POZEN is creating a GI-safer form of aspirin franchise of product candidates – the PA product platform. The investigational PA pipeline of cost-effective, integrated therapies is designed to enable the full power of aspirin by reducing its gastrointestinal damage.
The first candidates are PA8140 and PA32540. They are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around pH-sensitive enteric-coated aspirin (81 mg or 325 mg). This novel, patented product candidate is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. POZEN has completed two pivotal Phase III trials, and a long-term, open-label safety trial for secondary cardiovascular disease prevention was completed in 2011. Top-line results were announced in March 2012 and presented at both ACG and AHA in October and November 2012, respectively; the New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in March 2013. On August 25, 2014, POZEN received a complete response letter (CRL) from the FDA. In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier, inspection deficiencies were found. On June 30, 2014, following the suppliers response to the FDA, POZEN resubmitted the
NDA for PA8140/PA32540. On July 16, the FDA accepted the resubmission for review. The FDA indicated the NDA would be treated as a Class 2 resubmission, with a new user fee goal date of December 30, 2014. See the Posters & Publications page for more information.
To maximize the global sales potential of the PA product portfolio, identifying the right partner for PA8140 and PA32540, who can bring this potentially life-saving product to patients, has been a key activity for POZEN. In September 2013, we signed an exclusive license agreement with Sanofi US for the commercialization of PA8140 and PA32540. Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. Ex-US partnership discussions continue to progress.
Through a partnership with POZEN, the strategic licensing partners would be granted rights to the intellectual property behind PA8140 and PA32540 in the licensed territory and would benefit from POZEN’s manufacturing expertise and supply. Additionally, POZEN completed the initial commercial strategy development for PA8140 and PA32540, including all foundational market research, branding, positioning and innovative commercial marketing plan creation.
PA Proof of Concept Study Results
PA 32520 vs. 325mg EC Aspirin
PA 32520 vs. 81mg EC Aspirin
PA 32540 vs. 325mg EC Aspirin