POZN ($10.97)with FDA decision on Vimovo coming on (or before) april 30:
The decision whether or not to approve Pozen Inc.'s Vimovo, an investigational drug for the treatment of signs and symptoms of osteoarthritis , rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing *NSAID-associated gastric ulcers, will be issued by April 30. (*Non-steroidal Anti-inflammatory Drugs)
Vimovo is developed in partnership with AstraZeneca plc (AZN). The New Drug Application for Vimovo was submitted on June 30, 2009, and based on a standard 10-month review, the FDA decision date is April 30, 2010. Pozen's partner AstraZeneca is seeking approval of Vimovo in the European Union too.
Pozen, which has thus far received $80 million in upfront and milestone payments from AstraZeneca, is eligible to earn $20 million in milestone payment if Vimovo wins regulatory approval in the U.S. and another $25 million if the drugs gets approved outside of the U.S. Based on achievement of certain sales thresholds, Pozen is also entitled to receive sales performance milestones of $260 million.
Pozen shares, which have gained over 70% in the past three months, closed Friday's trading at $10.87 on a volume of 1.07 million shares.
