POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to their customers.

Since its founding in 1996, POZEN has had a long, successful history of creating novel pharmacologic agents by combining existing drug therapies that result in superior patient outcomes, primarily for pain and pain-related conditions. This approach allows for a potentially higher success rate than NCE (new chemical entity) development.

POZEN pioneered the concept of a strategic outsource drug development company whose products would be marketed by strong commercial partners. This model has allowed POZEN to commit nearly all its resources to developing new products while avoiding the high costs associated with basic research, manufacturing, and marketing. By virtue of the initial upfront payments, milestone payments, and ongoing royalties from partnerships, POZEN has been totally self-funding since the 2000 Initial Public Offering (IPO).

POZEN is evolving from solely a product development company into a company that retains control of the commercialization of its pipeline going forward. This allows us to utilize revenues from licensing and development agreements to fund the development and commercialization our own pipeline, beginning with our next generation of product candidates- the PA aspirin franchise. We believe this model will allow us to increase POZEN's future potential revenues and profits and deliver better shareholder value.

POZEN intends to stay at the leading edge of change in the pharmaceutical industry. To accomplish this, we are building a 21st century pharmaceutical company – evidence-based, patient-centered, efficient and cost-effective. Instead of trying to emulate the "old school" approach now being abandoned by the major pharmaceutical companies, POZEN is taking a fresh approach to sales, marketing and medical education. This will allow us to deliver high-quality, evidence-based, and affordable products to our customers while also providing shareholders with an appropriate return on investment.

Licensed Products

Treximet^®
In April 2008, the Food and Drug Administration (FDA) approved Treximet^® (sumatriptan and naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults.  The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™.  This migraine medication works in two ways - the triptan component shrinks the swollen blood vessels in the head, which correlates to the relief of migraine pain, while the NSAID component inhibits the enzyme responsible for the production of prostaglandins, which are the mediators of pain and inflammation.  As a result of this dual mechanism of action, Treximet^® has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components.  The FDA approval was an important milestone for the partnership between the two companies.  The partnership began in 2003, when GSK signed an agreement with POZEN for the development and commercialization of this product.

In May 2008, POZEN officially transferred the Investigational New Drug (IND) and New Drug Application (NDA) for the product to GSK.  GSK is responsible for the commercialization of Treximet^® in the US.  POZEN receives royalties based on net sales of Treximet^® from GSK and, beginning January 1, 2010, that royalty rate will more than triple to 18 percent.

POZEN also has ex-US rights to develop and market a lower dose sumatriptan and naproxen combination.

VIMOVO™
Another major licensed product program is for VIMOVO™, an investigational product under development by AstraZeneca (AZ) and POZEN that combines enteric coated naproxen (an NSAID) with immediate-release esomeprazole, a proton pump inhibitor (PPI).  VIMOVO™ is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers.  On August 31, 2009, the FDA informed AZ and POZEN. that it had accepted the NDA for VIMOVO™, 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.

Product Pipeline

POZEN is creating a “safer aspirin” franchise of product candidates – the PA product platform.  The PA family of product candidates is intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.  

The first candidate is PA32540.  It is a coordinated-delivery tablet combining immediate-release omeprazole, a PPI, layered around pH-sensitive aspirin.  This novel, patented product is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease.  POZEN has started enrolling patients in two pivotal Phase 3 trials and a long-term, open-label safety trial for secondary cardiovascular disease (CVD) prevention in October 2009.

Additionally, POZEN is considering investigating PA32540 for the secondary prevention of colorectal neoplasias (secondary recurrence of colonic polyps).  PA32540 may improve the risk/benefit of aspirin therapy in this population and could provide an important agent for the chemoprevention of colon neoplasias.