Vimovo Demonstrates Benefit Over Naproxen Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers. The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN. The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ...

Today Pozen (POZN) announced the submission of the new drug application (NDA) to the U.S. FDA, seeking marketing approval for Vimovo (proposed trade name for PN-400) for the treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.

Vimovo is a combination of 500mg enteric coated naproxen and 20mg immediate release esomeprazole. In early December 2008, Pozen released positive top-line data from its 400-301/-302 phase III program testing PN-400 (20mg esomeprazole / 500mg naproxen) vs. 500mg enteric coated naproxen alone. Results show that 400 patients total in both trials taking PN-400 experienced statistically significant fewer number of confirmed gastric ulcers by endoscopy compared to 400 subjects receiving enteric coated naproxen during the six-month period.

Pozen expects to receive a milestone payment of $10 million when the NDA is formally accepted for review by the FDA. We

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