[surf1944]

7:33AM POZEN beats by $0.04, misses on revs (POZN) 5.93 : Reports Q1 (Mar) loss of $0.19 per share, $0.04 better than the Thomson Reuters consensus of ($0.23); revenues rose 9.8% year/year to $4.5 mln vs the $4.6 mln consensus. At March 31, 2011, cash, cash equivalents and short-term investments totaled $56.8 mln compared to $64.1 mln at December 31, 2010. The co had an accounts receivable balance of $4.5 mln from GlaxoSmithKline and AstraZeneca at March 31, 2011. Co expects that patent litigation costs will be substantially less than the $9.4 mln spent in 2010. Co states that given that the final verdict on the Treximet patent litigation has not been issued, and the VIMOVO launch is still in its early stages, the co will not provide annual financial guidance at this time.

[surf1944]

7:31AM POZEN and AstraZeneca (AZN) file patent infringement lawsuit against Dr. Reddy's (RDY) (POZN) 5.78 : The filing of this patent infringement lawsuit by AstraZeneca and POZEN within forty-five days of receipt of Dr. Reddy's Notice Letter will result in the FDA automatically instituting a stay, or bar, of final approval of Dr. Reddy's ANDA for up to 30 months or until a final court decision is entered in the infringement suit in favor of Dr. Reddy's, whichever occurs first. VIMOVO currently has regulatory exclusivity through April 30, 2013. POZEN and AstraZeneca have full confidence in and will vigorously defend and enforce its intellectual property protecting VIMOVO.

[surf1944]

8:02AM POZEN announces preliminary injunction ordered in POZEN Treximet patent litigation (POZN) 5.82 : Co announced that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical (PRX) not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes with Treximet sold by GlaxoSmithKline (GSK) in the US under an exclusive license from the co. The order was entered in connection with the patent infringement lawsuit pending among the co and Par, Alphapharm, Teva Pharmaceuticals (TEVA), and Dr. Reddy's (RDY) relating to the submission to the FDA of Abbreviated New Drug Applications (ANDAs) by the four generic companies and the generic companies' plans to market sumatriptan and naproxen sodium products pursuant to such ANDAs, which the cocontends infringe three of its patents covering Treximet.

[Baldpiggy]

Something is cooking

UP big in AH

[1millman]

Got in this morning. Looks like a sleeper.

[Baldpiggy]

POZEN Announces Licensing Deal with Cilag GmbH, A Division of Johnson & Johnson, for MT 400, Migraine Treatment


http://www.businesswire.com/news/home/20110323005170/en/POZEN-Announces-Licensing-Deal-Cilag-GmbH-Division

[Sola Fide]

Looks like the insiders took the opportunity to dump a bucket of shares....sad indeed.

[Sola Fide]

Posted Great results for 2010. Webcast today @ 11am.
Looks like some knew the results yesterday, apparent by the volume and strong move up.
Anticipate a continuation today...

[QualityStocks]

POZN Video Chart 3/3/11

http://www.qualitystocks.net/videocharts.php

Pozen Inc. is not a current client of QualityStocks

[invest2win]

What happened to this crappy stock anyway? It has never recovered from the Approval down fall. Go figure!

[Baldpiggy]

I am LONG....but this has had GARBAGE performance


Anyone have any insight?

[Topgun21]

Proper Valuation with Vimovo sales Exploding etc..

WE shall see, I think POZN belongs at $9 share minimum!

Tim

[Baldpiggy]

What is coming up in Q1 of 2011?

[Topgun21]

Hmm...
Things should shape up nicely here starting Q1 2011!


Tim

[Topgun21]

Nice $25 million payment, things are adding up here nicely!

POZN, let's get to that fun 1st quarter 2011!!

Tim

[evo8asti]

Thanks! Looking to average down at these prices just need a few other stocks to get moving.

[Topgun21]

cool photo!!

[evo8asti]

Still here waiting.

[Topgun21]

POZN in sleeper mode till q1 of 2011!

This will be fun!

Go POZN!!

Tim

[Topgun21]

Hi EVO. COOL PHOTO! I think we are in a lull right now until q1 2011 to realize nice $$$ coming in for the EU 23 countries etc. I love POZN!!

Tim
Pozn

[evo8asti]

I agree.

[Topgun21]

POZN has huge things going for it...

Very nice to see!

Tim

[Topgun21]

POZN will be a double within 6 months in my humble opinion.

Tim

[Topgun21]

23 Countries.. Awesome!

Tim
POZN

[Baldpiggy]

European APPROVAL!!!

[dockside130]

I am dissapointed to tell you no one has been by the office to leave samples or detail the product. Appearently I am not on their target list at this time. I see a large amount of acute muscloskelatal injuries and write a lot of generic naproxen. So the fact they have not been by tells me they have not got their marketing act together. I actually sold some shares due to this.

[luvn socal]

any updates from your AZ rep?

[serlain]

Time to move north again. This has a huge potential. Target is 15$, so there's a huge discount.

[stocktrader001]

Pozen’s PA Offers Big Potential

By: Jason Napodano, CFA
August 04, 2010 | Comments: 0
Recommended this article (2)
POZN
Print Share
With the approval of pain drug Vimovo in late April 2010, Pozen (POZN - Analyst Report) now has two approved products on the market. AstraZeneca, Pozen’s commercial partner on Vimovo, should be in position to launch the drug later in the third quarter 2010.

Pozen’s first commercial product, Treximet, for migraines, posted sales of roughly $24 million in the second quarter at partner GlaxoSmithKline. This resulted in a royalty payment from Glaxo to Pozen of approximately $4.1 million. Both products were developed in-house using Pozen’s proprietary technology.

But Pozen isn’t done yet. The company is currently in phase III trials with its next commercial candidate, PA. PA is a “safer aspirin” that incorporates an immediate-release formulation of omeprazole for gastro-protection surrounding a pH sensitive aspirin. The opportunity with PA is significant, in our view.

Over 50 million Americans use aspirin daily for cardiovascular disease prevention. In 1988, the U.S. FDA approved the use of aspirin for the prevention of recurrent myocardial infarction (MI). Since that time, data reported in The Lancet from the ISIS-2 (2nd International Study of Infract Survival of MI) demonstrates that daily use of high-dose aspirin reduces the potential for vascular mortality by 23% (p<0.00001) vs. placebo in the first five weeks following a heart attack. Long-term follow-up data suggest the benefit of daily aspirin use persists in the prevention of recurrent MI as long as 10 years post event.

However, despite these impressive statistics, daily aspirin therapy isn’t being used to the fullest potential given the risk of harmful gastrointestinal (GI) effects of high-dose aspirin, including GI bleeding and gastric ulcers. In fact, 20% of the people who take daily aspirin therapy are at high risk for serious GI complications. Roughly 25% discontinue therapy due to these GI side effects.

Both the American Heart Association (AHA) and the American College of Cardiology (ACC) recommend gastro-protective therapy in patients who take daily aspirin. However, only 50% of the patients comply. That means potentially 50% of patients that are at risk for developing GI-related complications due to aspirin therapy (ulcers / bleedings) are not taking a gastro-protective.

Instead of taking a standard dose (325mg) of aspirin, patients and physicians are migrating down to less-effective doses at 81mg. In fact, the AHA and ACC recommend daily aspirin use at 75mg to 162mg per day, about one-fourth to one-half of the standard dose. These guidelines were put into place to reduce the potential for GI-related bleeding events. Data published in the American Journal of Cardiology shows a 2-fold reduction in major bleeding events and a 3-fold reduction in total bleeding events on daily aspirin use <100mg when compared to use >200mg.

Pozen’s PA-325/40 (325mg aspirin + 40mg omeprazole-IR) is designed to provide the full dose of aspirin therapy for secondary prevention of cardiovascular events, along with gastro-protection, in one pill. This should greatly work to improve effectiveness and compliance. Pozen’s initial market research shows that high receptiveness by both physicians (>60%) and patients (>75%) to PA-325/40 if approved. And, we note that Pozen plans to price PA-325/40 close to the generic components (we assume roughly $1/day), meaning that tier-2 and tier-3 open access if achievable with insurance providers.

Pozen is current enrolling two phase III programs at roughly 500 patients each under a U.S. FDA special protocol assessment (SPA) for PA-325/40. These programs began enrollment in October 2009. Enrollment should continue into the second half of 2011. Management has recently completed enrollment in a 400-patient long-term safety study with PA-325/40 as well. We believe management should be in position to file a new drug application (NDA) on PA-325/40 in 2012, potentially putting U.S. FDA action in 2013.

Besides secondary prevention of cardiovascular events, aspirin is widely used for the treatment of chronic pain in patients with osteoarthritis (OA). Pozen believes that there is a point of differentiation between a safer aspirin concept and commonly used NSAID products in the arthritis space.

All NSAIDs have a black box warning for cardiovascular risk. As such, the FDA requires a bolded risk on the label for contraindication in patients at risk for cardiovascular thrombotic events, myocardial infarction and stroke, or for patients undergoing at coronary artery bypass graft (CABG) surgery. Pozen’s PA-650/20 product could offer significant differentiation for the treatment of OA or chronic pain in a patient population at risk for cardiovascular or gastrointestinal disease.

Accordingly, management is looking to develop an even higher-dose PA product, PA-650/20, for pain. Pozen plans to meet with the U.S. FDA shortly to discuss plans for PA-650/20. However, we suspect that management will begin several non-pivotal programs with PA-650/20 before the end of the year.

These programs would include two trails: 1) a long-term safety trial, similar to the one currently ongoing with PA-325/40, seeking to enroll 300 to 400 patients, and 2) a phase III efficacy program in roughly 250 patients with an OA endpoint (WOMAC pain). Then, once these two programs are underway, management would begin the PA-650/20 registration program, which we expect to mirror the PA-325/40 design -- two phase III programs (300 – 400 patients in each) with a primary endpoint of cumulative incidence in gastric ulcers. A NDA for PA-650/20 is on deck for 2013.

Pozen’s PA franchise represents an attractive opportunity for investors. The company currently owns full rights to the product and is funding development of PA with its current cash balance (>$50 million on hand at the end of the second quarter) and the milestone and royalty payments coming from Treximet and Vimovo. If approved, we believe PA has $500+ million potential.

http://www.zacks.com/stock/news/38180/Pozen%92s+PA+Offers+Big+Potential

[$to©k_Pi©ker™]

Definitely going to be interesting what they report. Don't think they will have any write-downs, so the 20 million milestone payment they recieved will send them to a nicely profitable quarter. But it will be the GSK sales numbers that will ultimately push this much furter if they show a nice increase.

[stocktrader001]

tomorrow earnings Release POZN. trading in the red on a strong green day 7.90$. The company is expected to beat street consensus.

Analysts, on average, expect Pozen (NASDAQ:POZN) to report earnings of $0.49 on sales of $28 million on August 03, 2010.
For the full year, analysts expect the company to post a loss of $0.04. In the year-ago period, the company reported a loss of $0.14 on sales of $5 million.
In the previous quarter, the company reported a loss of $0.10, topping consensus estimates for a loss of $0.16.
SmarTrend is bearish on shares of Pozen and our subscribers were alerted to Sell on April 30, 2010 at $9.09. The stock has fallen 12.2% since the alert was issued./quote]

http://www.mysmartrend.com/news-briefs/news-watch/earnings-alert-pozen-expected-beat-street-consensus-when-it-reports-earnings-0

[$pmlg]

bulls in command here... look for a BB ride to 8.51

[dockside130]

Vimovo should be available in the pharmacy around the first of August. Official launch sounds like it will be in Sept. I am interested to see how it is priced.

[geodan]

thanks serlain, yep wish had bot more

XCHO another pain med stock, broke teh 50dma intraday today for first time in months, that might be a reversal point too.

Cheers

[serlain]

Nice buy, stock rose almost 10% since then.
Target is still far away.

[geodan]

Chart Setup is good on POZN here.

I just reopened position yesterday because like the chart on it. The MFI has bottomed out and gone over 20 on both weekly and daily chart.

I am not an expert at all on POZN fundementals, just know that when the good news came out from FDA the stock has tanked, be interested on long term holders opinion of it now, value wise.

I like pain med stocks, as see them as very recession resistant. Have started a new board just for pain med stocks, called Pain Med Investing http://investorshub.advfn.com/boards/board.aspx?board_id=18321

If antone wants to make a pitch for POZN there.

[$to©k_Pi©ker™]

interesting

keep us informed

[dockside130]

My AZ pharmaceutical rep said today they would begin detaining the new drug Vimovo the end of August. She is unable to discuss the drug until then.

[$to©k_Pi©ker™]

Likewise, i read elsewhere in an article but did not save link. I recall it saying 'expected late 2010'.

If i have time, i will do some digging.

[luvn socal]

You say that EU approval to come later this year...i have read elsewhere that it will be in the first Q 2011...just looking for clarification?

[bob smith]

agree, just waiting for this stock to settle down, would like to catch it on the upswing.

its below 4 Moving Averages, and its still bouncing....

gl

[$to©k_Pi©ker™]

I have yet to re-enter also. It's going to be soon though. EU approval expected late this year, combined with VIMOVO sales through astrazeneca.

Big 2011 coming.

[bob smith]

have been watching, but havent re-entered yet. was waiting for this to settle down after the run-up.

thanks for the article, have been folllowing one of the picks listed for the last 2 months.

gl

[Tina]

Thanks and still holding.

GLTA