Press Releases

Press Release List

FOR IMMEDIATE RELEASE

ProEthic Pharmaceuticals Announces Filing Of New Drug Application For Migraine Product Candidate

- Filing Based On 700-Patient Trial -

MONTGOMERY, AL, July 2, 2007 – ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses, and markets niche prescription products, today announced that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PRO-513, its lead product candidate for the treatment of migraine headaches. The basis for the NDA is positive outcomes from two randomized, well-controlled Phase III clinical trials in migraine sufferers.

Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, “The filing of an NDA for PRO-513 represents an important milestone for ProEthic, and our drug development team deserves the highest of praise for executing the filing in such an accelerated fashion. Our team successfully advanced PRO-513 from an Investigational New Drug to an NDA filing in approximately 18 months, an impressive achievement for an organization of any size. If approved, we believe PRO-513 could meet the recognized and growing demand by patients and physicians alike for new options to treat migraines. We look forward to working with the FDA during the registration process and remain committed to advancing the standard of care for the 30 million migraine sufferers in the U.S.”

In January 2007, ProEthic announced that all co-primary endpoints of the U.S. Phase III IMPACT trial for PRO-513 were successfully achieved. These endpoints included pain relief and the symptoms associated with migraine, including photophobia (sensitivity to light), phonophobia (sensitivity to sound) and nausea. PRO-513, a proprietary formulation of diclofenac potassium powder for oral solution, achieved statistical superiority to placebo in pain relief and nausea, photophobia and phonophobia at two hours for all conditions. In addition, results demonstrated that PRO-513 began to relieve the pain of migraine for patients within 30 minutes and that its benefits persisted up to 24 hours. PRO-513 was well tolerated in the eight month, randomized, double-blind, placebo-controlled trial.

Technology Platform

PRO-513 utilizes ProEthic’s patented Dynamic Buffering Technology (DBT), which enhances the absorption of its active ingredient, diclofenac potassium. By utilizing 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 to currently marketed reference drug, Cataflam^®.

About Migraines

Migraine headaches affect an estimated 30 million people in the United States and disproportionately affect women 3 to 1. According to a recent peer-reviewed publication authored by leading migraine researchers, more than 70 percent of patients indicated that they were less than completely satisfied with their current treatment. Over 85 percent complained that pain relief took too long and 25 percent decided to stop seeking treatment all together.

PRO-513 Development History

In 2005, ProEthic obtained exclusive U.S. and Canadian marketing rights for PRO-513 from APR, Applied Pharma Research, a Swiss drug delivery and drug development company. The product candidate is currently marketed by Novartis Pharma AG, under the trademarks Voltfast^® or Catafast^® in Switzerland, Italy, Egypt and Portugal. Novartis has also recently received marketing approval in a dozen additional countries outside of North America and expects to receive over two dozen additional approvals during 2007.

About ProEthic Pharmaceuticals, Inc.

ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. ProEthic also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC, a wholly owned subsidiary. For more information, please visit the ProEthic website at: www.proethic.com.