Pozen, Inc. (MM) (NASDAQ:POZN)
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From May 2019 to May 2024

AstraZeneca PLC (AZN) said Tuesday its development partner, Pozen Inc (POZN), has submitted a new drug application, or NDA, to the U.S. Food and Drug Administration for VIMOVO (PN400) tablets, which if approved will trigger a $10 million milestone payment to Pozen.

MAIN FACTS:

-PN400 is under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.

-PN400 is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole.

-The proposed trade name is VIMOVO, pending regulatory approval.

-Upon the FDA's notification of acceptance of the NDA filing for PN400, a $10 million milestone payment from AstraZeneca will be payable to Pozen.

-The NDA submission is based on data from a comprehensive clinical trials programme.

-The PN400 301/302 studies fully met their primary objective, showing subjects taking PN400 experienced significantly fewer endoscopically confirmed gastric ulcers compared to subjects receiving enteric coated (EC) naproxen.

-The primary endpoint was the cumulative incidence of gastric ulcers through six months.

-By London Bureau, Dow Jones Newswires; +44 (0)20 7842 9296; ian.walker@dowjones.com