Key Developments For POZEN Inc.
POZEN Inc. (POZN.O) (Consolidated Issue listed on NASDAQ Global Market)
POZEN Inc. Announces Results Of Phase I Study Of Investigational PA65020
POZEN Inc announced the results of a Phase I study that showed a investigational combination of enteric-coated aspirin (EC-ASA) and immediate-release omeprazole known as PA65020, is associated with a significantly decreased risk of GI mucosal damage compared to analgesic doses (650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in healthy adults treated for one month. The randomized, double-blind study highlighted that the majority of patients taking over-the-counter EC-ASA experienced significant gastroduodenal damage. The data were presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting today in San Diego, CA. ACG presented the study with a Presidential Award for winning science.
AstraZeneca PLC And POZEN Inc. Submit EU Marketing Application For Vimovo-DJ
Dow Jones reported that AstraZeneca PLC said that it and POZEN Inc. have submitted a marketing authorization application in the European Union via the decentralised procedure for Vimovo tablets.
POZEN Inc. Announces Federal District Court Grants Motion To Dismiss Securities Class Action Lawsuit
POZEN Inc. announced that on September 29, 2009, the United States District Court for the Middle District of North Carolina granted the Company`s motion to dismiss a consolidated class action lawsuit against the Company, its chief executive officer and certain of its officers. The plaintiffs in the case had alleged, among other claims, violations of Section 10(b) and Section 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 arising out of statements made by the Company concerning its migraine drug candidate, Treximet, during the purported class period, July 31, 2006 through August 1, 2007 which were alleged by the plaintiffs to have been false or misleading. The Court dismissed the claims in their entirety with prejudice. Under the federal rules, the plaintiffs have a period of 30 days in which to appeal the court's decision.
POZEN Inc. Announces FDA Acceptance Of NDA For VIMOVO
POZEN Inc. announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for VIMOVO (enteric-coated naproxen / immediate release esomeprazole magnesium, formerly know as PN 400). 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 (PPI), under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated gastric ulcers.
POZEN Inc. Submits New Drug Application For VIMOVO (PN 400)
POZEN Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca PLC entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers.
