Project name: luliconazole
Disease: Fungal infections
Peak sales estimate: Not available
Approved: Nov. 15
Companies: Valeant and Topica Pharmaceuticals
The FDA approved Valeant's ($VRX) 1% luliconazole topical cream Luzu late in 2013 for the treatment of fungal infections such as athlete's foot, jock itch and ringworm. For the latter two conditions, it is the first topical drug to work in one week.
Originally developed by Palo Alto-based Topica Pharmaceuticals, Medicis grabbed the license to luliconazole in 2010. And when Valeant bought out Medicis late in 2012 for $2.6 billion, the treatment came along with it.
Fungal infections are caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, Valeant wrote in a release. And luliconazole is considered the most powerful antifungal molecule, many times more potent than other approved treatments. The agent, which has been approved in Japan since 2005, is designed to penetrate nail beds to combat the fungus with limited side effects.
At the time of the approval in November, Luzu had undergone three pivotal trials: two for tinea pedis (athlete's foot) and one for tinea cruris (jock itch) in 679 patients overall. Luzu completely cleared tinea pedis in 26% of subjects after four weeks in the first study and 14% of subjects in the second study, according to a release from Valeant. And the cream cleared tinea cruris in 21% of patients for three weeks post-treatment.
"We are pleased to receive FDA approval for Luzu earlier than expected," Valeant CEO J. Michael Pearson said in a statement at the time. "This is the first safe and effective product indicated for daily use over a one week period. This will be a welcome alternative to current options that require two weeks of treatment, and we believe Luzu will position us well to address this growing unmet need."
And Topica is at it again with another product in development, this time with an even higher concentration of the active ingredient. According to the company, luliconazole had previously only been used in low concentrations because of its low water solubility. In the winter of 2008, the company began looking into increasing that concentration and by the next year found that luliconazole in concentrations as high as 12.5% were well-tolerated in animal models.
After successful early-stage clinical trials, Third Rock Ventures, Prospect Venture Partners and Yasuda Enterprise Development put together a $27 million round in 2011 for the stronger 10% luliconazole solution. Topica used the funds to begin a Phase IIb/III study, the results of which are expected in the fall of 2014. -- Michael Gibney (email | Twitter)
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