SOURCE: TOPICA Pharma

TOPICA Pharma

December 05, 2011 08:00 ET

TOPICA Names Dr. Amir Tavakkol Senior Vice President of Clinical Development and Operations

PALO ALTO, CA--(Marketwire - Dec 5, 2011) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced that Amir Tavakkol, Ph.D., has joined the company as senior vice president of clinical development and operations. With 20 years of experience in the pharmaceutical industry, consumer healthcare and academia, Dr. Tavakkol will be responsible for advancing the clinical development of luliconazole, TOPICA's broad-spectrum topical antifungal agent, for the treatment of onychomycosis, fungal infections of the nail.

"Dr. Tavakkol's considerable drug development skills and successes, particularly his clinical development expertise in onychomycosis, are an ideal fit for TOPICA. We are excited to have him join our team and are pleased that he shares our enthusiasm for luliconazole and its potential to be the first truly effective and safe topical therapy for onychomycosis," said Greg Vontz, president and chief executive officer of TOPICA. "We look forward to his leadership in taking luliconazole through our key Phase 2b/3 trial, a pivotal step in validating the molecule's considerable potential."

Dr. Tavakkol most recently served as senior director and project leader in the Infectious Diseases Franchise at Merck & Co, Inc., where he was the product development team leader for Merck's oral anti-fungal programs. Before Merck's acquisition of Schering-Plough, Dr. Tavakkol was senior director and head of Dermatology Global Clinical Research at Schering-Plough, where he led the clinical development of posaconazole oral suspension for onychomycosis through Phase 2. Prior to Schering-Plough, Dr. Tavakkol was the medical affairs medical director for Lamisil® (antifungal) and Famvir® (antiviral) products at Novartis. He led the onychomycosis trial IRON-CLAD, which evaluated the safety of Lamisil® in onychomycotic patients, including elderly on multiple medications, and the effect of debridement plus Lamisil® on clinical outcomes. Earlier in his career, Dr. Tavakkol led antioxidant skin clinical research at Colgate Palmolive and was a faculty member at the University of Michigan Dermatology Department.

Dr. Tavakkol has been awarded several patents and trademarks and is the author of more than 50 publications in leading medical and scientific journals. He earned a Ph.D. in bacteriology and virology from the University of Manchester, UK, and has a postgraduate diploma in infectious diseases. He spent a year of internship in infectious diseases at PHLS, Leeds Seacroft Hospital, UK, and holds a B.S. in medical technology.

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 of full thickness human toenails (infected and healthy) reaching concentrations well in excess of the MIC 90 concentrations needed to eradicate the dermatophytes that most commonly cause onychomycosis. This preclinical profile suggests that luliconazole has the potential to be an effective and safe topical therapy for onychomycosis.

TOPICA plans to initiate a robust Phase 2b/3 clinical trial of approximately 300 patients with mild-to-moderate distal subungual onychomycosis of the toenail in the first half of 2012. The trial will involve approximately 20 centers in the U.S. It will assess the safety and efficacy of the 10 percent luliconazole solution in two dosing regimens applied for 48 weeks and will evaluate the impact of luliconazole on clear nail growth and fungal eradication at week 52. The primary endpoint of the trial will be "complete cure at week 52," a combined endpoint of clinical assessment of a completely clear nail and a negative fungal assessment by KOH (potassium hydroxide staining) and mycologic culture. Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking U.S. Food and Drug Administration approval.

TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole for onychomycosis in the Americas and Europe. Luliconazole in 1 percent cream and solution formulations was approved in Japan in 2005 for the treatment of tinea infections of the skin. To date, more than 10 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 Onycomycosis
More than 35 million Americans are estimated to suffer from onychomycosis, for which treatment options are limited. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion.

About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately held clinical research stage pharmaceutical company focused on developing luliconazole for the treatment of onychomycosis, fungal infections of the nail. In a Phase 1/2a clinical trial completed in 2011, TOPICA's proprietary 10 percent luliconazole solution was shown to have the ability to rapidly cross the nail plate and to be well tolerated by patients. The company is now focused on conducting a robust dose finding and proof of efficacy study with luliconazole in onychomycosis starting in mid-2012 with the goal of making luliconazole the first highly effective and safe topical therapy for the treatment of onychomycosis. For more information, please visit http://www.topicapharma.com.

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