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.

VIMOVO™ 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 VIMOVO™ is designed to ensure adherence since the PPI is administered with every dose of NSAID.

The POZEN VIMOVO™ 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.

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 VIMOVO™ 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 Phase III pivotal trials for VIMOVO™ (naproxen/esomeprazole) were initiated in September 2007 and have been completed.  The New Drug Application (NDA) was submitted in June 2009.

On August 31, 2009, the FDA informed AZ and POZEN. that it had accepted the NDA for VIMOVOTM, submitted on June 30, 2009. AZ submitted a Marketing Authorization Application (MAA) to the European Union via the Decentralized Procedure for VIMOVO™ on October 16, 2009.