Pozen Inc. (POZN)

[IPO$]

I was told it was for SH's of record on 12/30 with payment in January....which is right???

[$$$eeker]

$POZN Pozen will pay $1.75 special dividend in December
Pozen says it will return cash to shareholders with special dividend of $1.75 in December.

CHAPEL HILL, N.C. (AP) -- Drugmaker Pozen said Thursday it will pay a special cash dividend of $1.75 as it has a "surplus of corporate cash."

Shares jumped 82 cents, or 12 percent, to $7.62 in after-hours trading.

Pozen Inc. said it will pay the dividend on Dec. 30 to shareholders of record as of Dec. 11.

http://yhoo.it/19VDFpQ

[IPO$]

How come the IHub board does not show any dividends. It says "N/A".

[IPO$]

that is a 20% dividend....is it cash or stock dividend?

[$$$eeker]

$POZN some people are buying for the $1.75 per share dividend at end of month.

[IPO$]

POZN has already made a 50% run this month, has doubled in price over 52 weeks, and has $.75 loss per share with a 1.94MM short interest or 7% of the float. Why would one buy this stock?

[jooo2222]

This wil become a 10 bagegr or even a 100 bagger over time.

Do the math yourself
30 million shares (one of the lowest in this sector)
$80m cash and no debts what so ever!!!
only 30 people get a salary
CEO owns a lot of shares and he is the founder!!!
Already 2 drugs approved by the FDA who were based on the same technics = approval very likely !!!
The FDA date is Januari the 24th.....(2014)
POZN has a 22% deal with Sanofi for all sales in the USA. This new drug, PA, is a better Aspirin. And Pozn asked Sanofi to sell it at the same price then the generic version, at $1/day
PA is 100% same as Aspirin, but, dalily taken Aspirin causes bleeding ulcers by 24% of the patients. Daily takers of PA will not have that problem anymore!!!
The insurance will pay back everything, so the patients are paying $360/year, but in fact will get the drug for free and by taking the drug, the chences to get heart troubles or cancers are reduced by about 25%.
ALl people older then 50 should be on daily Aspirin. There are 80 million people in the USA and 900 million people world wide older then 50.
In the USA, around 50 million are already on daily aspirin. If POZN/SANOFI can get 10% of this population we are talking about a pPS for POZN at around $330/share
Why? Because 5 million patients pays $1.8billion to Sanofi and POZN gets 22.5% = $400M/year = $13.5/share
Because the generic version costs as much as the approved version, all patients will stay on PA. Which means this income is steady year over year and POZN will start paying dividends. A P/E of 25 give a PPS of $330.
In case 20% of the patients take PA, this will more then double... and today POZN is at $6.
JAZZ also was at $6, Acor as well and amny others who became successful in launching a good drug.

[Psionic Trader]

POZN $5.87 Breaking out!

[buckiii2]

There will be buying tomorrow.

[Penny Roger$]

~ $POZN ~ Daily Par Sar Buy Signal ~ Criteria alert triggered during a recent trading session!

$POZN has just triggered the "Parabolic SAR Buy Signals" scan criteria at Stockcharts.com
~ http://tinyurl.com/SAR-BUY ~







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c

[surf1944]

7:30AM POZEN announces FDA acceptance of filing of New Drug Application for PA32540/PA8140 tablets (POZN) 5.22 : Co announced that the FDA has accepted for review, the New Drug Application (NDA) for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA also indicated the review classification is Standard; therefore, the user fee goal date is January 24, 2014. Pending FDA review and approval, an indication is sought for PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

[mlkrborn]

POZEN: Presence of gastric erosions in patients taking low-dose aspirin for secondary cardiovascular prevention may result in a 2-fold increase in future gastric ulcers (POZN) 4.96 : Co presents data from a post-hoc analysis of Phase 3 data from the investigational compound PA32540. The analysis of patients screened for the Phase 3 studies demonstrated that at any time point, over 4% of subjects on low dose aspirin for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers that go undetected. In addition, the analysis demonstrated that even the presence of small lesions known as endoscopic gastric erosions in aspirin-users was associated with a 2-fold increased risk of future development of endoscopic gastric ulcers.

Key Findings of Post-Hoc Analysis

The baseline rate of gastric ulcers in the screening of the general population of adults using ASA (325 mg) for =3 months for secondary cardiovascular prevention was 4.4%, and was 5.7% for both gastric or duodenal ulcers.
In the post-hoc analysis of subjects with and without gastric erosion at baseline endoscopy, the presence of gastric erosion at baseline was:
Predictive of a higher rate of subsequent gastric erosions for both EC-ASA (325 mg) and PA32540.
Associated with a significant propensity toward future gastric ulcer development in subjects treated with EC-ASA (325 mg), but not in those treated with PA32540.
In patients with baseline gastric erosions, a significantly higher percentage of patients taking EC-ASA (325 mg) developed a gastric ulcer over the six month study period than patients taking PA32540 (13% vs. 4.2%).

Co states these data highlight the need for physicians to identify aspirin patients at risk, and, where appropriate, prescribe gastroprotective agents. Based on American Heart Association and American College of Gastroenterology recommendations, the preferred gastroprotective agents are proton pump inhibitors.

[Ipbyrne]

POZN - Poising For A Loss(REPORT)

Read the full report here.

http://www.theddreport.com/1/post/2013/04/due-diligence-report-pozen-inc-poising-investors-for-a-loss.html

[surf1944]

7:33AM POZEN reports results from a Burden of Cardiovascular Disease Study: presentation demonstrates cost reduction when PPI used in combination with aspirin for both commercial and medicare populations (POZN) 4.69 : Co announces it presented the abstract, The Burden of Secondary Cardiovascular Disease in Commercial and Medicare Patients: A Managed Care Perspective. The secondary prevention of cardiovascular events includes the daily use of aspirin.

Co highlights chronic aspirin therapy is associated with significant gastrointestinal toxicity including dyspepsia, gastric ulcers and GI bleeding, all of which contribute to the disease and cost burden of secondary prevention. The GI toxicity of aspirin can be mitigated by the use of proton pump inhibitors. The Xcenda analysis demonstrated that the prevention of cardiovascular events with aspirin, plus a PPI, compared to aspirin alone is associated with a net per-patient per-year cost decrease of $103 and $145 and a potential overall cost decrease of $1.8 mln and $11.0 mln for a typical one million-member Commercial and Medicare Plan, respectively.

[surf1944]

7:30AM POZEN submits new drug application for PA32540/PA8140 (POZN) 5.24 : Co announced the submission of a New Drug Application to the FDA for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.

[surf1944]

7:30AM POZEN reports European Patent Office maintains PA/VIMOVO patent (POZN) 5.96 : Co announces that the Opposition Division of the European Patent Office has maintained the granted European patent, EP1411900, entitled Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs, which covers VIMOVO and its PA product candidates. The patent claims maintained in the opposition proceedings relate to combinations of proton pump inhibitors (PPI) and non-steroidal anti-inflammatory drugs.

The Opponent has the option of appealing the decision of the Opposition Division until May 5, 2013, which is two months from the date of the Opposition Division's written decision. Co expects the appeals process, if initiated, to take two years until a final decision of the Board of Appeals is rendered.

[surf1944]

7:30AM POZEN presents positive PA32540 Phase 3 data at the 2013 International Stroke Conference (POZN) 5.46 : Co presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7. According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%). PA32540 is associated with a lower rate of endoscopic gastroduodenal mucosal injury with a similar cerebrovascular event profile as EC-ASA therapy. PA32540, a single tablet containing EC aspirin and IR omeprazole, has a lower rate of discontinuation and, hence, may improve long-term adherence to ASA therapy.

[surf1944]

POZN back on watch list.....

[surf1944]

7:36AM POZEN misses by $0.04, misses on revs; announces positive results for Phase 3 trial for PA32540, studies achieve primary endpoints (POZN) 5.41 : Reports Q3 (Sep) loss of $0.19 per share, $0.04 worse than the Capital IQ Consensus Estimate of ($0.15); revenues fell 81.6% year/year to $0.9 mln vs the $2.73 mln consensus.

Key Points:

POZEN is currently preparing the NDA for PA and is planning to seek approval for two dosage forms, PA32540 and PA8140.
Q3 2012 global net sales of VIMOVO delayed-release tablets, as defined under the agreement, were $13.4 million, up 38% from Q3 2011 but down 19% vs. Q2 2012.

Data for Phase III trial for PA32540

As previously disclosed, during a pre-submission meeting for the Company's NDA for PA32540, the FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of aspirin. POZEN continues to anticipate filing the NDA for both products in the first half of 2013.
POZEN announced positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540. Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone.
In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations due to any adverse events (6.7% vs. 11.2%).
In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540.

[surf1944]

POZEN POZN Ascendiant Capital Markets Buy $8.25

http://www.briefing.com/investor/calendars/upgrades-downgrades/

[surf1944]

7:30AM POZEN announces PA32540 provides superior antiplatlet effects over a standard of care regimen in a Phase 1 study (POZN) 6.64 : The data from the Co-Rx Study suggest that PA32540 given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in greater antiplatelet effects than synchronously administered EC aspirin, clopidogrel, and EC omeprazole, in healthy volunteers. These data were further presented at the European Society of Cardiologists 2012 Congress in Munich, Germany on August 26, 2012. PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.

[surf1944]

7:31AM POZEN beats by $0.08, beats on revs (POZN) 6.31 : Reports Q2 (Jun) loss of $0.17 per share, $0.08 better than the Capital IQ Consensus Estimate of ($0.25); revenues fell 60.9% year/year to $1.8 mln vs the $1.73 mln consensus. The Company is currently preparing the New Drug Application (NDA) and is planning to seek approval for two dosage forms of PA, PA32540 and PA8140. As previously disclosed, during a pre-submission meeting for the Company's NDA for PA32540, the FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of aspirin. In light of recent discussions with the FDA regarding the NDA for PA32540, we are continuing to re-evaluate financial outlook for the year, and plan to update when complete assessment.

[surf1944]

7:33AM POZEN receives patent on PA products for treatment of cardiovascular disease and osteoarthritis (POZN) 6.11 : Co announced that the United States Patent and Trademark Office has issued to POZEN U.S. Patent 8,206,741 titled 'Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs'. This patent includes claims to pharmaceutical compositions that contain aspirin and a proton pump inhibitor (PPI). POZEN's PA (PPI/aspirin) combination drug candidates are covered under this patent. The '741 patent is the second U.S. patent issued to POZEN for the coordinated delivery of NSAIDs, but the first in which the claims are focused on aspirin-based products.

[surf1944]

1:18AM POZEN presents data showing PA32540 provides faster gastric acid reduction than enteric-coated Omeprazole (POZN) 6.49 : Co presentes data from a Phase 1 study that found that the investigational compound, PA32540, provides faster protection compared with delayed-release, enteric-coated omeprazole, as measured by mean time to gastric pH. The Key Findings include: Mean time to first gastric pH >4 was significantly faster with PA32540 compared to the enteric-coated aspirin + enteric-coated omeprazole group; The percent time gastric pH >4 was 50.6% for PA32540 and 57.6 for enteric-coated aspirin + enteric-coated omeprazole group; The relative bioavailability of omeprazole following seven daily doses with PA32540 was 43% lower than that from enteric-coated omeprazole 40 mg.

[surf1944]

7:50AM On The Wires (WIRES) :POZEN (POZN) has entered into a license agreement with Desitin Arzneimittel GmbH, for the development and commercialization of MT 400 for the 27 countries of the European Union, as well as Switzerland and Norway.

[surf1944]

7:40AM POZEN reports EPS in-line, beats on revs; co is re-evaluating financial outlook for the year (POZN) 6.66 : Reports Q1 (Mar) loss of $0.28 per share, in-line with the Capital IQ Consensus Estimate consensus of ($0.28); revenues fell 71.1% year/year to $1.3 mln vs the $1.2 mln consensus. In light of the recent discussions with the FDA regarding the NDA for PA32540, they are re-evaluating their financial outlook for the year, which they will update when they complete their assessment.

[mlkrborn]

Pozen tumbles on delay for cardiovascular drug
Pozen falls after saying cardiovascular drug filing will be delayed; approval could be limited
Associated PressAssociated Press – 20 minutes ago
Companies:

POZEN Inc.
AstraZeneca PLC
AstraZeneca PLC

RELATED QUOTES
Symbol Price Change
POZN 6.26 -1.47
AZN.L 2,680.50 14.00
ZEG.DE 32.62 0.00
AZN 43.64 0.28
Fantasy Finance

NEW YORK (AP) -- Shares of Pozen Inc. dropped Friday after the company said approval for an experimental cardiovascular drug may be delayed, and it is possible the product's marketing approval will be limited.

THE SPARK: The drug, code-named PA32540, is intended as an alternative to aspirin as a secondary treatment for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers. PA32540 contains aspirin and omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

Pozen said Friday that the Food and Drug Administration has suggested it seek approval of a lower-dose version of PA32540 — one that contains 81 milligrams of aspirin instead of 325 milligrams. Pozen said the FDA might only be willing to approve the 325-milligram version for use in patients who have just had heart bypass surgery, and it may recommend that patients take the drug for only one year.

The Chapel Hill, N.C., company said it is gathering on the FDA's proposed version of the drug. It does not plan to conduct a late-stage clinical trial. Pozen had planned to seek marketing approval of PA32540 in the third quarter of 2012, but it said the process of collecting data might delay that filing for up to six months.

THE BIG PICTURE: Pozen gets most of its revenue from sales of the arthritis treatment Vimovo, which contains a combination of naproxen, a common painkiller, and esomeprazole magnesium, the active ingredient in the heartburn drug Nexium. That reduces patients' risk of developing ulcers, a common side effect of treatment with some arthritis drugs.

Pozen developed Vimovo through a partnership with British drugmaker AstraZeneca PLC. It reported about $34 million in Vimovo sales in 2011, with $21 million in the U.S. and $13 million from the 27 other markets where the drug is approved. Early this year Pozen said prescriptions in the U.S. have been flat "for a number of months."

AstraZeneca is continuing to pursue approvals in other countries, and Pozen said growth in other markets is solid.

SHARE ACTION: Shares of Pozen sank $1.44, or 18.6 percent, to $6.29 in afternoon trading. The shares have more than tripled in value since Nov. 23, and closed at $7.73 Thursday.

[surf1944]

POZEN POZN C.K. Cooper Buy $11

http://www.briefing.com/investor/calendars/upgrades-downgrades/

[jimmytrain]

looks like a run to me
$10 would be nice

[jasonchanning]

May 1st for earnings.

It should trade sideways for a while. Lols

[jasonchanning]

this thing is a bit toppy?

[Doc Schu]

Nice chart, this will fly on the news!!

[rqtect]

heating up

[bleu22]

Do you think this will get a nice pop today? When market open.

[surf1944]

7:30AM POZEN announces preliminary top-line results from two pivotal Phase 3 studies of PA32540: primary and secondary endpoints met (POZN) 4.80 : PA32540 is a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). The two Phase 3 pivotal trials were randomized, double-blind, multi-center studies in which a total of 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325 mg once daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once daily. The primary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 vs. 325 mg enteric-coated aspirin over six months, was met in both studies. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325 mg enteric-coated aspirin. Reported adverse events were consistent with the trial population and the known adverse event profile of aspirin and omeprazole. Further analyses of the data will be conducted, and presentation of the data at an appropriate upcoming scientific meeting, as well as publication of the full results, is planned.

[surf1944]

7:32AM POZEN beats by $0.04, reports revs in-line (POZN) 4.47 : Reports Q4 (Dec) earnings of $2.04 per share, $0.04 better than the Capital IQ Consensus Estimate of $2.00; revenues rose 151.7% year/year to $73 mln vs the $72.91 mln consensus. Co says :2012 is an important year for POZEN. We are completing the pivotal Phase 3 studies for our leading product candidate PA32540. We expect to have the results of the studies in the second quarter and plan to file the NDA in the third quarter. We have made the decision to find a partner or partners for this and the other PA assets and, with the assistance of Keelin Reeds Partners LLC, are in discussions with potential partners. We are continuing to perform critical pre-commercialization activities required to ensure a timely launch by an eventual partner. From a financial standpoint, in 2012 we expect our R&D costs will be substantially lower due to the completion of our PA32540 Phase 3 studies and we expect our SG&A to be slightly lower year on year. Our current plan targets a year-end cash and short-term investment balance of greater than $85.0 million..

[surf1944]

Pozen Inc

For many investors, the pharmaceutical sector has been a portfolio staple for a long time. Companies like Eli Lilly and Company (LLY) or Pfizer Inc (PFE) have been great holdings with steady increases in both dividends and stock price. Pozen Inc is one such company; located in the Research Triangle Park area of North Carolina, Pozen received FDA approval on two medicines it has developed. One of these formulas has the company poised to surge in 2012.

Anti-migraine medicine Treximet has been a strong source of income for Pozen. The income will continue as the company sold the royalty rights of Treximet to Pantheon Pharmaceuticals (PTI) for $75 million. Sold in November of 2011, this deal will create a strong revenue stream and boost the company in the coming year. Currently selling around $3.90, (about half of its 52-week high) the 1-year target is $5.50, representing an expected increase of nearly 30%. Although it is a relative newcomer in pharma, look for Pozen to be a strong mover in 2012, with many analysts considering it either a hold or a buy.

http://seekingalpha.com/article/316609-6-great-stocks-to-buy-now-for-profits-in-2012?source=yahoo

[Mr. Ideally]

Where are the people that bought back in October???

haha awesome POZN.

[BEIJING BILL]

POZN cumpany trading at cash on hand levels. now if yu add a multiple for vivimo and pipeline of 5x multiple yu can easily see $10-415 stok here.

this is long term play unles somebody make offer to snatch up cumpany for cheep price now.

[mlkrborn]

POZEN announced on Wed. night that it entered into a Purchase and Sale Agreement with CPPIB Credit Investments (POZN) 2.50 : CII purchased the co's right to receive future royalty payments arising from U.S. sales of MT 400, including Treximet, the co's sumatriptan/naproxen sodium product which incorporates the co's MT 400 technology. Under the Agreement, the co received a purchase price of $75 mln and will receive a 20% interest in any Royalties received by CII relating to the period commencing on April 1, 2018. The Agreement also grants CII the right to receive certain reports relating to the Royalty Entitlement, and certain audit rights relating to the Royalty Entitlement. In connection with the Agreement, the Company granted CII a first priority security interest in the Purchased Assets.

[Superfly15]

What a deal.

UPDATE 2-Pozen sells migraine drug's U.S. rights to Canada fund

Wed Nov 23, 2011 6:22pm EST


* Sells U.S. royalties right for $75 mln

* Will get 20 pct of U.S. royalties from April 2018

* Shares up 32 pct after market

Nov 23 (Reuters) - Pozen Inc sold its right to receive American royalties from its migraine drug to Canada's national pension fund, sending the pharmaceutical company's shares up as much as 32 percent in extended trade.

The company received $75 million for the deal and would get a fifth of any royalties received by the fund, CPPIB Credit Investments, from April 1, 2018, Pozen said in a filing.

GlaxoSmithKline holds the license to develop and market Trexmet in the United States, and Pozen has the right to develop and market a lower dose of the drug outside the country.

Under its agreement with GSK, Pozen currently receives 18 percent of the net sales of Treximet, which makes for over 80 percent of the company's total revenue.

In October, Pozen forecast full-year revenue slightly below estimates after a U.S. district court upheld the drugmaker's litigation involving several pharmaceutical companies which had filed for marketing approvals for generic versions of Treximet.

The drug, which has been receiving generic threats from companies like Par Pharmaceutical and Dr. Reddy's Laboratories, was approved in April 2008 for the acute treatment of migraine attacks in adults.

It shrinks the swollen blood vessels in the head and inhibits the enzyme responsible for pain and inflammation.

Shares of Chapel Hill, North Carolina-based Pozen, which have lost 62 percent of their value in one year, were up at $3.30 in after-market trading. They had closed at $2.50 on Wednesday

[mlkrborn]

POZN $2.45 POZEN presented positive results today from a Phase 1 study (POZN) 2.45 -0.05 : Co presented positive results today from a Phase 1 study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated omeprazole, enteric-coated aspirin and clopidogrel. "Although the clinical significance of these results is presently unknown, treatment with PA32540 may be a promising option for the secondary prevention of heart attacks and strokes in cardiovascular patients who require prolonged aspirin and clopidogrel therapy but are at risk for gastric ulcers and bleeding."

[surf1944]

7:33AM POZEN reports EPS in-line, beats on revs; reaffirms FY11 revs guidance (POZN) 2.52 : Reports Q3 (Sep) loss of $0.24 per share, in-line with the Capital IQ Consensus Estimate consensus of ($0.24); revenues rose 14.0% year/year to $4.9 mln vs the $4.84 mln consensus. Co reaffirms guidance for FY11, sees FY11 revs of $18-19 mln vs. $19.07 mln Capital IQ Consensus Estimate. Co is estimating 2011 operating expenses to be in the range of $45.5-$47.5 mln and estimating a full year net loss of $27-$29 mln. At the end of the year, they project cash and short-term investment balance to be in the range of $39-$41 million. In 2012, they expect that R&D costs will be substantially lower due to the completion of our PA32540 Phase 3 studies and their current plan targets a 2012 year-end cash and short-term investment balance of greater than $30 mln.

[surf1944]

7:31AM POZEN reports top-line data from long-term safety study of PA32540 - 'data support the possibility that long-term treatment with PA32540 may provide patients with a safe and effective option' (POZN) 2.84 : In this open label study, adverse events were consistent with what would be expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the PA components. The rate of discontinuation due to adverse events was low, and few patients developed major cardiovascular adverse events. Co stated "These data support the possibility that long-term treatment with PA32540 may provide patients with a safe and effective option for secondary prevention of cardiovascular events, including heart attacks and strokes," said Tomas S. Bocanegra, M.D., FACP, Executive Vice President of Development of POZEN. "We are pleased that the results of this trial support the safety profile that we expected for PA32540. As soon as we obtain the results of the two ongoing pivotal Phase 3 trials in the first half of 2012, we will have all of the necessary components for the PA32540 NDA which is scheduled for submission to the FDA during the second half of 2012."

[surf1944]

7:32AM POZEN sees FY11 rev below consensus (POZN) 2.26 : As a result of the successful patent defense, co expects the royalty from Treximet sales will continue at 18% of net sales, at least through the August 2017 patent expiry, assuming the Court of Appeals upholds the decision. If the pediatric extension is granted, the exclusivity period could extend to February 2018. Co sees FY11 revs $18-19 mln vs $19.85 mln Capital IQ Consensus Estimate; they see FY11 op-ex of $45.5-47.5 mln and a net loss of $27-29 mln... Treximet is marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline (GSK). The District Court ruled U.S. Patent Nos. 6,060,499 and 6,586,458 to be valid, enforceable and infringed by Par Pharmaceutical (PRX), Alphapharm, and Dr. Reddy's Laboratories (RDY). A third patent, U.S. Patent No. 7,332,183 (the '183 patent) covering the Treximet formulation was held to be valid, enforceable and infringed by Par and DRL. The '183 patent was not asserted against Alphapharm. Each of the defendants have appealed the decision to the U.S. Court of Appeals for the Federal Circuit.

[surf1944]

7:32AM POZEN announces engaging Keelin Reeds Partners LLC to assist with PA32540 strategic partner search (POZN) 2.41 : Co announces the selection of Keelin Reeds to assist in the strategic partner search for PA32540, currently in late Phase 3 development.

[mlkrborn]

POZN Slightly above $2.72 52 weeks low level and reversal is detected.

[surf1944]

7:32AM POZEN misses by $0.02, misses on revs (POZN) 4.53 : Reports Q2 (Jun) loss of $0.21 per share, $0.02 worse than the Capital IQ Consensus Estimate of ($0.19); revenues fell 83.7% year/year to $4.6 mln vs the $5.4 mln consensus. During 2011, co plans to continue the late-stage clinical development of PA32540, along with its pre-commercialization activities. Additionally, co expects that patent litigation costs will be substantially less than the $9.4 mln spent in 2010. 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 pany will not provide annual financial guidance at this time. At June 30, 2011, cash, cash equivalents and short-term investments totaled $52.6 mln compared to $64.1 mln at December 31, 2010

[surf1944]

Pozen brings in digital advisers
Triangle Business Journal - by Dale Gibson
Date: Tuesday, July 19, 2011, 9:32am EDT

John Plachetka heads up Pozen.
Steve Wilson

John Plachetka heads up Pozen.

Digital and drugs are two words you don’t find together often. Chapel Hill pharma believes the two can fit like hand in glove to more effective move drugs forward to commercialization.

PozenbizWatch (Nasdaq:POZN) has established a digital advisory board, which the company describes as made up of “an esteemed group of digital thought-leaders both in and outside of healthcare to help progress the Company’s vision for revolutionizing the traditional pharmaceutical commercial model.”

The board will be called on to help Pozen and CEO John Plachetka use digital technology to “more effectively and efficiently engage and communicate with customers.”

http://www.bizjournals.com/triangle/news/2011/07/19/pozen-brings-in-digital-advisers.html?ana=yfcpc

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Pozen sues, saying patent infringed
Triangle Business Journal - by Chris Baysden
Date: Tuesday, May 31, 2011, 5:01pm EDT

John Plachetka heads up Pozen.

It looks like Pozen is headed back to the courtroom.

The Chapel Hill pharma said in an SEC document Tuesday that it has filed a lawsuit against Sun Pharma Global FZE for patent infringement in the United States District Court for the Eastern District of Texas.

The lawsuit was prompted by Sun’s previous filing of an Abbreviated New Drug Application with the United States Food and Drug Administration seeking regulatory approval to market a generic version of Treximet, a Pozen migraine drug sold by GlaxoSmithKline (NYSE: GSK).

The announcement comes not long after Pozen (NASDAQ: POZN) announced that it had won a round in the patent litigation that is a common occurrence for pharmaceutical companies.

Treximet provides an important revenue stream for Pozen. In the first quarter, Pozen posted $4.5 million in total revenue – including $4.1 million from Treximet. Pozen is led by CEO John Plachetka.

Read more: Pozen sues, saying patent infringed | Triangle Business Journal