POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, at The American Heart Association (AHA) Scientific Sessions 2012, as Poster #12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies. Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. Data for the primary endpoint are shown below:
|Primary Endpoint: Endoscopically-Confirmed Gastric Ulcer|
“The results of these Phase 3 pivotal studies are promising and report the important role that PA32540 may play in the long-term management of cardiovascular protection,” said Chris O’Connor, M.D., Director, Duke Heart Center, Duke University Hospital and one of the authors of the studies. “Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin. In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular events.”
A summary of discontinuation rates of the combined data are shown below:
|Discontinuation Due To Pre-Specified UGI Events:|
|Studies 301 & 302||1.5%||8.2%||< 0.001||82%|
In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations to any adverse events (6.7% vs. 11.2%).
In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540. The most commonly reported adverse events with PA32540 and enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia (11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5% vs. 16.0%) respectively. The incidence and nature of adjudicated Major Adverse Cardiac Events (MACE) such as heart attacks was similar between the 2 treatment arms: 9 subjects (1.7%) on PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin (325 mg). Please see the complete AHA poster, available at www.pozen.com, for more detail of the study results.
“Aspirin is often recommended for the secondary prevention of cardiovascular events; however, it also can be a contributing factor to the development of gastric ulcers as well as abdominal discomfort (dyspepsia) and other troublesome upper GI tract symptoms,” said Dr. Jay L. Goldstein, Vice Chairman of the Department of Medicine, and Head of the Division of Gastroenterology at NorthShore University Health System as well as one of the authors of the studies. “In these two randomized trials, the use of the combination product PA32540 was associated with fewer gastric ulcers and a lower rate of dyspepsia and other upper GI tract symptoms than aspirin alone. With a reduction of these symptoms, patients can be provided the option of an overall better-tolerated therapy for ongoing secondary prevention of cardiovascular events.”
The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049 subjects who were prescribed daily aspirin (325 mg) for greater than or equal to three months for secondary prevention of cardiovascular events. The primary endpoint was the cumulative observed incidence of gastric ulcers over six months. Secondary endpoints included cumulative incidence of gastric and duodenal ulcers, discontinuation due to pre-specified UGI adverse events and heartburn resolution. Subjects were randomly assigned to once-daily treatment with PA32540 or 325 mg of enteric-coated aspirin. Endoscopic assessments were performed at screening and at one, three and six months. Major adverse cardiac events were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.
Cardiovascular disease is the leading cause of death in the United States, and there are currently 24 million secondary prevention patients, most of whom are on a daily aspirin therapy. However, approximately 15 percent of people on low-dose aspirin are at risk for upper GI adverse events, and 12 percent discontinue or reduce intake due to these serious UGI side effects.
Additional data from the two pivotal Phase 3 PA32540 trials recently were presented at the American College of Gastroenterology 2012 Annual Meeting. For more detail of the study results, please see www.pozen.com for the complete poster.
Third Quarter 2012 Results
POZEN plans to release its third quarter 2012 earnings results on Thursday, November 8 before the market opens. The announcement will be followed by a live webcast at 11:00 a.m. ET with a discussion by POZEN management of the earnings and business results. The webcast can be accessed on POZEN’s website at www.pozen.com and will be archived and available for replay. The third quarter 2012 earnings release will be accessible in the “Media” section of POZEN’s website.
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.
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.
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.