POZEN Inc.

POZEN Inc.

Per wrote:

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Vagnum wrote:

hallo vagnum

noch sind wir ja noch über 1100 :roll:

hatte gestern keine zeit was zu machen.

behalte POZN im auge und reagiere dann situativ.

es kommen ja immerhin die zahlen und die EU zulassung? ende august?

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Ja die EU Zulasung kommt sehr warhscheinlich schon bald. wann genau weiss ich auch nicht. die Zahlen kommen am 3.August. ich muss nochmals zu Hause recherchieren. Die verkäufe für Vimovo starten diesem Sommer.

http://tinyurl.com/339ecer

ich bleibe hier bereit einzusteigen. denke nach dem Release der Zahlen. auch so um die 7.50$ wäre gut.

POZEN Inc.

Datum : 03/05/2010 @ 11h35

Quelle : Dow Jones News

Name : Pozen Inc. (POZN)

Kurs : 8.01 -0.09 (-1.11%) @ 07h22

UPDATE: Pozen, AstraZeneca Get FDA Approval For Arthritis Drug

Pozen (MM) (NASDAQ:POZN)

Historical Stock Chart

3 Monate : April 2010 bis July 2010

Pozen Inc. (POZN) and AstraZeneca PLC (AZN, AZN.LN) received U.S. Food and Drug Administration approval for Vimovo, an arthritis drug that combines a generic painkiller with popular heartburn pill Nexium.

The drug attempts to avoid the risk of stomach ulcers that can occur with commonly used pain drugs, aiming to fill a niche left open from the decline in use of a class of painkillers known as Cox-2 inhibitors. Vimovo is a combination of naproxen, an anti-inflammatory pain reliever, plus Nexium, AstraZeneca's blockbuster heartburn pill that had $4.96 billion in sales last year.

Shares of Pozen recently rose 5.1% to $11.40 and are up almost 90% for the year.

Pozen will earn a $20 million milestone payment from AstraZeneca for the FDA approval, and is also eligible to get up to $260 million in sales performance milestones, according to regulatory filings. It will receive a low double-digit royalty on annual U.S. sales and royalties ranging from the mid-single digits to the high-teens on sales outside the U.S.

If Vimovo gets approval and pricing authorization in one overseas market later this year, or in early 2011, Pozen will get a $25 million milestone payment, Chief Executive John Plachetka said in a conference call Monday.

Pozen uses an "outsourced business model," meaning it has no manufacturing or research and development operations of its own. It has fewer than 30 employees and spends about $15 million a year on research and development, Plachetka said.

Jefferies analyst Eun Yang projects peak annual sales of Vimovo at $300 million and expects it to launch in late summer, calling it a "modest" product for AstraZeneca.

Yang said Vimovo, as a combination product, mainly provides convenience to patients and could face insurance reimbursement challenges.

Pozen already sells Treximet, a two-drug combination for migraines, with GlaxoSmithKline PLC (GSK, GSK.LN). It had 2009 sales of $86.1 million, generating royalty revenue of $4.3 million for Pozen.

Glaxo and Pozen are fighting off generic challengers to Treximet and Yang expects Vimovo to face a similar patent challenge once generic Nexium enters the market in 2014.

Pozen and AstraZeneca signed a license agreement in August 2006 to develop Vimovo after safety issues arose in Cox-2 inhibitors, including Merck & Co.'s (MRK) Vioxx and Pfizer Inc.'s (PFE) Celebrex. Those drugs were designed to reduce the gastrointestinal side effects seen in older drugs like naproxen.

Merck withdrew Vioxx from the market in 2004 after it was linked to an increase risk of heart attacks and strokes. In an earlier study involving both Vioxx and naproxen, there were five times as many heart attacks among those taking Vioxx as in the naproxen group.

The following year, the FDA asked Pfizer to pull Bextra, but has allowed Celebrex to remain with strong warnings.

Vimovo offers naproxen's pain relief while Nexium, known as a proton-pump inhibitor, alleviates some of naproxen's gastrointestinal side effects such as ulcers and bleeding. Warnings of those side effects, along with details of the cardiovascular risks carried by nonsteroidal anti-inflammatory drugs like naproxen, are prominent on Vimovo's label.

The twice-daily pill was approved to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug-associated gastric ulcers.

In a clinical trial of the drug, there was a 4.1% incidence of ulcers in Vimovo patients, compared to 23.1% among patients taking a coated form of naproxen. In a second similarly structured study, the incidence was 7.1%, compared to 24.3%.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

(Shara Tibken and Peter Loftus contributed to this story)

POZEN Inc.

go POZN go....

bin ja wieder dabei :mrgreen:

robert wird es schon richten !

POZEN Inc.

Per wrote:

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go POZN go....

bin ja wieder dabei :mrgreen:

robert wird es schon richten !

POZN sieht gut aus. halten... 7.93$ wurden genommen. :):)

POZN doofe Aktie mit viel Potential

sehr wichtiger text für die Zukunft

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Pozen’s PA Offers Big Potential

By: Jason Napodano, CFA

August 04, 2010 | Comments: 0

Recommended this article (2)

POZN

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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

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 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.

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http://www.zacks.com/stock/new…s+PA+Offers+Big+Potential

POZEN Inc.

Ich denke ein Einstieg bei POZN ist gerade interessant? Was denkt Ihr?

POZEN Inc.

Vielen Dank für deine Info. Ich weiss eben nicht, ob ich nun einsteigen soll oder noch etwas abwarten soll. Charttechnisch gesehen wäre ein Einstieg sicher nicht so schlecht. Was denkst Du?

POZEN Inc.

equity holder wrote:

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Charttechnisch müsste sie einbisschen mehr performen. Ich warte bei POZN noch einbisschen ab. Einen Einstieg werde ich erst bei einem klaren Signal tätigen. Nächste Woche werde ich mir einen besseren Einblick verschaffen können.

zum glück muss ich da nicht mehr abwägen.

bin schon wieder dabei :mrgreen:

go POZN go.............

POZEN Inc.

equity holder wrote:

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POZN gefällt mir so langsam aber sicher mehr und mehr.

equity holder

ohhh, deine worte gefallen mir :mrgreen:

das börsen heigh light des tage!!!

POZEN Inc.

heute rauscht POZN an die 8er grenze !!

freitag 13 :lol: gooooooo

POZEN Inc.

equity holder wrote:

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POZN gefällt mir so langsam aber sicher mehr und mehr.

equity holder

hmmm...bin immer noch investiert ! wann kommt dann bald die EU zulassung? finde einfach nichts. keine echten news.

gefällt dir POZN immer noch ?

POZEN Inc.

Blindflug

POZEN Inc.

Fine-Tuner wrote:

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Blindflug

?????????? weiss nicht was du damit meinst?

POZEN Inc.

Wann ist die Europa-Zulassung für Vimovo? Kann auf die schnelle nichts finden...

Danke für die Info

POZEN Inc.

Press Release

POZEN To Present at the UBS 2010 Global Life Sciences Conference

CHAPEL HILL, N.C., Sep 08, 2010 (BUSINESS WIRE) --

POZEN Inc. (NASDAQ: POZN) announced today that Elizabeth A. Cermak, the Company's Executive Vice President and Chief Commercial Officer, will present at the UBS 2010 Global Life Sciences Conference on Monday, September 20, 2010 at 2:30 p.m. (EDT), at the Grand Hyatt Hotel in New York City. Ms. Cermak's presentation will be webcast and archived on POZEN's home page at http://www.pozen.com.

About POZEN

POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to their customers. The Company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN". For more detailed company information, including copies of this and other press releases, please visit: http://www.pozen.com.

SOURCE: POZEN Inc.

POZEN Inc.

Bill Hodges, Chief Financial Officer

919-913-1030

POZEN Inc.

wird langsam zu meinem sorgen kind :cry:

ok, habe ja noch roche :lol: