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Yosprala 325/40

Aralez Pharmaceuticals Inc.

Drug Names(s): PA32540, aspirin (acetylsalicylic acid) / omeprazole, EC-ASA 325mg / IR-Omeprazole 20 mg, PA 325, PA325/40, PA 32520/PA 32540

Description: PA 32520 contains 325 mg pH-sensitive coated aspirin with 20 mg immediate release omeprazole. PA 32540 contains 325 mg pH-sensitive coated aspirin with 40 mg immediate release omeprazole.

Aspirin is a salicylate that has demonstrated anti-inflammatory, analgesic, antipyretic, and anti-platelet activity. Aspirin acts on cyclooxygenase enzymes, irreversibly inhibiting COX-1 and modifying the activity of COX-2. In platelets, inhibition of COX-1 reduces thromboxane A2 production, and concomitantly platelet aggregation and new activation. COX-1, however, also suppresses gastric acid production in the stomach, so inhibition potentially leads to gastric-duodenal irritation and ulcer. COX-2 is inducible and rapidly up-regulated at inflammatory sites. Hence inhibition of COX-2 reduces inflammation. In addition to a peripheral effect, aspirin appears to produce analgesia via a CNS effect, where COX-2 is constitutively expressed and also rapidly up-regulated to reinforce pain perception.

Omeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid (H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells). By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal.

Deal Structure: Pozen and Sanofi
In September 2013, Sanofi and POZEN announced the signing of an exclusive license agreement for the commercialization of PA8140 and PA32540. Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15MM and will be eligible for pre-commercial milestone payments of up to $20MM and other future milestone payments and royalties on product sales. Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN will retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZEN will transfer the NDA to Sanofi US.

In November 2014, Pozen and Sanofi agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective...See full deal structure in Biomedtracker


Yosprala 325/40 News


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