Profile: POZEN Inc. (POZN.O)

POZEN Inc. (POZEN), incorporated on September 25, 1996, is a pharmaceutical company focused on developing products, which can provide improved efficacy, safety or patient convenience in the treatment of acute and chronic pain, and pain related conditions. The Company has developed Treximet (formerly known as Trexima) in collaboration with GlaxoSmithKline (GSK). Treximet is the brand name for the product combining sumatriptan 85 milligram, formulated with RT Technology and naproxen sodium 500 milligram in a single tablet designed for the acute treatment of migraine. On April 15, 2008, the United States Food and Drug Administration (FDA) approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet incorporates the Company’s MT 400 technology, which refers to its combinations of a triptan (5-HT1B/1D agonist) and a non-steroidal, anti-inflammatory drug (NSAID).

MT 400/Treximet

On April 15, 2008, the FDA approved Treximet for the acute treatment of migraine attacks with or without aura in adults. As part of the new drug application (NDA) program for Treximet, the Company conducted five Phase I trials, two Phase III pivotal trials, and one 12-month open label safety trial using a formulation of Treximet developed by GSK. The Phase III pivotal trials, including the endpoints required to evaluate Treximet, were designed to demonstrate superiority to placebo for relief of pain and the associated symptoms of migraine (nausea, photophobia and phonophobia) at two hours. Additionally, the program was designed to demonstrate that each component makes a contribution to the efficacy of Treximet.

PN Program

Under POZEN’s PN program, the Company has completed formulation development and clinical studies for several combinations of a proton pump inhibitor (PPI) and NSAIDs in a single tablet intended to provide effective management of pain and inflammation associated with chronic conditions, such as osteoarthritis, and intended to have fewer gastrointestinal complications compared to a NSAID taken alone in patients at risk for developing NSAID associated gastric ulcers. The Company initially conducted studies with two PN product formulations in this program: PN 100, a combination of the PPI lansoprazole and the NSAID naproxen, and PN 200, a combination of the PPI omeprazole and naproxen. Under the agreement with AstraZeneca, the Company and AstraZeneca are co-developing, and AstraZeneca will commercialize, fixed dose combinations of the PPI esomeprazole magnesium with the NSAID naproxen in a single tablet.

PA Program

As part of the Company’s PA program, it is exploring the development of a combination of a PPI and aspirin in a single tablet. Similar to the PN program, the Company’s PA product candidate is intended to induce fewer gastrointestinal complications compared to an aspirin taken alone in patients at risk for developing aspirin associated gastric ulcers. POZEN’s PA product candidates are covered under the same patent as PN. The Company’s initial PA product candidate, PA32540, is in early-stage clinical development. The Company completed a Phase I proof of concept study in Canada of a formulation of PA containing 325 milligram of aspirin and 20 milligram of omeprezole (PA32520) during the year ended December 31, 2007. In June 2008, the Company filed an service provider application (SPA) with the FDA for its pivotal Phase III trials for PA32540, the primary endpoint for which is the reduction in endoscopic gastric ulcers. In February 2009, the Company received written confirmation from FDA that endoscopic gastric ulcer incidence was an acceptable endpoint for the Phase III clinical studies. It is also conducting both formulation development and early stage clinical studies with other PA product candidates for indications in addition to cardiovascular protection.