TOPICA Begins Phase 2 Clinical Trial of Potent Antifungal, Luliconazole, in Athlete's...

TOPICA Begins Phase 2 Clinical Trial of Potent Antifungal, Luliconazole, in
Athlete's Foot

PALO ALTO, Calif., April 22 /PRNewswire/ -- TOPICA Pharmaceuticals today
announced the enrollment of patients in a Phase 2 clinical trial evaluating
luliconazole for the treatment of tinea pedis (athlete's foot). Luliconazole,
the company's lead product candidate, is the one of the most potent and broad
spectrum molecules in the imidiazole class of antifungal agents, giving it the
potential to provide physicians and patients with a needed topical solution to
a variety of skin and nail fungal infections.

"The initiation of this trial represents a significant milestone for TOPICA as
we begin our U.S. clinical development program of this promising drug
candidate, which already has been proven in millions of patients in Japan,"
said Greg Vontz, president and chief executive officer of TOPICA. "We expect
to complete this trial by the end of this year, potentially enabling us to
initiate our pivotal Phase 3 clinical trial in 2010."

Phase 3 data from clinical studies conducted in Japan demonstrated that
luliconazole successfully treated tinea pedis in half the time of commonly
prescribed products. Since the 2005 approval of luliconazole in Japan for the
treatment of tinea infections, more than 4 million patients have been safely
treated with luliconazole. TOPICA has an exclusive license to develop and
market luliconazole in the Americas and Europe.

The Phase 2, multi-center, randomized, double blind, trial is evaluating the
safety and optimal duration of 1 percent luliconazole cream administered once
daily for 14 or 28 days in patients with tinea pedis. The primary efficacy
endpoint is to achieve complete clearance of the infection at two weeks post
treatment. Currently in the U.S. available prescription medications generally
require treatment once or twice a day for up to four weeks to achieve this
result. The company expects to enroll approximately 120 patients in the trial,
which is being conducted at 5 clinical trial sites in the United States. For
more details on the trial go to http://www.topicapharma.com and clink on the
link for the trials posting on www.clinicaltrials.gov.

In addition, the company is developing luliconazole for onychomycosis (nail
and nail bed fungal infections) and plans to move ahead with clinical
development of onychomycosis shortly. The company's successful preclinical
studies of luliconazole demonstrate that it has the ability to easily
penetrate the toenail achieving rapid fungal eradication in the nail bed, as
measured by MedPharm's in vitro ChubTur infected nail model. Luliconazole is
also unique in that the molecule doesn't require devices, procedures or
"delivery enhancement" to cross the nail. Onychomycosis affects approximately
35 million people in the U.S. Of those affected, it is estimated that 47
percent are not receiving treatment. The disease can cause extreme
disfigurement of nails and can often result in pain. The potential annual
U.S. market for onychomycosis treatment is estimated at approximately $3.0
billion.

About Tinea Pedis
Tinea pedis (athlete's foot) is the most common fungal infection of the skin,
affecting about one in every 10 people at any given time. Patients with the
disease often experience itching and burning on the infected area. In severe
cases, the disease can cause cracking, pain and bleeding. In 2008, the U.S.
prescription market for tinea pedis was $385 million equating to approximately
22 million prescriptions. The topical prescription antifungal market has been
dominated in recent years by generics due to the fact that a new prescription
anti-fungal agent has been not been introduced into the market in over five
years.

About TOPICA Pharmaceuticals
TOPICA is a privately held, specialty pharmaceutical company, focused on
licensing, developing, and commercializing potent 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 is developing it for the treatment of tinea pedis (athlete's
foot) and onychomycosis (nail and nail bed fungal infections). For more
information, please visit http://www.topicapharma.com.

SOURCE TOPICA Pharmaceuticals

Daryl Messinger of WeissComm Partners, +1-415-946-1062,
dmessinger@wcpglobal.com