MISSISSAUGA, Canada I January 9, 2017 I Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (“Aralez” or the “Company”) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its investigational candidate, PA10040, for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
“As we seek to maximize the opportunity for Yosprala on a worldwide basis, we plan to engage in early discussions with potential partners for territories outside of the United States and Canada,” said Adrian Adams, Chief Executive Officer of Aralez. “At the same time, we are making significant progress with our commercial efforts in the United States.”
Aspirin and omeprazole is currently marketed in a tablet form under the brand name Yosprala™ in the United States and indicated for patients who require aspirin for secondary prevention of CV and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.
The MAA is based on the results from two randomized, double-blind controlled clinical trials in which patients were randomly assigned to receive either Yosprala 325 mg/40 mg (n=524) or 325 mg of enteric-coated aspirin (n=525) as well as bioavailability studies which evaluated the Yosprala 100 mg/40 mg dose. (The 100 mg aspirin dose is the most common in the European Union (EU) for secondary prevention of cardiovascular and cerebrovascular events.) In the Phase 3 efficacy studies with the 325 mg/40 mg dose, each study achieved its individual primary endpoint with patients in the Yosprala arm experiencing significantly fewer endoscopic gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. In addition, significantly fewer patients treated with Yosprala discontinued therapy because of prespecified upper gastrointestinal adverse events compared to patients in the enteric-coated aspirin (325 mg) arm.i The most common adverse reactions reported in adults (incidence ≥ 2% and greater than 325 mg EC aspirin) during the studies were gastritis, nausea, diarrhea, gastric polyps and non-cardiac chest pain.
About Yosprala™ in the EU
Yosprala for use in the EU is a combination of enteric-aspirin (100 mg), an anti-platelet agent, surrounded by immediate-release omeprazole (40 mg), a proton pump inhibitor. Aralez is seeking EU approval for patients who require aspirin for secondary prevention of CV and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.
The aspirin component of Yosprala, if approved in the EU, would be indicated for reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with a previous MI or unstable angina pectoris; and reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris. It is also indicated for use in patients who have undergone revascularization procedures − coronary artery bypass graft or percutaneous transluminal coronary angioplasty − when there is a pre-existing condition for which aspirin is already indicated.
The omeprazole component of Yosprala, if approved in the EU, would be indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
Yosprala, if approved in the EU, would not be for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute MI or before percutaneous coronary intervention. Yosprala was evaluated in clinical studies for the reduction of gastric ulcers. It was not evaluated for the reduction of GI bleeding and therefore has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. Yosprala would not be interchangeable with the individual components of aspirin and omeprazole.
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 in Princeton, NJ and the Ireland Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
SOURCE: Aralez Pharmaceuticals
Post Views: 133
MISSISSAUGA, Canada I January 9, 2017 I Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (“Aralez” or the “Company”) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its investigational candidate, PA10040, for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
“As we seek to maximize the opportunity for Yosprala on a worldwide basis, we plan to engage in early discussions with potential partners for territories outside of the United States and Canada,” said Adrian Adams, Chief Executive Officer of Aralez. “At the same time, we are making significant progress with our commercial efforts in the United States.”
Aspirin and omeprazole is currently marketed in a tablet form under the brand name Yosprala™ in the United States and indicated for patients who require aspirin for secondary prevention of CV and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.
The MAA is based on the results from two randomized, double-blind controlled clinical trials in which patients were randomly assigned to receive either Yosprala 325 mg/40 mg (n=524) or 325 mg of enteric-coated aspirin (n=525) as well as bioavailability studies which evaluated the Yosprala 100 mg/40 mg dose. (The 100 mg aspirin dose is the most common in the European Union (EU) for secondary prevention of cardiovascular and cerebrovascular events.) In the Phase 3 efficacy studies with the 325 mg/40 mg dose, each study achieved its individual primary endpoint with patients in the Yosprala arm experiencing significantly fewer endoscopic gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. In addition, significantly fewer patients treated with Yosprala discontinued therapy because of prespecified upper gastrointestinal adverse events compared to patients in the enteric-coated aspirin (325 mg) arm.i The most common adverse reactions reported in adults (incidence ≥ 2% and greater than 325 mg EC aspirin) during the studies were gastritis, nausea, diarrhea, gastric polyps and non-cardiac chest pain.
About Yosprala™ in the EU
Yosprala for use in the EU is a combination of enteric-aspirin (100 mg), an anti-platelet agent, surrounded by immediate-release omeprazole (40 mg), a proton pump inhibitor. Aralez is seeking EU approval for patients who require aspirin for secondary prevention of CV and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.
The aspirin component of Yosprala, if approved in the EU, would be indicated for reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with a previous MI or unstable angina pectoris; and reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris. It is also indicated for use in patients who have undergone revascularization procedures − coronary artery bypass graft or percutaneous transluminal coronary angioplasty − when there is a pre-existing condition for which aspirin is already indicated.
The omeprazole component of Yosprala, if approved in the EU, would be indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
Yosprala, if approved in the EU, would not be for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute MI or before percutaneous coronary intervention. Yosprala was evaluated in clinical studies for the reduction of gastric ulcers. It was not evaluated for the reduction of GI bleeding and therefore has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. Yosprala would not be interchangeable with the individual components of aspirin and omeprazole.
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 in Princeton, NJ and the Ireland Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
SOURCE: Aralez Pharmaceuticals
Post Views: 133
