Phase II...On October 6, 2009 Topica announced the successful completion of its Phase II trial in tinea pedis. In the Phase II trial, a 14-day once daily dose of luliconazole was demonstrated to be as clinically successful as dosing the product once daily for 28 days. When luliconazole was compared to placebo in the Phase II trial, luliconazole was demonstrated to be significantly superior in clinical efficacy and achieving mycologic eradication. The finding that luliconazole can be effectively dosed for 14 days is an important outcome for tinea patients. Approved prescription tinea products in the US are currently prescribed for once or twice daily treatment for 28 days.

Phase III...Topica intends to initiate the Phase III program for tinea pedis in 2010 using the 14-day once daily dosing regimen for luliconazole. If successful in the Phase III program, luliconazole will be one of the first new topical anti-fungals to be approved since 2004, and the only prescription product with a once-daily 14-day dose, providing physicians and patients with an important new and convenient solution to tinea infections.

Luliconazole in onychomycosis...Topica has developed a very unique and cosmetically elegant luliconazole solution for the treatment of onychomycosis. In independent in vitro testing in a human toenail model, Topica’s solution was shown to achieve complete fungal eradication in the nail bed by day 21. The company plans to file an IND (Investigational New Drug Application) with the FDA in late 2009 and plans for clinical trials to begin in early 2010.

...and beyond...Luliconazole’s unique properties and proven safety and efficacy profile have potential benefits in numerous additional fungal infections, such as seborrheic dermatitis and tinea capitis. Topica scientists are working with our Scientific Advisory Board to develop additional clinical evaluations in all of these indications. Furthermore, the company’s unique in-licensing relationships with our trans-Pacific partners will provide a rich pipeline of other novel compounds for development and marketing in the Americas and Europe.

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