Aralez Announces FDA Approval Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin-Associated Gastric Ulcers

MISSISSAUGA, Ontario,  Aralez Pharmaceuticals Inc. a global specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved once-daily YOSPRALA™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S. YOSPRALA is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The Company is expanding its U.S. sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the U.S. promotional launch of YOSPRALA the first week in October. 

"Daily aspirin is a standard of care for secondary cardiovascular event prevention, but gastrointestinal symptoms are often cited as the reason patients stop taking this important therapy. Discontinuation of daily aspirin therapy for secondary prevention can pose a significant cardiovascular risk," said Lori Mosca, M.D., M.P.H, Ph.D., a national expert in cardiovascular disease prevention and education. "Published research shows that patients who have or are at risk of coronary artery disease and discontinue daily aspirin treatment have a three-fold higher risk of a major adverse cardiac event, including death, shortly after stopping therapy. Another study documented that aspirin discontinuation following a gastrointestinal bleed in patients with CV disease increases the risk of a cardiovascular event or death almost 7-fold."  

YOSPRALA is designed to support both cardio- and gastro-protection for at-risk patients through the proprietary Intelli-COAT™ system, which is formulated to sequentially deliver immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths. The YOSPRALA immediate-release omeprazole is designed to elevate the gastric pH into a gastroprotective zone. The enteric-coated aspirin dissolves after the pH has been elevated to ≥ 5.5, within the gastroprotective zone, thereby reducing stomach ulcer risk.¹

"The approval of YOSPRALA marks a major achievement for Aralez and helps address the current public health dilemma around patient discontinuation of daily aspirin therapy, which has potentially serious consequences," said Adrian Adams, Chief Executive Officer of Aralez. "YOSPRALA is designed to help at-risk patients, who need the cardio-protective benefits of daily aspirin, stay on their important treatment while reducing the risk of developing gastric ulcers. We believe YOSPRALA represents an important new therapeutic option for this group of patients and healthcare providers who strive to improve patient adherence to daily aspirin therapy. Access to preventive care is critical and as such we will implement a responsible pricing strategy that is designed to remove access barriers to YOSPRALA by instituting an affordable patient copay of less than a dollar per day for most patients. The approval of YOSPRALA together with the recent acquisition of ZONTIVITY^®, a revenue generating oral anti-platelet product that represents an excellent strategic fit with YOSPRALA, underscores the continued execution of our corporate growth strategy designed to build Aralez organically and through seizing high potential opportunities through aggressive business development and licensing."

Source: Aralez Pharmaceuticals Inc.