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Preventive Aspirin Use Less Than Optimal in Stroke Survivors Despite Clinical Guidelines

New Patient Survey Presented at International Stroke Conference

NEW ORLEANS--(BUSINESS WIRE)--Feb. 1, 2012-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented results today from a survey of more than one thousand patients that found that preventive aspirin use is low among those who have experienced a stroke, despite the recent American Heart Association (AHA) guidelines advising its use in this population for secondary prevention. These data were presented for the first time at the American Heart Association’s 2012 International Stroke Conference on Wednesday, February 1 at 6 p.m. ET in New Orleans, Louisiana at the Ernest N. Morial Convention Center as poster board number P321.

According to the 2009 survey, approximately 40% of stroke survivors reported not taking daily aspirin, demonstrating minimal change in the use of aspirin between 2000 and 2009. These findings are similar to the results of the Agency for Healthcare Research and Quality survey from 2000 to 2006 that found 43% of stroke survivors did not take daily aspirin. However, the AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.

“The results of this patient survey demonstrate that many stroke survivors are not taking daily aspirin, despite AHA’s recommendation for secondary prevention of cardiovascular disease,” said John G. Fort, M.D., Chief Medical Officer of POZEN and co-author of the poster. “Continued effort is needed to address the unmet needs of this patient population to ensure that they are able to take the necessary preventive measures to reduce their risk of future cardiovascular events.”

The overall objective of the survey was to determine aspirin use among patients who have experienced a heart attack and/or stroke. The patient survey was sponsored by POZEN, whose lead pipeline product PA32540 is being investigated for the secondary prevention of cardiovascular disease in patients at risk for developing aspirin-associated gastric ulcers.

Key Findings

  • Aspirin use was 56% for patients who had a stroke only, vs. 88% for those who had a heart attack
  • While the most common aspirin dosing regimen for stroke sufferers was 81 mg (51%), one-third take 325 mg
  • The vast majority of stroke patients who did take aspirin, claimed they took it once daily (95%)

“This very provocative study by Dr. Fort and colleagues raises some important questions with significant clinical implications. It appears that a relatively high percentage of patients who should be taking aspirin are in fact not taking aspirin,” said Mark J. Alberts, MD, Chief, Division of Stroke and Cerebrovascular Disease, Northwestern University. “While it is possible they were taking other antiplatelet agents or anticoagulants, my clinical experience is that many patients simply stop their aspirin for unclear reasons. This puts them at a high risk for a recurrent stroke and MI. Clearly these findings warrant further study and improved strategies to improve the appropriate use of aspirin and other medications.”

About the Survey

The questionnaire was fielded by Marketing Information Systems International in December 2009 using a consumer internet panel of 23,139 U.S. households with an individual or caretaker of an individual who had suffered a stroke and/or heart attack. After confirming the household had someone who met the diagnostic criteria, random sampling was performed to obtain a sample of individuals with either previous stroke only or stroke and heart attack (the total stroke population) and individuals with only previous heart attack (the MI only population).

A random sample of 1,579 households was screened, yielding 842 total stroke and 737 MI only households. Aspirin was not used for 342 total stroke sufferers and 69 MI only sufferers, and these subjects were not questioned as to why they were not taking aspirin. The remaining 500 stroke households and 500 of the 668 MI only households were included in the analysis.

About Antiplatelet Therapy

Aspirin is the standard of care for the reduction of an individual's risk of a second heart attack. Clinical 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. Clopidogrel and aspirin are currently co-prescribed in some cardiovascular patients. However, the use of clopidogrel plus aspirin increases the risk of GI bleeding in certain patients. These at-risk patients may benefit from the use of gastroprotective agents such as PPIs, including omeprazole. Recently, the U.S. Food and Drug Administration (FDA) modified the clopidogrel and omeprazole labels to include warnings against co-prescribing omeprazole and clopidogrel, based on ex-vivo platelet aggregation studies.

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 FDA approval of two self-invented products in two years. 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 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 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, 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.

POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
or
Stephanie Bonestell, 919-913-1030
Manager, Investor Relations & Public Relations


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