Pozen confirmed receipt of a $20 million milestone payment from AstraZeneca following FDA’s recent approval of Vimovo™ delayed-release tablets for relieving the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and for decreasing the risk of NSAID-related gastric ulcers in high-risk patients. Pozen says it will transfer ownership of the Vimovo IND application and NDA to AstraZeneca over the next few weeks.
An additional $25 million milestone will be payable to Pozen if the drug receives marketing approval as well as pricing and reimbursement approval in a major non-U.S. market. The firm notes that AstraZeneca submitted an MAA to the European Medicines Association for Vimovo in October 2009. Pozen could in addition receive up to $260 million in sales performance milestones.
Pozen and AstraZeneca signed their global collaboration for Vimovo in August 2006. Under the terms of the agreement, Pozen received an upfront fee of $40 million and was eligible for potential aggregate development and regulatory milestone payments of $160 million. Pozen retained responsibility for the development and regulatory clearance of the drug in the U.S., with AstraZeneca taking on all non-U.S. development and regulatory activities for the drug as well as all aspects of manufacturing, marketing, sales, and distribution worldwide.