| Company: | POZEN Inc. |
| Ticker Symbol: | NASD: POZN |
| Class Period:: | July 31, 2006 to August 1, 2007 |
| Date Filed: | Aug-10-07 |
| Lead Plaintiff Deadline: | Oct-08-07 |
| Court: | Middle District, NC |
| Allegations: |
A class action 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").
The complaint charges POZEN and certain of its officers and directors with violations of the Securities Exchange Act of 1934. POZEN focuses on the development of drugs to treat migraine headaches.
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.
If you acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
The complaint charges POZEN and certain of its officers and directors with violations of the Securities Exchange Act of 1934. POZEN focuses on the development of drugs to treat migraine headaches.
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.
If you acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
