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AZ reports positive gastric ulcer study data
04 Dec 2008
Clinical Research
AstraZeneca (AZ) has reported positive data from two phase-three clinical studies of a potential gastric ulcer treatment.
The company, together with its co-development partner Pozen, said the compound PN 400 demonstrated a clinically meaningful benefit in reducing gastric ulcers compared to enteric-coated naproxen 500 milligrams (mg).
PN 400 comprises enteric-coated naproxen 500 mg and immediate-release esomeprazole 20 mg.
Each study involved around 400 patients receiving either PN 400 or enteric-coated naproxen 500 mg twice daily over a six-month period, with upper endoscopies being carried out at given points to assess the cumulative incidence of gastric ulcers.
The Food and Drug Administration recently informed Pozen that it is conducting an internal review to evaluate the acceptability of using endoscopic gastric ulcers as a primary endpoint in clinical trials - with an FDA meeting set to take place in the first quarter of 2009.
Meanwhile, AZ has entered into an agreement with Abraxis BioScience under which the latter is set to regain exclusive marketing rights to Abraxane in the US.
AZ is to continue promoting the product until it gets confirmation that the Abraxis board of directors has approved ending the co-promotion agreement.
