PALO ALTO, Calif., Sept. 21 /PRNewswire/ -- TOPICA Pharmaceuticals, Inc. a privately-held biotechnology company, today announced that it has 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. By agreement, additional terms of the deal were not disclosed.
In conjunction with the sublicensing agreement, TOPICA Pharmaceuticals will now focus on developing luliconazole exclusively for the treatment of onychomycosis. In February of 2010 the company's IND for onychomycosis was opened, paving the way for human clinical trials to begin later in 2010.
"We are looking forward to the initiation of luliconazole's clinical development program this fall and validating the molecule's promising preclinical profile in onychomycosis. If the molecule's preclinical profile is validated, luliconazole has the potential to be the first truly effective, safe and convenient topical therapy for onychomycosis; providing physicians and patients with a much needed alternative to currently available oral anti-fungal therapies that have risk of serious adverse events," said Greg Vontz, president & CEO of TOPICA Pharmaceuticals.
"This is a unique and well aligned transaction that will help to maximize the future potential of the molecule by partnering luliconazole with a well resourced partner and then advancing the molecule in a dedicated effort focused on resolving a long-standing medical need by providing an effective and safe topical therapy for onychomycosis," said Alex Barkas, TOPICA board member and managing director of Prospect Venture Partners. "We are pleased with the arrangement and the shareholder value we believe will result." TOPICA's existing investors will lead an additional financing for the onychomycosis company.
Luliconazole is one of the most potent and broad-spectrum topical antifungal agents. Going forward TOPICA Pharmaceuticals will be developing luliconazole for onychomycosis, which affects approximately 35 million people in the U.S. Currently approved therapies for onychomycosis are either marginally effective 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 effective 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 has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole for onychomycosis in the Americas and Europe.
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. 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 has been developing luliconazole for the treatment of tinea pedis (athlete's foot) which will now be developed by an undisclosed partner pursuant to a sublicense agreement. Going forward, TOPICA will be focused on onychomycosis (fungal infections of the nail). For more information, please visit http://www.topicapharma.com.
|SOURCE TOPICA Pharmaceuticals, Inc.|
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