POZEN Inc. (NASDAQ: POZN), announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration (FDA) approval of VIMOVO™ (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application (IND) and New Drug Application (NDA) for VIMOVO to AstraZeneca over the next few weeks.
An additional $25 million milestone will be payable if VIMOVO receives marketing approval in a major ex-U.S. market (including pricing and reimbursement approval). Under the terms of the agreement, AstraZeneca will pay POZEN royalties on net sales of VIMOVO worldwide and POZEN could receive up to $260 million in sales performance milestones, if certain sales thresholds are achieved. AstraZeneca has responsibility for all commercialization activities.
VIMOVO is approved for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a proton pump inhibitor.
The FDA approval of VIMOVO marks the second time in just two years that POZEN has received an FDA approval for a new product, which required the demonstration of superiority over an active comparator in two large pivotal Phase 3 trials. This makes POZEN a standout among biotech and specialty pharmaceutical companies, one of only a very few that have ever earned FDA approval for a self-invented product, and one of an even smaller number of companies to do this twice.