Aralez’s YOSPRALA wins FDA approval

Knobbe Martens Olson & Bear LLP

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of aspirin-associated gastric ulcers in patients who require daily aspirin for secondary prevention of cardiovascular and cerebrovascular events.

According to YOSPRALA™’s Prescribing Information, the aspirin component of YOSPRALA™ is designed to reduce risk of certain major cardiovascular events (such as death, nonfatal stroke, nonfatal myocardial infarction) in patients with certain pre-existing cardiovascular conditions or patients who have undergone revascularization procedure. The omeprazole component of YOSPRALA™ is designed to protect against aspirin-associated gastric ulcers.

YOSPRALA™ was developed by Canada-based Aralez Pharmaceuticals Inc, whose shares rose nearly 10 percent on the news. The Company is expanding its U.S. sales and plans to begin the U.S. promotional launch of YOSPRALA the first week in October.

In the U.S., there are approximately 24 million secondary prevention patients, with approximately 70% of them taking daily aspirin. However, the daily use of aspirin is associated with an increased risk of developing gastric ulcer. Thus, the addition of an agent that decreases stomach acid production, such as the proton pump inhibitor, omeprazole, is intended to decrease the chance for the development of ulcers. YOSPRALA™ 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 strength. Accordingly to Aralez’s press release, the 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 risks.”

In an interview with Reuters, Aralaz’s chief executive Adrian Adams said the price of YOSPRALA™ to patients will be equivalent to what they would pay to buy the products separately over the counter. He said he expects the drug to generate peak sales of about $200 million a year.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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