ProEthic Pharmaceuticals Presents Positive Data for PRO-513 at American Headache Society Meeting.

- Data Demonstrates Efficacy, Tolerability, Rapid and Prolonged Response of Migraine Treatment Candidate -

MONTGOMERY, Ala. -- ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses, and markets niche prescription products,

today presented detailed Phase III study data for PRO-513, the Company's product candidate for the treatment of migraine headaches. The results were presented in two poster presentations at the American Headache Society's 49th Annual Scientific Meeting in Chicago by Richard B. Lipton, MD, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Director of the Montefiore Headache Center. The findings showed that PRO-513 relieved the pain of migraine for patients within 30 minutes, reduced the associated symptoms of the migraine attack and that its benefits persisted up to 24 hours.

The first poster presentation provided efficacy and tolerability results from a Phase III clinical study for PRO-513, a randomized, double-blind, placebo-controlled trial that enrolled 690 adult patients.

The two-hour pain free response among patients, the primary efficacy endpoint of the trial, was 25 percent in the PRO-513 arm of the trial versus 10 percent for the placebo arm (P < 0.001). In addition, the two-hour pain headache response for the PRO-513 arm of the trial was 65 percent, compared with 41 percent for the placebo group. Statistically significant differences in pain intensity difference (PID) scores emerged at 30 minutes (P=0.013) and the PID remained significant at P < 0.001 at each of the subsequent 10 time points measured.

The findings also demonstrated that the proportion of patients who were free of symptoms accompanying migraine was statistically significant for PRO-513 compared to placebo at two hours for nausea (P=0.002), photophobia, or sensitivity to light (P < 0.001) and phonophobia, or sensitivity to sound (P < 0.001).

The second poster presentation detailed positive secondary endpoint results from the Phase III trial, including results from the 24-hour sustained pain-free response and 24-hour sustained headache response.

In the trial, significantly more patients in the PRO-513 arm achieved a 24-hour sustained pain-free response, than in the placebo arm. Among patients who were pain free at two hours, almost 80% had persistent benefits without headache recurrence or need for rescue medication.. In addition, the number of patients in the PRO-513 arm who were able to perform all daily activities increased eleven-fold from baseline to two hours and over 18 times within 24 hours.