Unter Beobachtung: Macht Pozen [POZN] den Anlegern wieder Kopfschmerzen? - 500 Beiträge pro Seite

[Ackergaul]

Pozen hat sich die Weiterentwicklung pharmazeutischer Wirkstoffe auf die Fahne geschrieben. So sollen Effizienz und Sicherheit verbessert werden und dem Patienten nutzerfreundlichere Produkte ermöglicht werden.
Zu den Eckdaten des Unternehmens: weniger als 40 Mitarbeiter, "richtige" Umsätze (z.B. aus Verkauf der Produkte und / oder Royalities) werden NICHT erzielt - und dies alles bei einer stattlichen Marktkapitalisierung von 450 Mil. $!
2006 wurden Milestones von 13,5 Mil. $ kassiert bei Ausgaben von über 35 Mil. $ - unterm Strich blieb es bei einem Defizit von knapp 20 Mil. $ was 0,66 $ je Aktie entspricht. Die letzten Q-Zahlen (bis März): Netto-Verlust 2,1 Mil. $ (0,07). Das Cash Vermögen (plus kurzfristige) ist mit 58 Mil. $ noch beruhigend...

Key Statitics: http://finance.yahoo.com/q/ks?s=POZN
Und die Bilanz Seite: http://finance.yahoo.com/q/bs?s=POZN

Der Grund weswegen Pozen interessant ist, heißt erst einmal Trexima (MT-400). Trexima bekämpft Migräne und ist vom Pharma Riesen GlaxoSmithKline (GSK) lizenziert worden. Der Migräne Markt ist über 3 Billionen $ groß! GSK partizipiert dort bisher mit einem Drittel an den Umsätzen, mit ihrem Produkt Imitrex (Wirkstoff Sumatriptan). Dass Problem ist folgendes: Der Patentschutz auf Sumatriptan läuft aus! GSK sieht nun seine Umsätze schwinden, da die ersten Generika schon an die Türe klopfen... Nun kommt Pozen in die Story. Trexima (MT-400) ist ein Zwei-in-Eins Mittel, besteht aus den Wirkstoffen Sumatriptan UND Naproxen. Naproxen ist ein NSAID (non-steroidal anti-inflammatory drug). NSAID sind Schmerzmittel die alleine in den USA von 60 Millionen genutzt werden - jährlich gibt es dabei zahlreiche Beschwerden, sogar bis hin zu geschätzten 16.000 Todesfällen. Migräne Patienten werden gerne in der Kombination Sumatriptan / Naproxen behandelt, da die Ergebnisse hier gut sind.
Trexima sollte bereits 2006 auf den Markt kommen. Im Juni 2006 gab die FDA allerdings nur einen approvable letter heraus. Wer das Kürzel DNDN kennt, weiß welche Folgen dies auf den Kurs eines Unternehmens haben kann! Die Bedenken betrafen NICHT die Effektivität, sondern die (Langzeit) Sicherheit. Als im Dezember die neu eingereichten Unterlagen der FDA nicht reichten kam Angst auf, dass erst ein neuer Trial gestartet werden müsste, der die Bedenken der FDA ausräumt. Wie auch immer, POZN und GSK reichten neue Daten ein und Anfang Februar 2007 meinte die FDA, dass dies soweit genüge. Ein Auf und Ab!
Nun wird am 1. August über die Zukunft Treximas entschieden, zumindest ist das PDUFA dann angesetzt. Wird Trexima zugelassen wird Pozen aus Ihren Zick-Zack Kursverlauf ausbrechen, falls das Gegenteil eintritt, wird das wieder eintreten, was im Juni 2006 passierte!
GSK plant bereits eine sofortige Vermarktung (natürlich NACH einer eventuell positiven Zulassung), da Imitrex nach und nach durch Trexima abgelöst werden soll. Die Umsätze für Imitrex von knapp 1,2 Billionen $ (2006) wird das neue Präparat aber NICHT erreichen. Durch den Einstieg der Generika (z.B. von TEVA) werden die Preise wohl um mind. 50 % im Migräne Markt fallen. Die Trexima Umsatzprognosen für 2009 würden bei geschätzten 370 Mil. $ liegen.

Folgendermassen sieht der Deal zwischen GSK und POZN aus:
Total Upfront and Milestone Payments $160 million
- Upfront fee and milestone payment in 2003 $25 million [erledigt]
- Initiation of Phase 3 program $15 million [erledigt]
- Acceptance of NDA filing by FDA $20 million [erledigt]
- NDA approval and GSK notification of “intent to commercialize” $20 million
- Sales performance milestones based on achievement of certain sales thresholds $80 million
- POZEN Will Receive Royalties Based On Sales

Wie hoch die Royalties ausfallen, wird vom Unsatz abhängig sein (wahrscheinlich in einer Breite von 8 bis 17 % der Brutto Umsätze). Zum Rest der Pozen-Pipeline werde ich noch was schreiben. Zumindest soviel vorab: Da kommt noch was!


Kritisch hinterfragen muss ich mich doch, warum überhaupt so eine Zwei-in-Eins Tablette auf den Markt kommen soll? Wer will kann doch Sumatriptan UND Naproxen (also z.B. Imitrex und Aleve) einzeln verschreiben...
Eine optimale Dosisanpassung, praktikabler und nur noch eine Verschreibung sprechen wiederum dafür. Der eigentliche Grund ist aber wohl vielmehr, dass GSK die Preise wieder Firmenfreundlicher gestalten kann - im Kampf gegen Generika und dem damit drohenden Umsatzeinbussen!
Die Dosierung ist im Übrigen so gewählt, dass diese mit den vorhandenen Tabletten nicht nachgebildet werden kann… 85 mg Sumatriptan und 500 mg naproxen sodium. Glaxo hat noch die patentierte „RT Technology“ für Trexima beigesteuert, mit der erreicht werden soll, dass der Wirkstoff schneller in das Blut gelangen soll, also auch schneller wirkt.


Was mich noch bedrückt:
POZN hat es bisher nicht geschafft ein Medikament auf den Markt zu bringen:
Mai 2004 setzte es ein not-approvable der FDA für MT-100 (metoclopramide hydrochloride und naproxen) auf Grund möglicher Sicherheitsrisiken! Allerdings gab es ein marketing approval (zum MAA) in Großbritannien. Ach ja: Sicherheitsbedenken auf Grund des Wirkstoffes metoclopramide hydrochloride!
Oktober 2003 gab es ein not-approvable der FDA für MT-300. Die Patienten die MT-300 benutzten litten - im Vergleich zum Placebo - unter Übelkeit / Unwohlsein.

Zudem: Was mir nicht gefällt, ist dass das Management etliche Ihrer Aktien auf den Markt geworfen hat. Vertrauen in das eigene Unternehmen sieht anders aus… Bin mir nicht mehr sicher, wo ich es gelesen habe, aber ein Kommentar darauf war, dass dies „geplante“ Aktienverkäufe aus dem Jahre 2006 waren. Mit dem Hintergrund, dass der Verkauf somit eigentlich NACH dem erfolgreichen Trexima Approval stattfinden sollte (was wir mittlerweile wissen nicht eingetreten ist). Aber hierzu sollte sich jeder tunlichst seine eigene Meinung bilden!

Die Pozen Homepage: http://www.pozen.com/default.asp
Um einen Überblick zu erhalten, die aktuellste Präsentation: http://media.corporate-ir.net/media_files/irol/12/121701/Cit…
Was die Analysten denken / schätzen: http://phx.corporate-ir.net/phoenix.zhtml?c=121701&p=irol-ea…
Und das wichtigste, dass 2006er 10-K: http://media.corporate-ir.net/media_files/irol/12/121701/Poz…


Werde als nächstes zur Effizienz und dann zur Sicherheit Treximas etwas Kurzes schreiben.

[Ackergaul]

kurz vorab, aus aktuellen Anlass:
Die Senior Vize Präsidentin hat sich aus vermutlich gesundheitlichen Gründen zurückgezogen...
http://biz.yahoo.com/bizj/070611/1475515.html?.v=1
Wage zu behaupten, dass dies überhaupt keinen (ob negativ oder positiv) Einfluss haben wird.

Ein Blick auf die Ergebnisse zu Trexima

Es gibt zahlreiche Studienergebnisse zu Trexima, die im Internet zu finden sind… Zur Effizienz wird es wohl seitens der FDA nichts zu meckern geben! Die Ergebnisse sind hochsignifikant zugunsten Trexima. Einzig und alleine „absence of nausea” in der 2. Studie schneidet zum placebo nicht signifikant ab. Ist aus meiner Sicht aber zu bezweifeln, dass dies ein KO Kriterium ist.

Hier 2 Berichte, die für Treximas Wirksamkeit sprechen sollten:

1.)
Sumatriptan-Naproxen for Acute Treatment of Migraine
A Randomized Trial

Jan Lewis Brandes, MD; David Kudrow, MD; Stuart R. Stark, MD; C. Phillip O’Carroll, MD; James U. Adelman, MD; Francis J. O’Donnell, DO; W. James Alexander, MD, MPH; Susan E. Spruill, MS; Pamela S. Barrett, PharmD; Shelly E. Lener, PharmD


JAMA. 2007;297:1443-1454.

Context
Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy.

Objective
To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine.

Design, Setting, and Participants
Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack.

Interventions
Patients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain.

Main Outcome Measures
Primary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptan–naproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptan–naproxen sodium and each monotherapy.

Results
Sumatriptan–naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptan–naproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptan–naproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptan–naproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptan–naproxen sodium and sumatriptan monotherapy.

Conclusion
Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile.

Trial Registration
clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2)


Author Affiliations: Nashville Neuroscience Group, Nashville, Tenn (Dr Brandes); California Medical Clinic for Headache, Santa Monica (Dr Kudrow); The Innovative Clinical Research Center, Alexandria, Va (Dr Stark); Headache Institute, Newport Beach, Calif (Dr O’Carroll); Headache Wellness Center, Greensboro, NC (Dr Adelman); OrthoNeuro, Columbus, Ohio (Dr O’Donnell); Pozen Inc, Chapel Hill, NC (Dr Alexander and Ms Spruill); and GlaxoSmithKline, Research Triangle Park, NC (Drs Barrett and Lener).



2.)
Sumatriptan-Naproxen Combination Effective Against Migraine
Dual therapy targets multiple mechanisms.

The pathophysiology of migraine headache includes the release of vasoactive and inflammatory chemicals, resulting in vasodilatation and meningeal and vascular inflammation. Triptans and nonsteroidal anti-inflammatory drugs mitigate different parts of this cascade. Researchers assessed the efficacy of dual therapy in two manufacturer-funded, randomized, double-blind, parallel-group studies conducted in a total of 2956 patients at 118 U.S. clinical centers.
Patients aged 18 to 65 with at least a 6-month history of migraine headache and a monthly average of two to six moderate or severe episodes were randomized to one of four treatments to be taken after migraine onset: a single tablet containing either sumatriptan (85 mg) plus naproxen sodium (500 mg), sumatriptan only, naproxen only, or placebo. (We provide data only for 1 study when results for the 2 studies are statistically similar.)
After 2 hours, sumatriptan plus naproxen was significantly more effective than placebo for headache relief, defined as reduction of pain from moderate or severe to mild or none without use of rescue medications (incidence, 65% vs. 28%), absence of photophobia (58% vs. 36%), and absence of phonophobia (61% vs. 38%). Absence of nausea at 2 hours was significantly more common with combined therapy than with placebo in study 1 (71% vs. 65%), but not in study 2 (65% vs. 68%). The incidence of sustained ( 24 hours) pain-free response was significantly higher with combined therapy (25%) than with sumatriptan (16%), naproxen (10%), or placebo (8%). Although all groups had low rates (<5%) of adverse events, such as dizziness, paresthesias, and somnolence, the overall incidence of adverse events was significantly higher with combined therapy (27%) than with placebo (12%) or naproxen (13%), but not sumatriptan (24%).

Comment: Despite the introduction of seven different triptans, patients with migraine headache continue to have poor responses to myriad treatment regimens. Migraine remains a frequent cause of emergency department visits. This methodologically rigorous pair of trials, the first to study a triptan-NSAID combination, yielded very promising results and provides sufficient evidence to support the use of this combination therapy in the ED. The authors postulate that the two drugs confer complementary therapeutic effects and alter pharmacokinetics to prolong treatment benefits.

— John A. Marx, MD, FAAEM, FACEP
Published in Journal Watch Emergency Medicine April 20, 2007

Citation(s):
Brandes JL et al. Sumatriptan-naproxen for acute treatment of migraine: A randomized trial. JAMA 2007 Apr 4; 297:1443-54.


Leider fehlen mir die dazugehörigen Links, da ich mir die einzelnen Seiten heruntergeladen habe. Mit dem Titel (Überschrift) und Google solltet Ihr aber die Seite im WWW wieder finden!

Sorry also…

[Ackergaul]

Antwort auf Beitrag Nr.: 29.835.503 von Ackergaul am 12.06.07 08:29:42

Sicherheitsbedenken?

Für mich unmöglich zu überblicken und bewerten. Es gibt zumindest aus meiner Sicht keine großen Auffälligkeiten...
NSAID im Allgemeinen bergen die Gefahr eines Schlaganfalls oder sogar Herzinfarkt, Naproxen ist weniger „gefährlich“. Sumatriptan zeigte keine „echten Gefahren“. Die FDA will nun wahrscheinlich herausfinden, ob die Kombination der RT Technologie mit Sumatriptan und Naproxen sich negativ auf das Herz-Kreislauf System auswirkt. Ich habe bisher nichts finden können, was auf Probleme in dieser Richtung deuten könnte oder aber diese Bedenken entkräftet.
Dies wird wahrscheinlich der Kernpunkt sein, ob es eine Zulassung geben wird oder noch weitere Studien erforderlich sind! Die Aussagen die ich bisher gefunden / gelesen habe, deuten auf keine Probleme hin – dies ist allerdings keine Gewähr dafür, dass die FDA keine Probleme sieht!!!


Mayo Clin Proc. 2007 Jan;82(1):61-8.Links

Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.

Winner P, Cady RK, Ruoff GE, Frishberg BM, Alexander WJ, Zhang Y, Kori SH, Lener SE.
Palm Beach Headache Center, 4631 N Congress Ave, Suite 200, West Palm Beach, FL 33407, USA. [e-mail]

OBJECTIVES:
To evaluate the long-term safety and tolerability of sumatriptan-naproxen sodium for the treatment of moderate to severe acute migraines and to assess the safety of administration of an optional second dose.
PATIENTS AND METHODS:
A 12-month, multicenter, open-label safety study was conducted in adults treated for migraine attacks of moderate to severe intensity from April 14, 2004, to August 18, 2005. Safety evaluations included adverse events and laboratory tests.
RESULTS:
Of 600 patients enrolled, 565 (94%) were treated for at least 1 migraine. Of treated patients, 414 (73%) and 362 (64%) completed 6 and 12 months of treatment, respectively. Of the 24,485 attacks treated, 17,144 (70%) were treated with only 1 dose. On average, patients treated 5 migraine attacks per month, with a median of 6 days between attacks. The most common treatment-related adverse events were nausea, muscle tightness, and dizziness. Fourteen patients reported 1 or more serious adverse event with only 1 judged probably related to treatment. No deaths occurred. Eight percent of patients discontinued participation in the study because of adverse events or pregnancy. The rates of adverse events reported were no higher after treatment with 2 tablets (at least 2 hours apart) compared with 1 tablet.
CONCLUSIONS:
In this 12-month data set of more than 24,000 migraine attacks in 565 patients, sumatriptan-naproxen sodium formulated in a single tablet was well tolerated when used episodically for the treatment of acute migraine. The adverse events did not differ from those expected for the individual components alone, and no new or unexpected findings occurred.

PMID: 17285787 [PubMed - indexed for MEDLINE]

[Ackergaul]

Der Rest der Pipeline - die nächsten Anwärter…

Unter dem Kürzel „PN“ verbirgt sich ebenfalls großes Potential wie bei Trexima! 2006 wurde dazu ein Lizenzabkommen mit AstraZeneca unter Dach und Fach gebracht. Vorab mal die finanziellen Vertragseckpunkte:
Total Upfront and Milestone Payments $375 million
- Upfront fee $40 million [erledigt]
- Development and regulatory milestones $160 million
- Sales performance milestones based on achievement of certain sales thresholds $175 million
- POZEN Will Receive Tiered Royalties Based On Sales

Royalties wahrscheinlich in einer Bandbreite von 5…15 % gemessen an den (wohl wieder Netto-) Umsätzen. 2011 sind für PN 400 Umsätze von über 300 Millionen $ angedacht. So, klar ist was möglicherweise kassiert werden kann, aber was ist „PN“ überhaupt?
Ein „neuartiges“ Schmerzmittel, welches (wieder) Naproxen, aber nun mit dem proton pump inhibitor (PPI) esomeprazole magnesium (Nexium) kombiniert. Ganz kurz PPIs sind Mittel, die die Magensäure reduzieren sollen… PN 400 soll dafür sorgen weniger Magen-Darm Probleme bei Patienten mit Chronischen Schmerzen (wie z.B. bei Gelenkentzündungen) zu verursachen. Dadurch soll wohl das Risiko Geschwüre zu bekommen reduziert werden. Die PN Tablette soll für eine sofortige Freisetzung des PPI Bestandteils im Magen sorgen. Das NSAID besitzt eine pH sensitive Schicht und wird NUR bei einem geringerem Bestand an Magensäure freigesetzt. Klingt gut, ist aber mit Sicherheit sehr „tricky“…

Schaut Ihr auf die Pipeline Übersicht Pozens, so stellt Ihr fest, dass es da noch einen PN 200 Trial (und PN 100 gab) gibt, der schon ziemlich weit ist. Dieser ist im eigentlichen Sinne nur ein Testlauf für den PN 400er – ein proof-of-concept. PN 200 wurde mit omeprazole und NSAID getestet und ergab deutlich weniger Probleme der Magenschleimhäute im Vergleich mit der „Standardausführung“. Bis spätestens Ende dieses Jahres soll der eigentliche zulassungs- entscheidende Phase III Trial bei PN 400 schon gestartet werden. Somit könnte frühestens 2009 mit einem möglichen Verkaufsstart gerechnet werden. Noch Zukunftsmusik! Gute oder schlechte Meldungen zum PN 200 Trial sind also mit dem 400er in Verbindung zu setzen.


Auf die beiden restlichen Sachen gehe ich nicht so stark ein. Sind noch früh dran… obwohl ich mir gut vorstellen kann, dass „PA“ eine „große Nummer“ werden kann! PA soll das sichere Aspirin werden – also nun zum einen PPI mit dem Aspirin gekoppelt…
Dann ist da nur noch Lornoxicam. Ein NSAID, das 3000fach stärker als Aspirin und 400fach Ibuprofen übertreffen soll. Und das ganze soll NICHT das Herz-Kreislauf System in Mitleidenschaft ziehen, hmmmmmh…

[Ackergaul]

Antwort auf Beitrag Nr.: 29.867.296 von Ackergaul am 13.06.07 09:00:32

Was geht?

Wirft man einen Blick auf die Analysten, sind diese zumindest positiv (buy) von Pozen überzeugt. Ob man dem Glauben schenken kann? Im Durchschnitt sehen die Analysten dass kurzfristige Kursziel von 21,63 Euro – nach erfolgreicher Zulassung oder was? Bedenkt man das Risiko einer Nichtzulassung (der Kurs würde wohl wieder einen einstelligen Wert haben), scheint dies Investment nicht gerade lohnenswert. Dennoch sollte man sich die Produktpipeline wieder ins Gedächtnis rufen: Der eigentliche „Kurs Antreiber“ kann mit PN 400 erst noch kommen. Obwohl mir unklar ist, welcher der beiden (Trexima oder PN 400) der größere Umsatzbringer werden könnte – doch soweit ist man bei Pozen noch lange nicht, um davon zu träumen!

Auf der Seite 7 von 19 könnt Ihr von Jefferies (Analyst) einen kleinen Überblick erhalten, über deren Kernpunkte. Vor allem Interessant sind die geplanten Peak Sales zu Trexima und PN 400.
http://www.cetv-net.com/file/u/equity_research/Jefferries_9_…

Einen groben Überblick der sonstigen Bewertungen bekommt Ihr auf newratings!
http://www.newratings.com/analyst_news/search.asp?search=poz…

Die 2. Jahreshälfte könnte interessant werden. Es ist nicht alleine dass Trexima Urteil (Stichtag 1. August), sondern auch die PN 400 (PN 200) Trials. Mehrere Phase I Trials wurden dazu gestartet, die z.B. beurteilen sollen wie Essensreste sich auf das Medikament auswirken und so weiter und so fort. Ist also noch viel zu tun! Allerdings muss man es DEUTLICH sagen: Versagt Trexima ist Holland in Not (nicht wörtlich nehmen – nur ne Redensart)!

Der 2007er Fahrplan:
2Q 07 – PN 400 Phase I studies initiated
3Q 07 – Initiate PN 400 Phase III trials
3Q 07 – Meet with FDA on PA program
3Q 07 – FDA action letter on Trexima
2H 07 – GSK planned launch of Trexima
2H 07 – Meet with FDA on Lornoxicam program


Einen Blick auf die Shorts: http://www.nasdaq.com/asp/quotes_full.asp?mode=&kind=shortin…

Ein Überblick über die „Institutional Holdings“: http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol=PO…

Die Frage ist nun erst einmal, was man von diesem Unternehmen noch erwarten kann. Ein Blick auf den Langzeitkursverlauf (Auf und Ab) gibt eher Anlass zum grübeln, demnach wäre wieder mal eine gehörige Abwärtsbewegung drin.
Schätzt man die Zulassungswahrscheinlichkeit auf 70 bis 80 % ein, ist das Risiko für einen momentanen Einstieg doch sehr hoch! Ist aber noch genügend Zeit vorhanden sich über einen mögliche Einstieg klar zu werden...
Alternativ bietet sich ein Investment nach dem PDUFA an. Ist der Trexima Ausgang negativ, sollte getrost der Name Pozen aus dem Kopf gestrichen werden.

[Ackergaul]

Ich habe mal mehr oder minder ältere Artikel hier reingestellt. Bei den älteren Artikeln sind einige Daten, die vielleicht für jemanden von Interesse sind...

http://www.businessweek.com/magazine/content/06_09/b3973118.…
Pozen's Trexima: Going To Market With Glaxo
FEBRUARY 27, 2006
INSIDE WALL STREET

Attention, migraine sufferers: Help is on the way from Pozen (POZN ) in the form of Trexima, a new drug for severe headaches that analysts claim is more effective and faster-acting than GlaxoSmithKline's (GSK ) $1 billion-a-year blockbuster Imitrex. It's expected to get U.S. approval in the second quarter. Imitrex' patent expires in 2009, and Pozen has teamed up with Glaxo to market Trexima in the U.S. It will focus on Trexima once it gets O.K.'d, says Pozen CEO John Plachetka. Joshua Schimmer of investment firm S.G. Cowen expects the stock to outscore the market once the new drug is launched. It has already been on a tear, leaping from 8 in August to 17 on Feb. 15. Schimmer figures Pozen will earn 50 cents a share in 2009 and $1.55 in 2010. Nadav Hazan of SunTrust Robinson Humphrey says Pozen should get $20 million from Glaxo once Trexima is approved, on top of the $60 million it has already received. Through 2009, Hazan figures Pozen will get a 6% royalty on U.S. sales of up to $600 million, and 17% above that. In addition, Pozen has an arthritis drug in clinical trials, which the company claims is a lot safer than its rival painkillers.


http://www.pharmaceutical-business-review.com/article_featur…
Pozen: Trexima to outperform market expectation
28th February 2006
By Staff Writer

Datamonitor forecasts Pozen's migraine treatment to achieve $1 billion in sales in 2009.
Having failed to win the FDA approval for two previous compounds designed to treat migraine, Pozen is set to enjoy more success with Trexima. With US marketing approval anticipated in June 2006, Datamonitor forecasts the drug to grow its sales to $1 billion in 2009, well beyond Wall Street expectations, before its revenues decline as a result of generic pressure.
'Content Pozen is developing Trexima in collaboration with GlaxoSmithKline following a licensing deal struck in June 2003. GSK has strong experience marketing the oldest and best selling triptan, Imitrex. The company will now use its expertise to successfully promote Trexima, a combination of sumatriptan (the active triptan in Imitrex) and the non-steroidal anti-inflammatory drug (NSAID) in Bayer?s Aleve, which is already widely genericized.

Physicians are likely to be receptive to Trexima as they have a high level of familiarity with the approach of combining a triptan with a NSAID for migraine treatment. According to interviewed opinion leaders, the drug will also benefit from clinical data which is expected to demonstrate superior efficacy to Imitrex.

Given these factors Datamonitor expects Trexima to experience a fast ramp-up in sales, inheriting significant market share from Imitrex, and also taking share from other triptans. Upon approval Trexima's sales are forecast to grow from $65 million in 2006 to $1 billion in 2009, above Street expectations of $10 million and $626 million respectively.

With a lack of late-stage migraine treatments currently in development and coupled with the size of the migraine market, a disorder which is estimated to affect 28 million Americans, Trexima presents Pozen with a key opportunity. At the same time, Trexima is also important to GSK as Imitrex is set to lose US patent protection in 2009. GSK will attempt to use Trexima to help manage the life cycle of Imitrex, and turn that drug?s market share over to Trexima, whose patent does not expire until 2017.

However, although Trexima will experience rapid early uptake, sales of the drug will suffer following the emergence of generic sumatriptan in 2009. Datamonitor forecasts that generic competition will take 35% of the sumatriptan market in 2010, rising to 48% by 2012. Sales of Trexima will therefore decline to $933 million in 2010 and continue to erode to $735 million in 2012.


http://healthcare.seekingalpha.com/article/31862
Pozen's Trexima Begins Six Month FDA Review
Posted on Apr 10th, 2007 with stocks: POZN

Anthony Payne submits: Pozen (POZN) develops of products for the treatment of acute and chronic pain, and other pain-related conditions. Its principal product candidate, Trexima, is being developed in collaboration with GlaxoSmithKline (GSK) for the acute treatment of migraine. Trexima is a single tablet containing sumatriptan succinate (Imitrex, also sold by GSK) and naproxen sodium (contained in Aleve amongst other non-steroidal anti-inflammatories (NSAID)).

Recently the company published data which showed Trexima provided superior sustained pain-free results compared to sumatriptan or naproxen alone. On June 9, 2006 the company announced that the FDA had issued an approvable letter for Trexima and the company saw more than half of its market cap erased. The FDA had determined that Trexima was effective as an acute treatment for migraine headaches, but requested additional safety information. There were fears that Trexima might require new studies.

In November 2006, the company submitted further data as required but the FDA indicated that the reply was incomplete. However, in March 2007 POZN announced its amended response to the approvable letter had been accepted for review by the FDA. According to company the FDA plans a six-month Class II review that could result in an August 1, 2007 decision date on the drug. Pozen said the product could be available to patients in the second half of 2007, contingent on FDA approval.

It is clear from data that Trexima is more effective and faster acting than Imitrex alone. Imitrex which goes off patent in 2009 has annual sales of over $1 billion. Assuming approval in August, which is likely, POZN could receive milestone payments from GSK and a healthy royalty on future sales of Trexima. Eventual sales of Trexima should exceed current sales of Imitrex. We expect the stock to rise significantly from its current level of approximately $14 to well over $26 within the next twelve months based on an expected EPS of approximately $1.5 in 2010.

In addition to Trexima, the company is developing a number of pain medications using the methodology of combining in a proprietary fashion two existing drugs. These therapies will be used for the management of pain associated with osteoarthritis and other such diseases. Clinical milestones in these earlier products will also support the stock over the next year. We think the valuation of POZN should be very attractive to investors at current levels considering the potential size of the migraine market, and the fact that the FDA has accepted their response for review thus lowering the risk that they will not approve the product in 2007.


"Akuellere" Neuigkeit zu Trexima:
http://biz.yahoo.com/prnews/070608/aqf014.html?.v=14
Trexima(TM) (Sumatriptan/Naproxen Sodium) Demonstrated Migraine-Free Response Across Multiple Attacks
Friday June 8, 12:00 pm ET
Nearly Twice as Many Patients Taking Trexima were Migraine Free Compared to Placebo

CHICAGO, June 8 /PRNewswire/ -- New data from two large trials show that Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours across multiple attacks with just one tablet. The findings will be presented tomorrow at the 49th Annual Scientific Meeting of the American Headache Society.

In addition to head pain, migraine attacks often include nausea, vomiting and sensitivity to light or sound, making it difficult for sufferers to participate in daily activities. Most migraine studies focus on pain relief or pain-freedom, which only assesses head pain. This is one of the few studies to measure migraine-free response across multiple attacks, which is significant because it means that the associated symptoms of migraine, as well as the head pain, are gone.

"I believe this key endpoint will have more meaning to patients, as it measures when the whole migraine is gone rather than just the head pain," said Dr. Paul Winner, lead author and director of the Palm Beach Headache Center. "In these studies we found Trexima consistently eliminated migraine symptoms in more patients without the need for rescue medication."

Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM) and naproxen sodium 500 mg, is currently under review by the FDA for the acute treatment of migraines in adults.

About the Studies

The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. Migraine-free response is defined as freedom from migraine pain, nausea, vomiting, sensitivity to light and sound, and without the use of rescue medication at or before the time points specified. Subjects were randomized to one of five sequence groups and instructed to treat four migraine attacks. Patients in four groups received Trexima in three of four attacks and placebo in the remaining attack. Patients in the fifth group received Trexima for all four attacks.

In each study, approximately 40 percent of patients taking Trexima were migraine-free at two hours, compared to about 20 percent on placebo. At four hours, about two-thirds of patients taking Trexima were migraine-free, compared to about one-third of those on placebo.

In more than 1,100 patients treating more than 3,300 attacks, the overall adverse event rate, corrected for attack, was 9 percent and 7 percent in Study 1 and 13 percent and 9 percent in Study 2, for Trexima and placebo, respectively. Adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.
...

[Ackergaul]

Antwort auf Beitrag Nr.: 29.936.638 von Ackergaul am 15.06.07 11:34:03

Auf der Seite von SeekingAlpha findet Ihr den kompletten Analyse-Bericht von Zacks (SEHR ausführlich):
http://healthcare.seekingalpha.com/article/29301
Pozen: On Track With New Pain Medications
Posted on Mar 12th, 2007 with stocks: POZN

Zacks.com submits:
Headquartered in Chapel Hill, NC, Pozen, Inc. (POZN) is a pharmaceutical company engaged in the research and development of drugs for afflictions such as migraine headache attacks and neuropathic pain. The company also seeks to license and collaborate on drug development activities and has several clinical stage candidates under development.

The main product candidate is Trexima. Trexima is an oral formulation with potential for use in acute migraine therapy for reducing pain and associated symptoms of migraine. The U.S. Food and Drug Administration [FDA] granted Trexima approvable in June 2006. Pozen and development partner Glaxo (GSK) have since re-filed information in early February 2007 and are now expecting approval in early August 2007.

Pozen is expected to receive a royalty on worldwide sales of Trexima. In August 2006 the company signed a new collaboration with AstraZeneca for PN-based products. PN is a fixed-dose combination of the proton pump inhibitor [PPI] esomeprazole magnesium (Nexium) with the non-steroidal anti-inflammatory drug [NSAID] naproxen. Pozen will also receive a tiered royalty on worldwide sales of PN-products ranging from mid-single digit to mid-teens.

Trexima is a single pill containing 85mg sumatriptan succinate (Glaxo's Imitrex) and 500mg naproxen sodium (sold over-the-counter as Aleve, by Bayer). The Imigran/Imitrex franchise posted global sales of £711 million ($1,315 million) at Glaxo in 2006, £551 million ($1,019 million) of which was in the U.S. Imitrex dominates the migraine headache market with an estimated 60% market share.

However, Imitrex growth has stalled to single-digit growth and generic manufacturers such as Teva Pharmaceuticals (TEVA) and Dr. Reddy are lining up to bring a generic Imitrex to market in 2008. Therefore, Glaxo will aggressively seek to convert Imitrex patients to the newer Trexima upon approval. Pozen is eligible for a stepped-up royalty on Trexima worldwide sales. The company will receive a high single digit royalty (we assume 8%) on Trexima sales through 2009.

Starting in 2010, Pozen's royalty rate will increase to high-teens (we assume 17%). We estimate that Glaxo can convert 50-60% of the total branded Imitrex market in the U.S. within three years after the launch. This means that the timing of the launch will be very important given the potential for generic Imitrex. We expect Glaxo to price Trexima at a premium to Imitrex (currently priced about $15/pill) and begin to immediately push the drug as the next-generation superior option using the existing Imigran/Imitrex filed force.

On June 9, 2006 Pozen and development partner GlaxoSmithKline received an approvable letter from the U.S. Food and Drug Administration [FDA] on Trexima. The FDA has determined that Trexima is effective as an acute treatment for migraine headaches, but the agency has requested additional safety information on the drug. Pozen and Glaxo met with the FDA in July 2006 to discuss the approvable letter and determine the appropriate next steps to gain final approval. At the meeting Pozen presented additional safety data from phase IIIb trials conducted by Glaxo not previously submitted to the FDA.

Two additional in vitro non-clinical studies were also submitted to the FDA in a complete response letter filed on November 9, 2006. On December 13, 2006 the FDA responded to the November 9th filing with the request for additional information helping compare the newly submitted phase IIIb data with previously submitted phase III data in the original NDA. We believe the FDA is looking for an apples-to-apples comparison of the data, focusing on key demographic profiles such as sex and age to determine safety. Pozen and Glaxo responded to this request in early February 2007.

At this time, we do not expect Pozen and Glaxo to have to conduct additional clinical trial work. We believe the FDA concerns over Trexima stem from the possible gastrointestinal or cardiovascular risks of naproxen, or the potential effect of naproxen on sumatriptan pharmacologic profile and visa versa. The FDA is no doubt concerned with the cardiovascular risk of taking naproxen daily. In a post-Vioxx market, the FDA has become very stringent on the approval of potentially risky non-steroidal anti-inflammatory drugs [NSAID]. However, we would be surprised if the FDA made Pozen and Glaxo conduct a long-term (2-3 year) safety trial on Trexima given that naproxen has been well studied in previous trials compared to Cox-II inhibitors.

The cardiovascular risk is an issue, but we believe it is already well understood. The GI risk of naproxen has also been well studies in the past. Therefore, we believe the FDA is probably most concerned with the potential drug-drug interaction between naproxen and sumatriptan. We are hoping that the response in February 2007 was enough to allay any FDA concerns.

Our current model assumes a PDUFA in early August 2007. Approval of Trexima will result in a $20 million milestone payment from Glaxo to Pozen ($10 million for approval + $10 million for intent to commercialize). We now model the launch during the third quarter of 2007 with a modest $40 million in sales for the second half of the year. We see $575 million in Trexima sales in 2010. We estimate peak sales for Trexima are around $1 billion, about 75% of the Imitrex market.

Trexima Background Info:
On April 5, 2006, Pozen and GSK presented two new clinical studies at the 58th Annual Meeting of the American Academy of Neurology [AAN]. The results in migraine sufferers showed that a single tablet of Trexima containing sumatriptan 85mg and naproxen sodium 500mg provides superior results for patient satisfaction and workplace productivity compared to the acute treatment of migraine with either sumatriptan or naproxen sodium alone. In addition, a long-term safety study of 12 months showed that the single tablet was well-tolerated.

On September 20, 2006, at the 16th Migraine Trust International Symposium [MTIS] in London, Glaxo and Pozen were very active in presenting follow-up data on Trexima. One study demonstrated that the 85mg of sumatriptan found in Trexima had a similar peak blood levels to the 100mg of sumatriptan in Imitrex two hours after dosing, but the Trexima pill achieved the peak level an average of 53 minutes earlier. For migraine sufferers, the rate at which their migraine medications are absorbed into the blood stream may make a difference in how fast the medicines work. This is encouraging data in Trexima's favor.

Another study demonstrated that earlier use of Trexima resulted in lower symptoms and less potential for recurring attacks versus waiting until the pain is more severe. Migraine sufferers frequently cite lack of recurrence of migraine symptoms as one of the most desired attributes of an acute migraine treatment. Glaxo and Pozen will market for quick use of Trexima on the first signs of migraine pain. This should promote rapid uptake.

Finally, at MTIS, Glaxo and Pozen presented efficacy and safety data from a large study examining more than 4,200 migraine attacks in more than 1,100 patients taking Trexima. The data was encouraging with respect to relief of migraine pain and time to return to normal daily activities. The data also demonstrated good tolerability with low and mild adverse events.

Animal data suggests that current migraine treatments alone do not address all of the components of migraine progression. Specifically, triptans cannot block the central neuronal sensitization that results from stimulation of the main sensory nerve (trigeminal nerve). Triptans works by stimulating receptors called serotonin (or 5HT) receptors that are found in the brain. In this study, investigators found that naproxen was effective at suppressing central neuronal sensitization. Recent data also suggested that Trexima is superior to both Imitrex and naproxen with regard to sustaining pain-free relief on a two-hour scale. We believe this is because of the both immediate impact (the sumatriptan succinate component) and sustained relief benefit (the naproxen sodium component) of Trexima. Finally, Trexima kept patients vomit-free (a common side-effect of migraine headaches), while reducing the feelings of nausea. We have witnessed no major safety concerns during the phase III trial that would lead us to believe the FDA has serious issues with the drug.

AstraZeneca (AZN) Licenses PN:
In early August 2006 Pozen announced that it has signed an exclusive global collaboration agreement with AstraZeneca for the co-development and commercialization of proprietary fixed dose combinations of the proton pump inhibitor [PPI] esomeprazole magnesium (Nexium), with the non-steroidal anti-inflammatory drug [NSAID] naproxen, in a single tablet. Under the terms of the agreement, AstraZeneca has paid Pozen an upfront fee totaling $40 million, and has the potential to pay aggregate milestone payments of $160 million for certain development and regulatory milestones; and $175 million of potential sales performance milestones, if certain thresholds are achieved.

Royalties will be paid on net sales on a tiered royalty structure that ranges from mid-single digits to midteens. Pozen will be responsible for the development and filing of the New Drug Application [NDA] in the United States, while AstraZeneca will have full responsibility for development activities outside of the U.S. as well as all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. AstraZeneca will also be responsible for all non-U.S. regulatory filings. We view the deal as extremely favorable for Pozen. The company s PPI partner in AstraZeneca is the industry leader, and Pozen has established itself as a credible mid-stage development company attractive to large-cap pharmaceutical companies seeking novel ideas.

PN Background Info:
The PN tablets are designed to provide immediate release of the PPI component in the stomach to enable local as well as systemic effects on the acid pumps that line the stomach lumen. The NSAID component contains a pH sensitive layer and is released only in an environment with decreased presence of acid. PN will be indicated for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers.

Prior to the collaboration, Pozen was working on two PN candidates that combined PPI s with naproxen. PN-100 was tested with Prevacid (lansoprazole) and PN-200 with Prilosec (omeprazole). In short-term proof-of-concept studies conducted by Pozen, PN drug candidates produced significantly less gastric mucosal injury compared to a similar regimen of enteric coated naproxen.

On April 20, 2006, the company announced that it had reached agreement with the U.S. Food and Drug Administration [FDA] on a New Drug Application program for PN-200, which included a Special Protocol Assessment [SPA] for the pivotal phase III trials. Pozen and AstraZeneca have met with the FDA to confirm that the core development program and the SPA already agreed upon will apply to this new product which will combined Nexium (esomeprazole) and naproxen now called PN-400. In the mean time, Pozen has enrolled a pilot study with PN-200 to help better design the pivotal trials for the new Nexium-based PN product later this year. Enrollment in the PN-200 pilot study completed earlier in the year, far ahead of expectations. We believe this is a sign of potential strong demand for such a product. The primary outcome of the trial will be significant reduction in gastric ulcers. Pharmacokinetic and safety data will also be studied and applied to the next-generation PN-400 product.

Pozen is currently planning several phase I trials on PN-400 to test bioequivalence and food interaction. Pozen will also conduct a phase II dose-finding study around mid-year. Should these prove to be positive, a pivotal phase III program on PN-400 should begin in the third quarter of 2007. Pozen is expected to receive two developmental milestones either late 2007 or early 2008 totaling $20 million. The first will be based on the outcome of the phase III pilot study on PN-200, and the second will be based on the profile determined in phase I trials for PN-400. We currently model these payments in early 2008 to be conservative. We are very excited about the PN-400 product. We estimate that Pozen and AstraZeneca can seek to file in 2008 and potentially launch PN-400 in 2009. Potential peak sales of PN-400 are $500 million.

PA Background Info:
Pozen is now looking to branch out with proton-pump inhibitor products to include a PA aspirin product. The PA product candidate combines aspirin with a PPI for cardiovascular protection along with the potential reduction in the risk of colorectal cancer and adenomas. Adenomas are precursors of most colorectal cancers and prevention of adenomas will most likely also prevent colorectal cancer, as reported in the New England Journal of Medicine in March 2003. The PA product candidate is intended to provide fewer gastrointestinal side effects and complications compared to an NSAID or enteric coated aspirin taken alone. A successful PA product will combine all the benefits of daily low-dose aspirin (i.e. both cardiovascular and adenoma benefit) with lower gastrointestinal [GI] risk. In our view this safer aspirin is another potential blockbuster idea.

In March 2007 Pozen released data from a proof-of-concept program dubbed PA-385 that tested aspirin with omeprazole. The trial was a 28 day study that involved two groups of 40 subjects over the age of 50. Each subject was treated with either once a day commercially available enteric coated aspirin 325mg or PA-325. The primary endpoint was gastrointestinal damage as measured by the Lanza scoring system used in previous PN studies. The results were highly significant with 10% of the PA group having Lanza 3 or 4 gastrointestinal damage, whereas 57.5% of the enteric coated aspirin group had this level of gastrointestinal damage. Furthermore, no ulcers were seen in the PA group, while 20% of subjects in the enteric coated aspirin 325mg group developed a gastric ulcer during the study.

This is highly encouraging data and grounds for a potential phase II program to begin later this year. Pozen will seek to partner the PA program for phase III trials when necessary. We can think of numerous potential partners for this program, including AstraZeneca or Glaxo, as well as several other large pharmaceutical companies that are major players in either PPI or aspirin Johnson & Johnson, Wyeth, Abbott, etc... Pozen commented that the initial target indication for PA will be secondary prevention of heart attack or stroke. Prevention of angina or acute coronary syndrome, as well as for prevention of colon cancer are other potential enormous opportunities for PA.

Lornoxicam Background Info:
Pozen also exercised its option agreement regarding Lornoxicam, an NSAID which is available outside the U.S. Lornoxicam is a member of the oxicam family of NSAIDs and has been described as a highly potent balanced dual inhibitor of the human cyclooxygenase [COX] -1 and COX-2 enzymes. This balance may provide the benefits of reducing inflammation without causing excess cardiovascular risk.

In laboratory tests, lornoxicam has been shown to be up to 3000 times more potent that aspirin in tests measuring inhibition of COX enzymes and is up to 400 times more potent than ibuprofen in these assays. Pozen aims to enter into phase III studies with in the next year. Lornoxicam will be developed both as a single agent and in combination with other drugs, for the treatment of acute pain (post surgical) and severe migraine indications.

RECENT NEWS
March 7, 2007: Pozen Inc. reported financial results for the fourth quarter and full year 2006. For the fourth quarter of 2006, Pozen reported revenue of $7.0 million resulting from the amortization of upfront payments received pursuant to our collaboration agreements with AstraZeneca and GlaxoSmithKline and revenue from development work performed under those agreements, as compared to $22.2 million for the fourth quarter ended December 31, 2005. For the twelve months ended December 31, 2006, Pozen reported revenue of $13.5 million compared to $28.6 million for the same period in 2005.

Pozen reported a net loss of $0.4 million, or $0.01 per share on a diluted basis, for the fourth quarter of 2006, compared to net income of $16.1 million, or $0.54 per share on a diluted basis, for the fourth quarter of 2005. Pozen reported a net loss of $19.3 million, or $0.66 per share on a diluted basis, for the twelve month period ended December 31, 2006, compared to net income of $2.0 million, or $0.07 per share on a diluted basis, for the same period in 2005. At December 31, 2006, cash, cash equivalents and short-term investments totaled $62.6 million.

March 6, 2007: Pozen Inc. announced top-line results of its "Safer Aspirin" PA-325 proof-of-concept study conducted during the fourth quarter of 2006. PA 325 is a patented formulation of 325mg of aspirin surrounded by a 20mg coating of an immediate release formulation of a proton pump inhibitor. The PA-325, 28 day study, involved two groups of 40 subjects over the age of 50. Each subject was treated with either once a day commercially available enteric coated aspirin 325mg or PA-325.

The primary endpoint was gastrointestinal damage as measured by the Lanza scoring system used in our previous PN studies. The results were highly significant with 10 percent of the PA group having Lanza 3 or 4 gastrointestinal damage, whereas 57.5 percent of the enteric coated aspirin group had this level of gastrointestinal damage. Furthermore, no ulcers were seen in the PA group, while 20 percent of subjects in the enteric coated aspirin 325mg group developed a gastric ulcer during the study. This difference was also statistically significant. Source: Pozen, Inc.

VALUATION
Although the approval process for Trexima has been a rather tumultuous one, we believe that Pozen and Glaxo may now finally be in position for an approval in early August 2007. Glaxo has stated they are in position to launch Trexima shortly after approval. We model $40 million in sale in 2007. This should be a year ahead of generic Imitrex expected late 2008 plenty of time to solidify the market in our view. We believe that Glaxo can capture at least 50% of the Imitrex/Imigran market ($1,315 million in 2006) by 2010.

The signing of the PN licensing deal with AstraZeneca now seems to have taken investor focus away from previous mishaps with MT-100, MT-300, and Trexima. The upfront milestone payment of $40 million with the potential for an additional $335 million in milestones truly is a transformational deal for Pozen. Nexium-naproxen (PN-400) has the potential to be a multi-hundred million dollar product. Pozen now has two of the largest pharmaceutical companies in the world funding development of its internally developed candidates.

What's even more exciting is that Pozen has a potential blockbuster in early-stage trials with its Safer Aspirin PA product. Knowledge learned from the PN trials should help Pozen expedite PA development and potentially sign yet another lucrative collaboration, similar to the AstraZeneca deal, in 2008. By 2009, Pozen has the potential to have both Trexima and PN on the market. Pozen will collect royalties on both products with no manufacturing and little distribution or marketing costs. This has the potential to turn Pozen into a highly profitable company. We currently rate the shares Buy with a $22 price target. We arrive at this target by applying an industry average 25x our 2011 EPS of $2.56 (fully-taxed) and then discounting back to present at 20%.

RISKS
The biggest near-term risk would be the FDA delaying approval of Trexima. We model approval in early August 2007. Much of our 2007 financial statement is based around this event. Approval will trigger two $10 million milestone payments from Glaxo to Pozen, as well as royalties on sales expected to start shortly after approval. A delay by the FDA would require a significant revision of our model and potentially rating and target price. Another risk to the company would be failure of the PN-200 pilot study or failure in a few of the early-stage bioequivance or dose-ranging studies for PN-400. This would cause a delay in the initiation of the pivotal trial for PN-400 and our launch assumptions in 2009.

KEY POINTS
We are upgrading our rating on Pozen to Buy with a price target of $22 per share (was Hold, $20). Our upgrade is based on several recent positive events.

* Firstly, we are pleased to see that Pozen and Glaxo have responded to the most recent FDA request on Trexima in early February 2007. The agency has pledged a six-month review and we now expect an action date in early August 2007. At that time we expect Trexima approval. This should be a significant catalyst for the shares Pozen is due a $20 million milestone on Trexima approval and launch ($10 million for each).
* Secondly, Pozen and AstraZeneca have enrolled the pilot study for PN-200 (naproxen + omeprazole) significantly ahead of schedule. We believe that data from this trial will help the duo better design the pivotal phase III program on PN-400 (naproxen + esomeprazole) expected to commence in the third quarter of 2007. Throughout the year we look for positive data on PN-200 and early-stage trials on PN-400 to act as a catalyst for the shares.
* Finally, in early March the company reported positive data from a proof-of-concept study on PA (omeprazole + aspirin) showing an impressive reduction in gastrointestinal damage with PA verse enteric coated aspirin. The trial also demonstrated that patients taking PA have no ulcers verse roughly 20% for enteric coated aspirin. This should form the basis for additional trials in 2007.
The several recently positive events listed above lead us to raise our price target from $20 to $22 per share (based on discounting forward earnings of $2.56 in 2011), all while the stock has declined 10% so far in 2007. We now recommend investors purchase Pozen given several potential positive catalysts and a low relative valuation.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.950.537 von Ackergaul am 16.06.07 09:41:02

Auf der BHI Page gab es auch mal ein paar Infos bezüglich Pozen:

http://biohealthinvestor.com/2007/04/pozen-valuation-attract…
Pozen: Valuation Attractive at Current Level
Monday, April 09, 2007
by Atlas BioResearch

Pozen (POZN) develops of products for the treatment of acute and chronic pain, and other pain-related conditions. Its principal product candidate, Trexima, is being developed in collaboration with GlaxoSmithKline (GSK) for the acute treatment of migraine.

Trexima is a single tablet containing sumatriptan succinate (Imitrex®, also sold by GSK) and naproxen sodium (contained in Aleve® amongst other non-steroidal anti-inflammatories (NSAID)). Recently the company published data which showed Trexima provided superior sustained pain-free results compared to sumatriptan or naproxen alone.

On June 9, 2006 the company announced that the FDA had issued an approvable letter for Trexima and the company saw more than half of its market cap erased. The FDA had determined that Trexima was effective as an acute treatment for migraine headaches, but requested additional safety information. There were fears that Trexima might require new studies.

In November 2006, the company submitted further data as required but the FDA indicated that the reply was incomplete. However, in March 2007 POZN announced its amended response to the approvable letter had been accepted for review by the FDA. According to the company the FDA plans a six-month Class II review that could result in an August 1, 2007 decision date on the drug. Pozen said the product could be available to patients in the second half of 2007, contingent on FDA approval.

It is clear from data that Trexima is more effective and faster acting than Imitrex® alone. Imitrex® which goes off patent in 2009 has annual sales of over $1 billion. Assuming approval in August, which is likely, POZN could receive milestone payments from GSK and a healthy royalty on future sales of Trexima. Eventual sales of Trexima should exceed current sales of Imitrex. We expect the stock to rise significantly from its current level of approximately $14 to well over $26 within the next twelve months based on an expected EPS of approximately $1.5 in 2010.

In addition to Trexima, the company is developing a number of pain medications using the methodology of combining in a proprietary fashion two existing drugs. These therapies will be used for the management of pain associated with osteoarthritis and other such diseases. Clinical milestones in these earlier products will also support the stock over the next year.

We think the valuation of POZN should be very attractive to investors at current levels considering the potential size of the migraine market, and the fact that the FDA has accepted their response for review thus lowering the risk that they will not approve the product in 2007.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.954.849 von Ackergaul am 16.06.07 16:49:02

Aus Fool.com wollte ich Euch auch noch einen Beitrag Nahe legen:
http://www.fool.com/investing/high-growth/2007/05/17/pozen-p…
Pozen Poised for Profits
By Mike Havrilla May 17, 2007

Earlier this month, Pozen (Nasdaq: POZN) reported first-quarter results. But investors should look to buy shares of this company because of how its results may look later this year.

A collaboration begun in 2003 with GlaxoSmithKline (NYSE: GSK) for the development and commercialization of Trexima (a combination of pain and anti-inflammatory drug naproxen with Glaxo's migraine drug Imitrex) is nearing a crucial milestone. The Food and Drug Administration is expected to finally approve the drug by Aug. 1.

Last month, results from two pivotal studies were published in the Journal of the American Medical Association, showing that Trexima provided superior headache relief at two hours and four hours compared with a placebo, and sustained pain-free results from two through 24 hours versus Imitrex or naproxen given by itself. Last month, Citigroup started coverage of Pozen with a buy rating and a $28 price target, predicting an 80% likelihood of FDA approval for Trexima. In addition, Citigroup believes that Pozen could trade as high as $35 in a year if it captures significant market share in the $2 billion migraine drug market.

Pozen's pipeline also includes a group of drugs that combine a non-steroidal anti-inflammatory drug with a proton pump inhibitor, offering the benefits of pain relief with fewer gastrointestinal side effects. Pozen and AstraZeneca (NYSE: AZN) are holding discussions on the timing and scope of marketing studies to support the commercialization of PN 400, and at the end of the second quarter, the company will update investors about these plans. Pozen has a related platform that combines aspirin with a proton pump inhibitor drug for reduced gastrointestinal side effects for individuals taking aspirin daily.

The AstraZeneca collaboration is worth up to $375 million in upfront and milestone payments, and focuses on combining naproxen (which appears to be the safest non-steroidal anti-inflammatory drug from a cardiovascular standpoint) with a top-selling proton pump inhibitor as an immediate-release shell that provides gastrointestinal protection. The company has also in-licensed lornoxicam, a non-steroidal anti-inflammatory drug with unique characteristics, which has been in clinical use outside of the U.S. for the past 10 years. Thus far, Pozen has completed one study that showed the effectiveness of single oral doses of the drug to alleviate the pain that occurs after a tooth has been extracted.

Pozen reported a first-quarter loss of $2.1 million on revenue of $7.7 million, with $58.2 million in cash and investments. It has a market cap of just $445 million, but the milestone payments and royalties it would receive from Glaxo if Trexima is approved could be quite substantial. The AstraZeneca collaboration provides additional upside, given the magnitude of potential milestone payments. I think Pozen could double in value over the next year or so if Trexima can capture a significant share of the $2 billion migraine market.


Und dazu noch kurz folgende beiden Mitteilungen:
1.)
Headache. 2007 May
Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes.
Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S.
Mercy Health Research and Ryan Headache Center, St. Louis, MO 63141, USA.

OBJECTIVE: To describe the pain relief, satisfaction, and health-related quality of life results of moderate or severe migraines treated with a sumatriptan/naproxen sodium combination tablet.

METHODS: Sumatriptan and naproxen sodium as a single-dose formulation tablet was used to treat moderate to severe migraines over a 12-month period in a phase 3, open-label, multicenter study (n = 565) in patients with at least 6 months' history of migraine headaches.

RESULTS: Seventy percent of all attacks were treated with 1 dose of sumatriptan/naproxen sodium. Overall subjects treated 24,485 attacks; of these, 81% attacks achieved pain relief and 60% pain-free by 2 hours. At 3 months, the percentage of patients satisfied or very satisfied increased from baseline on all 8 Patient Perception of Migraine Questionnaire (PPMQ) items and remained high throughout the study. Mean Migraine-Specific Quality of Life Questionnaire (MSQ) domain scores also increased by 13-15 points from baseline during this time and remained high.

CONCLUSIONS: Sumatriptan/naproxen sodium provides consistent relief of migraine attacks over 12 months, resulting in improved patient satisfaction and migraine specific quality of life.

PMID: 17501849 [PubMed - in process]

2.)
Fixkombi Sumatriptan plus Naproxen punktet deutlich bei Migräneschmerz
Ärzte Zeitung, 05.04.2007

Schmerzreduktion nach zwei Stunden bei mehr als jedem Zweiten / Seltener Recurrence

NASHVILLE (gwa). Mit der Fixkombination aus 85 mg Sumatriptan plus 500 mg Naproxen werden bei einer Migräneattacke die Schmerzen innerhalb von zwei Stunden signifikant stärker reduziert als mit Placebo. Und signifikant mehr Patienten bleiben 24 Stunden schmerzfrei als bei einer Monotherapie mit einem der Wirkstoffe oder Placebo.

Die Fixkombination von Sumatriptan und Naproxen in einer Tablette wurde in zwei Multicenter-Studien bei insgesamt knapp 3000 Migräne-Patienten geprüft (JAMA 13, 2007, 1443). Die Patienten erhielten randomisiert entweder das Kombipräparat (in Deutschland noch nicht erhältlich) oder die Einzelsubstanzen als Monotherapie oder Placebo.

Zum einen verglichen die Forscher um Dr. Jan L. Brandes von der Uni in Nashville, Tennessee, die Wirkung des Kombipräparates auf die Schmerzreduktion innerhalb von zwei Stunden mit der von Placebo. Als Schmerzreduktion war eine Abnahme der Kopfschmerzen von schwer oder moderat auf mild oder schmerzfrei definiert.

In den Fixkombi-Gruppen beider Studien war das bei 65 Prozent (Studie 1) und 57 Prozent (Studie 2) der Fall; mit Placebo bei 28 und 29 Prozent. Und: Sumatriptan allein reduzierte bei 55 und 50 Prozent der Patienten die Schmerzen; Naproxen bei 44 und 43 Prozent.

Außerdem prüften die Kollegen, wie viele Patienten innerhalb von 24 Stunden Wiederkehr-Kopfschmerzen bekamen. In den Kombitherapie-Gruppen hatten 25 Prozent (Studie 1) und 23 Prozent (Studie 2) keine Wiederkehr-Kopfschmerzen. Mit Sumatriptan allein waren es 16 und 14 Prozent; mit Naproxen jeweils zehn Prozent; mit Placebo acht und sieben Prozent.

Bei allen in die Studie aufgenommenen Patienten war Migräne nach den international gültigen IHS-Kriterien diagnostiziert worden. Geprüft wurden die Therapie-Wirkungen bei jeweils einer Attacke.

Copyright © 1997-2007 by Ärzte Zeitung


Das müsste als Infos erst einmal doch genügen - oder? Bis zum Stichtag 1. August ist es noch ein Weilchen, wir werden mal sehen, wie der Kurs sich bis dahin verhält...

[ipollit]

Antwort auf Beitrag Nr.: 29.992.335 von Ackergaul am 18.06.07 11:05:50

danke für die Infos.

Hatte mir vor ein paar Wochen welche ins Depot gelegt... mal sehen. Es kann auch passieren, dass Trexima ein Okay bekommt, der Kurs darauf aber gar nicht reagiert, weil es bereits eingepreist ist. So richtig überzeugt bin ich noch nicht von POZN, um wirklich ernsthaft long zu gehen.

mfg ipollit

[Ackergaul]

Antwort auf Beitrag Nr.: 29.995.773 von ipollit am 18.06.07 13:21:00

Hi ipollit;

kein Thema bzgl. der Infos...

Falls es zum Approval für Trexima kommen sollte, werden wir Kurse um 23 bis hin zu 24 Dollar sehen (in meinen Augen Minimum). Ist das nicht der Fall werde ich nachkaufen. Allerdings habe ich immer noch ein ungutes Gefühl, gerade im Hinblick bezüglich der letzten Zulassungsversuche Pozens.
Ich sehe Pozen auch selber nicht als Langfristanlage (dafür ist die Pipeline auch zu "einfach gestrickt") und habe mir persönlich auch kein bestimmtes Kursziel gesetzt. Vielmehr plane ich zumindest bis Jahresende noch dabei zu bleiben - unter den Vorraussetzungen dass alles den "geplanten Weg" läuft!

Eins habe ich bei Biotech Werten mittlerweile gelernt: Langfristig gibts bei diesen "Kleinen" nicht! Und wenn irgend etwas faul ist oder den Anschein hat Probleme zu verursachen - schnellstmöglich weg damit!

Wie dem auch sei - ebenfalls Viel Glück!

[ipollit]

Antwort auf Beitrag Nr.: 29.998.731 von Ackergaul am 18.06.07 15:37:59

der Kurs verhält sich heute ja nicht schlecht... neues 52WH.





zumindest kein schlechtes Zeichen für die nächsten Wochen...

sollte POZN mit der Zulassung einen Spike bilden, werde ich auch wieder rausgehen bzw. die Gewinne mitnehmen. Genau, du sagst es... die Pipeline wirkt irgendwie ein wenig einfach gestrickt... obwohl kann man auch im Auge behalten, denn wenn es breit funktioniert, warum nicht?

Danke... auch viel Glück!

mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 30.003.054 von ipollit am 18.06.07 18:32:49

wenig gehaltvoll... schafft aber Aufmerksamkeit...

Pozen shares hit 52-week high
Monday June 18, 3:08 pm ET

Shares of Chapel Hill pharmaceutical firm Pozen jumped to a 52-week high Monday as the expected approval of the company's first drug nears.
The company's stock was up 7.5 percent in mid-afternoon trading to $18.80. Its intraday high of $19.11 was well above the company's previous 52-week peak of $18.25, set in December.

Trading volume was 1.13 million shares, more than double the three-month average of 489,000.

Pozen (Nasdaq: Pozn - News) is expected to receive regulatory approval in August for Trexima, the migraine treatment it's developing with GlaxoSmithKline (NYSE: GSK - News). Analysts have labeled the drug a potential blockbuster that could top $1 billion in sales.

mfg ipollit

[Ackergaul]

Laut einem Bericht der regionalen Tageszeitung die ich lese, sterben in Deutschland jährlich rund 25.000 Menschen an Wechsel- und Nebenwirkungen "falscher" Arzneien. Weitere 300.000 müssen aus den gleichen Gründen stationär behandelt werden!
Falsche Arzneien haben nun nichts mit Pozen direkt zu schaffen, aber ich denke dass es immer entscheidender wird die Medikamente in der Sicherheit zu verbessern. Dies führt mich zu den PN und PA Trials von Pozen... PN 400 sieht vor das Präparat Nexium (AstraZeneca) in diesem Bereich zu verbessern PA 325 hat das Aspirin als Ziel.
Zu Nexium:
In der gleichen Zeitung wurden die 20 meistverkauften Arzneien veröffentlicht. Auf Platz 1 und 2 liegen Produnkte die "Säureerkrankungen des Magens" abhelfen sollen. Ihr könnt es Euch denken - oder? Platz 1 mit 191 Mio Euro (alleine in Deutschland) Nexium! Leider habe ich die Texte nicht auf der Internet Seite gefunden. Als Quelle wird die Gmünder Ersatzkasse genannt, dort habe ich aber auch nichts finden können...
Kritik im Bericht richtet sich auf "Me-too" Präparate. Das sind Arzneien mit Patentschutz (damit teurer) die als Neuheit verkauft werden, aber in etwa gleiche Wirkung und Struktur besitzen, wie Arzneien deren Patentschutz bereits abgelaufen sind. Schönes Beispiel ist Pozens und GSKs Trexima. Imitrex (Migräne) war im übrigen nicht unter den 20 aufgeführten Medikamenten.

Schönen Tag noch!

[Ackergaul]

Für mich nicht beunruhigend, dass der Kurs unter die 18 Dollar Marke gestern gefallen ist. War eigentlich mit zu rechnen, nach dem starken Anstieg schon in der letzten Woche. Gestern sind wieder über 600.000 Aktien gehandelt worden.
Interressant in den After Hours wurden nochmals über 100.000 gehandelt. Ist schon relativ viel...

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

Time             Price           Share Volume 

17:03               $ 18.1468         1,370 

16:10               $ 18.1468        11,500 

16:07               $ 18.1468       117,100 

[Ackergaul]

Antwort auf Beitrag Nr.: 30.012.478 von Ackergaul am 19.06.07 08:42:12

zum "sicheren Aspirin" eine Meldung die schon ein bischen zurückliegt...

http://biohealthinvestor.com/2007/03/biotech-daily-review-no…
Biotech Daily Review:
Tuesday, March 06, 2007
...
Pozen (POZN) reported its coated aspirin drug candidate passed a proof of concept test. PA325 coats 325 mg of aspirin with a proton pump inhibitor to prevent gastrointestinal damage. In the trial, the drug reduced the incidence of GI damage from 57% in the placebo to 10% in the active drug cohort. No ulcers were seen among the active drug recipients, but 20% of the placebo arm developed a gastric ulcer. Pozen climbed 10%, adding on $1.46 to end at $15.70.
...


Zum ansteigenden Handels-Volumen die wöchentlichen Zahlen:
http://finance.yahoo.com/q/hp?s=POZN&a=09&b=17&c=2000&d=05&e…

PRICES 

Date......Open..High..Low...Close.Avg Vol.Adj Close* 

18-Jun-07 17.68 19.11 17.12 17.56 935,900 17.56 

11-Jun-07 15.82 17.63 15.54 17.49 656,300 17.49 

04-Jun-07 15.48 15.92 15.21 15.83 416,400 15.83 

29-May-07 15.76 16.15 15.44 15.51 314,100 15.51 

21-May-07 15.58 15.84 15.10 15.65 340,800 15.65 

14-May-07 15.85 15.95 15.00 15.55 315,400 15.55 

 

[Ackergaul]

Noch ein Bericht zu Trexima... Auf der PBR Seite kann man auch ab und zu interessante Berichte entdecken - gilt natürlich nicht nur für Pozen.

http://www.pharmaceutical-business-review.com/article_featur…
GSK/Pozen: new data fails to relieve pain of Trexima delays
4th May 2007
By Martin Adams

Trexima has demonstrated consistent pain-free results across multiple migraine attacks
With the FDA currently reviewing the response made by GlaxoSmithKline and Pozen to its approvable letter for Trexima, this new data represents an attempt to further differentiate the migraine drug from existing triptans prior to launch. However, the drug's commercial success has already been restricted by approval delays and will be limited further by the impending launch of generic sumatriptan.
'Content New data from more than 1,100 patients presented at the American Academy of Neurology 59th Annual Meeting in Boston show that Trexima (sumatriptan/naproxen sodium) was effective at treating migraine attacks. When taken early, Trexima produced pain-free results at two and four hours, as well as sustained pain-free response 2-24 hours, across individual patients' multiple migraine attacks, demonstrating the consistency in efficacy. Furthermore, nearly one third of all patients were pain free at two hours.

With migraine sufferers frequently citing inconsistent effectiveness as a reason for their dissatisfaction with their medicine, these new data of Trexima demonstrating consistent pain-free results across multiple attacks adds to the anticipation of the drugs approval.

Trexima is an oral fixed dose combination tablet containing the popular migraine triptan therapy, sumatriptan 85mg, together with the anti-inflammatory drug, naproxen sodium 500mg. The drug is currently under review by the FDA for the acute treatment of migraines in adults, although its approval has been delayed. After issuing an approvable letter in June 2006, the FDA requested further safety information on the drug in November. However, the US regulator accepted an amended response to the approvable letter for review in March 2007, and a decision is now expected in August 2007, with a potential launch in the second half of 2007.

Following FDA approval, GSK is expected to aggressively market Trexima in the US. The combination of sumatriptan and naproxen will be marketed as a drug-line improvement and GSK will hope uptake will match this advancement. In the initial three years after launch, Datamonitor predicts Trexima will capture substantial market share from GSK's Imitrex (sumatriptan) and other triptans. However, sales growth will be significantly offset by the US launch of generic sumatriptan, expected in late 2008. As a result, Datamonitor forecasts Trexima sales to peak only two years after launch at $329 million in 2009.

[Ackergaul]

Antwort auf Beitrag Nr.: 30.312.718 von Ackergaul am 25.06.07 19:57:31

Mal ein paar kritische Punkte zu Trexima. Habe den Blog beim googeln gefunden. Auf der folgenden Seite mit Stichwort "trexima" suchen und Ihr findet (nicht nur die zwei) folgende Berichte. Bitte lest auch die comments!
http://www.thedailyheadache.com/
Rebound Headaches a Risk With Trexima

"Do you need a naproxen dose every time you need a triptan dose?" Headache specialist Christina Peterson weighed in on the Trexima discussion with that brilliant question.

As bad as it is to make money by ill-informing consumers, that's nothing compared to the possibility of worsening patients' headaches.

Dr. Peterson pointed out that "many [headache specialists] recommend combining them--as an initial dose at headache onset. The potential danger could lie in a second or further subsequent dose." This danger comes from medication overuse headache (commonly referred to as rebound headache or MOH).

This is as it sounds: Taking too many painkillers (and some other drugs) can lead to more frequent headaches. These more frequent headaches lead to taking more painkillers. And the cycle goes on.

So, while taking naproxen with the first dose of Imitrex during a migraine can be helpful, taking it with further doses can lead to more harm in the long run. As Dr. Peterson says, it's unlikely that insurance companies are going to be willing to pay for a prescription for Trexima and one for plain old Imitrex in the same month.

Here's her full comment:

No. That question, which desperately needs to be answered, has not been answered. That head-to-head study has not been done. Why? Nobody stands to gain financially from the answer. Nobody except, of course, you and me--the consumers.

True--there is not likely to be any advantage of Trexima over taking an Imitrex plus an equivalent dose of naproxen sodium. There is no voodoo in the combination.

Could there be harm, though? This is why the FDA is taking so long to look at Trexima. I don't think the concept of sumatriptan (or any other triptan) plus naproxen sodium is inherently dangerous. Many of us recommend combining them--as an initial dose at headache onset. The potential danger could lie in a second or further subsequent dose. Do you need a naproxen dose every time you need a triptan dose?

I have concerns that in the hands of doctors and patients who do not understand the intricacies of medication overuse headache--i.e., most--this combination product could result in an increased risk of excessive dosing in the frequent headache sufferer, possibly resulting in an increased number of headaches.

And I think we all know how slim the likelihood is that an insurance carrier will reimburse both a prescription of Trexima and plain Imitrex in a given month.


Trexima Aborts Migraines Better Than Imitrex or Aleve Alone

The new drug Trexima, a combination of Imitrex and Aleve (naproxen), "can provide faster, long-lasting relief of migraine pain than using either drug alone," according to results of a study published in yesterday's issue of the Journal of the American Medical Association.

In the study, Trexima relieved headaches within two hours in as many as 65% of participants, compared to 28% with the placebo. About 55% said Imitrex alone provided relief and as many as 44% said that naproxen did.

So it's better than either drug alone, but is Trexima is more effective than taking Imitrex and naproxen at the same time? I've never seen this question answered. It's a huge issue for patients because the Imitrex patent expires in 2009. Trexima extends profits from Imitrex because selling it in Trexima sales will cut into overall sales of Imitrex.

I get the arguments for using Trexima even if there's no difference. Patients are more likely to take one medication than two. They also may have more faith in prescribed meds than over-the-counter drugs, which naproxen is. But would patients who can't afford the brand-name drug be aware that they can get the same effect for much less money?

If Trexima is not more effective than taking Imitrex and naproxen in separate pills, physicians assume responsibility for giving patients the choice. At the very least, they should tell patients the different efficacy rates between the two. Some will for sure, but many others will follow the masses of drug rep cheerleaders.

GSK's foothold on the ethical side of the line is tenuous. I don't begrudge a company earning money, but knowing the drug's success rides on the pharmaceutical industry's phenomenal marketing, patients will undoubtably lose.



Der Patient als Melk(Geld-)Kuh... Mit Sicherheit würden/werden die Preise anfangs bei Trexima höher als bei Imitrex liegen - wer zweifelt daran. Erst 2009 mit dem Ansturm der Generika wird GSK herunterschrauben. Was mich im Übrigen auch stutzig gemacht hat: Warum hat Pozen / GSK die Studie nicht so aufgebaut, dass Trexima gegen Sumatriptan UND Naproxen verglichen wurde??? Die wollen Trexima mit der Kombi-Einnahme Sumatriptan UND Naproxen schwer vergleichbar machen, Patienten und Ärzte im Dunkeln lassen. Wie siehts mit der Sicherheit aus, wenn ich die zwei Pillen hintereinander schlucke? Wie Effektiv ist die Kombo im Vergleich zu Trexima?

[Ackergaul]

Antwort auf Beitrag Nr.: 30.361.800 von Ackergaul am 28.06.07 09:36:11

http://www.forbes.com/sciencesandmedicine/2006/04/13/pozen-t…
No More Headaches?
Andy Stone, 04.17.06, 6:00 AM ET

New York - Will Trexima finally end Pozen's headaches?

In its ten-year existence, Pozen (nasdaq: POZN - news - people ) has never managed to get a drug approved by the U.S. Food and Drug Administration. The two lead pain-control medications in its pipeline were both denied marketing approval by the regulatory agency within the past three years.

But a third drug, developed in conjunction with GlaxoSmithKline (nyse: GSK - news - people ) as a potential replacement for its blockbuster migraine drug Imitrex, turned in strong clinical trial data in early April and could earn FDA marketing approval by June. The drug, dubbed Trexima, could supplant Glaxo's Imitrex, which is due to lose patent protection in 2009. Imitrex holds 56% of the migraine drug market and brought in $1.1 billion in sales last year.

North Carolina-based Pozen, which has a market capitalization of $450 million, has never had significant revenues. But it spent less than $30 million on the development of Trexima, which is a combination of sumatriptan, the active ingredient in Imitrex, and the anti-inflammatory drug naproxen, found in over-the-counter pain medications such as Bayer's (nyse: BAY - news - people ) Aleve.

Doctors often prescribe a combination of a triptan (sumatriptan is one type of triptan) and an anti-inflammatory drug to migraine sufferers—there are 26 million in the United States—because each addresses one of the two causes of migraine pain: over-stimulation of nerve endings in the brain and the inflammation of nerves and blood vessels that results.

Pozen and Glaxo are hoping doctors will prefer to prescribe a single drug to migraine sufferers, since patients are more likely to take a single drug properly.

Critical to the drug's appeal will be Glaxo's quick-acting RT technology, which speeds the breakdown of the pill once it reaches the stomach, allowing medication to swiftly enter the bloodstream and bring pain relief that is faster and more complete than with either drug separately. The clinical trials showed less pain was perceived 24 hours after the onset of a migraine, reducing the need for patients to take so-called rescue medication.

Assuming Trexima earns FDA approval, Pozen could enjoy a redeeming payday, especially in light of the $55 million burned on the development of the two earlier unsuccessful drugs. Glaxo has paid Pozen $60 million, mostly in milestones thus far, and will pay another $20 million on FDA approval. Additional sales-level milestone payments could total $80 million. Pozen would get a gradually increasing royalty, reaching a reported 17% after Imitrex's patent expires.

RBC Capital Markets analyst Ken Trbovich forecasts $90 million in royalty revenue by 2009, when Imitrex's patent expires. Total cash flow to Pozen could top $1 billion by the time Trexima's own patent expires in 2017.

If pedigree has anything to do with a drug's success, then Trexima may have a leg up. Pozen was founded by Dr. John Plachetka, head of the U.S. team of Glaxo scientists who developed Imitrex, the first oral triptan for migraine, from 1987 to 1990. Plachetka left to run an independent drug research company, and he later started Pozen with the idea of combining a triptan with an anti-inflammatory.

One of the early investors in Pozen was Jacques Rejeange, the former president of U.S. operations for the Swiss pharmaceutical company Sandoz, which had been producing the injectable migraine drug DHE since the 1930s. Plachetka also took his idea to Glaxo, but the company had recently released Imitrex and wasn't yet interested in the ex-employee's idea. "If they hadn't turned me down, I wouldn't have started Pozen," Plachetka says.

Realizing the combination drug would take time to develop, Pozen chose to focus on two other migraine drugs, MT100 and MT300, while taking the company public in an $85 million public offering in 2000. MT300 was an updated form of Sandoz's decades-old migraine drug, and it ultimately failed to gain FDA approval.

The development of Trexima has not been smooth, either. In February 2005 Pozen released preliminary clinical results, pertaining to one-half of trial subjects, that showed that Trexima failed to relieve the nausea commonly associated with migraines. Investors feared the drug could ultimately fail, and the stock plummeted $3.55 by mid-April. Results for the second patient cohort, however, turned up no such problem. Investor fears were further allayed following recent comments by GlaxoSmithKline chief Jean-Pierre Garnier that Trexima would replace Imitrex, which he called the gold-standard migraine treatment.

Pozen shares closed recently at $15. Pozen investors, and migraine sufferers, will cross their fingers and hope for the best come June.


Für mich ist Trexima, das "schlechteste" Produkt in der Pipeline von Pozen. Ist im eigentlichen Sinne Überflüssig. Dennoch wird es wohl ein Renner, wenn die FDA JA sagen sollte... Aus dem einfachen Grund da GSK Imitrex platt machen und anstelle dessen Trexima verkaufen will. PN 400 und PA 325 haben das Ziel, die Medikamente sicherer zu machen. Trexima verknüpft "nur" zwei Wirkstoffe, die auch einzeln einzunehmen sind.

[blb]

Zulassungsentscheidung am 1.8.! Überlege einzusteigen, gibts Meinungen?

Grüße
blb

[Ackergaul]

Ich kann Dir nur Zusammenfassend sagen:

Chancen der Zulassung sind eindeutig > 70% - JEDOCH sind die Kursrisiken deutlich höher. Bei Nicht Zulassung könnte der Kurs sich im worst case Fall bei 10 $ befinden. Bei Zulassung wohl wahrscheinlicher bei 24 $ rum...

Ich wollte Zahlenspiel unterlassen, aber (kann man eh nur bei verlieren):
Ich denke in 4 Jahren dürfte es möglich sein mit Trexima 800 Millionen $ umzusetzen. Viel mehr wird wohl nicht drin sein. In den ersten 2 Jahren wird GSK noch Milestones zahlen (ca. 40 Mil. $) - danach nur noch die Royalities. 800 Mil. würd bei mir bedeuten Royalities bei etwa 88 Mil. (500 Mil. mit 8 % und 300 mit dann etwa 16 % - Grenze habe ich bei 500 Mil. angenommen). Ausgaben: Verwaltung etwa 23 Mil. und R&D 35 Mil. Damit vor Steuern Gewinn con etwa 30 Mil. Nach Steuern und Gewinn pro Aktie möglicherweise bei 0,7 Dollar.

"Sexy" wird die Rechnung erst mit der Hereinnahme von PN. Hier sind denke ich bis zu 1000 Mil. möglich! Trexima ist NICHT gerade mein Liebling von Pozen. Deswegen bin ich mir noch nicht 100%-ig klar, ob ich das Risiko 1.8. eingehe. Natürlich würde eine Zulassung auch als Initialzündung hier gesehen werden, schon mit Blick auf PN. Dann wäre mit der üblichen Börsen Phantasie auch wesentlich höhere Kurse drin...

Aber Biotech ist in meinen Augen immer noch ein bischen wie Lotto. Ist nur mein "Zahlenspiel", mit Sicherheit wird der eine oder ander sagen: Was hat der denn da gemacht...

Tschau!

[blb]

Naja hat sich erledigt, etz hats grad meine Demag zerfetzt. Hab glücklicherweise vor der Gewinnwarnung noch nen Teilverkauf gemacht und GPC-Optionsscheine gekauft. Teilweise Glückgehabt, teilweise trotzdem dumm gelaufen, dr Chart sah super aus. Tja, vielleicht ist es nichtmal so schlecht bei POZN zuzuschauen. Hab bei GPC ja genug Spannung zur Zeit!

Wünsch euch viel Erfolg mit POZN! Der Langfristchart sieht auf alle Fälle super aus!

Grüße
blb

[Ackergaul]

Wer den Bericht von "the street" noch nicht kennt...

http://www.thestreet.com/s/pozen-pins-hopes-on-an-fda-booste…
Pozen Pins Hopes on an FDA Booster Shot
By Adam Feuerstein
7/10/2007 10:53 AM EDT

An approaching Aug. 1 decision by U.S. regulators on approving Pozen's (POZN - Cramer's Take - Stockpickr - Rating) migraine headache drug makes the stock one to watch during the next few weeks.

Pozen is seeking its first drug approval following the Food and Drug Administration's rejection of two previous migraine drugs. Each of the prior failed efforts were solo affairs, but Pozen has some big-time assistance for its Trexima drug in the form of a partnership with GlaxoSmithKline (GSK - Cramer's Take - Stockpickr - Rating).

Trexima combines Imitrex, the leading migraine headache drug marketed by Glaxo, with naproxen, an over-the-counter pain reliever and anti-inflammatory drug. Naproxen, a so-called NSAID (nonsteroidal, anti-inflammatory drug), is probably best known as the brand name Aleve.

Imitrex and related product sales totaled $1.4 billion in 2006, but the blockbuster migraine drug franchise has begun to lose patent protection. Glaxo is hoping to switch patients to Trexima before Imitrex goes fully generic in 2009.

For Pozen, which holds patents on the combination of Imitrex and naproxen, and conducted the Trexima clinical trials, the drug's approval represents a potential cash cow in the form of expense-free royalty payments from Glaxo tied to the drug's sales.

Pozen filed Trexima for approval with the FDA in August 2005. In June 2006, the agency issued an approvable letter, requesting additional safety data on the drug before it could be approved. Glaxo and Pozen submitted the additional safety data in November 2006. The FDA is expected to issue its approval decision by August 1.

Pozen shares have performed well lately as investors seem to be anticipating a Trexima approval. The stock is up almost 40% since its recent lows in mid-April. Pozen closed Monday down 57 cents to $17.99.

Drug safety and the FDA can be a tricky thing to handicap, especially when it comes to drug combinations. Generally speaking, the FDA will want to make sure that two drugs combined don't exacerbate or magnify toxicity caused by the drugs taken individually.

In the case of Imitrex and naproxen, cardiovascular side effects are the primary safety concern.

One hedge fund analyst who has followed Pozen but doesn't have a position in the stock says the company and Glaxo appear to have collected safety data from enough patients (upwards of 3,000 Trexima patients) to assuage any FDA concerns.

"The biggest risk to full approval, in my opinion, is if the FDA just goes crazy with worry and asks the companies to conduct a huge safety trial," he says. "I don't see why they would do that since Imitrex and naproxen are well-understood drugs already on the market, but with the FDA, you never know for sure."

The other lingering question is the value of a Trexima approval to Pozen's stock price. At around $18, Trexima approval is somewhat baked into the stock already, so how much upside is there for good news on Aug. 1?

Pozen is expected to earn $1.33 a share in 2009, according to the consensus analyst estimate collected by Thomson Financial. Using a price-to-earnings multiple in the range of 25 to 30, and discounting back by 20-25%, gives a stock price of $22.

Assuming approval, Pozen's royalty on Trexima sales from Glaxo are fairly modest in the first couple of years of the drug's launch, building substantially once Imitrex goes fully generic. For example, analysts, on average, are forecasting Pozen earnings of $2.60 a share in 2010 -- essentially doubling year over year.

Using 2010 earnings as a base valuation year -- but leaving all other variables constant -- gets a higher Pozen stock price of around $35.

Of course, relying on the accuracy of sell-side earnings estimates three years into the future for a drug that's not even approved yet can be a dicey proposition. (They don't call them sell-siders for nothing.)

And approval doesn't guarantee unbridled success. Glaxo might be able to convince doctors and migraine patients to switch from Imitrex to Trexima, but getting managed care companies to pay for the drug when Imitrex will be generic and cheap won't be as easy.

Compounding the difficulties in marketing Trexima will likely be the fact that some doctors will simply instruct patients to take Imitrex and an over-the-counter tablet of naproxen to get a similar effect as the all-in-one Trexima.



Die Frage der fairen Bewertung muss jeder mit sich ausmachen. Wie Feuerstein schreibt, geben die Analysten 2010 einen Gewinn pro Aktie von 2,60 $ aus. Ich gehe davon aus, dass diese Analysten sich mehr Mühe mit der Bewertung Pozens als Feuerstein gemacht haben und mögliche Milestone und Royalitie Zahlungen von PN-400 auch bereits berücksichtigt haben. Eine reine Bewertung nach dem KGV halte ich persönlich vorerst nicht für Fair, da die Pipeline gut gefüllt ist.
Hier nochmals die Gewinnaussichten von der POZN Homepage:
http://phx.corporate-ir.net/phoenix.zhtml?c=121701&p=irol-ea…


Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 30.689.444 von Ackergaul am 14.07.07 19:43:20

Der Barrons online Artikel zu Pozen ist nur mittels Regestrierung möglich. Den Bericht habe ich im Y! Board gefunden:

"MIGRAINES, ACCORDING TO THE NATIONAL LIBRARY of Medicine, can be triggered by bright lights, loud noises, weather changes, smoke, perfumes, alcohol, caffeine, red wine, aged cheese, smoked fish, bacon, chocolates, nuts, avocado, bananas, onions ...you get the idea. Over the past year, 18% of U.S. women and 6% of men have suffered at least one attack.

So it's easy to see why shares of a little-known drug-development company, Pozen (POZN), have run up 16% since June. Pozen has developed with GlaxoSmithKline (GSK) a tablet for treating migraines, and a regulatory decision regarding the remedy, known as Trexima, is expected Aug. 1.

Option prices suggest that the market sees a 60% chance Trexima will be approved by the Food and Drug Administration, but Citigroup analyst Lucy Lu is more optimistic. She pegs the odds of an FDA nod at 80%, given Trexima's superior efficacy results in clinical trials and a safety profile comparable to Imitrex, currently the go-to drug with 55% of the U.S. market. Imitrex already is a winner for GlaxoSmithKline.

Lu believes a yes could drive Pozen shares, trading at 18.50 recently, to between 23 and 25 and towards her 12-month target of 28. "We believe Trexima will be the new gold standard treatment of migraine headaches," she notes.

There are other catalysts, too. Because partner GlaxoSmithKline's bestselling Imitrex will become a generic drug by late 2008, "we believe GSK intends to aggressively convert its Imitrex sales" -- about $1.1 billion in the U.S. last year -- "to Trexima in order to capture significant market share in the migraine market before its Imitrex sales are at risk," Lu says. Trexima sales pegged at $53 million this year could reach $571 million in 2010, and Pozen's 5% royalty jumps to 17% in 2010 and after.

But because Trexima is Pozen's primary candidate, any regulatory glitch can send shares tumbling to 7 or 8. Given that slim but real risk, bulls might consider buying August call options or call spreads on Pozen. And because option buyers never risk more than the premium paid, any FDA surprise would trigger less of a headache"

[Ackergaul]

Zwei Berichte habe ich noch nachzutragen. Hier der erste von Andrew Vaino, der sich wiederholt sehr negativ zu POZN aüßert:

Problems Posed for Pozen
By Andrew R. Vaino July 17, 2007

Pozen (Nasdaq: POZN) is awaiting an FDA decision on its New Drug Application for Trexima as a treatment for migraine headaches. In June 2006, the company received an approvable letter from the FDA requesting more data, specifically on the interaction between Trexima's component drugs, naproxen and sumitriptan. The FDA is set to rule on this resubmission by Aug. 1.

The two drugs treat migraines in different ways. Sumatriptan stimulates serotonin receptors, constricting blood vessels to provide migraine relief, while naproxen is a non-steroidal anti-inflammatory drug. In addition to their varying approaches to attacking migraines, the two drugs may be absorbed by the body at different rates when jointly administered. This sort of combination therapy is common in treating cancer, and it's a good idea.

A recent paper in the Journal of the American Medical Association (JAMA) presented results from two phase 3 studies of Trexima, which Pozen is developing in partnership with GlaxoSmithKline (NYSE: GSK). In the studies cited in JAMA, patients who received a single Trexima tablet had better pain relief results than patients receiving either sumatriptan or naproxen alone. Other effects of migraines, including nausea and sensitivity to light and sound, were similarly reduced. The authors of the JAMA article also point out that the levels of the two drugs used in Trexima's current formulation may or may not be the most effective combination -- only further study will tell.

For me, this study leaves a pretty big unanswered question: What is the benefit of a single pill combining two existing drugs, compared to just taking each drug separately?

I did some more digging and discovered a paper published in 2005, which found that the combination of the two drugs was superior to either given alone.

With clear benefits to Trexima, it will be interesting to see whether Pozen can get the FDA's thumbs-up. The company has a dubious track record at getting such combination drugs approved; it recently settled a shareholder lawsuit arising from previous failures to do so.

Both of these drugs are well-known, so approval is likely, though not assured. But I'm also wondering whether insurance companies will foot the bill for Trexima. At the end of the day, sales are all that matter. With naproxen already available as a cheap generic, and sumatriptan soon to follow, convincing patients to pay more for a single pill may be tough.

If Trexima's not approved, Pozen's stock will clearly tank. Any benefits stemming from the drug's successful approval are harder to gauge. The stock price could get a bump up, or it could slump as investors betting on approval sell to lock in gains. In the long term, Trexima's sales will drive Pozen's share price. I don't think the prognosis looks good for either one.

[Ackergaul]

Antwort auf Beitrag Nr.: 30.808.490 von Ackergaul am 23.07.07 09:45:54

Der zweite Artikel ist von Atlas Bioresearch:

What will August 1, 2007 hold for POZN; Earnings on July 26 May !?
publication date: Jul 21, 2007

In an earlier article in April 2007 we published a positive review of POZN. In that article we indicated that POZN was an attractive buy at the current levels. IT traded at approximately $14 at that time and is now in the high $18 range hitting a 52 week high in June. Since that time the stock has weakened as investors await results of the resubmission on August 1, 2007 from the FDA. The company submitted the additional data in November 2006. The two drugs treat migraines in different ways, which is a good thing for the company. Both have been approved by the FDA and it is clear that interaction between the two will have been well studied in the past. POZN is developing this compound with GlaxoSmithKline. Both these facts especially the proven nature of the two drugs are positive indiocations of success. With a good partner in GSK and Trexima being key to the furture of POZN we continue to believe that the stock is good buy at these levels. Any problem with the FDA approval from here will have a very significant negative effect on the stock so as with all biotechs at this level it is buyer beware. The company will report results on July 26, 2007 and may offer additional information on this submission although too much information with a drug this close to approval will be unlikely. A good stock to watch in the next ten days.

[blb]

Hab ne Zockerposition drin für nächste Woche...

[Ackergaul]

Antwort auf Beitrag Nr.: 30.879.768 von blb am 27.07.07 17:35:18

Moin-Moin allerseits,

Gehe jetzt mal NICHT auf den 1.8. als Termin ein, sondern auf die 2.Q Zahlen / News: Dass der Verlust um 1 Mil $ höher ausgefallen als erwartet worden ist, darüber darf natürlich gemeckert werden. Mir ist dass erstmal wurscht.
Vielmehr fand ich den Ausblick interessant. Zur PN 400 Studie wird berichtet, dass die proof-of-concept Studien (PN 200-301) wie gewünscht laufen und bereits statistisch signifiklante Ergebnisse aufweisen. Das hört sich für mich danach an, dass AstraZeneca Pozen die Freigabe erteilen wird, bis Ende August die Hauptstudie (Phase III) bei PN 400 einzuleiten - wie geplant! Was mich persönlich überrascht hat, war die Meldung, dass PA 325 bereits im 1.Q 2008 in eine Phase III gelangt! Obs der "pivotal Trial" ist, kann ich nicht deuten, aber möglicherweise ist das ein Vor-Zeichen, dass PA 325 für einen potentiellen Partner zur Lizensierung bereit steht (Milestones). Wie erwähnt der Langfristige Ausblick, ist nicht mal so uninteressant...

http://home.businesswire.com/portal/site/google/index.jsp?nd…
...
Corporate Highlights

The PN 400 anti-secretory study demonstrated significant acid inhibition. The interim look at the PN 200-301 (naproxen/omeprazole) study indicates a statistically significant difference in favor of PN versus naproxen relative to the difference in patients with gastric ulcers at six months. Per our agreement with AstraZeneca, they will determine whether to proceed with the Phase 3 studies after they have had a suitable opportunity to evaluate the information.

POZEN had discussions with the FDA regarding the PA 325 development program. The FDA agreed that we can follow a similar regulatory pathway as agreed upon for the PN program. POZEN plans to be in a position to start the Phase 3 studies as early as the first quarter of 2008.
...


Grüße

[Ackergaul]

June 13, 2006
Disapproval of Approvability
Posted by Derek

I've written before about how seemingly obvioius combination therapies can be hard to develop. Last Friday we had some more evidence of that.

Pozen, partnering with GlaxoSmithKline, has been trying to put together two well-established drugs for migraine: GSK's Imitrex (sumitriptan) and the OTC pain reliever naproxyn. But the FDA sent them the dreaded "approvable" letter, requesting more information (which, who knows, might require more studies) and Pozen's stock took the plunge. (Another small company, Neurocrine, went through a similar wringer a couple of weeks ago - I'm backed up on writing about that, but I hope to soon).

Analysts seem to be optimistic about the drug's eventual chances, but that doesn't do you as much good if you were holding the stock before the FDA letter. These "approvable" letters seem to have been increasing in frequency the last couple of years, and it's turning into a real problem. Such a letter either turns out to be not too big a deal, in which case a company's stock has been slaughtered for nothing, or it turns out to be such a big deal that you wonder why the company (and the agency) didn't come to some understanding about it before.

Is the FDA too risk-averse, or are companies trying to get too-thin NDAs through? My money's on the first explanation, in most cases. I think that the whole COX-2 debacle has helped to put the agency into a better-safe-than-sorry mode. I understand the need for caution, but (here comes a general principle of life): just because you can mess things up in one direction doesn't mean that you can't mess them up in the opposite one. Saying that the agency is too cautious doesn't mean that I think that they should let everything through - but letting some things through would be nice.

(See this Business Week piece for more on the approvable problem).

[blb]

So, heute ist also der Tag der Entscheidung. Wie geschrieben rechne ich mit einem positiven Bescheid für Trexima. Sollte ein erneutes "Approvable" kommen, sehn wir uns wohl bei 6-7$ wieder. Bei Zulassung ist die Reaktion noch unklar, ich rechne mit einem Kurs zwischen 20 und 25$. Bin daher wie geschrieben nur mit einer kleinen Position dabei.

Grüße
blb

[Der.Eroberer]

Ich fiebere seit Tagen diesem Termin entgegen. Da dürfte auch nichts schief gehen...
Auf alle Fälle ist die Wahrscheinlichkeit einer Zulassung größer als beim GPC-Desaster.
Hoffen wir mal das Beste.

[Der.Eroberer]

POZN springt an!!!

Jetzt wird es spannend...

[blb]

Mann wo bleiben die News??!!

[Der.Eroberer]

Antwort auf Beitrag Nr.: 30.975.038 von blb am 01.08.07 23:23:19

In Amerika ausserbörslich bis zu 20% im Minus. Ich hoffe, dass da nur ein paar Ungeduldige geschmissen haben. Offiziell ist noch nichts raus.

[Der.Eroberer]

Der CEO von Pozen tritt um 13:40 Uhr unserer Zeit bei CNBC auf. Bis dahin wird die Nachricht wohl raus sein. Im Moment wird in Frankfurt der niedrigere After Hour Kurs getaxt. Nochmal die Chance günstig einzusteigen...

[blb]

Oder die Chance günstig auszusteigen??!! Bin grad etwas irritiert...

[Der.Eroberer]

Hab vorhin noch versucht in Frankfurt ein paar Stücke zu 12,05
abzustauben, aber der MM hat direkt hochgetaxt. So ein Spielverderber!

[Der.Eroberer]

Der CEO tritt in ein paar Minuten vor die Kamera und es ist immer
noch keine Meldung raus. Was hat das zu bedeuten? Die Nachricht darf
er zumindest nicht über TV verbreiten, dazu müsste eine ad-hoc
verfasst werden, die aber noch nicht im Umlauf ist.

Es bleibt spannend...

[blb]

Ich find das alles sehr strange, erst gestern keine Meldung, dann bislang immer noch nichts. Schlafen die alle oder wie?

[blb]

Approvable. Was sich die FDA zur Zeit leistet ist wirklich unter aller Sau...

http://www.reuters.com/article/marketsNews/idUKWLB0106200708…

[grafbibi]

Antwort auf Beitrag Nr.: 30.980.814 von Der.Eroberer am 02.08.07 10:46:45

Haste aber Glück gehabt 7,06 € :O

[grafbibi]

Antwort auf Beitrag Nr.: 30.987.026 von grafbibi am 02.08.07 17:00:09

AP
Pozen Gets 2nd FDA Approvable Letter
Thursday August 2, 9:45 am ET
Pozen and Glaxo Get 2nd Approval Letter From FDA for Added Data on Migraine Treatment Trexima


CHAPEL HILL, N.C. (AP) -- The Food and Drug Administration issued a second approvable letter seeking more data from Pozen Inc. and GlaxoSmithKline on their migraine medication, Trexima, further delaying the drug's approval.
ADVERTISEMENT


Shares of Pozen plunged $7.67, or 44 percent, to $9.78 in morning trading.

The companies said Thursday the FDA asked Pozen to address potential implications from a preclinical study into chromosomal risks -- one of four standard genotoxicity studies -- in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone.

Trexima combines Glaxo's migraine drug Imitrex, known generically as sumatriptan, with naproxen sodium, an older anti-inflammatory drug.

None of the other three standard genotoxicity studies demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan, according to the companies.

An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.

The companies said they plan to request a meeting with the FDA as quickly as possible to discuss the necessary steps to address the agency's concerns.

In June 2006, the FDA issued an approvable letter on Trexima that asked for additional drug safety information. The FDA did not accept the additional data submitted by the company in November. The companies then filed additional safety data in January

[Ackergaul]

Ich wusste, dass ich mich heute so oder so ärgern würde, da ich die Hälfte meiner Aktien bei 19 $ verkloppt habe. Allerdings habe ich nicht gedacht, dass es so kommen würde...
Sumatriptan und Naproxen werden schon jahrelang von Ärzten zur Migräne Behandlung verschrieben und die FDA meint Trexima berge Risiken? Für mich ist dass vielmehr eine politische Entscheidung zu Gunsten der kommenden Sumatriptan Generika (Spiel auf Zeit)! Wie erwähnt halte ich nicht richtig viel von Trexima, ich gehe aber davon aus, dass es der Goldstandard hier werden wird.
Nun heißt es abwarten. Was will die FDA noch sehen? Drohen neue Trials (Langfriststudien)? Was genau hat man überhaupt auszusetzen?

Im besten Fall kann Pozen und GSK in etwa 3 Monaten die Fragen wieder mit der FDA klären. Schaut Euch auch den Langfristchart einmal an, nach dem vorigen approvable letter.

[blb]

Antwort auf Beitrag Nr.: 30.987.350 von Ackergaul am 02.08.07 17:15:58

Ich hör gerade den CC! Also was die FDA sich da geleistet hat, ist einfach nur noch lächerlich. Ich würd sogar so weit gehn wie Ackergaul und es mit den kommenden Generika begründen.

Soweit ich es verstehe war der aktuelle Punkt der FDA auch im ersten Approvable Letter ein Thema, jedoch wurden in einer anderen Studie genau diese Bedenken ausgeräumt. Zudem war der Punkt in einem einstündigen Gespräch mit der FDA maximal 5 Minuten ein Thema. Nun wurden die Einwände des ersten Approvable Letter ausgeräumt und sie kommen wieder mit den alten Sachen. Zudem sind beide verschiedene Substanzen ja schon getrennt auf den Markt, bislang ohne Bedenken.

Also für mich macht das wirklich alles keinen Sinn mehr. Bin heute noch ganz gut rausgekommen, da es nur eine Tradingposition war. Vielleicht geh ich vor der nächsten Entscheidung wieder rein, mal schaun.

Eins ist jedoch sicher. Bei der FDA überrascht mich langsam wirklich nichts mehr...

Grüße
blb

[HLoew]

das ist ein hammerharter abschlag fast 50%, was erwartet ihr für die zukunft, wie tief kann es noch fallen?

[Der.Eroberer]

Ich habe für mich heute größtenteils einen Schlussstrich unter
meine Biotech-Investments gesetzt und werde auch dementsprechend
keine weiteren Positionen (außer Alizyme) eingehen.

Die FDA lässt leider jede Linie vermissen und wird selbst zu einem
unvorhersehbaren Risiko für jeden Investor.

Zum Glück gibt es nicht nur Biotechwerte...

[Ackergaul]

Einen verärgerten guten Morgen. Selbst das gestrige Grillen hat meine Laune nicht heben können.

Chromosomenabweichung heißen nun die Bedenken… Zum Herz-Kreislauf-System gab’s nichts mehr auszusetzen – keine Bedenken. Bei einer Tierversuchstudie an Hamstern sind nach meinen Infos eben der FDA „chromosomal abnormalities“ aufgefallen. Dies war in einer vorklinische Studie, in der den Hamstern die 100-fache Dosis gegeben wurde. Nun wird wahrscheinlich die FDA mittels besagtem Schreckens-Letter um eine zusätzliche „kurze“ Studie an Menschen bitten.
Was mich irritiert: Warum hat die FDA diese Bedenken nicht schon beim letzten approvable letter kundgetan??? Für mich ist dass ein Spiel auf Zeit! Stichwort Generika.
Werde meine restlichen Anteile halten und möglicherweise noch zukaufen. Ich kann mir vorstellen, dass dieses Problem relativ zügig zu lösen ist. Innerhalb von 3 Monaten sollte mit der FDA geklärt worden sein, was zu machen ist. Im besten Fall ist keine weitere Studie mehr erforderlich, rechne aber nicht damit. Historisch gesehen dürfte dies ein Einstiegs Geschenk sein, allerdings könnte der Trexima Start um etliche Monate nach hinten verschoben werden… 2009 kommen die Flutwellen der ersten Generika dann!


Bis denn erstmal...

[blb]

Sauer bin ich auch Ackergaul, das kannste mir glauben. Klar kann das immer passieren, wenn man auf eine Zulassung spekuliert. Aber in diesem Fall klingt das wirklich komisch.

Wie du schreibst, sämtliche Bedenken des ersten Approvable Letters wurden ausgeräumt und die FDA zaubert nun etwas anderes aus dem Hut, das in den Gesprächen mit Pozen quasi kein Thema war. Hinzu kommt, dass 3 von 4 Studien wohl gerade NICHT Toxizitätsprobleme aufwiesen.

Du könntest Recht haben mit der Kaufchance im Hinblick auf die anderen Produkte in der Pipeline. Bei Trexima wird sich zeigen müssen, ob es überhaupt angenommen wird oder die Patienten nicht eher zu den Generika greifen werden.

Kurzum aktuell macht es wirklich keine Freude in Biotechs engagiert zu sein.

Grüße
blb

[HLoew]

heute 9$

[Ackergaul]

Die bewusst provokante Fragestellung des Threads, kann seit Donnerstag eindeutig mit JA beantwortet werden. Mal sehen, wie sich der Schmerz innerhalb der nächsten 6 Monate weiterentwickelt...

Another Headache for Pozen Investors
By Brian Orelli
August 3, 2007

Pozen (Nasdaq: POZN) investors just got a major headache, and they won't be able to relieve it with the company's migraine drug, Trexima. Pozen received an approvable letter for the drug from the Food and Drug Administration on Thursday.

This is the second approvable letter that Pozen and marketing partner GlaxoSmithKline (NYSE: GSK) have received for the drug. The first letter, from June 2006, requested more data on the interaction between Trexima's component drugs, naproxen and sumatriptan.

The FDA is no longer worried about the potential cardiovascular side effects from the combination of the drugs. Now it's worried about a preclinical test for cancer that Pozen performed. The test involved putting a high level of the drug on cells grown in a laboratory. At a drug concentration that is 100 times higher than would be used in humans, the combination of drugs killed the cells.

The results may be an artifact, or an unusual result, of the test; in fact, the FDA acknowledged that in its approvable letter. If Pozen and GlaxoSmithKline can explain the reason for the weird result, they could receive an approval fairly quickly.

More likely, Pozen will need to run a small clinical trial to show that the effect isn't seen in humans. The trial might be as small as a single dose given to subjects, followed by analyzing blood cells for chromosomal aberrations. That would take a few months at most, and then the companies could submit the data.

Given that the drugs will be given at a much lower dose, I expect there wouldn't be a safety problem with the new trial. Drugs can have weird effects at high concentrations. Vitamin C, for instance, is fairly toxic at high doses, but certainly has benefits at normal concentrations.

On average, safety issues result in less of a delay than when the FDA has issues with a drug's effectiveness, which doesn't seem to be a problem here. Sure, there's times when the FDA requires lifetime carcinogenicity studies, but in this case, this issue appears to be fairly minimal, and Pozen should be able to wrap it up relatively quickly.

As a fellow Fool pointed out, Pozen's biggest problems may begin after the drug is approved. A cheap generic for naproxen is already available, and one for sumatriptan will be available soon. Pozen would need to convince patients to take its overpriced combination pill when doctors could just prescribe the two drugs separately.


Ich kann mir gut vorstellen, dass der Kurs noch weiter absacken wird, auch unter die 9 $ Marke (gerade auch auf Grund des aktuell schlechten Börsenumfeldes). Beim letzten Letter hat sich POZN und GSK 2 Monate später bei der FDA gemeldet - Ihr könnt dies gut am Chartbild erkennen. Auf eine ähnliche Reaktion hoffe ich...



Schönen Tag noch!

[grafbibi]

Antwort auf Beitrag Nr.: 31.018.436 von Ackergaul am 04.08.07 09:00:16

Pozen Direktor Wise Sells Shares
Montag August 6, 3:28 P.M. UND
Pozen Direktor Peter J. Wise Sells 10.000 Anteile


New York (AP) -- ein Direktor von Pozen Inc., eine pharmazeutische Firma, verkauft 10.000 Anteilen Stammaktien unter einem vorarrangierten handelnden Plan, entsprechend Sicherheiten und Austausch-Kommission Archivierung Freitag.
In einer Form 4, die mit der sek eingeordnet wurde, berichtete Peter J. Wise über ihn verkaufte die Anteile am Mittwoch für $16.51 bis $16.65 pro stück.

Der auf lagerverkauf wurde unter einen vorarrangierten handelnden Plan 10b5-1 geleitet, der einem Firmaeingeweihten erlaubt, ein Programm für solche Verhandlungen im voraus aufzustellen und mit ihnen fortzufahren, selbst wenn er oder sie in Besitz der materiellen nicht öffentlichen Informationen kommen.

Eingeweihte ordnen Form 4s mit der sek ein, um über Verhandlungen in ihren der Gesellschaften Anteilen zu berichten. Erwerbe und Verkäufe des freien Marktes müssen innerhalb zwei Werktage der Verhandlung berichtet werden.

Pozen basiert im Kapelle-Hügel, N.C

[Ackergaul]

Antwort auf Beitrag Nr.: 29.816.676 von Ackergaul am 11.06.07 10:59:34

Zu den ständigen Aktien Verkäufen der Pozen Bosse will ich mich eigentlich nicht äussern. Ich halte dies für eine firmenschädliche Sache, auch wenn die Verkäufe im Vorfeld bereits beschlossen sind. Anscheinend ist dass aber Teil der Firmen Philosophie keine Anteile lange zu halten, sondern direkt in Cash umzuwandeln.

Nochmals zur FDA Entscheidung: Verstehen kann ich es - gerade als Laie - immer noch nicht, aber hier muss ich auch Pozen einen Vorwurf machen. Wenn im Vorfeld bei Tierversuchen, solche Sicherheitsproblematischen Auffälligkeiten enstanden sind, sollte man dieser Sache doch direkt nachgehen - oder? Auch wenn es sich um eine 100-fache Dosis in Hamstern handelt. Dieser Test wurde doch sicherlich nicht aus "Jux und Dollerei" gemacht, sondern um Erkenntnisse daraus zu gewinnen. Natürlich hat die FDA dann Recht und kann hinterfragen (hat sie ja auch...)

FDA and Drug Safety: It Keeps Getting Worse
How bad is the drug safety climate? Just ask GlaxoSmithKline.
Tuesday, August 07, 2007

Sure, last Monday was a rough day—nothing like having two FDA officials tell an advisory committee that one of your biggest products ought to be pulled—but we’re not talking about Avandia today.

No, today we are talking about the product formerly known as Trexima, a fixed-dose combination of the GSK’s migraine drug sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug naproxen. GSK is developing the combo in partnership with Pozen. On July 31, the Food & Drug Administration issued a second “approvable” letter for Trexima, saying that it is still not convinced the combination is safe enough for marketing. (FDA has already told the companies that it will not approve the Trexima brand name, but the firms are still using it until they settle on a new one.)

In particular, Pozen says, FDA is concerned about a positive genotoxicity test. The agency apparently wants the company to conduct a relatively simple human study to provide reassurance that it is a false signal. This comes after FDA previously declined to approve Trexima because of concerns about the cardiovascular safety profile of the combination.

Keep in mind that this pill combines two ingredients that have been used together countless times in the 15 years that Imitrex has been on the market. If there really is a safety problem here, FDA probably should be doing more than just sending an “approvable” letter to Pozen.

To be fair, Imitrex has well known cardiovascular risks, and naproxen’s cardiovascular safety profile became an issue in the context of the cox-2 inhibitor safety brouhaha. So you can understand why FDA asked for more data. Now, Pozen says, the agency is satisfied on that front (thanks in part to GSK’s willingness to do a post-marketing study on the blood pressure effects of the combo). But the drug is still on hold.

Welcome to the world of new drug reviews in 2007. Trexima is just the latest indication that this may be the worst time ever to try to get a new drug through FDA.

There should be good news soon. Congress is on the verge of enacting historic drug safety legislation—at least, Congress says it will after August vacation. The bill will put new burdens on manufacturers to be sure, but it will also allow Congress to declare the drug safety problem to be fixed. That may lead to increased confidence in FDA as a regulator—and maybe increased confidence within FDA itself to allow the agency to approve drugs even if they do have a safety signal.


Teilweise halte ich das Vorgehen der FDA auch für richtig. Die Pharma Preise müssten eigentlich fallen (Generika durch auslaufen der Patente), aber blickt man in die Zeitung, stellt man fest - die Preise steigen! Erfinderische Unternehmen, wie etwa GSK und Pozen, verändern die Substanzen so, dass die Produkte "leicht" verbessert werden und möglichst wieder per Patent geschützt werden können. Dadurch können auch andere Preise verlangt werden. Streiten sollen sich andere darüber, Pozen hat mit Trexima ein Produkt, welches Migräne Patienten SEHR GUT hilft! Wenn es auf den Markt kommt, ist es wahrscheinlich, dass es langfristig zu dem Goldstandard hier wird (obwohl Naproxen und Sumatriptan auch als Generika Version erhältlich sind). Mag sein, dass dies jetzt ein Fall war, warum die FDA hier genauer hingeschaut hat...

[Ackergaul]

Antwort auf Beitrag Nr.: 31.075.511 von Ackergaul am 08.08.07 10:42:29

den Bericht hatte ich übersehen:
http://biz.yahoo.com/zacks/070803/8855.html?.v=1
Staying Positive on Trexima\'s Future
Friday August 3, 1:02 pm ET
By Zacks Equity Research

The following are excerpts from an interview with Zacks senior drug industry analyst Jason Napodano, CFA regarding the recent negative developments pertaining to Trexima, a migraine relief drug developed by Pozen (NasdaqGM: POZN - News), with GlaxoSmithKline (NYSE: GSK - News) partnering:

Pozen was seeking approval of a migraine relief drug called Trexima with their partner Glaxo, and unfortunately an FDA letter came back on Wednesday night saying that the drug was designated \'approvable.\' And \'approvable\' is a letter the FDA issues on drugs where they feel that the majority of the information is complete, but they would like an answer to a couple more questions before they grant outright approval.

Weve been positive on Pozen for awhile now, and we kind of got burned with this surprise request, which looks to set back this drug six-to-nine months. Trexima is a drug that we clearly think is superior to its components, which is rare; you take a drug like Imitrex and a drug like naproxen and stick them together in one pill, and there seems to be some synergistic benefit to that. The phase III clinical trials showed that Trexima is not only superior to Imitrex and naproxen separately, but superior to dosing the same components together. You get a benefit if you put them into one pill. And doctors like that, too, because its easier, better compliance, easier for the patients.

So were big fans of Trexima; we think its going to be a big drug. GlaxoSmithKline has one of the largest sales forces in the world. They are masters at taking these older-generation products and converting patients into newer-generation products. Theyve done it with Paxil, theyve done it with Wellbutrin, theyve done it with their HIV franchise, theyve done it with Advair. And theyll do it again with Imitrex - all those Imitrex patients theyre going to try to switch over to Trexima. We think it could still be a billion-dollar drug.

[Ackergaul]

Sammelklage gegen Pozen, auf Grund angeblichen Verstoßes der Wertpapier Gesetzlichkeiten der Pozen Bosse. Desweiteren sollen selbige zu Trexima ungenaue Darstellungen begangen haben... Was auch immer damit gemeint ist.

Schatz Nobel Izard P.C. Announces Class Action Lawsuit Against POZEN, Inc.
August 10, 2007: 06:45 PM EST

HARTFORD, Conn., Aug. 10, 2007 (PRIME NEWSWIRE) -- The law firm of Schatz Nobel Izard P.C., which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the Middle District of North Carolina on behalf of all persons who purchased the publicly traded securities of POZEN, Inc. ("POZEN") (Nasdaq:POZN) between July 31, 2006 and August 1, 2007, inclusive (the "Class Period").

The Complaint charges that POZEN and certain of its officers and directors violated federal securities laws. Specifically, the Complaint alleges that POZEN made misrepresentations concerning its lead product candidate, Trexima, a combination of sumatriptan and naproxen sodium. POZEN was developing Trexima pursuant to an agreement with GlaxoSmithKline. 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, defendants announced they had reached an agreement with regulators requiring only that POZEN 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.

On August 2, 2007, 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. On this news, POZEN shares -- which had traded above $19 in recent days -- fell to below $10 per share in intra-day trading.

If you are a member of the class, you may, no later than October 9, 2007, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a class member that acts on behalf of other class members in directing the litigation. Although your ability to share in any recovery is not affected by the decision whether or not to seek appointment as a lead plaintiff, lead plaintiffs make important decisions which could affect the overall recovery for class members, including decisions concerning settlement. The securities laws require the Court to consider the class member(s) with the largest financial interest as presumptively the most adequate lead plaintiff(s).

While Schatz Nobel Izard P.C. has not filed a lawsuit against the defendants, to view a copy of the Complaint initiating the class action or for more information about the case, class action cases in general, and your rights, please contact Schatz Nobel Izard P.C. toll-free at [phone], or by e-mail at [e-mail], or visit our website: www.snilaw.com.

[Ackergaul]

Delay for drug costly to Pozen
Worker incentives tied to Trexima

Sabine Vollmer, Staff Writer
The Food and Drug Administration's decision to delay approval of Pozen's migraine pill Trexima could cost employees at the Chapel Hill drug company more than $2 million.
At stake are stock options available to all 35 employees and cash bonuses of two top executives -- all tied to Trexima incentive programs.

The stock options and the cash bonuses will be forfeited if Trexima isn't cleared for sale by the end of the year, filings with the Securities and Exchange Commission show.

Pozen's board of directors has "clearly tied compensation to approval," said Ken Trbovich, a pharmaceutical analyst with RBC Capital Markets. It's a common practice at smaller companies, Trbovich said.

Trexima is Pozen's third attempt to get a drug to market. The company and its partner GlaxoSmithKline, a British drug maker with a U.S. headquarters in Research Triangle Park, have spent more than four years testing the migraine medicine.

Fourteen months ago, the FDA found that Trexima works, but requested more data about the drug's potential to cause heart attacks, stroke and genetic damage.

Follow-up lab work and additional data eased FDA concerns about Trexima's cardiovascular risks. But a week ago, regulators told Pozen and GSK that they still had questions about a lab test that suggested the pill's two ingredients are toxic when taken in large doses together. The drug combines the painkiller sumatriptan and naproxen, an anti-inflammatory that is in the over-the-counter medicine Aleve.

The FDA decision was a setback for Pozen and GSK, which is trying to find new medicines that can offset slowing sales of other products such as the asthma treatment Advair and the controversial Avandia diabetes pill. GSK had planned to start selling Trexima by the end of September.

Pozen scientists are checking whether the lab test result is a fluke, said Bill Hodges, Pozen's chief financial officer. They also expect to meet with the FDA in about four to six weeks to find out whether another study is required.

"We're taking parallel paths to do this as quickly as possible," Hodges said.

Analysts have projected that the regulatory review could last another six to 12 months.

The delays have already cost Pozen employees 25 percent of the stock options they bought, SEC filings show. On Dec. 31, another 261,000 stock options could be in jeopardy. Pozen employees paid about $1.84 million to get a chance at turning a Trexima success into a personal gain.

At $8.55 per share at the close of trading Tuesday, the stock options were worth about $2.2 million.

John Plachetka, Pozen's chief executive, and Marshall Reese, the company's executive vice president of product development, have portions of their 2006 cash bonus on the line, according to SEC filings.

If the drug isn't approved by Dec. 31, Plachetka stands to lose about $75,000. Reese has about $48,000 at risk.


Staff writer Sabine Vollmer can be reached at 829-8992 or [e-mail].


Für Plachetka und Reese sind die Verluste wohl mehr als verschmerzbar... Naja.

Grüße

[Ackergaul]

Momentan gibt es keine Neuigkeiten, allenfalls Spekulationen ob Pozen den nächsten Trexima FDA Termin auf 2 Monate verkürzen könnte (sonst 6 Monaten). Was an zusätzlichen Daten benötigt wird, scheint immer noch nicht endgültig geklärt (oder zumindest öffentlich) zu sein. Dennoch ist wahrscheinlich, dass eine "Mini" Studie, die die Überdosis noch genauer unter die Lupe nimmt, gefahren werden muss. Danach ein verkürztes 2 Monats Review wäre schon nett, aber ich denke nicht, dass die FDA hier mitspielen wird.

Ansonsten habe ich zuletzt kaum interessantes gefunden:
...
Speaking of headaches, Glaxo and its partner Pozen (POZN - Cramer’s Take - Stockpickr) were recently hit with another delay for their migraine treatment Trexima. The FDA granted conditional approval in early August, but one condition is more testing, which could take several months. The original application was filed two years ago, and the FDA issued its first conditional approval in June 2006. “We think the drug has a decent chance of being approved,” says a recent note by the independent research publication BioMedTracker, which analyzes drug and biotechnology prospects.

Trexima represents a standard Big Pharma generic-competition defense — developing a close relative of a brand-name drug. Trexima combines the generic pain reliever naproxen with Glaxo’s patented Imitrex.

For the first half of 2007, Imitrex produced $656 million. U.S. sales rose 11%, but sales in Europe and other foreign markets were down. U.S. generic competition will start in February 2009. Glaxo wants to secure early FDA approval so it has more time to persuade doctors and patients that newer is better.
...


Pozen "buy"

Monday, August 20, 2007 4:48:23 PM ET
Morgan Joseph & Co

NEW YORK, August 20 (newratings.com) - Analyst Eugene Trogan of Morgan Joseph reiterates her "buy" rating on Pozen Inc (POZN.NAS). The target price is set to $13.

In a research note published this morning, the analyst mentions that concerns over the August 1 approvable letter for Trexima are overdone. The analyst says that although the market introduction of the drug may be delayed by 7-12 months due to the approvable letter, it is expected to be approved eventually. Pozen’s pipeline excluding Trexima is undervalued, Morgan Joseph adds.


Grüße

Ich werde meinen restl. halbierten Anteil von Pozen auf jeden Fall erst einmal weiterhalten. Sollte eine Klärung mit der FDA erfolgen und ein neuer NDA Termin vereinbart werden, wird dies mit Sicherheit entsprechend von der Anlegergemeinde honoriert werden.

[Ackergaul]

Zu den Sammelklagen etwas:
http://www.bizjournals.com/triangle/stories/2007/08/13/daily…

Legal headaches: Pozen sued over migraine drug
Triangle Business Journal - August 13, 2007

Two class-action law firms have filed suit against Pozen, claiming the Chapel Hill biotech misled investors about the prospects of migraine drug Trexima.

The firms - San Diego's Lerach Coughlin Stoia Geller Rudman & Robbins and Hartford, Conn.-based Schatz Nobel Izard - say Pozen misled investors by making false claims about Trexima, which was denied approval by the U.S. Food and Drug Administration on Aug. 1.

The FDA issued Pozen and its Trexima co-developer, GlaxoSmithKline, what's known as an "approvable letter," which means the agency wants to see more information before it will allow a drug to be sold. FDA officials said they had concerns about preclinical studies showing that Trexima led to genetic mutations in lab tests.

The lawsuits, filed in North Carolina District Court, allege that Pozen and its CEO, John Plachetka, knew about the preclinical data but continued to hype Trexima's chances for approval.

Such statements caused the company's stock price to inch above $19, the suits say. When Pozen disclosed that the FDA had issued its approvable letter, shares of the company sank below $10.

This isn't the first time Pozen (NASDAQ: POZN) has been sued on disappointing news. The company recently settled a class-action suit related to FDA denial of a pair of previous migraine drugs, known as MT-100 and MT-300.

Terms of that settlement weren't disclosed, though the company said it doesn't expect the settlement to be materially adverse to business.

[Ackergaul]

Start der PN 400 Phase III

http://www.forbes.com/feeds/ap/2007/09/07/ap4092756.html
Pozen, AstraZeneca Amend Pain Drug Deal
Associated Press 09.07.07, 7:58 AM ET

CHAPEL HILL, N.C. - Drug developer Pozen Inc. said Friday it started a late-stage clinical trial of its antinflammatory treatment candidate and will receive larger payments from partner AstraZeneca PLC than previously expected.

Shares jumped $1.02, or 10.2 percent, to $11 in premarket trading, having closed Thursday at $9.98.

The drug is a combination of the company's proton pump inhibitor, esomeprazole magnesium and the anti-inflammatory drug naproxen. It is aimed at treating osteoarthritis pain.

AstraZeneca (nyse: AZN - news - people ) will now pay Pozen up to $345 million in development, regulatory and sales milestones, up from $335 million as originally expected. Pozen will receive an immediate $30 million, and $55 million will be paid based on certain development and regulatory milestones. The remaining $260 million will paid for sales performance milestones.

Pozen said it expects to file an application for the drug candidate with the Food and Drug Administration in the first half of 2009.

[Ackergaul]

Nochmals die Meldung zum Phase III Start (PN 400). Dass AstraZeneca ein wenig tiefer in die Tasche greift und der Beginn noch in diesem Monat erfolgt, ist für mich schon überraschend gekommen...

AstraZeneca and Pozen To Start Phase III Trials With PN400
07 Sep 2007
The Phase III programme is scheduled to begin in 3Q 2007

LONDON, UK | September 7, 2007 | AstraZeneca announced today that it will start a Phase III programme for PN400, a new pain product under co-development with POZEN, Inc. The Phase III programme is scheduled to begin in 3Q 2007, with a US submission currently targeted for 1H 2009.
POZEN and AstraZeneca entered into an agreement in August 2006 to co-develop a new pain product that combines naproxen and esomeprazole in a single tablet using POZEN’s proprietary formulation technology.

PN400 is an investigational product for patients who require chronic NSAID (non-steroidal anti-inflammation drug) treatment for arthritis pain and are at risk for NSAID associated gastric ulcers.

By mutual agreement, POZEN and AstraZeneca have amended certain terms of their August 2006 collaboration and license agreement.

Under the terms of the amended agreement, AstraZeneca will pay POZEN up to $345 million, in the aggregate, for the achievement of development, regulatory, and sales milestones. POZEN will receive an immediate $30 million payment, which includes recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved. Under the original agreement, development and regulatory milestones totalled $160 million, of which, $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones totalled $175 million.

The U.S. royalty structure has been revised from the tiered structure previously announced to one low double-digit rate for the life of the agreement. The royalty structure outside the U.S. is a slightly revised multi-tiered structure ranging from mid-single digits to high-teens.

The development programme is co-funded, with POZEN responsible for the US development programme and for regulatory filings in the US. AstraZeneca has responsibility for all development activities and regulatory filings outside of the US. AstraZeneca has responsibility for all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. Both parties will contribute scientific, development and regulatory expertise to the collaboration. The patent for PN400 expires in 2023 in the United States.

"AstraZeneca is pleased to announce that we are progressing PN 400 into phase III clinical development in collaboration with POZEN. Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients." Said Mr. Tony P. Zook, President and Chief Executive Officer, AstraZeneca LP, US. "PN400, represents an important product development opportunity for AstraZeneca in line with our commitment to bring additional new pain medicines to market that can make a difference in peoples' lives. We are committed to working with POZEN to develop this innovative product and hope to bring it to market as quickly as possible.''

More than 60 million patients in the US and Europe (US/ France, Germany, UK, Spain and Italy) currently suffer from osteo and rheumatoid arthritis and it is a leading cause of disability in the US. Fifty nine percent of all people over 65 in the US suffer from arthritis.

...


Schönen Sonntag noch!

[Ackergaul]

Pozen "hold," estimates raised

Monday, September 10, 2007 3:17:05 AM ET
Lazard Capital Markets

NEW YORK, September 10 (newratings.com) - Analyst Megan Murphy of Lazard Capital maintains her "hold" rating on Pozen Inc (POZN.NAS), while raising her estimates for the company.

In a research note published on September 7, the analyst mentions that Pozen and AstraZeneca are proceeding with the development of PN400. Pozen has reiterated its aim to file the NDA for PN400 in 1H09 and launch the product in 1H10, the analyst says. The EPS estimate for 2007 has been raised to $0.23 to reflect a shift in a milestone payment from AstraZeneca.

[Ackergaul]

Antwort auf Beitrag Nr.: 31.502.592 von Ackergaul am 10.09.07 15:57:47

POZEN "outperform," estimates raised

Wednesday, September 12, 2007 4:06:47 AM ET
Robert W. Baird

NEW YORK, September 12 (newratings.com) - Analysts at Robert W Baird maintain their "outperform" rating on POZEN Inc (POZN.NAS), while raising their estimates for the company. The target price is set to $21.

In a research note published yesterday, the analysts mention that the company would receive a $30 million payment for its PN programme from AZN. POZEN plans to recognize $20 million of the total payment in 3Q07, amortizing the rest through 4Q09, the analysts say. The EPS estimates for FY07 and FY08 have been raised from -$0.70 to $0.04 and from $0.24 to $0.42, respectively.

[Ackergaul]

Zum gestrigen (prozentual zweistelligen) Abschlag:
3x höheres Volumen und dann in Richtung Süden. Konkrete Meldungen / Fakten fehlen hierzu. Einige wollen dies an Hand Endo / Vernalis FDA Ablehnung festmachen (menstrual migraine).

http://www.pharmaceutical-business-review.com/article_news.a…
Vernalis shares plunge on FDA rejection
3rd October 2007
By Sarah Routledge
Shares in UK biopharmaceutical company Vernalis have halved in value following the FDA's rejection of Frova for the prevention of menstrual migraine.
...

Für mich unsinnig dies hiermit in Verbindung zu setzen... Möglicherweise hat sich ein größerer Anteilseigner zu einen Rückzieher aus Ihrem Pozen Investment entschlossen.

Werde vorerst mit meinen restl. Anteilen halten und warten solch einen Schrit in Erwägung zu ziehen:
- Trexima Klärung mit der FDA
- PN Phase III
- PA mögliche Lizensierung
sprechen für mich erst einmal nicht gegen ein Abschied!


Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 31.837.335 von Ackergaul am 04.10.07 08:31:38

dass ging zu schnell:
sprechen für mich erst einmal nicht gegen ein Abschied!

Korektur:
soll heißen, bleib erst einmal dabei...

[Ackergaul]

So, der Stein kommt nun langsam ins Rollen. Wollen wir hoffen, das er den Berg hochrollt...
POZEN Plans to Submit Response to Approvable Letter For Trexima(TM) Within the Next Ten Days
POZEN Inc. (NASDAQ: POZN) announced today that it plans to submit a response to the Approvable letter for Trexima received on August 1, 2007, within the NEXT ten days. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter.
POZEN believes the submission will constitute a full response. The submission will include clarifying non-clinical information to further address the agency?s concern regarding the genotoxic potential of Trexima and, as required by FDA, a routine clinical safety update. The FDA may take up to six months to review this submission, although POZEN will request an expedited review.

About POZEN
...

Natürlich sind die 6 monate, die sich die FDA wohl Zeit nehmen wird nicht schön ABER ich denke momentan ist Fundamental ALLES besser, als nach dem 1. August!
- Astra Zeneca verbessert den PN Vertrag (mehr Geld) und bestätigt das Vetrauen Ihrerseits in Pozen
- Dazu die Ankündindigung des Phase III Starts!
- Trexima Aufklärung ist mittlerweile "im vollen Gange"

Im Hinterkopf sollte man auch den Artikel des fool.com haben:
Dort ging es darum, dass selbst eine hohe Dosis von Vitamin C auch wohl sicherheitsbedenkliche Bedenken bei der FDA auslösen würde! Wie auch immer, hier gibts jede Menge zu mutmassen... Es könnte ja auch jemand genauere Infos zu dem Einspruch von Pozen haben.


Grüße

[Ackergaul]

Pozen Submits Safety Data
By Brian Orelli, Ph.D. October 8, 2007

When Pozen (Nasdaq: POZN) and partner GlaxoSmithKline (NYSE: GSK) received their second approvable letter for Trexima, I predicted that the companies would likely have to run another clinical trial to ensure that the FDA would approve the drug. The companies didn't listen to me and announced Friday that they'll submit a response without any new trial data. You may be surprised to hear that I think they're making the right move.

The companies are under a time constraint: Trexima is a combination of the generic painkiller naproxen and Glaxo's migraine drug Imitrex, which loses patent protection in 2009. After both of those drugs have generic equivalents available, it may be hard for Pozen to get doctors to prescribe Trexima when prescribing two generics would serve the same purpose.

Essentially Pozen is taking a calculated risk, with the understanding that Trexima is worth a heck of a lot more if it gets an approval in six months or less, than if it runs a six-month clinical trial and gets an approval in well over a year. It's certainly possible that the FDA might be satisfied with the non-trial safety data that Pozen plans to submit in its response -- after all, it was pre-clinical data that triggered the second approvable letter.

Since I haven't sat in on the meetings at the FDA, it's difficult to know if this is what's really going on, or if the FDA has assured Pozen that the drug will be approved after the additional safety data is turned in. The latter is how the companies presented it in their press release, but Encysive Pharmaceuticals (Nasdaq: ENCY) and GPC Biotech (Nasdaq: GPCB) also thought they could get away with submitting less data than the FDA wanted, so I'm inclined to take Pozen's opinion with a grain of salt.

Now, I do I think it's a good idea for the companies to take the risk, but that doesn't mean Pozen is a good investment. I'm no more convinced that the drug will be approved without a clinical trial than I was before the companies announced their intention to submit their response. In addition, taking the gamble now will cost you about 8% more than it would have on Thursday.

[Ackergaul]

Antwort auf Beitrag Nr.: 31.905.296 von Ackergaul am 09.10.07 06:40:45

noch zur gestrigen Meldung:

Pozen to test toxicity of migraine drug
Monday October 15, 1:07 pm ET
Pozen will conduct a toxicity study of its migraine drug Trexima, it said Monday, even as the biotech concern is
betting that the data won't be needed to win regulatory approval for the drug.
The study, to be done in humans, comes on top of preclinical data Pozen recently submitted to the Food and
Drug Administration.
The extra data are meant to alleviate FDA concerns over a preclinical study showing that high doses of Trexima
could be toxic. But Pozen said regulators also might want safety data from human studies.
"Although we believe that our submission addresses FDA's concern regarding the genotoxic potential of Trexima,
we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required,"
Marshall Reese, Pozen's executive vice president for product development, said in a written statement.
The FDA has six months to review the additional data submitted by Pozen, though the company has asked for a
60-day expedited review.
Pozen's share price was cut nearly in half in early August after the FDA made its latest request for more
information on Trexima, which Pozen is developing with GlaxoSmithKline. The drug also saw its approval
delayed in June 2006, when the FDA asked for more information on cardiovascular risks.
Shares of Pozen (NASDAQ: POZN - News) were up 6.60 percent in early-morning trading Monday to $10.20.


Jetzt doch noch ein Test? Hmmmh, irgendwie ein wenig beunruhigend. Man antwortet der FDA erst und gibt kurz dadrauf noch bekant, dass sicherheitshalber doch noch ein Test gemacht wird, falls die FDA sich nicht mit der Antwort begnügt!?


Grüße

[Ackergaul]

Berg- und Talfahrt momentan, wobei es abwärts leider überwiegt...

Out of the Gate: Pozen Down on Downgrade

NEW YORK (AP) - Shares of Pozen Inc. retreated Tuesday, reversing Monday's gains after a Broadpoint Capital analyst downgraded the stock and predicted more delays for Pozen's migraine headache drug Trexima.

Pozen said Monday it sent the Food and Drug Administration more data about Trexima, and asked the agency to review the data within 60 days. It also said it would start a new clinical trial to examine the drug's genotoxicity.

Downgrading the stock to "Underperform" from "Neutral," David Lickrish said the agency will probably start reviewing the application after Pozen submits data from that trial, and may not complete its review until the third quarter of 2008.

The agency is concerned about a preclinical trial that showed the drug may have genotoxic effects, which can cause mutations in DNA that lead to tumors. Lickrish said those worries may lead to a harsh warning on Trexima's label, which would hurt sales.

Pozen shares slid 36 cents, or 3.7 percent, to $9.48. Lickrish reiterated his price target of $8.25 per share.

The stock rose 3 percent Monday.

The FDA began reviewing Trexima in October 2005, and sent Pozen approvable letters in June 2006 and in August.

© 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

[Ackergaul]

Mahlzeit,

hatte gestern einen hochinteressanten Beitrag auf SWR3 verfolgt. Thema: sichere Medikamente
Bin immer mehr davon überzeugt, dass weniger NEUE Medikamente auf den Markt gelangen, sondern stattdessen mehr ALTE Wirkstoffe verbessert werden, um Nebenwirkungen abzustellen. Sieht man von Trexima ab (hier gibt es ja Sicherheitsbedenken) verfolgt Pozen diese Strategie: Naproxen; Ibuprofen; Aspirin


Arznei-Klassiker unter Herzinfarkt-Verdacht

Nach dem Skandal um die Rheuma-Arznei Vioxx geraten nun auch ältere Schmerzmittel, die als Alternativen verschrieben werden, unter Verdacht. Neuen Studien zufolge könnten weit verbreitete Wirkstoffe wie Ibuprofen und Diclofenac ebenfalls das Herzinfarkt-Risiko steigern.

Es war einer der größten Skandale in der Geschichte der modernen Medizin: Bis zu 140.000 Menschen, so das Ergebnis einer Studie der Food and Drug Administration (FDA) in den USA, könnten durch die Einnahme des Arthritis-Medikaments Vioxx schwere Herz-Kreislauf-Krankheiten davongetragen haben. Der Hersteller, die US-Firma Merck & Co., nahm das Medikament im September 2004 freiwillig vom Markt. In der Folge geriet mit den sogenannten Cox-2-Hemmern eine ganze Klasse von entzündungshemmenden Schmerzmitteln unter Generalverdacht.

Viele Ärzte griffen daraufhin als Alternative zu älteren Entzündungshemmern wie Ibuprofen oder Diclofenac - in der Hoffnung, dass diese millionenfach verschriebenen Medikamente, auch wenn sie weniger magenschonend sind als die Cox-2-Hemmer, nicht mit einem erhöhten Herzinfarktrisiko behaftet seien.

Entsprechende Studien waren aber nie durchgeführt worden. Das hat sich unter dem Eindruck des Vioxx-Skandals nun geändert - mit ernüchterndem Ergebnis. Alle sogenannten nicht-steroidalen Entzündungshemmer, also neben den Cox-2-Hemmern auch alte Wirkstoffe wie Ibuprofen oder Diclofenac, steigern das Herzinfarktrisiko, so das Ergebnis zweier aktueller Untersuchungen.

Auswertung von mehr als 9000 Krankenakten

Mediziner der englischen University of Nottingham verfolgten die Entwicklung von 9218 Herzinfarkt-Patienten über einen Zeitraum von vier Jahren. Die Studie, jetzt veröffentlicht im renommierten "British Medical Journal", ist nach Angaben der Forscher die bisher größte ihrer Art. Und sie habe ein eindeutiges Ergebnis: Wer ein entzündungshemmendes Schmerzmittel verschrieben bekam, habe in den folgenden drei Monaten ein deutlich höheres Infarktrisiko gehabt als Patienten, die kein solches Medikament eingenommen hätten. Ibuprofen habe die Herzinfarktgefahr um 24 Prozent, Diclofenac gar um 55 Prozent erhöht.

Auch die neueren Cox-2-Hemmer wie etwa Celecoxib oder der Vioxx-Wirkstoff Rofecoxib waren Teil der Untersuchung. Der Studie zufolge erhöhte Rofecoxib das Infarktrisiko um 32, Celecoxib um 21 Prozent. In der Altersgruppe der über 65-Jährigen habe die Behandlung mit Diclofenac statistisch gesehen einen zusätzlichen Herzinfarkt pro 521 Patienten verursacht. Bei Rofecoxib habe das Verhältnis bei 1 zu 695, bei Ibuprofen bei 1 zu 1005 gelegen.

"Angesichts der weit verbreiteten Benutzung dieser Medikamente bei älteren Menschen und dem steigenden Infarktrisiko mit zunehmendem Alter könnten diese Zahlen beachtliche Folgen für die öffentliche Gesundheit haben", betonen die britischen Forscher um Julia Hippisley-Cox. Patienten sollten zwar aufgrund der Studie nicht ihre bisherigen Schmerzmittel absetzen, erklärte die Medizinerin. Es bestehe aber "ausreichende Besorgnis", um alle nicht-steroidalen Entzündungshemmer auf ihre Sicherheit zu überprüfen.

Deutliche Steigerung der Herzinfarkt-Gefahr

Zu ähnlichen Schlüssen kommt Gurkirpal Singh, Medizinprofessor der amerikanischen Stanford University. "Es ist ziemlich klar, dass Cox-2-Hemmer und nicht-steroidale Entzündungshemmer das Herzinfarktrisiko erhöhen", sagte Singh, der seine Untersuchung beim diesjährigen Europäischen Rheumatologie-Kongress in Wien vorstellte.

Sing hatte die Daten von mehr als 650.000 Patienten analysiert, die zwischen Januar 1999 und Juni 2004 mit Cox-2-Blockern oder älteren Entzündungshemmern behandelt worden waren. Unter den älteren Wirkstoffen sei Ibuprofen mit einem um 11 Prozent erhöhten Herzinfarktrisiko noch eines der harmloseren Mittel. Meloxicam erhöhe die Infarktgefahr dagegen um 37, Sulindac um 41 und Indomethacin gar um 71 Prozent.

Bei den neueren Cox-2-Hemmern errechnete Singh für den Vioxx-Wirkstoff Rofecoxib mit einer Risikosteigerung von 32 Prozent das größte Gefahrenpotential. Celecoxib mache einen Herzinfarkt 9 Prozent wahrscheinlicher, bei Valdecoxib konnte Singh keine erhöhte Gefahr feststellen.

"Bei hoher Dosierung sorgen sowohl die nicht-steroidalen Entzündungshemmer als auch die Cox-2-Blocker für eine moderate Steigerung des Herzinfarktrisikos", sagte Singh in Wien. Dennoch wollte auch er Medizinern nicht empfehlen, die Medikamente künftig gänzlich zu meiden. "Die Ärzte müssen die individuellen Risiken der Patienten beachten."

Bestseller unter Verdacht

Sollten die entzündungshemmenden Schmerzmittel weiterhin in Verruf geraten, könnte dies die Pharmaindustrie vor große Herausforderungen stellen. Denn die nicht-steroidalen Entzündungshemmer gehören zu den meistverordneten Arzneien überhaupt. Von Medikamenten auf Basis von Diclofenac oder Ibuprofen werden allein in Deutschland jährlich rund 900 Millionen Tagesdosen verschrieben.

Zudem macht sich neben der Herzinfarkt-Risikosteigerung ein weiterer Verdacht gegen die Schmerzmittel breit. Die US-Zeitschrift "Journal of the National Cancer Institute" berichtete in der vergangenen Woche, dass die langfristige Einnahme von Ibuprofen das Brustkrebsrisiko erhöht. Der tägliche Konsum des Medikaments über mehrere Jahre erhöhe die Gefahr vor allem sogenannter nicht lokalisierter Mammakarzinome, fanden Forscher der University of Southern California heraus.

Das Team um Sarah Marshall hatte die Daten von knapp 115.000 gesunden Frauen über einen Zeitraum von sechs Jahren ausgewertet - und eigentlich erwartet, dass Ibuprofen vor Krebs schützt. Doch am Ende waren 2400 der Teilnehmerinnen an Brustkrebs erkrankt.



Grundsätzlich ist doch jede Arznei ein Risiko - es kommt nur auf die Nutzen an, die dem gegenübergestellt werden. Stichwort Viagra: wohl kaum ein Medikament verursacht so viele Todesfälle wie Viagra. Trotz allem werden wohl viele nicht darauf verzichten wollen... Kommen wir zu Trexima: Möglicherweise, NUR möglicherweise, kann diese Kombinationspille Krebs verursachen. Dies kann aus 1 der 3 "Hamster" Studien als Vermutung heraus geschlossen werden (DNA Schaden aus den Proben). Obs an der 1000fachen Dosis lag oder (Stichwort Vitamin C) doch an der Sumatriptan-Naproxen Kombi liegt?


Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 32.119.462 von Ackergaul am 23.10.07 13:21:46

nach den zuletzt guten Q-Zahlen und relativ gutem Ausblick:

POZEN Submits Human Lymphocyte Study for Treximet(TM) (Formerly Known as Trexima(TM))

Tuesday, January 15, 2008; Posted: 08:00 AM

CHAPEL HILL, N.C., Jan 15, 2008 (BUSINESS WIRE) -- POZN | news | PowerRating | PR Charts -- POZEN Inc. (NASDAQ: POZN | news | PowerRating | PR Charts ) announced today that it has submitted the findings from the short-term human volunteer study of the genotoxic potential of Treximet(TM) (formerly known as Trexima(TM)) to the U.S. Food and Drug Administration (FDA). The results of this study, the design of which was agreed upon with the FDA prior to its conduct, indicate that no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered to volunteers for seven days. The submission of this study report is in addition to the response made to the FDA in October 2007 which provided clarifying information on the Chinese Hamster Ovary (CHO) assay.
The company has received notification from the FDA that it has tentatively accepted the trade name Treximet (formerly known as Trexima), subject to final NDA Approval, for the proposed product candidate combining sumatriptan 85 mg, formulated with RT Technology(TM), and naproxen sodium 500 mg in a single tablet.
Treximet, which is currently under review by the FDA for the acute treatment of migraine, is being developed by POZEN under an alliance with GlaxoSmithKline.

[Ackergaul]

Die Q-Zahlen waren überraschend gut, weniger verluste als gedacht - insgesamt hat POZN in den letzten 12 monaten sogar Gewinn erzielt und Cash ist auch erst einmal genügend vorhanden (über 70 mil.). Mitte April ist Treximet wieder an der Reihe für Aufregung zu sorgen: sagt die FDA zum dritten Mal nein? PN läuft sehr zufriedenstellend und PA könnte auch bald ins Stadium kommen einen finanzstarken Partner zu bekommen.

http://www.forbes.com/afxnewslimited/feeds/afx/2008/02/26/af…
Pozen 4Q loss widens, but posts better performance than analysts had anticipated

02.26.08, 8:05 AM ET

LONDON (Thomson Financial) - Pozen Inc said Tuesday its fourth-quarter loss widened to $4.2 million, or 14 cents a share from a loss of $400,000, or a penny a share in the same quarter a year ago.

The pharmaceutical company, specialized in treatments for acute pain, said fourth quarter revenue came in at $6.2 million due to the amortization of upfront payments received from AstraZeneca (nyse: AZN - news - people ), and revenue for development work performed under AstraZeneca and GlaxoSmithKline (nyse: GSK - news - people ) agreements.

The company posted revenue of $7 million in the same quarter a year ago.

The mean estimate of analysts polled by Thomson Financial was for a quarterly loss of 18 cents a share on revenue of $6.38 million.

The stock closed Monday at $12.52.


POZEN Reports Fourth Quarter and Year End 2007 Results
POZEN Profitable Two of Last Three Years

CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN), today announced results for the fourth quarter and year ended December 31, 2007.

Fourth-Quarter Results

POZEN reported a net loss of ($4.2) million, or ($0.14) per share on a diluted basis, for the fourth quarter of 2007, compared to a net loss of ($0.4) million, or ($0.01) per share on a diluted basis, for the fourth quarter of 2006.

For the fourth quarter of 2007, POZEN reported revenue of $6.2 million resulting from the amortization of upfront payments received from AstraZeneca, and revenue for development work performed under the AstraZeneca and GlaxoSmithKline agreements, as compared to $7.0 million for the fourth quarter ended December 31, 2006.

Operating expenses for the fourth quarter of 2007 totaled $12.4 million as compared to $8.4 million for the same period in 2006. The increase in operating expenses was primarily due to an increase in development costs for the PN and PA programs.

At December 31, 2007, cash, cash equivalents and short-term investments totaled $73.9 million compared to $62.6 million at December 31, 2006. The increase in cash and cash equivalents resulted from the receipt of $30 million in payments from AstraZeneca in September 2007.

Twelve-Month Results

POZEN reported net income of $4.7 million, or $0.15 per share on a diluted basis, for the twelve month period ended December 31, 2007, compared to a net loss of ($19.3) million, or ($0.66) per share on a diluted basis, for the same period in 2006.

For the twelve months ended December 31, 2007, POZEN reported revenue of $53.4 million compared to $13.5 million for the same period in 2006. The increase was primarily due to receipt of a $20 million milestone payment from AstraZeneca in September 2007, $5.8 million of increased amortization of deferred revenue, and $14.2 million more revenue for development work performed under the AstraZeneca and GlaxoSmithKline agreements.

Operating expenses for the twelve months ended December 31, 2007 were $51.4 million as compared to $35.2 million for the comparable period in 2006. The increase in operating expenses was primarily due to an increase in development costs for the PN and PA programs. Non-cash stock-based compensation expense was $4.3 million for the year ended December 31, 2007, which included a $0.9 million reversal of cost expensed in previous years.

Corporate Highlights

In October 2007, POZEN submitted the Treximet™ (formerly known as Trexima™) response to the U.S. Food and Drug Administration (FDA) approvable letter and received notification from the FDA that the submission was complete.

POZEN also submitted the findings from the short-term human lymphocyte volunteer study of the genotoxic potential on Treximet to the FDA in mid-January 2008. The results of this study indicate that no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered to volunteers for seven days. We believe that the submission of this additional data will not result in any change to the April 15, 2008 PDUFA date; however, the FDA could decide to extend the date.

In December 2007, POZEN filed an Investigational New Drug Application (IND) with the FDA for PA32540, the product candidate designed to reduce gastrointestinal damage associated with aspirin.

Financial Guidance

We are not in a position at this time to provide guidance for the 2008 year. We believe we will be in a better position to provide guidance for the year when we report the financial results for the second quarter of 2008. At that time, we will have a more accurate estimate of the costs and timing of the marketing support studies, which we will conduct at the request of AstraZeneca, and have better insight into the status of FDA marketing approval for Treximet and subsequent launch, if approved.

Fourth-Quarter and Year End 2007 Results Webcast

POZEN will hold a webcast to present fourth quarter and year end results and management’s outlook on Tuesday, February 26, 2008 at 11:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.

...


Grüße

[Ackergaul]

Pozen Answering FDA Questions
Posted Tue Feb 26, 04:53 pm ET
Posted By: Jason Napodano, CFA
Pozen, Inc. (POZN) announced on February 25, 2008 the company has submitted the findings from a short-term genotoxic study as part of the complete response filing to the FDA on Treximet (formerly Trexima). Results of the study indication no chromosomal aberration was induced by Treximet after seven days of dosing.
These results should be sufficient to answer the questions raised in the August 2007 Approvable letter. The FDA has accepted the CRL filing on Treximet and pledged a PDUFA action date of April 15, 2008. We think it is possible the FDA acts favorably before that time, and we see GlaxoSmithKline Plc (GSK) being able to launch the drug in the second quarter 2008. This should help drive Pozen shares up toward our $18 target.
Pozen and Glaxo completed the short-term genotox study and submitted the data as part of its response filing on January 15, 2008. This data indicates an all clear with respect to chromosomal aberrations as expected. The Treximet PDUFA had been previously set for April 15, 2008 based on the CRL filing in October 2007.
Will that date hold up or will the FDA require more time? That's the big question near-term. It is our belief that the FDA will rule favorably in April. Approval and launch of Treximet will result in a $20 million milestone from Glaxo in the second quarter of 2008.
If the FDA requires more time to decided, we would have to adjust our model to include these revenues in the third quarter (July) 2008. Either way, milestone and royalties on Treximet have the potential to make Pozen profitable in 2009. We rate the shares Buy with an $18 price target. We arrive at this target applying an industry average 20x our 2011 EPS of $2.40 (fully-taxed) and then discounting back to present at 25%.


POZEN "outperform," target price reduced
02/27/08 - Robert W. Baird
NEW YORK, February 27 (newratings.com) - In a research note published yesterday, analysts at Robert W Baird maintain their "outperform" rating on POZEN Inc (POZN), while reducing their estimates for the company. The target price has been reduced from $24 to $23.

[Ackergaul]

Am 15. April - also am Dienstag in der nächsten Woche - soll die wiederholte Treximet Entscheidung anstehen. Aktuell gibt es einen Riesen Ärger zwischen der FDA und POZNs Partner GSK. Die FDA fordert noch ausstehende Daten zu GSKs Avandia und droht damit keine Produkte von Glaxo bis zur Kläruing dieses Punktes zuzulassen...
Mit der FDA ist es immer so eine Sache. Wenn man glaubt es ist alles in Butter, gibt es einen auf den Deckel. Andersherum sind positive Überraschungen auch immer drin (sieh Avastin vbei Brustkrebs). Also Quo vadis POZN?

UPDATE: Pozen shares slide after partner GlaxoSmithKline gets FDA warning letter
April 08, 2008: 03:54 PM EST

Adds Citigroup (NYSE:C) comments, latest share price
BOSTON, Apr. 8, 2008 (Thomson Financial delivered by Newstex) -- Shares of Pozen Inc. (NASDAQ:POZN) tumbled Tuesday after GlaxoSmithKline (NYSE:GSK) , its partner on the development of Treximet as a treatment for migraine headaches, received a warning letter from the Food and Drug Administration.

Jefferies (NYSE:JEF) & Co. said the potential impact of GlaxoSmithKline's news on Pozen's new drug application, or NDA, for Treximet is still unclear but the situation is 'discouraging' with word expected from the FDA on April 15, 90 days after the filing of the Treximet NDA on Jan. 15.

'Given GSK's involvement in Treximet development and post-marketing studies, it is uncertain, in our view, whether this would have absolutely no impact on the upcoming FDA action on Treximet,' the firm said.

Shares of Chapel Hill, N.C.-based Pozen were off about 8% to $10.73 in late trades. The stock fell as low as $10.21 earlier in the session. Volume of 1.62 million was more than three times the issue's 30-day average churn of 459,546.

Pozen itself took a calm approach to GlaxoSmithKline's news.

'We know of no reason that this would affect the FDA's decision,' said Bill Hodges, the company's chief financial officer, in reference to the evaluation of Treximet.

Before the opening bell, GlaxoSmithKline disclosed its receipt of the warning letter from the FDA related to its post-marketing reporting on Avandia, a diabetes product.

The letter was sent after a routine audit of the company's reporting processes last year noted omissions from the reports related to Avandia, which included the start, and progress, of clinical trials and the data summaries, GlaxoSmithKline said. Shares of GlaxoSmithKline were down 3.8% to $43.34 in late trades on the New York Stock Exchange.

Jefferies noted that the warning letter includes language referring to a potential impact on pending NDAs from GlaxoSmithKline but pointed out that the Treximet NDA is in Pozen's name.

In light of the news, the firm said it remains cautious on the regulatory side and that it believes the FDA will take more time to review the Treximet data, meaning it sees the more likely outcome regarding Treximet on April 15 as an extension, rather than full approval or an approvable letter.

Jefferies, which maintained its hold rating and $10 price target on Pozen shares, said it expects the FDA could potentially extend its evaluation of the human data for Treximet submitted in January by between three and six months, making a final action possible in the second half of 2008.

Citigroup attributed the weakness in Pozen's shares to the warning letter but said, based on a conversation with Pozen, that it doesn't see an impact because the NDA is in Pozen's name.

'Although we are not making a call on the outcome of the FDA decision on Treximet, we believe we should hear a decision on April 15 and that the drug should be approved, as the company has addressed the last of the FDA concerns,' stated Citigroup, which kept a buy rating and $15 price target on the stock.

Greg Saulnier
Copyright Thomson Financial News Limited 2007. All rights reserved.

The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.


Grüße

[Ackergaul]

Gut vorstellbar, dass Pozen heute kein OK der FDA bekommt. Möglicherweise ähnlich wie bei CRME wird der PDUFA Termin ohne nähere Angaben unbestimmt verschoben... Wäre natürlich sehr negativ!

Published: Apr 15, 2008 12:30 AM
Modified: Apr 15, 2008 02:46 AM
Pozen, GSK hope FDA will OK pill

Today, regulators may rule on migraine drug
SABINE VOLLMER, Staff Writer

The third try is supposed to be the charm for Pozen's migraine pill
Treximet.
Concerns about possible side effects caused the medicine to come up
short of regulatory approval twice in the past two years.
Today, the Chapel Hill drug development company and its partner,
British pharmaceutical giant GlaxoSmithKline, expect to learn whether
additional safety information answered all of the FDA's questions.
Regulatory approval would allow Pozen to bring its first product to market, an
accomplishment that has eluded the company and its co-founder and chief executive, John
Plachetka, with two other drugs.
It would also benefit GSK, which is struggling with slowing sales and increasing competition.
Treximet is made at GSK's plant in Zebulon, which has been hit with layoffs as part of the
company's broader cost cuts.
But the Food and Drug Administration's decision will have a bigger effect on Pozen, one of
dozens of small drug developers based in the Triangle.
Winning permission to sell Treximet, which analysts project could reach $1 billion a year in
sales by 2011, will likely boost Pozen's stock immediately, offering some relief to investors
that have seen the value of their shares fall 32 percent in the past year.
If the FDA delays approval or rejects the drug, Pozen's stock will fall sharply as fed-up
investors head for the exit. Analysts expect another delay could cause the stock to drop by
as much as 30 percent.
Might work this time
Analyst Ken Trbovich with RBC Capital Markets expects that Treximet will make the cut this
time.
So does Pozen.
But Robert Hazlett, a BMO Capital Markets analyst, isn't so sure. GSK angered regulators by
failing to disclose some safety studies that it conducted for a controversial diabetes drug.
Last week, the FDA warned that approval of all GSK drugs might be delayed until the drug
maker addresses regulators' concerns about its reporting compliance.
Pozen's name is on Treximet's regulatory paperwork, but GSK's problems could put
Treximet's application for approval at risk, Hazlett wrote in a research note.
GSK "has run some of the Treximet studies and is manufacturing Treximet," the note reads.
"If the FDA has any concerns in this area, the agency might delay the application until
[GSK] ... addresses the problems fully."
Linda Bannister, an Edward Jones analyst who tracks GSK, agreed with Hazlett that there is
risk of a delay.
"It'll be interesting to see what will come out," Bannister said.
A GSK spokesperson declined to comment until the FDA has issued a decision.
Pozen spokeswoman Fran Barsky said GSK's spat with the FDA should not have an effect on
Treximet's chances for approval. Treximet has always been Pozen's drug, not GSK's, Barsky
said.
But the uncertainty has weighed on Pozen shares.
The day GSK's problems with regulators became public last week, Pozen's stock lost about 8
percent. In the four trading days since then, its shares dropped another 7.5 percent, closing
at $9.90 Monday, down 10 cents.
Timing of the regulatory approval would be crucial for future Treximet sales, analysts said.
For Pozen, royalties and payments on sales milestones are at stake.
GSK plans to market the pill as a replacement for its migraine treatment Imitrex, which
generated $1.37 billion in sales last year. Pozen CEO Plachetka is a former GSK executive
who helped develop Imitrex for the U.S. market.
Imitrex will lose patent protection at the end of the year, which opens the door for cheaper
generic versions to be sold in the United States.
A further delay in regulatory approval would position Treximet face-to-face with a generic
version of Imitrex.
"It would be difficult for Treximet to break into a heavily generic market," Hazlett wrote in
his note.
Competition is also looming from a new, possibly more effective migraine treatment that
Merck is hoping to bring to market as early as next year.

[e-mail] or [phone]



Grüße

[Ackergaul]

Ja, ja, die FDA... Antizyklisches Denken ist hier erforderlich! Denkt man einer zulassung steht nichts im Wege, tritt die FDA auf die Bremse. Scheint es dagegen kompliziert zu werden (die kritischen Töne im Vorfeld), geht alles gut.
Was aus meiner Sicht sehr wichtig ist, dass POZN nun dass erste Produkt durch die FDA genehmigt bekommen hat und damit der Weg für PN400 gebahnt erscheint.


UPDATE 1-U.S. FDA approves migraine
drug from Glaxo, Pozen
Tue Apr 15, 2008 9:38pm EDT

WASHINGTON, April 15 (Reuters) - The U.S. Food and Drug Administration
has approved a combination migraine drug from GlaxoSmithKline Plc
(GSK.L: Quote, Profile, Research) (GSK.N: Quote, Profile, Research) and
Pozen Inc (POZN.O: Quote, Profile, Research), the companies said on
Tuesday.
The drug, Treximet, is expected to be available in U.S. pharmacies by the
middle of May, the companies said.
The two-in-one drug has faced repeated delays since Pozen sought U.S.
approval in 2005. FDA officials had earlier expressed concern over heart
safety and the risk of gene toxicity, asking for more data.
The drug combines common painkiller naproxen with Glaxo's Imitrex, the
most widely used drug in the lucrative triptan class of migraine drugs. The
duo aims to act faster and last longer by targeting different pathways in the
brain.
Last August, the FDA asked the drugmakers for more data after a preclinical
study pointed to possible chromosomal risks. In January, Pozen said a study
found no genetic abnormalities.
Investors have been anxious for an approval decision since then, with some
analysts cutting sales forecasts. Others have been more positive, citing the
drug's combination advantage.
At issue is how much the repeated delays have hurt the drugmakers' ability to
switch patients to Treximet, formerly known as Trexima, before cheaper
generic versions of Imitrex become available in late 2008.
Shares of GlaxoSmithKline fell 0.3 percent to close at $42.41 on Tuesday,
while Pozen's shares rose about 6.4 percent to $10.53. (Reporting by Susan
Heavey in Washington, with additional reporting by Justin Grant in New York;
Editing by Braden Reddall)



Grüße

[blb]

Antwort auf Beitrag Nr.: 33.894.416 von Ackergaul am 16.04.08 08:15:48

Glückwunsch Ackergaul!

Mir war es diesmal irgendwie zu blöde, nochmal reinzugehen. Nachbörslich reagiert der Kurs auch etwas enttäuschend. WObei das leicht zu erklären ist. Im Herbst kommen die Imitrex-Generika auf den Markt, die Frage ist nun ob Tremixet, das sicherlich teurer ist, auf genügend Nachfrage trifft oder die Leute nicht lieber doch zu den Generikaprodukten greifen werden.

Ich werd Pozen aber weiterhin im Blickfeld behalten!

Grüße
blb

[Ackergaul]

Antwort auf Beitrag Nr.: 33.895.235 von blb am 16.04.08 09:53:23

Ich bin mir nicht sicher, ob dass schon alles war...

Der gestrige After Hours Handel in aller Ehren, jedoch glaube ich, dass heute noch ein wenig Bewegung in den Kurs kommt, alleine auf Grund der fast 20 % Short Quote:
Settlement Date - Short Interest - Avg Daily Share Volume - Days To Cover
3/31/2008 - 5,603,326 - 349,297 - 16.041724


Ein kurzer POZN Überblick:

- KEINE Schulden
- noch knapp 70 Mil. $ auf dem Konto
- Treximet genehmigt:
Ungefähr 8% bzw. 16% (ab 350 Mil. $) Royalities und zusätzliche Milestone Zahlungen durch GSK: 20 Mil bei Zulassung und nochmals bis zu 80 bei erreichen bestimmter Umsatzziele.
- PN400 auf guten Weg:
"Proof of Concept" durch Treximet. Ungefähr 7% bzw. 15% (ab 500 Mil. $) Royalities und zusätzliche Milestone Zahlungen durch AZ: 55 Mil bei weiterem Fortschreiten und Zulassung sowie nochmals bis zu 260 bei erreichen bestimmter Umsatzziele. Ende Phase III in der 2h 2008. Mögliche Zulassung Anfang 2010.
- PA32520:
Noch ohne Partner! Bei einer erfolgreichen Verkoppelung würde der Deal den Komplett-Wert des PN400 Deals voraussichtlich übersteigen!


Den Einwand der billigen Generika sehe ich ebenfalls, dennoch kann ich mir vorstellen, dass Treximet bis 2012 etwa 500 Mil. $ Umsatz bedeuten kann (entspräche dann etwa 80 Mil für POZN). Mehr Potential sehe ich hier nicht. PN-400 würde eventuell einen Blockbuster nahe kommen.
Ich hatte folgendes kalkuliert für 2012:
Treximet entspr. oberen Zahlen (80 Mil für POZN) sowie PN-400 mit 530 Mil. Umsatz (79,5 Mil. für POZN) OHNE PA32520 und OHNE Milestone Zahlungen in diesen späteren Jahren... Bei Ausgaben von SG&A von 16 und R&D von 50 Mil blieben etwa 94 Mil die mit gut 35% versteuert werden müssten: Bedeutet bei dann 32 Mil Aktien im Umlauf 1,90 $ pro Aktie.

Für mich eindeutig ein klares HOLD weiterhin!


Grüße

[blb]

Antwort auf Beitrag Nr.: 33.896.349 von Ackergaul am 16.04.08 11:30:32

Wow, doch knapp 40 Prozent Aufschlag! Naja war klar, wenn ich nicht dabei bin steigt es dann. Beim letzten Mal aber "approvable". Naja was solls, denk bei Jerini sollte es dafür klappen.

Grüße
blb

[Ackergaul]

Anbei ein Posting aus dem Y! Board, dass ich für eine gute Treximet Zusammenfassung halte. Für interessant halte ich die Preisfestsetzung Treximets: etwa 10 % unter Imitrex (bedeutet die Aleve Tablette sowie GSKs RT Technologie sind geschenkt!). Dies senkt natürlich die Gewinnspanne, da Herstellungskosten teurer und gleichzeitig der Verkaufspreis gesenkt wird... Dies wird aber mehr GSK treffen als POZN! Am 8. Mai kommen die 1.Q Zahlen, die wohl auch auf Grund der 20 Mil Milestones von GSK gut ausfallen sollten. Bin gespannt wie der Verkaufsstart anläuft...

Executive summary: Treximet works FASTER and lasts LONGER than ALL Triptan-based migraine drugs. Treximet will replace Imitrex, STEAL more market share from other Triptan-based drugs, and treat a 60% segment of the migraine patient population that is currently UNTREATABLE by Triptan-only drugs that solve only one part of the migraine equation.

Visit www.gsk.com and read the labels of Imitrex and Treximet to find the following facts:


1. Quick Relief Onset with Treximet

-- Imitrex: maximum sumatripan concentration occurs at 2.5 hours during an attack and 2 hours without attack.

-- Treximet: maximum sumatriptan concentration occurs at about 1 hour... TREXIMET IS FASTER than ALL triptan-based drugs.

-- Treximet: more patients show CONTINUED pain relief at 24 hours versus sumatriptan... TREXIMET lasts LONGER than ALL triptan-based drugs.

-- GSK's "RT" technology makes a large difference regarding onset of symptom relief.


2. Long-Acting NSAID (the Anti-Inflammatory "advil-like" component)

-- Treximet: maximum naproxen concentration occurs at about 5 hours

-- A "controlled-release" technology has been employed to the naproxen component in Treximet


Conclusion: a Treximet tablet is far superior to an Imitrex tablet plus an Aleve tablet.


Treximet sells for 10% less than Imitrex... so there is incentive for all doctors to switch to the new and improved drug quickly. GSK will hand out free drug samples to be used for the purpose of switching people over with ZERO RISK.

Most of the multi-billion dollar worldwide prescription market for migraines is represented by triptans. Although this class of drug represents a major breakthrough in migraine care, fewer than 40% of triptan patients consistently get 24-hour pain relief. So Treximet has the potential to address 60% of the migraine market that is WIDE OPEN with NO COMPETITION because it is scientifically proven to work FASTER and last LONGER than triptan-only products on the market today.

In the 40% of the migraine patient population where triptans are effective, Imitrex controls 55% of the $2.4 billion market. Not only will Treximet replace Imitrex for GSK, Treximet will ALSO TAKE MARKET SHARE from the other Triptan-only drugs manufactured by other drug companies.

From a Jeffries Investor Presentation:

"What we've seen in our clinical trials is a faster onset of action, with a longer duration of action, so we've seen it be effective in more patients."


Grüße

[Ackergaul]

Heute gab es 1Q-Zahlen:
http://biz.yahoo.com/bw/080508/20080508005144.html?.v=1

Das Wichtigste:
- hoher Verlust von 7,4 Mio $ (von 2,1)
- Gesamtausgaben lagen bei 16,2 Mio $. Vor allem begründet durch erhöhte Forschungskosten in der PN 400 Reihe
- Cash noch etwa 62 Mio $

Ausblick ist Gut:
- Jahres Umsatz soll zw. 62 und 68 Mil. $ liegen. Davon 5 bis 9 Mio durch Treximet Royalities (also Umsatz für GSK vermutlich etwa 40 bis 80 Mio $ in diesem Jahr)
- Ergebnis wird wohl eine rote Null, denn Ausgaben sollen bis etwa 70 Mio $ ansteigen...
- Die PN 400 Trials sind komplett. Dass NDA soll etwa 2H 2009 gestellt werden. Also 2010 vielleicht dass nächste POZN Produkt auf dem Markt.

Negativ für mich:
- Hätte in diesem Jahr > 100 Mio $ an Treximet Gesamtumsatz für GSK erwartet
- Von PA32520 wurde NICHTS erwähnt...


Bleibe weiterhin positiv gestimmt!
Grüße

[Ackergaul]

anbei eine Analyse von Zacks...

Buy-Rated Pozen Worth the Risks
Posted Thu May 08, 03:09 pm ET

Pozen, Inc. (POZN) and partner GlaxoSmithKline (GSK) announced in mid-April that the U.S. Food and Drug Administration (FDA) has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. The product should become commercially available here in May 2008.
The news is a big positive for Pozen. Besides the $20 million milestone from Glaxo, Pozen will start receiving royalties on Treximet sales here in the second quarter. Couple that with expected positive newsflow on the rest of the pipeline, and we remain very bullish on the future prospects for Pozen. We are maintaining our Buy rating and increasing our price target to $22 per share.
Pozen has only 35 employees. The company has no manufacturing, no sales force, no significant internal R&D costs and very low overhead. Based on the royalties from Treximet alone, Pozen should be able to deliver positive operating cash flow in 2009. We expect the second quarter 2008 will be positive with respect to EPS and cash-flow based on the $20 million Glaxo milestone on the approval of Treximet.
Biotechnology stock investing carries significant risk. Besides the obvious drug development risk, stocks in the industry also have significant regulatory and financing risk. Thus, the ideal situation to be in from a company standpoint is to have low product development risk, low regulatory risk, have plenty of cash (or at least be operating cash-flow positive), and have big catalysts head.
However, by 2010 Pozen should be generating significant free cash-flow. We think that makes the company an attractive acquisition target for Glaxo, AstraZeneca Plc (AZN), or anyone else. Finally, besides the upside expected from Glaxo reporting strong Treximet sales in the coming quarters, Pozen is expected to sign a development partner on PA-325/40 in 2008.
We remind investors that the PN-400 deal with AstraZeneca was $375 million. PA-325/40 could be similar in size. This is a significant positive catalyst that could help drive the shares higher toward our $22 target.


Grüße

[Ackergaul]

Traue keinen Analysten! Dennoch mal ein kurzer Überblick, gesammelt vom Y! Board. Bin weiterhin sehr optimistisch bezgl POZN in 2008. Mal ein kurzer Überblick:
- Robert W Baird. Ziel 33 $
- Zack's: Ziel 22 $
- Citi's: Ziel 19 $
- Morgan Joseph: Ziel 24 $

http://stage.theflyonthewall.com/entry.php?symbol=POZN
May 9, 2008 Recommendations story about POZN from Robert W Baird

Treximet is being launched next week with implied sales of $100-$180M in 2008 which is way above $60M consensus and the firm's $90M estimate. Expectations are for submitting to the FDA in July a SPA for PA-32540 while other pipeline projects are rapidly advancing. Target price $33 and Outperform rating. :theflyonthewall.com



http://mlga.com/equity/pozn070711.pdf
Morgan Joseph $24 price target, 7-11-07

Our price target is $24.00.

Valuation Methodology

Our $24 price target is derived by applying a 22X multiple to our 2010 fully-taxed EPS estimate of $1.86 and discounting back at 30%. We believe that 2010 is an appropriate year upon which to base our valuation since it is the first year that we estimate both Trexima and PN400 will be on the market. We believe that a 30% discount is warranted given that Trexima, as well as PN400, have yet to be approved. Upside could come from better-than-expected sales of Trexima or from milestone payments from PN400 and PA325, both of which are not included in our model.



http://biz.yahoo.com/zacks/080508/12668.html?.v=1
Zack's $22 price target, 5-8-08

Buy-Rated Pozen Worth the Risks
Thursday May 8, 3:00 pm ET
By Jason Napodano, CFA


Pozen, Inc. (NasdaqGM: POZN - News)and partner GlaxoSmithKline (NYSE: GSK - News) announced in mid-April that the U.S. Food and Drug Administration (FDA) has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. The product should become commercially available here in May 2008.

The news is a big positive for Pozen. Besides the $20 million milestone from Glaxo, Pozen will start receiving royalties on Treximet sales here in the second quarter. Couple that with expected positive newsflow on the rest of the pipeline, and we remain very bullish on the future prospects for Pozen. We are maintaining our Buy rating and increasing our price target to $22 per share.

Biotechnology stock investing carries significant risk. Besides the obvious drug development risk, stocks in the industry also have significant regulatory and financing risk. Thus, the ideal situation to be in from a company standpoint is to have low product development risk, low regulatory risk, have plenty of cash (or at least be operating cash-flow positive), and have big catalysts head.

However, by 2010 Pozen should be generating significant free cash-flow. We think that makes the company an attractive acquisition target for Glaxo, AstraZeneca Plc (NYSE: AZN - News), or anyone else. Finally, besides the upside expected from Glaxo reporting strong Treximet sales in the coming quarters, Pozen is expected to sign a development partner on PA-325/40 in 2008.

We remind investors that the PN-400 deal with AstraZeneca was $375 million. PA-325/40 could be similar in size. This is a significant positive catalyst that could help drive the shares higher toward our $22 target.



http://www.streetinsider.com/Downgrades/Citi+Maintains+Buy+o…
Citi's $19 price target, 4-16-08

Citi Maintains 'Buy' on POZEN (POZN), Increases Price Target

Citi maintains 'Buy' rating on POZEN (Nasdaq: POZN). Price target increased from $15 to $19.

Citi analyst says, "Treximet has received FDA approval. We expect Treximet to gain significant market share in the $2 billion migraine market, as Glaxo (Nasdaq: GSK) intends to aggressively convert its Imitrex sales (55% of the migraine market) to Treximet. We believe POZEN has a solid product pipeline that targets a significant market opportunity. PN 400, which is a combination of AstraZeneca's Nexium (NYSE: AZN) and naproxen, would target the $3B market left vacant by Cox-2 inhibitor drug class (e.g. Vioxx and Bextra). POZN recently announced positive proof of concept results for PA 325, an aspirin-PPI combination that helps reduce the risk of cardiovascular disease while reducing or eliminating the side effects that are normally associated with chronic aspirin use. We believe a partnership announcement for PA325 would be a positive catalyst for the stock."



http://www.newratings.com/en/main/company_headline.m?isin=US…
POZEN upgraded to "neutral"

04/21/08 - Broadpoint Capital

NEW YORK, April 21 (newratings.com) - Analysts at Broadpoint Capital upgrade POZEN Inc (POZN) from "underperform" to "neutral."



http://www.newratings.com/en/main/company_headline.m?section…
Pozen downgraded to "neutral"

04/18/08 - Susquehanna Financial

NEW YORK, April 18 (newratings.com) - Analysts at Susquehanna Financial downgrade Pozen Inc (POZN) from "positive" to "neutral."



Baird rechnet ebenfalls mit 3-stelligen Mio Umsätzen Treximets. Ehrlich gesagt wäre ich auch enttäuscht, wenn dies nicht eintreffen sollte...
Die Nachrichten Meldungen in 2008 werden wohl spärlich ausfallen, dennoch sollte sich POZN gut bis Jahresende entwickeln (Vorraussetzung: GSK verkauft ordentlich Treximet...)!


Grüße

[Ackergaul]

Was steht noch an? Im Juni / Juli werden wohl noch folgende Neuigkeiten kommen:

* Bioäquivalenz Studienergebnisse zu PN 400
* Bioäquivalenz Studienergebnisse zu PA 325/40
* Ein SPA zu PA 325/40 (spätestens Ende 2008 sollte dann etwa geklärt sein, was die FDA für Studien verlangt)
* Am 12. Juni präsentiert sich POZN bei Needham

Insbesondere die beiden Ergebnisse zu PN und PA könnten interesant (und lohnenswert) ausfallen.


Was ich von Treximet erwarte:
In KW 19 ist der Verkausstart angelaufen. Etwa 2500 "Vertreter" hat GSK für Treximet eingeplant. Ich erwarte folgende Umsätze:
für dass 2. Q: GSK Umsatz Treximet 8,0 Mio $ - Royalities an POZN 0,5 Mio $
für dass 3. Q: GSK Umsatz Treximet 43,1 Mio $ - Royalities an POZN 2,8 Mio $
für dass 4. Q: GSK Umsatz Treximet 80,5 Mio $ - Royalities an POZN 5,2 Mio $
2008 Gesamt: GSK Umsatz Treximet 131,6 Mio $ - Royalities an POZN 8,4 Mio $

Ich habe jeweils mit einen wöchentlichen Treximet Anstieg von 0,5 % kalkuliert, also linearer Anstieg (Gegen Jahresende schätze ich den Treximet Anteil am "Kuchen" also auf 17 %). Um den GSK Umsatz dann zu errechnen, habe ich den weltweiten Migräne Medikamenten Jahresumsatz von 2.300 Mio $ durch die 52 Kalenderwochen geteilt... Herstellkosten von Treximet 20 % (werden wohl fallen, bei steigender Produktion) und dann 8 % Royalities an POZN. Interessant wird dass letzte Quartal, da Imitrex Patent bekanntlich ausläuft (Stichwort Generika, die wohl bei 50 % der Treximet Kosten liegen werden)!

Ich denke wenn die Marke von 200 mio $ überschritten wird, wird GSK einen fetten Milestone Bonus von etwa 15 oder 20 Mio $ überweisen. Wahrscheinlich bei überschreiten von 400 oder 500 Mio. ebenfalls...



Grüße

[Ackergaul]

Gleich 2 Punkte können von meiner letzten Meldung abgehakt werden:
* SPA zu PA 325/40
* Bioäquivalenz Studienergebnisse zu PA 325/40

Ich denke mehr Infos bekommen wir hierzu am Donnerstag vermittelt. Interessant finde ich, dass schon bis September der Umfang der Trials mit der FDA geklärt sein soll... Hier wird Gas gegeben!


June 09, 2008 09:00 AM Eastern Daylight Time
POZEN Demonstrates Bioequivalence to Enteric Coated Aspirin for PA32540
Company Announces Filing of Special Protocol Assessment for PA32540
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ:POZN), today announced that is has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for its pivotal Phase 3 trials for PA32540. The company had previously met with the FDA to discuss the overall development program requirements.
As part of the SPA submission, the company has provided data indicating that PA32540 is bioequivalent to 325mg enteric coated aspirin. By demonstrating bioequivalence to enteric coated aspirin, we believe PA32540, if approved, will receive all of aspirin’s claims for the secondary prevention of cardiovascular events, such as heart attacks and strokes.
Dr. Marshall E. Reese, executive vice president, product development stated, “All aspects of the PA program are on target, and we expect to be in a position to begin the Phase 3 trials after we finalize the SPA with the FDA, which we anticipate will be during the third quarter of 2008.”
PA32540, a patented investigational product containing aspirin 325mg and omeprazole 40mg in a unique dosage form, is designed to deliver the cardiovascular benefits of aspirin with a lower incidence of gastric ulcers than enteric coated aspirin.
About Cardiovascular Disease and Stroke
Nearly 2,400 Americans die of cardiovascular disease each day—an average of one death every 37 seconds. In 2008, an estimated 770,000 Americans will have a new coronary attack, and about 430,000 will have a recurrent attack.
Each year, about 780,000 people experience a new or recurrent stroke.


Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 34.267.376 von Ackergaul am 09.06.08 15:28:34

http://www.forbes.com/feeds/ap/2008/06/09/ap5096600.html
Pozen says drug candidate shows bioequivalence
Associated Press 06.09.08, 1:49 PM ET

CHAPEL HILL, N.C. -
Drug developer Pozen Inc. said Monday that a cardiovascular disease drug candidate demonstrated bioequivalence to enteric-coated aspirin, possibly paving the way for regulatory approval.

Bioequivalence means the active ingredient of a drug is absorbed and metabolized in the body in about the same amount, over about the same time, as the active ingredient in a comparable drug.

Pozen also said it submitted a special protocol assessment with the Food and Drug Administration with regards to late-stage trials for PA32540. An SPA agreement generally reduces the risks involved in developing a drug because the drug maker and the FDA agree ahead of time on how the trial will be conducted, and what will be considered proof that the drug works.

The company added PA32540 is designed to have the cardiovascular benefits of aspirin, but with a lower rate of ulcers than enteric-coated aspirin. Aspirin is often used for the prevention of heart attacks and strokes.

PA32540 contains aspirin and the heartburn drug omeprazole, which is sold as the over-the-counter medication Prilosec OTC by Procter & Gamble Pharmaceuticals.

Shares of Pozen fell 18 cents to $13.50 in midday trading.



Pillen für Amerika

In den USA sind zahlreiche Arzneimittel im freien Verkauf erhältlich.
Verbraucher profitieren vom Rabattkampf der Drogeriemärkte.

von Tim Schäfer, New York

Es ist ein warmer Donnerstagnachmittag in New York. Auf den Gehwegen am Times Square herrscht wie gewohnt Gedränge. In der Menschenmasse auf dem Broadway verteilen junge Leute Schmerzmittel der Marke Advil an Passanten. In der Gratispackung befinden sich jeweils zwei Pillen inklusive Werbezettel. „Advil hilft – egal, wo es wehtut. Und nichts wirkt besser bei starkem Schmerz“, so der Spruch darauf. Amerikanische Pharmakonzerne streuen so ihre Produk­te unters Volk. In Deutschland dagegen fallen solche Arzneien unter das Apothekenmonopol. In den USA kann man Advil sogar im Internet über Drogeriemärkte bestellen.

Alles in allem führt das zu einem intensiven Preiswettbewerb auf dem US-Pharmamarkt. Beim Apothekenriesen CVS Caremark kostet beispielsweise die „CVS Aspirin“-Packung „81 mg Low Strength“ 14,79 Dollar. In der Box befinden sich 500 Tabletten. Macht pro Stück nur knapp 0,03 Dollar beziehungsweise 0,02 Euro. Mancher Amerikaner schluckt jeden Tag ein Aspirin zur Prävention eines Herzinfarkts. Im Fernsehen trommelt Bayer derzeit für die vorbeugende Wirkung. Hierzulande bieten Internetapotheken 50 Aspirin-­Tabletten für 8,91 Euro an, allerdings ist die Dosis mit 500 mg weitaus höher. Pro Stück bedeutet das 0,18 Euro. Am billigsten ist das Generikum „ASS Ratiopharm 300“ – es kostet bei einem deutschen Online-Apotheken-Discounter 0,03 Euro.

Im Land der unbegrenzten Möglichkeiten ist CVS Caremark die mächtigste Drogeriemarktkette mit integrierter Apotheke. Im vergangenen Jahr schloss sich CVS mit dem Wettbewerber Caremark zusammen. Von Küste zu Küste verfügt das Imperium jetzt über mehr als 6300 Filialen. 72 Prozent der Zweigstellen sind durchgehend Tag und Nacht geöffnet. 60 Prozent der Niederlassungen bieten sogar Drive-Thru-Apotheken an. Mehr als 1,2 Milliarden Rezepte wickelte der Multi im vergangenen Jahr ab. Damit herrscht CVS über fast ein Drittel aller Rezepte in den USA. 50 Millionen Amerikaner führen die knallrote Rabattkarte ExtraCare in ihrem Portemonnaie mit sich. Nach Angaben des Unternehmens sparten die Kunden schon knapp zwei Milliarden Dollar mit ihr.

Im Jahr 2007 setzten die 200.000 CVS-Beschäftigten 76,3 Milliarden Dollar um. Fusionsbedingt waren das 74 Prozent mehr als im Vorjahr. Selbst auf vergleichbarer Verkaufsfläche, also ohne den Verschmelzungseffekt, kletterte der Umsatz um 5,3 Prozent. Die großflächigen Filialen gleichen einem Kaufhaus. Neben Arzneimitteln gibt es Hautcremes, Kosmetika, Sonnenbrillen, Bücher, Magazine, Schulhefte, Nüsse, Milch, Grußkarten, Luftballons und sogar Eiscreme. Als Gillette den batteriebetriebenen Nassrasierer Fusion einführte, eroberte die Kette in nur vier Wochen einen Marktanteil von 47 Prozent mit dem Model. Seither spricht die Führungsspitze stolz vom „Fusion Phenomenon“.

Darüber hinaus betreibt der Medikamentenhändler in 25 Bundesstaaten 462 kleinere Kliniken. In den sogenannten Minute Clinics behandeln Krankenschwestern ohne Terminvereinbarung kleinere Wehwehchen und impfen die Kundschaft. Allein von September bis Dezember 2007 sahen die CVS-Weißkittel mehr als 500.000 Patienten. Mit Großkonzernen wie Bank of America, Harley Davidson oder AT?&?T hat CVS Rahmenverträge für eine umfassende Arzneimittelversorgung inklusive Beratung für die Beschäftigten getroffen. Weitere Bluechipkunden sollen dem Beispiel folgen.

Vorstandschef Tom Ryan löste im Zuge der Fusion mit Caremark ein wahres Kursfeuerwerk an der New York Stock Exchange aus. Trotz des allgemeinen Abwärtstrends markiert die CVS-Aktie immer neue Höhen. Vor der Fusion brachten CVS und Caremark 25,1 beziehungsweise 21 Milliarden Dollar auf die Börsenwaage. Mittlerweile sind es 62 Milliarden geworden, rund 16 Milliarden Dollar mehr – Rivale Walgreen bringt es auf 36 Milliarden. Die meisten Analysten schätzen die Aussichten für CVS nach wie vor positiv ein: Sieben raten zum „Starken Kauf“, neun stufen den Titel als Kauf und drei mit Halten ein.

Als die Führungsspitze am 21. Mai im Mandarin Oriental Luxushotel in New York die neue Strategie erläuterte, verfolgten gut 300 Analysten die Präsentation. Das waren so viele wie nie zuvor. Bis auf den letzten Platz war der große Ballraum belegt. Der Zuspruch mag mit den exzellenten Perspektiven zusammen­hängen.
Nicht zuletzt gilt der Pharmasektor besonders in Rezessionsphasen als ein sicherer Hafen. Für das laufende Jahr stellte Steuermann Ryan ein Umsatzplus zwischen 13 und 16 Prozent in Aussicht. 83 Prozent der Einnahmen stammen dabei aus dem Verkauf von Medikamenten, 17 Prozent entfallen auf Drogerieartikel. Insofern wird CVS nicht so hart von der Krise getroffen wie viele der Konkurrenten. Finanzchef David Rickard hob hervor, dass Kunden ohne zu zögern kleinere Anschaffungen tätigten. So landete etwa der Snickers-Riegel bevorzugt im Warenkorb. Teure Artikel würden dahingegen seltener erworben.

Einer der größten Einnahmetreiber in dem Sektor sind die Babyboomer, die in die Jahre kommen: Derzeit sind rund 36 Millionen Amerikaner 65 Jahre alt und älter. Bis 2010 soll die Zahl der Rentner auf fast 40 Millionen und bis 2025 sogar auf 64 Millionen zunehmen.

Auch durch den medizinischen Fortschritt steigt die Rezeptvergabe: Erhielt im Jahr 1996 ein durchschnittlicher Rentner noch 17 verschreibungspflichtige Arzneimittel, sind es jetzt 26. Unterstützend wirkt sich dabei der Trend zu günstigen Nachahmerpräparaten, sogenannten Generika, aus. 2007 machten sie bereits 59 Prozent aller Medikamente aus. Bis 2012 wird ein Anstieg auf 75 Prozent erwartet. Allein im Zeitraum 2003 bis 2007 liefen Patentrechte mit einem Umsatzvolumen von 68 Milliarden Dollar ab.
Hinzu kommt: Viele Beobachter gehen davon aus, dass der nächste Präsident das staatliche Budget für Krankenversicherungen massiv ausweiten wird. Dabei spielt es voraussichtlich keine Rolle, wer die Wahl letztendlich gewinnt – ob es der Demokrat Barack Obama oder der Republikaner John McCain sein wird. Es herrscht Einigkeit in den Parteien darüber, dass etwas geschehen muss.

„Ich habe keine Angst vor den Wahlen und favorisiere auch keinen Kandidaten“, sagte unlängst Humana-Finanzvorstand James H. Bloem entspannt in kleiner Runde. Humana ist einer der größten Krankenversicherer mit über 18 Millionen Kunden. Allein im vergangenen Jahr nahm die Zahl der Mitglieder um 14 Prozent zu. In den USA besitzen mehr als 40 Millionen Menschen keine Krankenversicherung. Sobald mehr Menschen Zugang zu den Assekuranzen erhalten, dürften auch die Behandlungsfälle zunehmen. Und das sollte sich für die Apotheken auszahlen.

Die aktuellsten Nachrichten aus Wirtschaft und Finanzen sowie Hintergrundberichte und charttechnische Besprechungen von Aktien und Indizes lesen Sie immer sonntags in der neuen Ausgabe von Euro am Sonntag.


Es gibt noch Fragezeichen für mich zu PA325/40:
* Wird PA325/40 ein OTC Produkt (freier Verkauf) oder über den Arzt verschrieben?
* Ist man bereit viel mehr Geld für eine sichere Pille auszugeben?


Grüße

[Ackergaul]

Mahlzeit,

anbei mal eine Einsschätzung von Feuerstein (thestreet) und Eun Yang die ich noch nicht kannte...

I couldn't make a call on whether the U.S. Food and Drug Administration was going to approve Pozen's (POZN - Cramer's Take - Stockpickr) migraine drug Treximet -- just too much uncertainty. But yes, regulators did approve the drug April 15, and Pozen shares reacted accordingly, up about 30% to $13.27 as I peck out this column.
The approval prompted Cal T. to write and ask, "Have you changed your mind on Pozen since [the] FDA approval [of Treximet]?"

The approval was clearly a positive for Pozen, especially after all of the previous Treximet delays, but I think it gets harder for the company from here. With approval complete, GlaxoSmithKline (GSK - Cramer's Take - Stockpickr), Pozen's partner, now has to sell Treximet. The U.K. drug giant has to convince doctors -- and more important, insurance companies -- that the benefits of Treximet outweigh putting migraine sufferers on cheaper, generic Imitrex, which will come out at the end of the year.

I think that's going to be a very tough task. Insurance companies don't take kindly to me-too drugs designed primarily to protect drug company profits. Let's face it, that's what Treximet is -- a not-so-new drug that Glaxo needed to develop so it wouldn't lose entirely the nearly $1 billion in U.S. sales generated by brand-name Imitrex. We're not talking groundbreaking medicine here.

As The Wall Street Journal spelled out quite well in a recent article, the only thing Glaxo seems to do these days is modify existing drugs in an attempt to stave off generic competition.

I must say I stand with Jefferies & Co. analyst Eun Yang, who raised her price target to $14 with a hold rating based on her guess that Glaxo will be able to convert about 20% of Imitrex users to Treximet. That translates into $200 million in peak revenue, or about $25 million in royalty revenue to Pozen.


Also, demnach erwartet Jeffries lediglich Spitzenumsätze von Treximet in Höhe von 200 mio. $...



Grüße

[Ackergaul]

Quelle AstraZeneca (FY 2007 Results Presentation):

Slide 21
PN400 is a project that we’re running in combination with Pozen using a fixed combination of
Enteric Coated Naproxen and immediate release ES-omeprazole in patients who would
receive a non-steroidal anti-inflammatory drug for pain relief in arthritis. We expect this fixed
combination to produce a significant reduction in NSAID related gastric ulcers which can lead
to GI bleeds, which are a significant cause of morbidity in this population. Whilst
approximately 20% of NSAID patients are currently prescribed a PPI with their pain relief,
over half are non-compliant with their PPI medication. The fixed combination seeks to
address both the adherence to PPI therapy and the timing of NSAID release into the gut. The
Phase III programme is now running well and Phase II data have been submitted as an
abstract to DDW.

[Ackergaul]

Ich denke dass die letzten Rx Zahlen von Treximet leicht enttäuschten und dies auch am Kursverlauf sichtbar wurde. 1,7 % wurden nach 4 Wochen und ein 2,7 % Anteil nach der 7. Woche berichtet - nicht der ganz große Wurf... Wir werden hier definitives bei den nächsten Q-Zahlen hören. Die Jeffries Präsentation sah in meinen Augen gut aus: http://library.corporate-ir.net/library/12/121/121701/items/…

Und dann noch was neueres:
GlaxoSmithKline's Treximet found effective against migraine
30th June 2008
By Staff Writer

GlaxoSmithKline has reported that treatment with Treximet provided sustained pain-free results at two through 24 hours and was generally well-tolerated in two studies of migraineurs who had poor response to, or did not tolerate, short-acting triptans.

The data are from two identical randomized multi-center, double-blind, placebo-controlled crossover trials that evaluated 283 men and women who typically had a history of four to five migraines each month. Subjects were randomized to receive Treximet or placebo and were instructed to treat within an hour of onset of the migraine while the headache pain was still mild.

In both studies - Treximet was superior to placebo in producing sustained pain-free results from two through 24 hours (26% versus eight percent in Study one; and 31% versus eight percent in Study two). At two hours, four in 10 subjects taking Treximet were pain-free as compared to fewer than two in 10 subjects taking placebo.

The majority of subjects taking Treximet were pain-free at eight hours (65%in Study one; 66% in Study two). Fewer than three in 10 subjects taking Treximet reported the need for a rescue medication as compared to approximately six in 10 subjects taking placebo.

Each study demonstrated that, as compared to placebo, Treximet provided sustained relief at two through 24 hours of traditional migraine-associated symptoms including nausea and sensitivity to light and sound, as well as non-traditional migraine-associated symptoms including sinus and neck pain. In addition, subjects taking Treximet reported higher medication satisfaction, as compared to placebo and the triptans used prior to the study.


Grüße

[Ackergaul]

Plachetka zu den Aussichten Treximets und den Royalities, die nicht Umsatzabhängig sondern Zeitabhängig erhöht werden:

Pozen’s CEO Presents Market Opportunities
at Jefferies 2nd Annual Healthcare Conference

The Chairman and CEO of Pozen Inc. (POZN), Dr. John R. Plachetka, presented yesterday at the Jefferies 2nd Annual Healthcare Conference in New York, NY. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet(TM)(sumatriptan and naproxen sodium), which was recently approved by the FDA for the acute treatment of migraine attacks in adults, and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. Dr. Plachetka explained at the conference, "Treximet has been a very lucrative deal so far. We received $80 million in upfront payments and milestones. We are eligible for an additional $80 million in sales-structured milestones. Until the end of 2009, our royalty structure is tiered. beginning in 2010, we are going to receive a high-teens royalty rate that will continue for as long as the product is sold. We have been able to hold our burn rate for fixed expenses relatively constant. In our business model, once a product hits the market our expenses are over. We do not share in the commercialization or manufacturing costs. This allows us to have tremendous return on all our programs." "Even though this is the early days of Treximet, there are a lot of good reasons to believe this product is going to be very successful in the marketplace. It is a superior product and is the only product for migraines that has a multi-mechanism of action. Most importantly, GSK has said that we are going to be very competitive in the marketplace from a price standpoint, and that is going to help us get there very quickly." "Another important fact is that the migraine market is very unsatisfied. We are entering a $2 billion market in which 80% of patients are willing to try a new product. That is a very fertile market that GSK is entering. GSK has created the migraine space. They made Imitrex(R) the market leader and none of the other triptans were able to shake that market position, so they know the space better than anyone." "Treximet is entering the market as the Imitrex patent is expiring very soon. However, Treximet is a better product. It is a product that has the capacity to take market share from everybody else in this space." Dr. Plachetka added, "We are a small pharmaceutical company, but we have very strong fundamentals. Our business model is very efficient, and we have run it successfully. Our model has been self-funded since the year 2000. Our investors have suffered no dilution since our IPO. In the class of 2000 IPO companies, I am not sure that there is any company that can make that particular claim. We have a very strong cash position and have been profitable for two of the last three years. These characteristics separate us from many small pharmaceutical companies.


Grüße

[Ackergaul]

GSK hat heute Q-Zahlen veröffentlicht. In meinen Augen ist der Treximet Verkauf eher enttäuschend - hatte mehr erwartet...

8 Mio Pfund wurden berichtet also ungefähr 16 Mio $. Wenn man überlegt dass Ende des Jahres der Migräne Markt mit Imitrex Generika überflutet wird, kein richtig gelungener Start. Umsätze kommen nur aus den USA!
Quelle: http://www.gsk.com/investors/reports/q22008/q22008_statutory…

Abwarten wie es weitergeht. Dürfte zumindest erst einmal bedeuten, dass POZN etwa > 1 Mio $ an Royalities von GSK auch noch in diesem Q bekommt.


Grüße

[Ackergaul]

so, nun die POZN Q-Zahlen, die man durchweg mit "in-line" bewerten kann...

POZEN Reports Second Quarter 2008 Results
Tuesday July 29, 8:00 am ET


CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News), today announced results for the second quarter ended June 30, 2008.

Second-Quarter Results

POZEN reported net income of $13.3 million, or $0.43 per share on a diluted basis, for the second quarter of 2008, compared to a net loss of ($3.8) million, or ($0.13) loss per share on a diluted basis, for the second quarter of 2007.

For the second quarter of 2008, POZEN reported revenue of $33.1 million as compared to $11.9 million for the second quarter of 2007. The increase in revenue was primarily due to the receipt of $20 million in milestone payments from GlaxoSmithKline (GSK).

Operating expenses for the second quarter of 2008 totaled $20.3 million as compared to $16.5 million for the comparable period in 2007. The increase in operating expenses was primarily due to an increase in costs associated with the PN program.

At June 30, 2008, cash, cash equivalents and short-term investments totaled $72.2 million compared to $73.9 million at December 31, 2007. POZEN has a $9.4 million receivable balance due from AstraZeneca and GSK at June 30, 2008.

Six-Month Results

POZEN reported net income of $6.0 million, or $0.19 per share on a diluted basis, for the six-month period ended June 30, 2008, compared with a net loss of ($5.9) million, or ($0.20) loss per share on a diluted basis, for the same period in 2007.

For the six months ended June 30, 2008, POZEN reported revenue of $41.0 million compared to $19.6 million for the same period in 2007. The increase in revenue was primarily due to the receipt of $20 million in milestone payments from GSK.

Operating expenses for the six months ended June 30, 2008 were $36.2 million as compared to $27.1 million for the comparable period in 2007. The increase in operating expenses was primarily due to increase in costs associated with the PN program.

Corporate Highlights

Treximet™ (sumatriptan and naproxen sodium) tablets were launched by GlaxoSmithKline in mid-May for the acute treatment of migraine, with or without aura, in adults. POZEN accrued $0.8 million for royalties in the quarter based on estimated Treximet net sales. Treximet has already overtaken the three smallest products in the category and achieved 3.7% of new migraine prescriptions for the month of June 2008, according to IMS.

A podium presentation on the PN 200 (immediate release omeprazole 20 mg, and enteric coated naproxen 500 mg) concept trial was presented at Digestive Disease Week on May 18, 2008 by Dr. Jay Goldstein, Professor of Medicine with the Department of Medicine, University of Illinois at Chicago. The results demonstrated a clinically significant benefit (p<0.001) for PN 200 versus enteric coated naproxen through the six-month treatment period, and showed a cumulative incidence of gastric ulcers (the primary endpoint) of 8.3% for PN 200 vs. 29.4% for 500 mg enteric coated naproxen.

POZEN filed a Special Protocol Assessment (SPA) for PA32540 in June 2008. As part of the submission, POZEN provided data indicating that PA32540 is bioequivalent to 325 mg enteric coated aspirin.

Financial Guidance

For the 2008 year, POZEN continues to expect total revenue to be in the range of $62 to $68 million. Expected revenue includes the $20 million in milestone payments already received from GSK in April 2008. Total operating expenses are expected to be in the range of $67 to $71 million, including $5 to $6 million of non-cash stock-based compensation expense.

Second-Quarter Results Webcast

POZEN will hold a webcast to present second quarter results and management’s outlook on Tuesday, July 29, 2008 at 10:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.


Gewinn war klar (auf Grund der 20 Mille von GSK) um die Größenordnung zwischen 40 und 45 Cent (IST 43). Die Royalities durch Treximet waren "nur" 0,8 Millionen $ (entspricht bei 16 Mil. GSK Umsatz effektiv knapp 5% Royalities). Dies wird denke ich ansteigen, da durch größere Mengen auch die Herstellungskosten geringer werden...
Die nächsten Q-Zahlen werden zeigen, wohin die Reise mit Treximet geht!


Grüße

[Ackergaul]

die ungefähren Kernpunkte des Q2 CC:
- großes Vertrauen in Treximet bezüglich der Überlegenheit zu Imitrex
- 100 bis 200 mio $ GSK Umsatz Treximt 2008 = 5 bis 9 Mio (effektiv 5%) - genauere Aussagen im nächsten Q
- mögliche Verzögerung beim NDA für PN 400 auf Grund der High Risk Patienten
- PN Daten im 1Q 2009
- mögliche Verpartnerung PA: frühestens nach dem SPA
- wenn Marketing angelaufen (siehe Bericht) wird auf ein deutliches Treximet Umsatzwachstum spekuliert

Published: Jul 30, 2008 12:30 AM
Modified: Jul 30, 2008 05:50 AM

Pozen: Migraine pill's success hinges on FDA
DAVID RANII, Staff Writer
Comment on this story
Sales of Treximet, a new migraine medication, will take off once regulators approve
advertising for the drug, the CEO of Chapel Hill drug company Pozen said.
The company's marketing partner, pharmaceutical giant GlaxoSmithKline, is awaiting Food
and Drug Administration approval of its consumer advertising and other promotional
materials for Treximet. The pill hit pharmacy shelves in mid-May.
"I look for a major upturn in market share and penetration once they have all their tools
available to them," CEO John Plachetka said during a conference call with analysts Tuesday
morning.
Plachetka said he expects the FDA to approve the Treximet promotional materials during the
current quarter.
Treximet is the designated successor to GSK's Imitrex, which generated $1.37 billion in sales
last year. Treximet will face competition from cheaper, generic versions of Imitrex that could
debut as early as December, but analysts expect annual sales to exceed $1 billion by 2011.
GSK, based in the United Kingdom, has one of its two U.S. headquarters in Research
Triangle Park. It packages Treximet at its Zebulon plant.
Pozen said Treximet accounted for 3.7 percent of new migraine prescriptions in June,
according to IMS, which provides market data to the pharmaceutical industry. The company
received $824,000 in royalties from Treximet sales in the second quarter.
Pozen reaffirmed that it expects revenue this year to reach between $62 million and $68
million, including $5 million to $9 million in Treximet royalty payments. Bill Hodges, the
company's chief financial officer, said the company will refine its Treximet revenue estimate
when it announces third-quarter earnings.
"We think it is too early to know what the exact sales trend is," he said. Pozen's royalties on
Treximet, which will change in coming years, this year amounts to the mid-single digits, by
percentage of total sales.
GSK spokeswoman Robin Gaitens declined to discuss the company's plans to promote
Treximet but confirmed that a direct-to-consumer advertising campaign is planned.
'A very good start'
Last week GSK reported that Treximet sales through June 30 totaled $16 million.
"We feel we're off to a very good start," Gaitens said.
On Tuesday, Pozen reported a $13.3 million profit in the second-quarter -- reversing its loss
of a year ago -- because of a $20 million milestone payment from GSK. The milestone
payment was triggered by the FDA's April 15 approval of Treximet.
The 43 cents per-share profit compares with a loss of $3.8 million, or 13 cents per share, a
year ago. Revenue in the second quarter was $33.1 million, versus $11.9 million a year ago.
Operating expenses rose to $20.3 million, up from $16.5 million a year ago, an increase the
company attributed to increased drug-development costs. Pozen is developing other pain
medications, including one in partnership with AstraZeneca.
Pozen shares closed Tuesday at $11.74, up 36 cents. Shares have fallen 33 percent in the
past year.


Grüße

[Ackergaul]

Die FDA hat zu PA32540 noch ihren "Wunsch" geäußert, dass POZN einen zusätzlichen Trial noch starten soll (wie schnell PA32540 im Vergleich zu Aspirin, vom Körper aufgenommen wird). Bedeutet natürlich mehr Kosten...

POZEN Receives Initial FDA Response To PA32540 SPA

Last update: 4:05 p.m. EDT Aug. 1, 2008

CHAPEL HILL, N.C., Aug 01, 2008 (BUSINESS WIRE) -- POZEN Inc., today announced that the U.S. Food and Drug Administration (FDA) has provided an initial response to POZEN's Special Protocol Assessment (SPA) for PA32540, which was submitted in June 2008. The company plans to meet with the FDA to discuss their responses to our proposed protocol for the Phase 3 pivotal studies, including the inclusion/exclusion criteria, the stratification plan, the primary endpoint, and the statistical methodology to be used in the study. The company also plans to discuss an additional pharmacodynamic study requested by the FDA which would support the bioequivalence study previously conducted for PA32540.
The SPA is a process by which the FDA and the company reach an agreement on the Phase 3 pivotal trial protocol design, clinical endpoints, and statistical analyses that are acceptable to support regulatory approval. An SPA is binding upon the FDA and the Sponsor unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf.