Profile: POZEN Inc (POZN.OQ)

POZN.OQ on NASDAQ Stock Exchange Global Select Market

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POZEN Inc. (POZEN), incorporated on September 25, 1996, is a pharmaceutical company focused on transforming medicine. The Company had developed Treximet 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. The Company has developed VIMOVO with AstraZeneca AB (AstraZeneca). VIMOVO is the brand name for a fixed dose combination of the proton pump inhibitor (PPI) esomeprazole magnesium with the non-steroidal anti-inflammatory drug (NSAID) naproxen in a single tablet. The Food and Drug Association (FDA) approved VIMOVO for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. Treximet incorporates its MT 400 technology, which refers to its combinations of a triptan (5-HT1B/1D agonist) and a non-steroidal anti-inflammatory drug. On November 23, 2011, the Company entered into a Purchase and Sale Agreement with CPPIB Credit Investments Inc (CII,), pursuant to which it sold, and CII purchased, its right to receive future royalty payments arising from United States sales of MT 400, including Treximet.

MT 400/Treximet

The FDA approved Treximet for the acute treatment of migraine attacks with or without aura in adults. The Company conducted five Phase I trials, two Phase 3 pivotal trials, and one 12-month open label safety trial using a formulation of Treximet developed by GSK. The Phase 3 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. In addition, the program was designed to demonstrate that each component makes a contribution to the efficacy of Treximet.

PN/VIMOVO Program

Under its PN program, the Company has completed formulation development and clinical studies for combinations of a PPI and a NSAID in a single tablet intended to provide management of pain and inflammation associated with chronic conditions, such as osteoarthritis, and focuses on having 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, prior to entering into its collaboration with AstraZeneca.

PA Program

As part of its PA program, the Company is exploring the development of a combination of a PPI and aspirin in a single tablet. Its PA product candidate focuses on inducing fewer gastrointestinal complications compared to an aspirin taken alone in patients at risk for developing aspirin associated gastric ulcers. Its PA product candidates are covered under the same patent as PN. Its initial PA product candidate, PA32540, is in clinical development. It completed a Phase I proof of concept study in Canada of an earlier formulation of PA containing 325 milligram of aspirin and 20 milligram of omeprazole (PA32520). The Company also completed a second proof of concept study with PA32520 as compared to 81 milligram of EC aspirin. The Company began two pivotal phase III and one long-term safety study for PA32540 for the cardiovascular indication.

Company Address

POZEN Inc

Suite 400, 1414 Raleigh Rd
CHAPEL HILL   NC   27517
P: +1919.9131030
F: +1919.9131039

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