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Pozen Receives Milestone Payment From AstraZeneca For Vimovo

Pozen has received $20m milestone payment from AstraZeneca for the FDA approval of Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets.

Vimovo is approved for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing non-steroidal anti-inflammatory drug (NSAID) associated gastric ulcers.

Vimovo is a fixed-dose combination of enteric-coated naproxen, a pain relieving NSAID and immediate release esomeprazole, a proton pump inhibitor.

Pozen is expected to transfer ownership of the investigational new drug application and new drug application for Vimovo to AstraZeneca over the next few weeks.

Pozen said that an additional $25m milestone is expected to be payable if Vimovo receives marketing approval in US market (including pricing and reimbursement approval).

As per the terms of the agreement, AstraZeneca is expected to pay Pozen royalties on net sales of Vimovo and Pozen could receive up to $260m in sales performance milestones, if certain sales thresholds are achieved. AstraZeneca has responsibility for all commercialisation activities.

The FDA approval of Vimovo required the demonstration of superiority over an active comparator in two pivotal Phase 3 trials.