Aralez Pharma re-submits Yosprala (PA32540/PA8140) to FDA as a treatment for secondary prevention of CV disease in patients at risk for aspirin-induced gastric ulcers.

Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that it has resubmitted to the FDA the New Drug Application ("NDA") for its investigational candidate, Yosprala (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris, chronic stable angina pectoris and those who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated and ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli.

Aralez resubmitted the NDA in response to a Complete Response Letter from the FDA in which the only deficiencies identified related to findings by the FDA during an audit of the manufacturing facility of the active pharmaceutical ingredient aspirin ("API") supplier. The NDA resubmission includes a new primary aspirin API supplier, together with an alternative supplier intended to address the deficiencies the FDA outlined in the CRL. Final agreement on draft product labeling is also pending.

Comment: Aralez Pharmaceuticals Inc. is the result of the merger of the businesses of Pozen Inc. and Tribute Pharmaceuticals Canada Inc.