This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study. The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year. Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk ...

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 ...

Highlights include Pozen, Inc. (POZN), GlaxoSmithKline plc (GSK) and AstraZeneca plc (AZN).Pozen, Inc. (POZN) reported financial results for the first quarter 2009 on April 30, 2009. Total revenues for the first quarter were $8.8 million, an increase of 12% from the first quarter in 2008 and slightly ahead of our forecasts. Revenues consisted of $4.1 million in licensing revenue and $4.7 of development revenues.  Included in this figures is approximately $1.0 million in royalty on sales of Treximet $20.3 million.Net loss for the quarter totaled $3.5 million, or $0.12 per share, slightly worse than our $2.8 million forecast. Operating expenses were slightly higher than expected during the quarter. Management is incurring legal fees associated with the patent litigation lawsuit against Par for the paragraph IV challenge to Treximet. Management exited the first quarter 2009 with $52.3 million in cash and investment....