POZEN announces results from a Burden of Cardiovascular Disease Study: a Managed Care Perspective

CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced the results of a POZEN sponsored study at the Academy of Managed Care Pharmacy’s 25th Annual Meeting and Expo on April 4, 2013. Ryan S. Clark, Pharm.D., MBA, Health Outcomes and Managed Markets Fellow, Global Health Economics & Outcomes Research at Xcenda, presented the abstract, The Burden of Secondary Cardiovascular Disease in Commercial and Medicare Patients: A Managed Care Perspective. The secondary prevention of cardiovascular events includes the daily use of aspirin. Chronic aspirin therapy is associated with significant gastrointestinal (GI) toxicity including dyspepsia, gastric ulcers and GI bleeding, all of which contribute to the disease and cost burden of secondary prevention. The GI toxicity of aspirin can be mitigated by the use of proton pump inhibitors (PPIs). The Xcenda analysis demonstrated that the prevention of cardiovascular events with aspirin, plus a PPI, compared to aspirin alone is associated with a net per-patient per-year cost decrease of $103 and $145 and a potential overall cost decrease of $1.8 million and $11.0 million for a typical one million-member Commercial and Medicare Plan, respectively.

“The overall cost of secondary cardiovascular events in patients with a history of coronary heart disease, transient ischemic attack, or ischemic stroke represents a significant financial burden on managed care,” said Rashad Carlton, Pharm.D., MSPH, Assistant Director, Global Health Economics & Outcomes Research at Xcenda. “Despite American College of Cardiology and American Heart Association guideline recommendations to start aspirin therapy and continue indefinitely in all patients unless contraindicated, aspirin remains underutilized.”

About the Study

The primary objective of the study was to characterize the financial burden of secondary cardiovascular disease and its long-term complications in patients at risk for a secondary cardiovascular event.

An economic model designed to yield the annual secondary cardiovascular disease cost burden was constructed using literature-based population, medication discontinuation/non-adherence, and cardiovascular event incidence data. Care records of secondary cardiovascular disease patients were reviewed based on treatment either with aspirin, aspirin + PPI, or no aspirin. Secondary events were calculated based on annual recurrence rates adjusted for treatment discontinuation/non-adherence. The treatment cohort cost per member and total cost, along with the overall annual secondary cardiovascular disease expense to the plan, were determined based on AWP/MAC drug pricing and published discharge data for cardiovascular and GI events.

A typical commercial plan with 1 million lives has an estimated 68,276 members who are considered to have secondary cardiovascular disease (26,753 who have experienced a stroke or TIA, 41,523 who have CHD). A typical Medicare population with 1 million lives has an estimated 295,711 members who have had secondary cardiovascular disease (124,451 stroke or TIA members, 171,260 CHD members). Of those members with secondary cardiovascular disease, 14.8% do not take any aspirin therapy, while 70.7% take aspirin (25.6% use aspirin alone and 45.1% use aspirin + PPI). The remaining 14.5% of patients were on an antiplatelet other than aspirin with or without an anticoagulant are not the focus of this analysis and are excluded.

About Cardiovascular Disease

Patients with established coronary heart disease or cerebrovascular disease have a high risk of a subsequent cardiovascular event including myocardial infarction (MI), stroke and death from cardiovascular disease. For such patients, lifestyle changes and drug therapy are of proven benefit and will improve outcomes. Coronary artery disease is caused by atherosclerosis and often develops into angina pectoris and MI. The condition caused about 445,000 deaths in 2005 and remains the leading single cause of death in America today. Roughly 16.8 million people have a history of MI and/or angina. An estimated 24 million have been identified as secondary prevention patients (post-event). It is estimated that cardiovascular disease causes one in every three deaths in the United States. Every 25 seconds, someone in the United States will suffer a coronary event. About every minute, someone will die from one.

Aspirin therapy has become the standard of care for reducing an individual’s risk of a second heart attack or stroke. 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. Aspirin has been incorporated into the American Heart Association’s (AHA) clinical guidelines for the secondary prevention of cardiovascular events. In accordance with these guidelines, approximately 24 million Americans should be taking aspirin for secondary prevention of cardiovascular events. Although the cardiovascular disease (CVD) benefits of aspirin are well established, the use of aspirin is associated with the risk of upper gastrointestinal bleeding (UGIB). The use of aspirin is associated with a 2- to 4- fold increased risk of UGIB. In addition, aspirin use for CVD is an important cause of gastrointestinal bleeding-related death. The use of the proton pump inhibitors, such as omeprazole can significantly reduce the risk of upper gastrointestinal bleeding. The American College of Cardiology with the AHA issued a Clinical Expert Consensus in 2008 recommending PPIs as preferred agents for the therapy and prophylaxis of aspirin-associated gastrointestinal injury.

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 enteric-coated or plain 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 POZEN

POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. 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 milestones/royalty streams, POZEN is 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 opportunities 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 inability to file a new drug application with the FDA for our PA product candidates in the timeframe we anticipate, 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 Annual Report on Form 10-K for the period ended December 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.