NEW YORK, Aug. 13, 2007 LAWFUEL.com – The Litigation Newswire — The Brualdi Law Firm announces that a securities class action lawsuit has been commenced in the United States District Court for the Middle District of North Carolina on behalf of purchasers of POZEN Inc. (“POZEN”) (Nasdaq:POZN) publicly traded securities during the period between July 31, 2006 and August 1, 2007 (the “Class Period”).
No class has yet been certified in the above action. Until a class is certified, you are not represented by counsel unless you retain one. If you purchased POZEN common stock during the period described above, you have certain rights, and have until no later than 60 days, in which to move for Lead Plaintiff status. Any member of the purported class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.
To be a member of the class you need not take any action at this time, and you may retain counsel of your choice. If you wish to discuss this action or have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Tali Leger, Director of Shareholder Relations at The Brualdi Law Firm, 29 Broadway, Suite 2400, New York, New York 10006, by telephone toll free at (877)
495-1877 or (212) 952-0602, by email to [email protected] or visit our website at http://www.brualdilawfirm.com/
The complaint alleges that the Company’s lead product candidate during the Class Period was Trexima, a combination of sumatriptan — the active ingredient in GlaxoSmithKline plc’s current blockbuster migraine drug Imitrex — and naproxen sodium, the active ingredient in many over-the-counter common pain medicines such as Aleve. POZEN was developing Trexima pursuant to an agreement with GlaxoSmithKline. If approved, GlaxoSmithKline would market Trexima and POZEN would receive royalty payments. The Company first sought regulatory approval of Trexima in August of 2005. That request was delayed in June 2006 when regulators asked for more safety information on the drug’s effect on the heart. On July 31, 2006, the start of the Class Period, defendants announced they had reached an agreement with regulators requiring only that the Company gather and produce study data defendants said they (and GlaxoSmithKline) already had which would satisfy the regulator’s limited concerns about Trexima’s cardiovascular safety. Throughout the Class Period defendants provided multiple false status updates regarding the approval process and the drug’s safety profile.
Then, on August 2, 2007, before the market opened, defendants announced that regulators would again delay approval of Trexima, now requiring that POZEN address potential safety implications indicated by the very preclinical data POZEN provided the regulators in which increased tumor/cancer risk was seen when naproxen sodium and sumatriptan were combined, but not with either component alone. Defendants also disclosed that their July 2006 “agreement” with regulators actually required additional clinical data/testing on Trexima’s effect on blood pressure.
According to the complaint, the delays in regulatory approval diminished the drug’s commercial viability and POZEN’s future profitability. On news of the mandatory delay, POZEN shares — which had traded above $19 per share in recent days reflecting the market’s anticipation of imminent regulatory approval based on defendants’ false statements – fell to below $10 per share in intra-day trading, or over 45%, on volume of over 16 million shares.