POZEN is developing a suite of proprietary product candidates, designated as its PN products platform, that combine an acid inhibitor, e.g., a proton pump inhibitor ("PPI"), with a non-steroidal anti-inflammatory drug (NSAID) in a single tablet. The products are intended to provide effective management of pain and inflammation with fewer gastrointestinal side effects and complications compared to an NSAID taken alone.

PN 400 is being developed for the relief of the signs and symptoms associated with conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated gastric ulcers. In the wake of cardiovascular safety concerns regarding the COX-2 selective NSAIDs, many physicians are now recommending traditional non-selective NSAIDs with gastroprotective co-therapy using acid-suppressive agents to prevent gastrointestinal complications. POZEN's PN 400 is designed to ensure adherence since the PPI is administered with every dose of NSAID.

The POZEN PN tablets are designed to provide immediate release of the PPI component in the stomach to enable local as well as systemic effects on the acid pumps that line the stomach lumen. The NSAID component contains a pH sensitive layer and is released only in an environment with decreased presence of acid.

POZEN has conducted formulation development and clinical studies to support two PN combinations, designated PN 100 (lansoprazole/naproxen) and PN 200 (omeprazole/naproxen) and has begun formulation development for a third combination, designated PA, comprising a PPI and aspirin.

In two 14-day proof-of-concept studies in human volunteers, both PN 100 and PN 200 were shown to be effective in preventing gastric mucosal injury when compared with enteric-coated ("EC") naproxen alone. As expected, subjects who were administered EC naproxen alone were shown to develop ulcers over the treatment period; in contrast, none of the volunteers who were administered either PN product candidate had gastric or duodenal ulcers at the end of the 14-day study period.

In April 2006, the company completed a Special Protocol Assessment (SPA) and reached agreement with the FDA on the design of its pivotal trials for the PN 200 product candidate.

In August 2006, POZEN announced that it signed an exclusive global collaboration agreement with AstraZeneca for the co-development and commercialization of a proprietary fixed dose combination of the PPI, esomeprazole magnesium, with the NSAID, naproxen, in a single tablet. 

The PA product candidate combines aspirin with a PPI for cardiovascular protection along with the potential reduction in the risk of colorectal cancer and adenomas.  Adenomas are precursors of most colorectal cancers and prevention of adenomas will most likely also prevent colorectal cancer, as reported in the New England Journal of Medicine in March 2003.  The PA product candidate is intended to provide fewer gastrointestinal side effects and complications compared to an NSAID or enteric coated aspirin taken alone. POZEN has completed a proof-of-concept study with its PA product candidate with positive results.

PA Proof of Concept Study Results

 

PA 32520 vs. 325mg EC Aspirin	PA 32520 vs. 81mg EC Aspirin
PA 32540 vs. 325mg EC Aspirin