Aralez Pharmaceuticals Inc (NASDAQ:ARLZ) 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. (Original Source)
Shares of Aralez closed last Friday at $4.47, down $0.09 or -1.97%. ARLZ has a 1-year high of $6.80 and a 1-year low of $3.10. The stock’s 50-day moving average is $4.80 and its 200-day moving average is $4.59.
On the ratings front, Aralez has been the subject of a number of recent research reports. In a report issued on November 8, Chardan analyst Keay Nakae reiterated a Buy rating on ARLZ, with a price target of $10, which implies an upside of 124% from current levels. Separately, on October 10, Guggenheim’s Louise Chen maintained a Buy rating on the stock and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Keay Nakae and Louise Chen have a yearly average loss of -21.1% and -11.6% respectively. Nakae has a success rate of 33% and is ranked #4231 out of 4350 analysts, while Chen has a success rate of 35% and is ranked #4222.
Aralez Pharmaceuticals Inc. operates as a pharmaceutical company. It focuses on the development, acquisition, and commercialization of cardiovascular, pain, and other product therapies.