PROETHIC ANNOUNCES RESULTS FROM MIGRAINE TRIAL

ProEthic Pharmaceuticals has announced successful Phase III clinical trial results for PRO-513, its product candidate for the treatment of migraine headaches. These findings will serve as the basis for a new drug application (NDA) the company expects to file with the FDA in early 2007.

In an eight-month randomized, double-blind, placebo-controlled trial that enrolled 690 adult patients, PRO-513, a proprietary formulation of diclofenac potassium powder for oral solution, reached all of its primary endpoints by achieving statistical superiority to placebo in pain relief and the associated symptoms of nausea, photophobia or sensitivity to light, and phonophobia or sensitivity to sound at two hours for all conditions. PRO-513 was well tolerated in the study, with no safety issues reported.

Secondary endpoints from the trial confirmed PRO-513's ability to offer rapid and sustained migraine pain relief. Approximately 65 percent of patients on PRO-513 had an improvement in headache response scores within two hours compared with only 40 percent of placebo patients. Statistically significant pain relief was achieved within 30 minutes of treatment. PR0-513 also achieved statistical superiority versus placebo in the percent of patients that remained pain free for the entire 24-hour observation period.

PRO-513 uses ProEthic's patented Dynamic Buffering Technology (DBT), which enhances the absorption of its active ingredient, diclofenac potassium. By using potassium bicarbonate as a localized buffer, DBT enables diclofenac to enter the bloodstream more quickly, resulting in a faster rate of drug absorption and increased peak plasma concentrations while not increasing the total amount of drug exposure for the patient compared with the currently marketed reference drug, Cataflam.