AstraZeneca Partner Pozen Submits PN400 New Drug Application
30 6월 2009 - 9:57PM
Dow Jones News
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