Pozen and GlaxoSmithKline announced the start of the Phase III program for Trexima. Trexima is the proposed brand name for the combination of sumatriptan (5-HT1B/1D agonist) and naproxen sodium in a single tablet.

The Phase III program will begin immediately. Pozen will conduct two Phase III pivotal trials, designed to determine the effectiveness and safety of Trexima for the acute treatment of migraine. In addition, Pozen will conduct a long-term, open label safety study.

"Moving into Phase III is a major step in the development of this important new medicine," said Stan Hull, GSK senior vice president, US Pharmaceuticals. "GSK has long been a leader in discovering and developing migraine treatments, and we are pleased to be working with Pozen to move Trexima into the final stage of development."

"We look forward to a rapid development program for Trexima, with a targeted NDA filing in the second half of 2005. We believe Trexima, which uses Pozen's MT 400 technology, has the potential to be one of the best treatments for migraine," said John R. Plachetka, Pozen 's chairman, president and chief executive officer.

Pozen and GSK signed an agreement in June 2003 for the development and commercialization of proprietary combinations of a triptan (5-HT1B/1D agonist) and a non-steroidal anti-inflammatory drug (NSAID), including the combination that makes up Trexima. Under the agreement, Pozen is responsible for the pre-clinical, clinical, and regulatory development activities for Trexima, while GSK is responsible for formulation development, manufacturing and commercialization.

The commencement of the Phase III program will trigger a $15 million development milestone payment to Pozen by GSK. The companies expect the New Drug Application (NDA) for Trexima to be filed in the second half of 2005.