MILTON, Canada I March 15, 2016 I Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (“Aralez” or the “Company”), a global specialty pharmaceutical company, today announced that it has resubmitted to the U.S. Food and Drug Administration (“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 (“CRL”) 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.
The FDA is expected to issue Aralez an acknowledgment letter within 30 days of resubmission as to whether the resubmission addresses all the deficiencies identified in the CRL. If accepted, this acknowledgement would also include a new Prescription Drug User Fee Act (“PDUFA”) date.
“We are pleased to resubmit the NDA package for YOSPRALA,” said Adrian Adams, Chief Executive Officer of Aralez. “Depending on acknowledgement and feedback from the FDA, the PDUFA date could be early fourth quarter of this year. We believe that, if approved, YOSPRALA has the potential to help millions of adults at risk for aspirin-induced ulcers. This is an important milestone for Aralez and underscores our commitment to providing cardiovascular treatment options to patients in need.”
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while focusing on creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez’s Global Headquarters is in Ontario, Canada, the U.S. Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
About YOSPRALA
The Company has developed an investigational aspirin therapy, known as YOSPRALA 81/40, containing 81 mg of aspirin, and YOSPRALA 325/40, containing 325 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
SOURCE: Aralez
Post Views: 172
MILTON, Canada I March 15, 2016 I Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (“Aralez” or the “Company”), a global specialty pharmaceutical company, today announced that it has resubmitted to the U.S. Food and Drug Administration (“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 (“CRL”) 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.
The FDA is expected to issue Aralez an acknowledgment letter within 30 days of resubmission as to whether the resubmission addresses all the deficiencies identified in the CRL. If accepted, this acknowledgement would also include a new Prescription Drug User Fee Act (“PDUFA”) date.
“We are pleased to resubmit the NDA package for YOSPRALA,” said Adrian Adams, Chief Executive Officer of Aralez. “Depending on acknowledgement and feedback from the FDA, the PDUFA date could be early fourth quarter of this year. We believe that, if approved, YOSPRALA has the potential to help millions of adults at risk for aspirin-induced ulcers. This is an important milestone for Aralez and underscores our commitment to providing cardiovascular treatment options to patients in need.”
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while focusing on creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez’s Global Headquarters is in Ontario, Canada, the U.S. Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
About YOSPRALA
The Company has developed an investigational aspirin therapy, known as YOSPRALA 81/40, containing 81 mg of aspirin, and YOSPRALA 325/40, containing 325 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
SOURCE: Aralez
Post Views: 172
