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 within the PA product portfolio 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) core. The pivotal Phase III trials of PA32540 are complete. 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. On December 17, 2014, POZEN received a second CRL from the FDA. In this CRL, the FDA used identical wording to that of the first CRL. Satisfactory resolution of these deficiencies is required before this application may be approved. Subsequently, The active ingredient supplier informed POZEN that they received a warning letter relating to the Form 483 inspection deficiencies. They are evaluating what additional corrective actions may be required to address the matters raised in the warning letter. POZEN will continue to provide assistance to our active ingredient supplier in taking corrective actions to address the inspectional observations at its facility. 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 would have had exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. In November, 2014, we executed a termination agreement with Sanofi US terminating the license agreement for PA. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. We are currently evaluating all strategic options available to us now that we have full ownership of the PA products. Ex-US partnership discussions continue to progress.
For additional information about the PA product portfolio, visit the Development Products – PA Pipeline page.
PA Proof of Concept Study Results
PA 32520 vs. 325mg EC Aspirin
PA 32520 vs. 81mg EC Aspirin
PA 32540 vs. 325mg EC Aspirin