|POZEN Reports Top-Line Data from Long-Term Safety Study of PA32540|
CHAPEL HILL, N.C., Oct 13, 2011 (BUSINESS WIRE) --
POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, announced today top-line results from study 303, a Phase 3 trial designed to track the long-term safety of PA32540 in patients who are at risk for developing aspirin-associated gastric ulcers. In this open label study, adverse events were consistent with what would be expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the PA components. The rate of discontinuation due to adverse events was low, and few patients developed major cardiovascular adverse events.
"These data support the possibility that long-term treatment with PA32540 may provide patients with a safe and effective option for secondary prevention of cardiovascular events, including heart attacks and strokes," said Tomás S. Bocanegra, M.D., FACP, Executive Vice President of Development of POZEN. "We are pleased that the results of this trial support the safety profile that we expected for PA32540. As soon as we obtain the results of the two ongoing pivotal Phase 3 trials in the first half of 2012, we will have all of the necessary components for the PA32540 NDA which is scheduled for submission to the FDA during the second half of 2012."
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 developing aspirin-associated gastric ulcers. This investigational product is part of POZEN's pipeline of integrated aspirin therapies, called the PA portfolio, all of which are designed to deliver the benefits of aspirin therapy with a reduced incidence of gastrointestinal toxicity.
About Study 303
Study 303 is a Phase 3, open-label study conducted at 39 medical centers around the United States. Subjects with known cardiovascular disease and already taking aspirin at a dose of 325 mg once daily were treated with PA32540 instead of their usual aspirin product once daily for as long as one year. As expected, most study participants had other comorbidities and were on many other concomitant medications. Of the 379 patients enrolled in this trial, 290 completed therapy for one year, 51 (13.4%) withdrew from the trial because of any adverse event, and one patient died. The cause of death, a non-hemorrhagic stroke, was judged by the investigator as being unrelated to PA32540.
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 - 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, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
The Company's common stock is traded on The NASDAQ Global Market under the symbol "POZN". For more detailed company information, including copies of this and other press releases, please visit 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 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 GlaxoSmithKline for the sales and marketing of Treximet(R) and our dependence on AstraZeneca for the sales and marketing of VIMOVO(TM); 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, 2011. 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.