POZEN Inc. (NASDAQ:POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that following ongoing interactions with the United States Food & Drug Administration (FDA) concerning its New Drug Application (NDA) for PA8140/PA32540 tablets, the Company has decided to conduct a comparative Phase 1 pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA8140 tablets and compare it to that of PA32540 tablets. Both PA dosage forms contain 40 mg of omeprazole in an immediate release form and are manufactured using nearly identical procedures.
The Company anticipates that this study, which will enroll up to 30 subjects, will cost approximately $750,000. Final data are expected to be available in March 2014. POZEN and the FDA have agreed that the Company will submit study information and data to the FDA as it becomes available during the conduct of the study and that FDA will review such information and data from the study when submitted. The FDA has informed POZEN that the Company’s user fee date of January 24, 2014 (PDUFA Date) is now April 25, 2014.
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 has created 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, our ability to return value to our stockholders, including any cash distributions, and our future prospects 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 further 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 for all expected indications, 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 and Horizon Pharma for the sales and marketing of VIMOVO ® , our dependence on Sanofi US for the sales and marketing of PA8140/PA32540 in the United States, if approved, and our dependence on Patheon for the manufacture of PA8140/PA32540; 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, 2013. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.