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Aralez Announces FDA Acceptance of New Drug Application for YOSPRALA™

MILTON, Ontario, March 28, 2016 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of 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. The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.

"The acceptance of our NDA for YOSPRALA marks an important and exciting step toward approval of this product," said Adrian Adams, Chief Executive Officer of Aralez. "We look forward to working with the FDA during the review process in order to bring YOSPRALA to market as quickly as possible."
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Source: press release, 3/28/16. http://ir.aralez.com/phoenix.zhtml?c=254163&p=irol-newsArticle&ID=215105...

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Aralez resubmits to FDA New Drug Application for YOSPRALA
MILTON, Ontario, March 15, 2016 /PRNewswire/ -- 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."
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Source: press release, 3/15/16. http://ir.aralez.com/phoenix.zhtml?c=254163&p=irol-newsArticle&ID=214845...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Yosprala (PA-32540) (Asprin 325 mg coated with Esomeprazole (Nexium))CardiovascularCardiovascular event prophylaxisCombination cardiovascular and GI complication prophylaxis therapeuticPlatelets and proton pumps

Mechanism of action: Yosprala (PA-32540) (Asprin 325 mg coated with Esomeprazole (Nexium)) combines the platelet-inhibitory effect of aspirin to prevent the formation of arterial thrombi on atherosclerotic plaques thus reducing cardiovascular events, with the gastric acid control of a proton pump inhibitor, thus reducing the gastro-intestinal (GI) complications of prolonged aspirin therapy.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-09-14

Results:

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Aralez Announces FDA Approval Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin-Associated Gastric Ulcers
-Aralez Sales Force Will Be Expanded by 85 to 110 Sales Representatives by Launch-

-YOSPRALA U.S. Commercial Launch Planned for First Week of October-

-Company to Host Conference Call Today at 11:00 a.m. ET-

MISSISSAUGA, Ontario, Sept. 15, 2016 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ), 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.

Aralez_Pharmaceuticals_Inc_Yosprala_Logo
"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."

Aspirin is the "Gold Standard" for Secondary Prevention
Up 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 years2 of that first event, equating to an estimated 200,000 Americans a year who go on to have a second heart attack.3

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 gastrointestinal 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.4

"In the randomized controlled trials, YOSPRALA outperformed enteric-coated aspirin in terms of the primary endpoint, reduction in gastric ulceration, with higher adherence in patients at higher risk for aspirin-associated gastric ulcerations, a secondary endpoint," said Dr. David J. Whellan, the first author of the publication and the James C. Wilson Professor of Medicine, Sidney Kimmel Medical College. "We know that over one third of patients who should be taking aspirin for secondary prevention discontinue aspirin due in part to gastrointestinal symptoms and that this discontinuation increases the risk of death and recurrent heart attacks."

Studies Demonstrate YOSPRALA Clinical Benefit
The FDA approval of YOSPRALA was based on the results from two randomized, double-blind controlled clinical trials that patients were randomly assigned to receive either YOSPRALA 325 mg/40 mg (n=524) or 325 mg of enteric-coated aspirin (n=525). 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.5 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.
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Source: press release, 9/14/16. http://ir.aralez.com/phoenix.zhtml?c=254163&p=irol-newsArticle&ID=220215...

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