POZN class action suit

You fellas who got toasted by POZN might be interested in this, I know I am...

Summary of the Case:

A securities class action has been filed against Pozen Inc. (POZN) ("POZEN" or the "Company") on behalf of all securities purchasers from July 31, 2006 through August 1, 2007 (Class Period) in the United States District Court for the Middle District of North Carolina.  The complaint alleges that POZEN'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.

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.

 

Class Period:

July 31, 2006 - August 1, 2007
Lead Plaintiff Deadline:	October 9, 2007
Date Filed:	August 10, 2007
Court:	USDC, North Carolina (Middle)

Only when the government starts putting white collar criminals into hard core state prisons will these types stop doing what they have been doing for many many moons. Going to federal prison for a few months (a father of a friend of mine laughingly referred to his 6 month stint as a stay in the 'Florida Hilton") will never dissuade anyone who stands to bank millions. 

Vermeer,

This actually is for those who had shares and want to be part of the class action suit..usually companies settle, lawyers get a hunk and the investors get somthing out of it..

Reading the details of the suit allegations makes it look pretty bad on POZN though..trying to hand shake their way through approval and not address the issues correctly.

ACC,

Did you read the allegations? The company did little to address the concerns made from the last time it was declined..just banked approval on a study which didnt address the larger issues.

I felt duped after reading the details of the claim and felt that POZN was quite smug in how they handled things.

I hope you are right, but keep in mind the real big gain for Trexima was before the patent expired for Immitrex (sp) and by the time the next approval date comes it will be in generic form.

POZN at 40 means they get Trexima and two to three other combo therapies approved..it cannot get to 40 based on Trexima alone, especially with Immitrex being off patent..

ACC,

I will try and get the info I read, but from what I saw POZN knew about the problems which were the cause for the approvable letter which killed us trading wise.

I think based on Immitrex going off patent, the appeal to doctors to subscribe drops dramatically..and I even wonder if with approval the stock goes to those levels this time (meaning prior to the approvable letter)

ACC,


Read the first post, the lower portion..looks to me that POZN didnt really do much outside the small study class.. I wonder if the FDA was a bit miffed at the fact POZN didnt really do much else to address issues brought up.

I think they lose the CA suit..usually companies settle and pay the attorneys, the investors get scraps..

acc,

Interesting possible scenarios..

What about the issue with GSK losing Immitrex patent before any of these events takes place?

The real money was to be made within the previous 9-12 months, but even at best case scenarios, they wont be to market for around another year..

I also think the FDA will require some extensive studies, not just scientists who give an opinion..they said NO and that wont be resolved by some high paid scientists. They will need a large study class and a good ammount of data which leans to your #3 and worst looking scenario.

I still think this delayed approval takes a HUGE chunk of potential profit from both parties..and who knows with all the bad pub on the Trexima if physicians are going to jump all over it if/when approved?

ACC,

Why the 17.50s?

Go with the 15s or 12.50s.

It might cut your number in half contract wise but you are buying down 2.50 in strike!

accventures,

Only 2k in total?

I hope it works out for you..