Aralez Announces U.S. Commercial Launch of Yosprala for Secondary Prevention of Cardiovascular and Cerebrovascular Events in Patients at Risk for Aspirin-Associated Gastric Ulcers
 MISSISSAUGA, Ontario – October 3, 2016 – Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ), a global specialty pharmaceutical company, announced today the availability of 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. YOSPRALA is being promoted by 110 sales representatives in the U.S. and is currently available in the wholesale chain. 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.   “We are pleased to announce the commercial launch of YOSPRALA in the U.S. supported by our fully trained, 110 person sales force deployed to promote YOSPRALA to cardiologists and high prescribing primary care physicians,” said Adrian Adams, Chief Executive Officer of Aralez. “YOSPRALA, a product that is specifically designed to reduce aspirin intolerance and therefore potentially improve compliance to therapy, has the promise to benefit healthcare practitioners, payors and patients. We believe that YOSPRALA represents a significant market opportunity and will contribute to solidifying our core therapeutic anchor position in cardiovascular disease alongside FibricorÒ.” Aspirin is the “Gold Standard” for Secondary PreventionUp to an estimated 26.2 million adults in the U.S. are at risk for secondary CV events. The occurrence of secondary CV events among people with heart disease continues to be a significant problem in the U.S. Patients who have experienced a heart attack have an elevated CV risk within the first six years of that first event, equating to an estimated 200,000 Americans a year who go on to have a second heart attack. Recent guidelines from the American College of Cardiology and American Heart Association affirm the importance of daily aspirin therapy. Daily aspirin therapy, however, can cause gastrointestinal symptoms and damage, such as gastroesophageal reflux disease, gastric ulcers and even gastrointestinal bleeding, through both direct and indirect mechanisms. A 2008 Expert Consensus Task Force specifically examined ways to reduce the gastrointestinal risks of antiplatelet therapy and nonsteroidal anti-inflammatory drugs (NSAID) use including aspirin. The findings included data which demonstrated that gastrointestinal risk may occur regardless of aspirin dose or formulation, meaning low-dose, buffered and enteric-coated aspirin preparations may not be gastro protective. The Task Force also devised an algorithm for the prevention and treatment of aspirin and NSAID-related gastroduodenal injury. PPI therapy is believed to reduce the risk in all patients and was a proposed strategy for gastroprotection.

About Aralez Pharmaceuticals Inc.Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez’s Global Headquarters is in Mississauga, Ontario, Canada, its 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.

 

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