliconazole exclusively for tinea infections of the skin in the Americas and Europe. Simultaneously, the current TOPICA was spun out of the former Topica. TOPICA is now focused on developing luliconazole for the treatment of onychomycosis (nail and nail bed fungal infections) and is exploring luliconazole’s potential for the treatment of mucosal candidiasis (fungal infections caused by yeast, including oral thrush and vaginitis). For more information, please visit http://www.topicapharma.com.
(*) Any views expressed herein by Dr. Cohen are his personal views and do not represent the views of NYU Langone Medical Center.
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