POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced the presentation of Phase 1 data, at the European Society of Cardiologists 2012 Congress, from a study of PA32540, a novel coordinated-delivery tablet of enteric-coated (EC) aspirin (325 mg) and immediate-release (IR) omeprazole (40 mg). The data from the Co-Rx Study (pronounced “Co-Rex”) suggest that PA32540 given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in greater antiplatelet effects than synchronously administered EC aspirin (81 mg), clopidogrel (75 mg), and EC omeprazole (46.5% versus 39.9%, respectively, at day 7: 95% confidence interval of the difference [2.57, 11.91]; p=0.004), in healthy volunteers. These data were further presented at the European Society of Cardiologists 2012 Congress in Munich, Germany on August 26, 2012. “The results of the Co-Rx study provide important insights into the interaction between omeprazole and clopidogrel," said Paul Gurbel, M.D., Director of the Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore, who is a lead investigator for the study and an international authority on the pharmacodynamic effects of clopidogrel, stated that, "Although the clinical significance of these results is presently unknown, treatment with PA32540 may be a promising option for the secondary prevention of heart attacks and strokes in cardiovascular patients who require prolonged aspirin and clopidogrel therapy but are at risk for gastric ulcers and bleeding.” PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor (PPI), layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. This investigational product is part of POZEN’s pipeline of integrated aspirin therapies, called the PA product portfolio. Separately, POZEN is pleased to announce the acceptance of abstracts with regard to its clinical program for PA32540 at both the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting, as well as at The American Heart Association (AHA) 2012 Scientific Sessions.
Additionally, POZEN provided an update on its PA program and the results of its Type A meeting with the FDA last week, wherein the Company indicated that it is currently anticipating an NDA submission in the first half of 2013.About the Co-Rx Study The Co-Rx study was a Phase 1, randomized, open-label, two-arm crossover study in which 30 healthy subjects were treated with one of the following: A) PA32540 in the morning plus Plavix ®* (clopidogrel) (300 mg) over 10 hours later on day 1, and PA32540 in the morning plus clopidogrel (75 mg) 10 hours later on days two through seven; B) enteric-coated aspirin (81 mg) plus clopidogrel (300 mg) plus Prilosec ®* (EC omeprazole) (40 mg) all in the morning on day 1 followed by enteric-coated aspirin (81 mg) plus clopidogrel (75 mg) plus EC omeprazole (40 mg) all in the morning on days two through seven. Subjects were first randomized to treatment A or treatment B and then crossed over to the alternate treatment. Each treatment was separated by a 14 day washout period. The primary objective of the study was to assess the effects of PA32540 and EC omeprazole (40 mg) on clopidogrel activity as measured by ex-vivo platelet aggregation using 20 uM adenosine diphosphate (ADP), a commonly used platelet assay of clopidogrel effect. The primary endpoint was the percent inhibition of platelet aggregation (IPA) after morning dosing on day seven of each period. In the study, PA32540 in the morning, plus clopidogrel 10 hours later, resulted in a significantly greater IPA than enteric-coated aspirin (81 mg) plus EC omeprazole (40 mg) plus clopidogrel all dosed in the morning. * Plavix ® is a registered trademark of Sanofi Aventis Corporation; Prilosec ® is a registered trademark of the AstraZeneca AB group of companies. About PA POZEN is creating a portfolio of integrated aspirin therapies - the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and an indication will be sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.About Antiplatelet Therapy Aspirin has become the standard of care for the reduction of an individual’s risk of a second heart attack. Clinical studies have found that a daily aspirin regimen for people who have experienced a previous heart attack reduces the risk of a second heart attack by about one-third. Clopidogrel and aspirin are currently co-prescribed in some cardiovascular patients; however, the use of clopidogrel plus aspirin increases the risk of gastrointestinal (GI) bleeding in certain patients. These at-risk patients may benefit from the use of gastro-protective agents such as proton pump inhibitors (PPIs), including omeprazole. Recently, the U.S. Food and Drug Administration (FDA) modified the clopidogrel and omeprazole labels to include warnings against co-prescribing omeprazole and clopidogrel, based on ex-vivo platelet aggregation studies. About POZEN POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage. POZEN is currently seeking strategic partners to help maximize the opportunity for its portfolio assets. The Company's common stock is traded under the symbol “POZN” on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to license our PA product candidates on terms and timing acceptable to us, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca for the sales and marketing of VIMOVO™; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended June 30, 2012. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.