Pozen, Inc.'s PA32540 Provides Faster Gastric Acid Reduction Than Enteric-Coated Omeprazole (40 mg)
“In this study, the mean time to a gastric pH of greater than 4.0 was faster with PA32540 than with 40 mg of delayed-release, enteric-coated omeprazole,” said Philip B. Miner, Jr., M.D., President and Medical Director of the Oklahoma Foundation for Digestive Research and co-author of the study. “In addition, the 24-hour pH control achieved with the immediate release form of omeprazole in PA32540 should be sufficient for control of gastric acidity in patients taking chronic aspirin therapy for secondary cardiovascular prevention.”
About Study 112
Study 112 is a Phase 1, single-center, open-label, randomized, two-way crossover study that examined 26 healthy male and female volunteers who were H. pylori negative. The study rationale was to gain an understanding of the anti-secretory and gastrointestinal (GI) therapeutic effect of the immediate-release omeprazole in PA32540. Subjects received either PA32540 once daily for seven days or enteric-coated aspirin (325 mg) plus enteric-coated omeprazole (40 mg) administered concomitantly once daily for seven days. After at least a seven-day washout, subjects were crossed over to the alternate treatment. Gastric pH and pharmacokinetics were measured over 24 hours on day seven of each treatment period.
Key Findings
• Mean time to first gastric pH >4 was significantly faster with PA32540 compared to the enteric-coated aspirin + enteric-coated omeprazole group (PA32540: 17 minutes; enteric-coated aspirin + enteric-coated omeprazole: 36 minutes; p=0.011).
• The percent time gastric pH >4 was 50.6 percent for PA32540 and 57.6 percent for enteric-coated aspirin + enteric-coated omeprazole group (p=0.004).
• The relative bioavailability of omeprazole following seven daily doses with PA32540 was 43 percent lower than that from enteric-coated omeprazole 40 mg.
“In patients who require aspirin therapy and are at risk for UGI events, PA32540 could provide a consistent and coordinated therapeutic approach to cardio protection and reduced risk of UGI injury,” said John G. Fort, M.D., Chief Medical Officer of POZEN and co-author of the study. “These Phase 1 study findings support the coordinated-release design of PA32540, with the omeprazole in the outer layer of the tablet released first followed by aspirin. The Phase 3 top-line results of PA32540 support the gastro protective effects of PA32540.”
About PA
POZEN is creating a portfolio of integrated aspirin therapies – the PA 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 candidate is PA32540. It is a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor, 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 in patients at risk for aspirin-induced ulcers.
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 U.S. Food and Drug Administration (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 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 March 31, 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.
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