|POZENPA32540 Phase 1 Data Presented at The American Heart Association Scientific Sessions|
CHICAGO, Nov 14, 2010 (BUSINESS WIRE) --
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today the results of a Phase 1 study, which reported that PA32540, a novel coordinated-delivery tablet of enteric-coated aspirin (325 mg) and immediate-release omeprazole (40 mg), showed no ex vivo drug-drug interaction with clopidogrel when administered 10 hours apart in healthy patients, based on the study's pre-specified analysis. The results from this investigation were presented today, Sunday, November 14, 2010, at the American Heart Association (AHA) Scientific Sessions in Chicago, Illinois (Poster Board 6004, Abstract #3120).
"The results of the SPACING study provide important insights into the interaction between immediate-release omeprazole and clopidogrel," said Paul Gurbel, M.D., Director of Cardiovascular Research at the Center for Thrombosis Research at Sinai Hospital of Baltimore, and lead investigator for the study. "Further investigation of PA32540 is warranted for patients who require dual antiplatelet therapy but are at risk for a gastric ulcers and bleeding."
PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a 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 portfolio of integrated aspirin therapies, called the PA product platform.
"This Phase 1 study may further support the promise of PA32540. The immediate-release omeprazole contained in PA32540 may offer a different clopidogrel-antiplatelet interaction profile for PA32540 as compared to enteric coated PPIs and clopidogrel," said John G. Fort, M.D., Chief Medical Officer of POZEN and co-investigator for the study. "At POZEN, we are looking forward to further investigating the potential of PA32540 for patients who may benefit from aspirin therapy but are at risk for gastric ulcers."
About the Study
The study is a Phase 1, randomized, open-label, single-center, three-arm crossover study in which 30 healthy subjects were treated with A) clopidogrel (300 mg) plus enteric-coated aspirin (325 mg) on day one, and clopidogrel (75 mg) plus enteric-coated aspirin (325 mg) on days two through seven; B) clopidogrel (300 mg) plus PA32540 on day one, and clopidogrel (75 mg) plus PA32540 on days two through seven; and C) PA32540 in the morning plus clopidogrel (300 mg) over 10 hours later on day one, and PA32540 in the morning plus clopidogrel (75 mg) 10 hours later 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 period was separated by a 14-day washout period. Following a second washout period, subjects were administered treatment C.
The primary endpoint was the percent inhibition of platelet aggregation (IPA) one hour after morning dosing on day seven of each period. The analysis was to demonstrate the non-inferiority of PA32540 plus clopidogrel compared to enteric-coated aspirin (325 mg) plus clopidogrel if the upper bound of a two-sided 95 percent confidence interval for treatment A-treatment B or treatment A-treatment C was less than or equal to the margin of 10 percent IPA.
In the study, when PA32540 and clopidogrel were taken together, the non-inferiority margin of 10 percent was exceeded. When PA32540 and clopidogrel were spaced by at least 10 hours apart, the non-inferiority margin was met. No serious adverse events were reported and no subject withdrew from the study due to adverse events. Adverse events between the treatments groups were similar.
About PA and PA32540
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 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 is being studied for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. POZEN has completed enrollment for the long-term safety study and continues enrollment on the two pivotal studies, targeting an NDA filing in 2012.
Additionally, POZEN is conducting exploratory work on integrated aspirin therapies for other pain and pain-related conditions.
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 a focus on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years - something almost no other small pharmaceutical company has done. Funded by these two milestone/royalty streams, POZEN is now creating a portfolio of cost-effective integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI toxicity. The lead candidate, PA32540, is being investigated for the secondary prevention of cardiovascular disease and has entered Phase 3 clinical trials. POZEN is retaining commercial control of the pipeline assets and will launch creatively using a new sales force model and digital communications. The Company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN". For more detailed company information, including copies of this and other press releases, please visit: http://www.pozen.com.
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 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 GlaxoSmithKline for the sales and marketing of Treximet and 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 September 30, 2010. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
SOURCE: POZEN Inc.
for POZEN Inc.