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AstraZeneca, Pozen To Partner On Fixed-Dose Naproxen/Esomeprazole

This article was originally published in The Pink Sheet Daily

Executive Summary

AstraZeneca will oversee global manufacturing, marketing, sales and distribution for the arthritis pain compound.

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Pozen to file NSAID/PPI combo

Pozen will file the NDA for the NSAID/PPI combination product PN 400 in mid-2009, the firm announced May 13. With partner AstraZeneca, Pozen developed the fixed-dose combination of the NSAID naproxen with the PPI esomeprazole to treat the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers (1"The Pink Sheet" DAILY, Aug. 2, 2006). Pozen's announcement suggests that FDA has resolved its concerns about the appropriateness of reduction in gastric ulcers as an endpoint for approval of a gastroprotective claim for NSAID/PPI combos (2"Pharmaceutical Approvals Monthly," December 2008, p. 34)

Pozen to file NSAID/PPI combo

Pozen will file the NDA for the NSAID/PPI combination product PN 400 in mid-2009, the firm announced May 13. With partner AstraZeneca, Pozen developed the fixed-dose combination of the NSAID naproxen with the PPI esomeprazole to treat the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers (1"The Pink Sheet" DAILY, Aug. 2, 2006). Pozen's announcement suggests that FDA has resolved its concerns about the appropriateness of reduction in gastric ulcers as an endpoint for approval of a gastroprotective claim for NSAID/PPI combos (2"Pharmaceutical Approvals Monthly," December 2008, p. 34)

AstraZeneca/Pozen Target 2009 For Arthritis Combination Filing

Companies will initiate a Phase III clinical trial for PN400, a combination of naproxen and the esomeprazole.

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