Pozen Inc. (POZN)

[eastunder]

Pozen Submits Final Study Report for PA8140/PA32540 Phase 1 Study on Schedule


April 2, 2014 7:30 AM


http://finance.yahoo.com/news/pozen-submits-final-study-report-113000621.html


POZEN Inc. (POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that they have submitted the final study report for the Phase 1 study comparing the pharmacokinetic profile of the omeprazole component of PA8140 tablets to that of PA32540 tablets as agreed with the U.S. Food and Drug Administration.

____________________________________________________________

http://www.fool.com/investing/general/2014/04/02/3-stocks-to-get-on-your-watchlist.aspx


April 2, 2014 7:30 AM


In just three weeks POZEN shareholders will finally know the fate of safer-aspirin products PA32540 (containing 325 milligrams of aspirin) and P8140 (containing 81 mg of aspirin) as a secondary prevention treatment of cardiovascular disease in patients with a high risk for developing aspirin-induced gastric ulcers.

POZEN's shareholders had the wind let out of their sails once before when the Food and Drug Administration postponed its initial PDUFA date in January by a full three months to April 25. PA32540 alone could have peak sales potential of up to $400 million in the United States, according to a company presentation last April.

I'd lean toward the FDA approving PA32540, as it decisively met both its primary and secondary endpoints in clinical studies while demonstrating notable efficacy and tolerability. Overall, POZEN conducted two phase 3 studies of PA32540, in which patients were able to stay on its therapy longer than on enteric-coated aspirin and also suffered significantly fewer endoscopically confirmed gastric ulcers relative to the enteric-coated aspirin. Gastric ulcers were reduced by 56% in the PA32540 arm in study 301 and by 68% in study 302. In other words, POZEN's safer aspirin therapies are in good shape for a possible approval.

What makes this even more unique is that POZEN has already landed a behemoth partner for its secondary prevention cardiovascular disease therapy in Sanofi (NYSE: SNY ) . Although POZEN is still looking for an international partner, Sanofi and POZEN signed an agreement last September to commercialize both PA32540 and PA8140 tablets in the U.S. The deal also netted POZEN $15 million up front, $20 million in pre-commercial milestone payments, and royalties on future product sales. Given its inexperienced sales force, this was a genius move for POZEN.

Biotech-savvy investors would be wise to get POZEN on their watchlist in anticipation of the PDUFA decision on or before April 25.