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Biotech Depot 2010 - 500 Beiträge pro Seite



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Begriffe und/oder Benutzer

 

Auf ein neues! :)

Während im letzten Jahr Dax, Nasdaq usw große Gewinne einbrachten, hat sich mein Biotech-Depot Thread: Biotech Depot 2009 leider nur sehr durchwachsen entwickelt, was ein wenig entäuschend ist... am Ende blieb es bei einem kleinen Minus. Ein wesentlicher Grund lag in der sehr schlechten Entwicklung von Genmab, die im Laufe des Jahres fast 2/3 an Wert verloren und die ich recht hoch gewichtet hatte.

Dieses Jahr starte ich nun mit folgenden Werten:
11,9% Regeneron http://finance.yahoo.com/q?s=REGN
10,2% Incyte http://finance.yahoo.com/q?s=INCY
8,0% Genmab http://finance.yahoo.com/q?s=GEN.CO
7,3% Cubist http://finance.yahoo.com/q?s=CBST
6,3% Exelixis http://finance.yahoo.com/q?s=EXEL
6,1% Rigel http://finance.yahoo.com/q?s=RIGL
6,0% Onyx http://finance.yahoo.com/q?s=ONXX
5,9% Allos http://finance.yahoo.com/q?s=ALTH
5,4% Isis http://finance.yahoo.com/q?s=ISIS
5,1% Micromet http://finance.yahoo.com/q?s=MITI
3,9% Seattle Genetics http://finance.yahoo.com/q?s=SGEN
3,8% ArQule http://finance.yahoo.com/q?s=ARQL
3,7% Evotec http://finance.yahoo.com/q?s=EVT.DE
3,6% Medigene http://finance.yahoo.com/q?s=MDG.DE
3,3% Array http://finance.yahoo.com/q?s=ARRY
2,3% Arena http://finance.yahoo.com/q?s=ARNA
2,1% ViroPharma http://finance.yahoo.com/q?s=VPHM
1,8% NicOx http://finance.yahoo.com/q?s=COX.PA
1,2% Progenics http://finance.yahoo.com/q?s=PGNX
1,2% Addex http://finance.yahoo.com/q?s=ADXN.SW
1,0% Sucampo http://finance.yahoo.com/q?s=SCMP

Die letzten Änderungen in 2009 waren:
Aufstockung von ALTH, REGN und ISIS... Reduzierung von Evotec und Kauf von ARQL.

Ob es wohl diesmal eine gute Mischung ergibt?

Mal schauen, was dieses Jahr so bringt... wünsche jedenfalls allen ein gutes und erfolgreiches Jahr 2010 und viel Spaß mit ihren Investments!

mfg ipollit
Antwort auf Beitrag Nr.: 38.656.864 von ipollit am 03.01.10 16:49:57Zum Vergleich der Nasdaq Biotech Index...



Regeneron (REGN) - MK 1,95 Mrd USD (bei 24,18 USD)
http://finance.yahoo.com/q?s=regn
starke Pipeline und Partner, Avastin-ähnliches Aflibercept in PIII mit Sanofi (50% Gewinnanteil), Lucentis-ähnliches VEGF-Trap Eye in PIII mit Bayer (100% US-Rechte, 50% weltweit), Arcalyst zugelassen als Nischenprodukt gegen CAPS, in PIII gegen Gicht (100% weltweit), große AK-Allianz mit Sanofi... Regeneron erhält jährlich 160 Mio USD bis 2017 mit dem Ziel jährlich 4 bis 5 AKs in die PI zu bekommen


Incyte (INCY) - MK 1,08 Mrd USD (bei 9,11 USD)
http://finance.yahoo.com/q?s=incy
die Schuldenkrise scheint überwunden... zuletzt extrem gute Deals für die JAK1/2-Hemmer: Novartis hat die ex-US Rechte am sehr aussichtsreichen INCB018424 gegen Krebs in PIII gekauft (Incyte besitzt 100% der US-Rechte), EliLilly finanziert die teure Entwicklung von INCB28050 gegen Immunkrankheiten wie RA (Incyte bekommt bis zu 20% Royalties)... das brachte zusammen 300 Mio USD Upfront ein. In der Pipeline befinden sich aktuell noch 2 Kandidaten in PII gegen Brustkrebs und Diabetes, die theoretisch auslizensiert werden können


Genmab - MK 710 Mio USD (bei 82 DKK)
recht enttäuschend. zwar haben Genmab/GSK die Zulassung für Arzerra (Rituxan-ähnlich) gegen CLL erhalten, doch ist eine riskante PIII gegen die wichtige Indikation NHL fehlgeschlagen. Damit ist offen, ob Arzerra mit Rituxan konkurrieren kann... direkte, aber riskante Vergleichstudien mit Rituxan wurden begonnen. Zudem wird Arzerra subkutan gegen RA entwickelt. Wichtige PIII-Ergebnisse zum zweiten Kandidaten Zalutumumab (Erbitux-ähnlich) gegen HN-Krebs sollen in Kürze erfolgen... auch hier besteht ein großes Risiko, dass sich Zalutumumab nicht gegen Erbitux absetzen kann. Die Entwicklung von R1507 (Roche) wurde leider gestoppt... wohl aufgrund der Genentech-Übernahme. Zudem ist der (Zwangs-)Verkauf der AK-Produktionsstädten enttäuschend.


Cubist (CBST) - MK 1,1 Mrd USD (bei 18,97 USD)
http://finance.yahoo.com/q?s=cbst
KGV10e von 12,5... das Antibiotikum Cubicin bringt hohe Gewinne ein und entwickelt sich zum Blockbuster. Der relativ niedrige Kurs (und der Einbruch in 2009) ist nur dadurch zu erklären, dass Teva versucht, die Patente (bis 2017/19) auszuhebeln, um Cubicin generisch zu vertreiben. 2011 wird dieser Fall vor Gericht behandelt. In der Pipeline gab es ein paar Rückschläge... ALN-RSV01 in PII wurde vorerst an Alnylam zurückgegeben, Cubist will den präklinischen Nachfolger gegen eine größere Indikation entwickeln. Die PII von Ecallantide gegen Blutungen (lizensiert von Dyax, die zuletzt dafür die Zulassung als Kalbitor gegen akute Schwellungen HAE von der FDA erhalten haben) wurde wegen Unregelmäßigkeiten frühzeitig geschlossen... es besteht das Risiko, dass damit die PII scheitert. Dafür wurde zuletzt mit der Übernahme von Calixa mit CXA-201 ein weiteres ausichtsreiches Antibiotikum erworben, welches 2014 auf den Markt kommen könnte.


Exelixis (EXEL) - MK 791 Mio USD (bei 7,37 USD)
http://finance.yahoo.com/q?s=exel
große Pipline mit 11 Kandidaten in der klinischen Entwicklung, die im wesentlichen von namhaften Pharma-Partnern finanziert wird. In 2009 konnten mehrere gute Deals abgeschlossen werden.


Rigel (RIGL) - MK 493 Mio USD (bei 9,51 USD)
http://finance.yahoo.com/q?s=rigl
Unsicherheit bezügliche R788 als orales Mittel gegen RA. Die PII-Daten zeigten zwar eine gute Wirkung, doch könnten störende Nebenwirkungen wie leicht erhöhter Blutdruck Probleme bereiten. PIII ist in Vorbeitung... es konnte aber immer noch kein Pharma-Partner gefunden werden. R788 ist von der Indikation gegen Autoimmunskrankheiten und Krebs ähnlich wie INCY's JAK-Hemmer... nur handelt es sich mit SYK um ein anderes Target.


Onyx (ONXX) - MK 1,82 Mrd USD (bei 29,34 USD)
http://finance.yahoo.com/q?s=onxx
KGV10e von 38. Nexavar gegen Krebs entwickelt weiter positiv... doch versucht der Partner Bayer an Onyx vorbei eine leicht modifizierte Version zu entwickeln, worauf Onyx Bayer verklagt hat. Nexavar könnte gegen Brustkrebs wirksam sein... dies würde das Potential deutlich erhöhen. Durch die Übernahme von Proteolix wurde zuletzt das Krebsmedikament Carfilzomib in PII erworben, dass ein nebenwirkungsfreieres Velcade sein könnte. Sind die Daten bei MM in 2010 positiv, könnte bereits 2011 ein weiterer potentieller Blockbuster von Onyx auf den Markt kommen.


Allos (ALTH) - MK 684 Mio USD (bei 6,58 USD)
http://finance.yahoo.com/q?s=alth
Ein-Produkt Unternehmen... im September hat Allos die Zulassung von Folotyn (neuartiges Chemotherapeutikum) gegen die seltene Krebsart PTCL erhalten. Es ist zwar eine kleine Indikation, aber es gibt keine Alternativen und der Preis für Folotyn ist entsprechend sehr hoch. Außerdem kann Allos es mit einer kleinen Vertriebsstruktur selber vermarkten. Folotyn wird nun bei größeren Indikationen wie NHL oder NSCLC getestet


Isis (ISIS) - MK 1,09 Mrd USD (bei 11,11 USD)
http://finance.yahoo.com/q?s=isis
Führend in der RNAi-Technologie... umfangreiche Pipeline und Kooperationen, die einiges an Bargeld einbringen (teilweise cashflow positiv), hoher Bargeldbestand mit 600 Mio USD. Wichtigstes Projekt ist Mipomersen in PIII, das zusammen mit Genzyme zur Senkung von Cholesterin, wenn z.B. Statine nicht ausreichend helfen, entwickelt wird. Bis Mitte 2010 sollen Daten von 3 weiteren PIIIs vorliegen... die Zulassung für Hochrisikopatienten soll im Sommer 2011 erfolgen, etwas später als ursprünglich geplant. Zwar konnte in der ersten PIII Mipomersen bei Hochrisiko-Patienten das Cholesterin senken, doch gab es auch bei einem Teil der Patienten erhöhte Leberwerte, ein Anzeichen von möglicher Leberschädigung. Die Frage ist nun, in wie weit Mipomersen dafür verantwortlich ist und ob dies auch bei Patienten, die keine lebensgefährlichen Cholesterinwerte aufweisen, auftritt, denn nur damit kann Mipomersen zu einem Blockbuster werden. Daher ist der Kurs zuletzt gefallen.


Micromet (MITI) - MK 459 Mio USD (bei 6,66 USD)
http://finance.yahoo.com/q?s=miti
hat spezielle BiTE-AKs in der Pipeline, mit denen T-Killerzellen des Immunsystems an bestimmte Targets gebunden werden sollen, damit der Körper diese zerstört. Der CD19-BiTE-AK Blinatumomab hat in PI/II Studien gute Ergebnisse geliefert... so war bei 80% von Patienten mit ALL der Krebs nicht mehr nachweisbar und die Ansprechrate bei NHL, bei denen andere Therapien nicht ansprechen, lag bei 100%. Dies sind zwar unsichere, aber ermutigende Ergebnisse. Der AK ist noch nicht verpartnert und es könnte bald eine Zulassungsstudie begonnen werden.


Seattle Genetics (SGEN) - MK 1,02 Mrd USD (bei 10,16 UDS)
http://finance.yahoo.com/q?s=sgen
Technologie, die AKs mit einer Chemo belädt, um die Wirkung der AKs zu erhöhen. Mit dem CD40-AK SGN-40 gab es einen Rückschlag... eine PII wurde gestoppt und Genentech ist aus der Entwickung ausgestiegen. Vielversprechender CD30 AK SGN-35 gegen HL in PIII konnte mit Takeda/Millennium verpartnert werden... SGEN besitzt noch die vollen US-Rechte. PIII Ergebnisse sollen in Laufe von 2010 vorliegen und die Zulassung in 2011 beantragt werden. Desweiteren sollen in 1H10 PII-Daten zum CD33-AK SGN-33 in AML kommen, die bereits für eine Zulassung ausreichend sein könnten. SGN-33 ist noch nicht verpartnert.


ArQule (ARQL) - MK 165 Mio USD (bei 3,69 USD)
http://finance.yahoo.com/q?s=arql
vielversprechender CMet-Hemmer ARQ-197 in PII gegen Krebs zusammen mit Daiichi... PII-Daten bei NSCLC in Kombination mit Tarceva in 1H10. Mit etwa 160 Mio USD Cash (netto 110) in etwa auf Cash-Niveau.


Evotec - MK 334 Mio USD (bei 1,13 EUR)
Mehrere Rückschläge in 2009 mit Scheitern von u.a. EVT201, EVT302. Umstrukturierung auf mehr Dienstleistung mit dem Ziel, ab 2012 profitabel zu werden. Die Pipeline befindet sich noch in einem sehr frühen Stadium... eine neue Kooperation mit Roche für EVT101/3 in PI gegen Depressionen. Daneben den oralen P2X7-Antagonisten gegen RA in PI.


Medigene - MK 183 Mio USD (bei 3,58 EUR)
Mit Eligard und Veregen 2 Produkte am Markt. Negative Kursentwicklung, da es laufend zu Verzögerungen kommt... Hoffungsträger ist EndoTag-1, liposomales Paclitaxel in PII, auf das sich nun ganz fokussiert wird. Es konnte trotz positiver PII-Daten bei BSDK immer noch kein Partner für eine PIII gefunden werden... in 2010 sollen Daten bei der größeren Indikation Brustkrebs folgen.


Array (ARRY) - MK 139 Mio USD (bei 2,81 USD)
http://finance.yahoo.com/q?s=arry
Ähnlich wie EXEL Konzentration auf Krebs und Autoimmunerkrankungen und unterschiedlichen Targets (7 Kandidaten in der Klinik). Mehrere negative Studienergebnisse in 2009. Finanzierungsprobleme, die mit der letzten Verpartnerung von ARRY-403 gegen Diabetes mit Amgen etwas gelindert werden konnten. In 2010 stehen weitere klinische Daten an.


Arena (ARNA) - MK 329 Mio USD (bei 3,55 USD)
http://finance.yahoo.com/q?s=arna
Arena hängt von Lorcaserin ab, ein Mittel gegen Fettsucht. Zwar gibt es einen großen Bedarf an Mitteln, die das Übergewicht reduzieren, doch dürfen diese keine Nebenwirkungen aufweisen. Lorcaserin scheint kaum Nebenwirkungen zu besitzen, doch ist die Wirkung nur gering, so dass es nicht klar ist, ob es für eine Zulassung ausreicht und ob das Mittel dann auch vom Markt angenommen wird. Es konnte kein Partner gefunden werden... die Zulassung wurde vor Kurzem alleine beantragt. Die Zulassungsentscheidung der FDA dürfte nächstes Jahr fallen... bei einer Zulassung wäre es das erste Mittel dieser Art am Markt.


ViroPharma (VPHM) - MK 650 Mio USD (bei 8,39 USD)
Anfang 2009 gab es mit dem überraschenden Scheitern von Maribavir in PIII einen größeren Rückschlag. Zudem wurde das wichtigste Produkt, das Antibiotikum Vancocin, wie seit langem erwartet generisch. Dafür entwickelt sich das in 2008 erworbene Cinryze als einziges Mittel zur Prophylaxe von HAE gut, so dass Vancocin vielleicht ersetzt werden kann.


NicOx - MK 590 Mio USD (bei 5,68 EUR)
Es konnte immer noch kein Partner für das Schmerzmittel Naproxcinod gefunden werden. Zuletzt wurde alleine die Zulassung beantragt.


Progenics (PGNX) - MK 141 Mio USD (bei 4,44 USD)
http://finance.yahoo.com/q?s=pgnx
Ein zugelassenes Produkt mit Relistor, das Verdauungsprobleme bei Gabe von Morphium verhindern soll. Relistor hat bisher sehr enttäuscht und wurde von Wyeth an PGNX zurückgegeben. PGNX sucht nun nach neuen Vermarktungsstrategien und entwickelt eine orale Version. Mit zuletzt 100 Mio USD Cash relativ hoher Cashbestand.


Addex - MK 120 Mio USD (bei 13,8 CHF)
Allosterische Modulatoren insbesondere für CNS, die u.a. bisherige etablierte Wirkansätze verbessern sollen. Zuletzt gab es mit dem unerwarteten Stopp der Entwicklung von ADX10059 für Langzeittherapien wegen möglicher Leberschäden einen schweren Rückschlag.


Sucampo - MK 169 Mio USD (bei 4,04 USD)
http://finance.yahoo.com/q?s=SCMP
Mit Amitiza ein Produkt am Markt... teilweise in der Gewinnzone


mfg ipollit
Vl. kann man heute ja "Decode Genetics"(Island) aufnehmen?;);)

Zwar in Ch11 - Mcap aktuell 4Mio USD. Sehr bekanntes Unternehmen, 300Mio USD Schulden.
Davon mal abgesehen, kennt jemand die Pipeline und den Hintergrund?
Wird morgen von der Nasdaq delistet wegen Kursunterschreitung.

Soll keine Kaufempfehlung sein, nur, um die Hintergründe zu diskutieren, falls bekannt.
Cubist - aktuelle Pipeline

noch nicht enthalten ist das durch die Übernahme von Calixa erworbene Antibiotikum CXA-201 in PI (bzw. CXA-101 in PII)...



mfg ipollit
Antwort auf Beitrag Nr.: 38.670.572 von MrRipley am 05.01.10 19:24:09DCGN... naja, ist ein wenig heiß, sich ein bereits bankrottes Unternehmen ins Depot zu legen mit der Hoffnung, dass es doch noch irgendwie überlebt. Davon lasse ich lieber die Finger. Trotzdem danke für den Hinweis!

mfg ipollit
Ich erlaube mir mal den Hinweis auf ein noch sehr kleines und ziemlich spezielles Unternehmen, nämlich:

NeurogesX


http://www.neurogesx.com/


Sie konzentrieren sich auf die Behandlung von Schmerzen, die durch Nervenschädigungen hervorgerufen werden.

Die Marktkapitalisierung beträgt 130 Millionen Dollar, wobei zum Ende des Q3/2009 ca. 57 Mio. Dollar Cash vorhanden waren.

Hier der Chart:




Der Kursaufschwung hat einen realen Grund, nämlich die Zulassung des Wirkstoffes Qutenza.

Was ist Qutenza?

Qutenza ist ein kutanes Pflaster (ein Pflaster, das ein Arzneimittel durch die Haut abgibt). Es enthält den Wirkstoff Capsaicin (8 %).

Wofür wird Qutenza angewendet?

Qutenza ist für die Behandlung von peripheren neuropathischen Schmerzen (d. h. Schmerzen, die durch Nervenschädigungen hervorgerufen werden) bei erwachsenen Nichtdiabetikern angezeigt. Es kann als Monotherapie oder in Kombination mit anderen Schmerzmitteln angewendet werden.
Das Arzneimittel ist nur auf ärztliche Verschreibung erhältlich.

Hier das File der EMEA:

http://www.emea.europa.eu/humandocs/PDFs/EPAR/Qutenza/H-909-…


Qutenza wird in Europa durch Astellas vertrieben (gegen double-digit royalties), die US-Rechte hält NeurogesX weiterhin selbst und will im 1. HJ 2010 einen eigenen Vertrieb in den USA aufbauen und zu einem Produktunternehmen werden.

Aufgrund der erfolgten Zulassungen werden im Jahre 2010 erstmals relevante Umsätze erzielt werden.

Das ist die Pipeline:





Das Unternehmen hängt also derzeit sehr stark am Wirkstoff capsaicin (Qutenza), was sicher nicht so wirklich schön ist.

Aber: Der Markt für Schmerzmittel in diesem Bereich ist Milliarden-Dollar schwer und Analysten trauen Qutenza langfristig (in einigen Jahren) Umsätze im Bereich mehrerer hundert Millionen Dollar zu.

Außerdem ist es überhaupt eine Leistung, einen Wirkstoff zugelassen und verpartnert zu bekommen. Da müssen andere erst mal "hinriechen", wo NeurogesX schon ist.

Letztlich kostet der ganze Laden nach Abzug des Cash derzeit vielleicht 80 Mio. Dollar oder so. Sollte Qutenza am Markt seine Nische erobern, ist das sicher nicht zu teuer bezahlt.

Kritik willkommen!

Gruß
Antwort auf Beitrag Nr.: 38.656.864 von ipollit am 03.01.10 16:49:57warum hast du keine mologen in deinem depot? :confused:
Antwort auf Beitrag Nr.: 38.672.882 von SLGramann am 06.01.10 09:37:06Hallo SLGramann!

Danke für die Infos!... NGSX - hast du die auch aus dem Ohad Hammer Blog. Kritik kann ich da nicht äußern... hört sich schon sehr interessant an. Falls es einen Haken gibt, habe ich ihn bisher nicht entdeckt. Das Marktpotential ist relativ zur MK schon recht hoch... es ist nur ein wenig unsicher, ob NGSX das auf dem US-Markt auch eigenständig gut vermarktet bekommt. Der US-Markt könnte einige 100 Mio Umsatz bringen... und hier in der EU ebenfalls. Könnte mir vorstellen, mir eine paar Stücke ins Depot zu legen. Im Kurs steckt das Potential bisher jedenfalls nicht drin, finde ich.

Ich suche auch immer nach interessanten Werten... was käme sonst noch in Frage? Im Moment habe ich da z.B. Xoma, Theravance, Basilea, Neurosearch und Wilex auf meiner Liste.

mfg ipollit
Antwort auf Beitrag Nr.: 38.677.562 von ipollit am 06.01.10 18:37:35
Hi ipollit,

richtig, die Idee kam von Hammer. Er hat die Aktie nach der Zulassung in Europa ins Depot genommen, aber leider nie einen Artikel dazu geschrieben.

Wie die Vermarktung laufen wird, ist wirklich die entscheidende Frage. Ich bin sehr gespannt, wann genau und mit welchem Erfolg das in den USA anläuft.

Es mag auch Leute geben, die den Wirkstoff nicht "sexy" finden. Ist ja nur ne "geraspelte Chilischote", könnte man boshaft (und ziemlich falsch) sagen und kein schicker Antikörper. Aber ganz so simpel ist es dann wohl doch nicht, denn sonst hätte Astellas nicht 42 Millionen upfront überwiesen.

Ansonsten habe ich derzeit nur noch ArQule im Visier, aber die hast Du ja eh schon im Depot. ;)

Von Actelion habe ich mich getrennt und habe jetzt folgendes im Depot:

MorphoSys
Biotest
Seattle Genetics
Immunogen
Micromet
Incyte
Exelixis
NeurogesX

Wir haben also ne Menge Überschneidungen.

Außerdem finde auch ich Regeneron sehr interessant. Aber ich trau mich da nicht ran, weil ich über die P III - Programme nicht genug weiß, an denen aber meiner Meinung nach 30 bis 50% der Marktkapitalisierung hängt.

Gruß
Antwort auf Beitrag Nr.: 38.672.907 von pokemon am 06.01.10 09:42:41warum sollte ich Mologen haben?... nichts über PI hinaus. da gibt es meiner Meinung nach aussichtsreichere Sachen.

mfg ipollit
Antwort auf Beitrag Nr.: 38.678.515 von SLGramann am 06.01.10 20:21:12"nur ne geraspelte Chilischote"... naja, in Chili befindet sich nur zufällig derselbe Wirkstoff, der, wie man wahrscheinlich selber schon die Erfahrung gemacht hat, wunderbar auf die Schmerzrezeptoren wirkt, denn nichts anderes ist ja die Schärfe. Die Eigenschaften von Qutenza hören sich gut an... anderes als bei den bisherigen Schmerzmitteln sollen die Nebenwirkungen gering sein... außerdem ist die Schmerzfreiheit sehr lange anhaltend: eine Stunde Anwendung sollen zu 3 Monaten schmerzfreiheit führen. Wie gesagt... hört sich interessant an!

Regeneron... eine MK von aktuell 2 Mrd USD ist zwar nicht wenig, doch ist REGN eben nicht nur von einem Produkt abhängig. Quasi zwei Produkte sind bereits auf dem Markt... Arcalyst und Novartis Ilaris (wofür REGN Royalties erhält)... beide wirken auf IL1, was vielversprechend ist (was man z.B. auch an XOMAs 052 sieht). Ist REGN mit Arcalyst gegen Gicht erfolgreich, so könnte wohl alleine das schon ein Blockbuster werden. Arcalyst, Aflibercept und VEGF Trap-Eye sind keine AKs sondern Traps. Traps sind freie Rezeptoren, die wie AKs an den Targets binden, um sie zu neutralisieren. Ob Aflibercept erfolgreich wird, muss man sehen... aber immerhin stellt es eine Alternative zu Avastin dar und die Entwicklung wird zu 100% von Sanofi finanziert. VEGF-Trap Eye scheint vielversprechend zu sein. Nach den bisherigen Ergebnissen scheint es dauerhafter als Lucentis die Sehschärfe zu erhalten und/oder seltener verabreicht werden zu mussen (Spritze durch das Auge hindurch, was ja das Risiko einer Infektion beinhaltet). Zuletzt habe ich zugekauft, weil Sanofi sehr viel in REGN investiert, was Sanofi wohl nur macht, wenn sie in REGN einen wichtigen Partner sehen (vielleicht soetwas wie Roche und Genentech): in den nächsten Jahren erhält REGN weit über 1 Mrd USD von Sanofi für die Entwicklung von AKs... Ziel ist es, 5 neue AKs pro Jahr in die PI zu bringen. Sanofi fianziert dann die komplette klinische Entwicklung und Vermarktung. Dafür erhält REGN am Ende nicht 5% Royalties oder soetwas, sondern die Gewinne werden geteilt (wobei REGN aus dem Anteil dann zunächst die Hälte der Entwicklungskosten an Sanofi zurückzahlt). Das hört sich für mich nach einem sehr guten Deal an. Dadurch konnte REGN zuletzt 400 zusätzliche Mitarbeiter einstellen. 5 Aks pro Jahr... das könnten am Ende insgesamt bis zu 40 neue klinische AKs sein, an denen REGN zur Hälfte beteiligt ist. Naja... wie das zu bewerten ist, ist eine andere Frage... daher ist REGN auch nicht ganz billig.

mfg ipollit
zu ALTH...

JMP SECURITIES
Allos ($6.65, ALTH, Market Outperform, PT: $20)

Scarcity value makes this hematology company with an approved product an obvious Target. We continue to view Allos as a prime take-out candidate and believe that interim data from a Phase II trial in lung cancer could act as a driving catalyst for acquirers. FOLOTYN is now approved and available in the US for the treatment of PTCL, and we expect a full commercial launch to gain traction early this year. Although early in the launch ramp, we believe that initial sales indications from November and December 2009 may provide upside to Street expectations. We also look forward to learning how quickly and readily reimbursement authorities are adopting the drug’s use.


mfg ipollit
Array - aktuelle Pipeline
(ARRY-403 ist inzwischen an Amgen verpartnert)




mfg ipollit
Arena - aktuelle Pipeline
(die Entwicklung von Mercks Niacin Receptor Agonist ist vor Kurzem gestoppt worden)


mfg ipollit
ViroPharma - aktuelle Pipeline
(Maribavir ist in 2009 in der PIII gescheitert)


mfg ipollit
Addex - aktuelle Pipeline
ADX10059 scheint leider wegen Nebenwirkungen gescheitert zu sein!


mfg ipollit
und zu guter letzt noch die aktuelle Pipeline von Sucampo



soviel zu den Pipelines Anfang 2010... mal schauen, wie sie sich im Laufe des Jahres entwickeln werden

mfg ipollit
Antwort auf Beitrag Nr.: 38.680.068 von ipollit am 07.01.10 00:42:33Guten Morgen ipollit,

Human Genome ist zwar letztes Jahr schon stark gestiegen, aber da geht noch mehr!
Wenn die endgültige Zulassung für Benlysta kommt geht der Kurs über 40 $.
Danach hat Human Genome so viel Kohle, um auch seine anderen Entwicklungen erfolgreich voranzutreiben, oder es kommt ein Übernahmeangebot von Glaxo o.ä.

Ich habe letztes Jahr bei Human fast den absoluten Tiefpunkt erwischt und konnte meine gesamten Aktienverluste aus den letzten Jahren damit ausgleichen ;)

Viele Grüße
af
Antwort auf Beitrag Nr.: 38.680.263 von againstfotsch am 07.01.10 07:41:02Glückwunsch! Soetwas wie bei HGSI findet man nicht oft... ohne Benlysta hätte die Zukunft wohl düster ausgesehen... jetzt stehen die wieder blendend da. Allerdings beträgt die MK nun auch schon mehr als 5 Mrd USD. 40 USD wäre "nur" noch ein bisschen mehr als +20%... wenn dagegen doch noch etwas schief geht, dann gehts wohl wieder steil nach unten. Anfangs war ich nicht dabei gewesen und schaue nun lieber zu, wie es weiter geht.

mfg ipollit
Antwort auf Beitrag Nr.: 38.686.985 von ipollit am 07.01.10 19:36:50Hi ipollit, schön wieder von dir zu lesen. Drück dir die Daumen bei den US-Biotechs. Werd mich dieses Jahr aber hauptsächlich auf die deutschen konzentrieren. Hab noch paar Vertex im Depot liegen, da geht es ja dieses Jahr um die Wurst.

Grüße
blb
Antwort auf Beitrag Nr.: 38.687.140 von blb am 07.01.10 19:50:49Hallo blb!

Danke! - zu den deutschen Bios... wenn ich sie im Vergleich mit beispielsweise den US-Biotechs sehe, dann scheinen sie doch noch ziemlich hinterher zu hängen, so dass ich sie einfach im Vergleich zu wenig interessant finde. Welches deutsche Biotechunternehmen würde denn international Beachtung finden? Da sehe ich eigentlich nur eine Morphosys (Qiagen lasse ich mal außen vor, naja und eine Micromet ist ja eigentlich auch deutsch). Ich habe zwar auch Evotec und Medigene im Depot... aber das sind eigentlich im wesentlichen Spekulationen auf gute Deals für EndoTag-1 und EVT201 gewesen. Letzteres hat nichts ergeben und auch EndoTag-1 zieht sich ewig hin. Interessant finde ich vielleicht noch eine Wilex... vielleicht gelingt denen mal der Durchbruch, zumal die auch eine etwas breitere Pipeline besitzen, wofür sie allerdings recht wenig Geld zur Verfügung haben... immerhin etwas Potential.

Naja, wünsche dir trotzdem viel Glück dabei... z.B. Evotec war letztes Jahr vom Kurs her auch sehr erfolgreich, also warum nicht.

mfg ipollit
Antwort auf Beitrag Nr.: 38.689.434 von ipollit am 08.01.10 00:00:58du solltest dir ein paar mologene dazulegen.
unbeachtet von den meisten machen die ihren weg! mgn1703 könnte binnen jahresfrist auslizenziert sein, so independent research in deren letzten studie.
Antwort auf Beitrag Nr.: 38.679.857 von ipollit am 06.01.10 23:21:36
So, habe jetzt auch ArQule und Regeneron ins Depot genommen. Hoffe, dass ich an den Biotech-Werten dieses Jahr nicht mehr rumschrauben muss und gut aufgestellt bin. Entscheidende Daten kommen in 2010 jedenfalls massenweise...
Antwort auf Beitrag Nr.: 38.694.977 von SLGramann am 08.01.10 16:13:42ja, hoffentlich wird dieses Jahr ein gutes für Biotechs. Ich habe jetzt auch meine Evotec in NGSX getauscht. So ein kleines Unternehmen, welches am Markt bisher nur wenig Beachtung findet, macht mich zwar etwas nervös, aber in dem immerhin zugelassenen Produkt steckt auch einiges an Potential, wenn es erfolgreich wird. Im Erfolgsfall könnten hier in Europa alleine Royalties von über 100 Mio USD drin sein. Bei einem Unternehmen, welches sich im Bereich einer 100 Mio MK bewegt, ist das ja schon ein ganze Menge. Naja... das Risiko besteht wohl aber auch, dass sich Qutenza ähnlich schwach wie z.B. Relistor entwickelt. Dann helfen alle tollen Prognosen nicht.

mfg ipollit
Antwort auf Beitrag Nr.: 38.697.089 von ipollit am 08.01.10 19:28:28Hallo ipollit, kennst du:

IMMUNOMEDICS INC. REGISTERED SHARES DL -,01 (872983)

Was hälst du von der Firma bzw. dem Kursverlauf?

Gruß
af
Antwort auf Beitrag Nr.: 38.679.580 von ipollit am 06.01.10 22:31:19heute war MOLOGEN + 11,5 %!
Antwort auf Beitrag Nr.: 38.679.580 von ipollit am 06.01.10 22:31:19sofern TLR 9 behandlungsansatz weiter gute ergebnisse zeigt, dann wird es noch ganz andere unternehmensbewertungen geben.

bei TLR 9 ist mologen international erste liga.

zulassungsrelevate phase II beim metas. darmkrebs nach der erstmaligen chemotheraoie soll in 1/2010 beginnen und bereits in 4/2010 soll erste zwischenauswertung erfolgen.
:cool:
Antwort auf Beitrag Nr.: 38.712.750 von pokemon am 11.01.10 21:45:28dann Glückwunsch! Trotzdem ist es mir so zu unsicher... vielleicht schaue ich sie mir in ein paar Jahren an.

mfg ipollit
Antwort auf Beitrag Nr.: 38.712.207 von againstfotsch am 11.01.10 20:52:29mit IMMU kenne ich mich nicht aus, sorry... waren mir nur die Tage aufgefallen, weil es einen größeren Kurssprung gab. Ich weiß nicht recht, ob er gerechtfertigt ist... scheinen etwas vom HGSI-Hype zu profitieren, weil sie auch ein Medikament gegen Lupus in der Pipeline haben. Was mir zum Beispiel nicht gefiel, war der geringe Cash, falls das auf yahoo korrekt ist: 20 Mio USD sind nicht allzu viel. Eine MK von 300 Mio USD ist da auch nicht gerade wenig. Aber wie gesagt, kenne ich mich mit denen nicht aus und kann es somit nicht wirklich einschätzen.

mfg ipollit
zu ALTH...

JPM - Allos Therapeutics: Optionality Lies to the Upside Ahead of Folotyn Lung Data; Initiating at Overweight
We are initiating coverage of Allos Therapeutics (NASDAQ: ALTH) with an Overweight rating and a $10 Price Target. We see favorable risk-reward in ALTH shares given mitigated downside risk from one FDA approved indication (PTCL) for key value driver Folotyn, and clear upside potential from Folotyn label-expansion opportunities. The key near-term clinical catalyst is phase 2b data expected in 2nd/3rd-line non-small cell lung cancer (NSCLC) 1H10, which could reveal a sizable NSCLC opportunity but also demonstrate activity in solid tumors. With a valuation that seems anchored on PTCL only, we are Overweight given several free call options in the pipeline.

Folotyn a lower risk asset that could cross the liquid/solid tumor divide. Folotyn is approved in PTCL, a niche market within hematological cancers and could gain compendia listing near term in cutaneous T cell lymphoma (CTCL). However, its mechanism of action is validated in solid tumors as well, and we are focused on the NSCLC data 1H10e given early signs of activity and strong comps vs. Alimta.

PTCL supports valuation. The initial FDA approval is in PTCL, a niche indication of ~5-10k addressable patients. We believe the peak sales opportunity is $500M in PTCL, which in our view, easily supports the current valuation. Concern over potential competition is not a deal breaker, and could assist in expanding the PTCL market.

CTCL up next, but lung cancer the key driver. Folotyn could become compendia-listed by 1H10e in CTCL, a niche indication. However, the real upside near-term driver in our view is the phase 2b data vs. Tarceva in 2nd-/3rd-line NSCLC, which, as we see it, could add $4-5 per share in NPV, assuming activity implies sales in NSCLC and other solid tumors.
Several catalysts in 2010. While we view 1H10e NSCLC data as the key catalyst in 2010, there are other catalysts expected throughout the year. Compendia listing for Folotyn in CTCL could come in 1H10e, while 2H10e data readouts for Folotyn in NHL and CTCL could drive additional upside.

Valuation attractive. Our Dec 2010 PT is $10 (implying 49% upside potential), which is based on a probability-adjusted NPV analysis of the three commercial scenarios for Folotyn. With a risk/reward profile that we view as attractive and not reflected in current levels, we rate ALTH shares Overweight, especially when considering the scarcity value of approved products that are owned exclusively in all indications


mfg ipollit
zu VPHM... Cinryze entwickelt sich ganz gut

ViroPharma Provides 2010 Cinryze(TM) (C1 Esterase Inhibitor [Human]) Outlook
http://finance.yahoo.com/news/ViroPharma-Provides-2010-prnew…

- Company Also Provides Update to U.S. Hereditary Angioedema (HAE) Peak Year Sales Estimates -

EXTON, Pa., Jan. 11 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will provide an overview of the company's business and present a financial update during the 28th Annual J.P. Morgan Healthcare Conference. As previously announced, this presentation will be webcast live at 11:00 A.M. ET (8:00 A.M. PT) on Wednesday, January 13, 2010 and may be accessed via the company's website at www.viropharma.com . The company expects to release full-year 2009 financial results and further discuss 2010 guidance later in the first quarter of 2010.

"The ultimate reward for us in any given year is to achieve our goal of providing solutions for patients with serious diseases and unmet medical needs; 2009 was a remarkable year in that respect," stated Vincent Milano, ViroPharma's chief executive officer. "In 2009 we successfully launched Cinryze™ (C1 esterase inhibitor [human]), the first and only drug approved to prevent HAE attacks. Thanks to meticulous execution by our team, we were able to provide Cinryze during 2009 to over 400 patients who are now actively preventing their attacks. We are pleased to announce that for 2009, we expect our net Cinryze sales will be toward the high end of our previous guidance range of $90 to $95 million, placing Cinryze among the best ever launches of an ultra orphan drug product."

Milano continued, "Our momentum into 2010 is also strong, as we announced this morning an agreement with our partner, Sanquin for the global rights to market and develop Cinryze, and as we continue our execution on our manufacturing scale up efforts to serve HAE patients including the hundreds who are now enrolled in CinryzeSolutions™. We are now producing Cinryze through our scaled-up parallel chromatography process, or PCP, which will begin to enter the trade in the second quarter of this year. Further, we recently conducted a successful meeting with the FDA on our industrial scale initiative where we were able to confirm our previous expectations of the path forward for this significantly expanded manufacturing process. As a result, we are announcing 2010 Cinryze net sales guidance of between $145 and $165 million, which represents tremendous revenue growth over 2009. Although we anticipate that we will be profitable in 2010, we will provide our full guidance later in the first quarter of this year. Finally, I am pleased to announce we have increased our projection of U.S. HAE peak year Cinryze sales to between $350 and $450 million. Our objective continues to be to ensure that every patient who can benefit from Cinryze will have access to this important drug."

***********

ViroPharma expands licensing deal for angioedema drug Cinryze
http://philadelphia.bizjournals.com/philadelphia/stories/201…
ViroPharma Inc. said Monday it has expanded it global licensing deal for Cinryze with Sanquin Blood Supply Foundation in the Netherlands.

The Exton, Pa., specialty pharmaceutical company said the revised agreement “significantly expands ViroPharma's rights to commercialize Cinryze in regions beyond the originally licensed territories of North America, most of the countries in South America, and Israel, and allows for development of potential new indications.”

In October 2008, the Food and Drug Administration approved the use of Cinryze to prevent against angioedema attacks in adolescent and adult patients with hereditary angioedema or HAE. HAE is a rare, severely debilitating, and life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. The drug is only approved in the United States.

“We have developed an outstanding relationship with Sanquin during the first year of the launch of Cinryze in the United States, and the expansion of our collaboration represents a significant step in our combined efforts to expand the potential markets in which we may commercialize Cinryze,” said Vincent Milano, ViroPharma's president and CEO.

Milano said ViroPharma (NASDAQ:VPHM) will look to getting Cinryze approved in new territories and for other C1-mediated diseases. The company also plans to develop new forms of administration for the drug, which is now delivered intravenously.

Under the terms of the expanded deal, which involved no upfront payments, ViroPharma agreed to modify the existing manufacturing fee, establish minimum purchase requirements, fund research efforts at Sanquin at the rate of 1 million Euros ($1.45 million) a year for five years, and provide an additional loan to Sanquin to fund capacity expansions.

ViroPharma has been granted the exclusive right and license to research, develop, obtain regulatory approvals for and commercialize Cinryze in all countries in Europe and the rest of world, other than certain European and other territories in which Sanquin has existing relationships. ViroPharma also has been granted the right to develop Cinryze for all potential new indications.


mfg ipollit
zu ONXX...

http://www.thestreet.com/_yahoo/story/10658357/1/more-biotec…

More Biotech Nuggets From the J.P. Morgan Confab

China was a big topic at the Onyx Pharmaceuticals(ONXX Quote) breakout session. Specifically, investors are anxious for some visibility into the Chinese government's plan to reimburse for targeted cancer drugs, which would include Onyx's liver cancer drug Nexavar.

China represents an enormous commercial market opportunity for Nexavar, since about half of the 600,000 liver cancer deaths worldwide occur there. Nexavar is approved in China today but patients have to pay out of pocket for the drug. Sales in China could rocket, however, if the Chinese government decides to pay for the drug.

Onyx executives said the company expects the Chinese government to hold meetings with cancer drug companies over the next year as part of the decision-making process for reimbursement.

Meantime, Onyx expects to report results from the phase III "Nexus" study of Nexavar in non-small cell lung cancer sometime in 2010. A previous phase III study in lung cancer failed, but Onyx has increased the number of patients in the current trial and is using a different chemotherapy backbone, which may help yield more positive results.


mfg ipollit
Antwort auf Beitrag Nr.: 38.713.802 von ipollit am 12.01.10 00:24:15Hallo ipollit,

habe noch eine Frage an dich:
Was hälst du von Affymetrix?

Affymetrix underweight
13.01.2010 - 16:55
Rating-Update:
London (aktiencheck.de AG) - Die Analysten von Barclays Capital stufen die Aktie von Affymetrix (ISIN US00826T1088/ WKN 901198) von "equal weight" auf "underweight" herab. Das Kursziel werde von 6 USD auf 3 USD reduziert. (13.01.2010/ac/a/u)Analyse-Datum: 13.01.2010
Quelle: Finanzen.net

3$ halte ich für untertrieben, was meinst du?

Gruß
af
Antwort auf Beitrag Nr.: 38.689.434 von ipollit am 08.01.10 00:00:58hi ipollit,

ich verstehe nicht ganz, eine morphosys findest du ok, hast sie aber wie's scheint nicht im depot? bitte kurz um aufklärung.

ansonsten halte ich von SGEN und EXEL sehr viel und habe dementsprechend einiges davon.

diese NGSX muss ich mir mal anschaun - klingt interessant.

lg
pf2
@SL

nochmal zu dieser NGSX: in der aktuell in EU und USA zugelassenen indikation dürfte das marktpotenzial doch recht beschränkt sein, oder?!

wann folgen hier weitere indikationsgebiete?
Antwort auf Beitrag Nr.: 38.729.096 von againstfotsch am 13.01.10 17:44:01sorry, ich kenne Affymetrix nicht näher... da sie eher Systeme verkaufen, also weniger klassischer Biotech als mehr Gerätehersteller, sind sie nicht ganz so interessant für mich.

Nur weil irgendwelche Analysten ein Kursziel ausgeben, muss das noch lange nichts bedeuten. Der Kurs ist nachwievor über 6 USD... also keine Auswirkung. Interessant wäre höchstens deren Grund für die Abstufung.

mfg ipollit
Antwort auf Beitrag Nr.: 38.731.676 von PathFinder2 am 13.01.10 22:21:12Ich finde, dass Morphoys auch international Beachtung finden kann, da sie recht breit aufgestellt sind und diese klassische AK-Technolgie besitzen, während mehrere Konkurrenten ja schon aufgekauft worden sind. Ich finde die Kooperation mit Novartis interessant und vielversprechend. Die Partner-Pipeline macht langsam Fortschritte und auch aus der eigenen Pipeline könnte etwas werden. Im Depot habe ich sie allerdings nicht... da warte ich noch etwas, bis es mit der Pipeline deutlich Richtung PIII geht. Die MK liegt ja, wenn ich das richtig sehe bereits über 500 Mio USD. Wäre z.B. eine Kursverdopplung d.h. eine MK von mehr als 1 Mrd USD angemessen für ein Unternehmen, dass zwar eine breite Pipeline hat, aber noch weit von möglichen Marktzulassungen entfernt ist? Ich denke, dass MOR im Moment gut bewertet ist... also warte ich erst einmal ab. Stattdessen habe ich bezügl. AK-Technologie z.B. REGN... die haben mehrere eigene PIIIs und eine deutlich bessere AK-Allianz mit Sanofi.

mfg ipollit
Antwort auf Beitrag Nr.: 38.747.915 von PathFinder2 am 15.01.10 19:05:13zu NGSX...

so schlecht ist die zugelassene Indikation PHN nicht, zumal HIV und PDN offlabel Umsätze einbringen können, auch wenn noch keine Zulassung dafür vorliegt.

Die aktuelle Zulassung+Offlabel soll so ca. 350+ Mio USD peak sales weltweit einbringen, was ja für ein Unternehmen mit einer MK von etwas über 100 Mio USD nicht wenig ist, auch wenn es teilweise nur Royalties usw sind.


http://www.europharmatoday.com/2009/06/neurogesx-brings-aste…

June 25, 2009
NeurogesX Brings Astellas On Board To Launch Pain Patch in Europe

A deal with Astellas to market and distribute the neuropathic pain patch Qutenza in Europe will bolster NeurogesX's cash position, giving the company some breathing room to prepare for regulatory approval and a 2010 launch in the U.S. market.

Qutenza was approved for neuropathic pain in non-diabetic patients by the European Medicines Agency in May and it is pending review at the FDA, with an Aug. 16 user fee date.

NeurogesX is set to get €30 million ($42 million) upfront for Qutenza commercialization rights from the European subsidiary of Japanese drug maker Astellas, according to a deal announced on June 22. In addition to 27 countries in the European Union, the deal covers Iceland, Switzerland, and some countries in the Middle East and Africa. The product will be launched in Europe by the first half of 2010.

Qutenza is a dermal patch packing a high concentration form of synthetic capsaicin (also called trans-capsaicin), which is the substance found in chili peppers. Capsaicin stimulates transient vanilloid 1 receptors in the skin, which in turn subdue overactive pain receptors. The effects are long-lasting, but also reversible, the company says.

As part of the agreement, Astellas also will pay €5 million upfront ($7 million) for a co-development and commercialization option on NGX-1998, a Phase I liquid formulation of the NeurogesX product.

NeurogesX now is eligible for €70 million ($97 million) in sales-based milestone payments and additional option payments for the liquid formulation. Royalty rates start in the high teens and escalate into the mid-20s, the company said during a June 22 investors' call.

Deal gives financial peace of mind

NeurogesX had about $19 million in cash and marketable securities at the close of the first quarter, enough to carry it through 2009, but insufficient to give the company much comfort in making plans for breaking into the U.S. market.

During the call, Chief Financial Officer Stephen Giglieri declined to provide runway guidance, which he says is likely to come in the company's second-quarter earnings report.

"The reason I am hesitant to do that [now] is we will be looking at our development plans and of course that has an impact on our cash runway," he said. "But obviously, putting $49 million into the bank is going to extend our runway fairly significantly."

NeurogesX estimates the potential for each market- the U.S. and Europe- is worth from $300 million to $500 million. Assuming the company receives a 17 percent royalty on net sales in the EU, Lazard analysts project the company could get $110 million in peak sales, including some off-label use in diabetic neuropathy.

In the U.S., Lazard forecasts Qutenza revenues of $40 million in 2010 and $88 million in 2011, with peak sales of at least $400 million in 2015. These figures are based on a treated patient population of 56,000 in HIV-distal sensory polyneuropathy, 256,000 in post-herpetic neuralgia, and 556,000 in diabetic peripheral neuropathy in 2008.

Astellas to foot bill for post-marketing trials

Qutenza, a 179 mg cutaneous patch, was approved in May by the European Medicines Agency for peripheral neuropathic pain in non-diabetic adults. This label includes two of the biggest neuropathic pain conditions- post-herpetic neuralgia, which is caused by shingles, and HIV-DSP, a common neurological problem linked with HIV infection. To get approved in Europe for diabetic neuropathy, the product's third-biggest indication, the company needs to accumulate more data.

Astellas will fund additional studies to support Qutenza marketing and promotion, and will fulfill post-marketing commitments linked to European approval, including a long-term safety study in approved indications.

In the U.S., Qutenza is pending review for post-herpetic neuralgia. Despite the user fee date in August, the company and analysts are expecting delays. After questioning the use of Endo Pharmaceuticals' local pain reliever Lidoderm in the pretreatment phase before Qutenza was applied, the agency requested a small, non-efficacy comparability study of the two treatments. NeurogesX says it has completed enrollment and treated all patients, and hopes to submit the data before the Aug. 19 PDUFA date.

"Although the PDUFA date is Aug. 16, submission of additional data late in a review cycle typically triggers a delay and we would expect this to be the case for Qutenza," wrote Lazard analyst William Tanner in a June 22 note.

During the investors' call CEO Tony DiTonno said the company is hopeful that any delay in the FDA's decision will be relatively short and expressed guarded optimism that an agency action will occur before the end of the year and a launch could happen in the first half of 2010.

Timing of European launch uncertain

Astellas declined to comment on its plans for the European launch, aside from saying that it will take place "as soon as possible." Astellas also is not disclosing its sales and marketing strategy, beyond confirming it will be targeting pain specialists who work in hospitals.

It's possible that that Astellas will launch in Europe in the first half of 2010, not necessarily at the same time of the U.S. rollout, according to NeurogesX executives.

Other compounds approved for neuropathic pain include Lidoderm(lidocaine patch 5 percent), the anti-convulsant gabapentin (Pfizer's Neurontin and generics), Pfizer's Neurontin follow-on compound, Lyrica (pregabalin) and serotonin and Lilly's norepinephrine reuptake inhibitor Cymbalta (duloxetine).

Anti-convulsants and anti-depressants act on the central nervous system and, therefore, have worrisome central side effects including sleepiness, and risk for suicidality, DiTonno pointed out. These medications also require chronic dosing to maintain therapeutic effects.

Qutenza acts locally at the site of pain and is administered for one hour by a doctor, with results lasting 12 weeks. Lidoderm also acts locally but requires much more frequent administration by the patient, raising concerns about compliance, DiTonno maintained. With that product, up to three patches are administered once a day for up to 12 hours (12 hours on and 12 hours off).

Preparing for launch in Europe and U.S.

DiTonno noted that Astellas has pain drugs in its pipeline and will build a pain-focused specialty pharma franchise starting with Qutenza.

Astellas had been working with XenoPort to develop XP13512 (gabapentin enacarbil) in diabetic peripheral neuropathy, but halted a trial in the third quarter of 2008 after an interim analysis showed the drug was unlikely to meet its primary endpoint of pain reduction (1 'The Pink Sheet' DAILY, April 27, 2009).

The company published positive preclinical results for FK1706 in diabetic neuropathy in the journal Neuropharmacology in December 2008. Researchers reported that the compound, a non-immunosuppressive immunophilin ligand, relieved painful neuropathy by changing underlying disease pathology, a different mechanism from gabapentin.

DiTonno declined to comment on which European countries would be targeted first, but he did say that, traditionally, companies focus initially on the UK and Germany because these countries offer the most flexibility on pricing.

In the U.S., NeurogesX plans to build its own sales force of 80 to 100 people to target about 12,000 specialists and will seek a partner to reach about the same number of primary care doctors who prescribe pain medications. "We have already started planning for that and will ramp that up," he said.



http://blog.taragana.com/business/2009/11/17/neurogesx-share…

NeurogesX shares rise as Food and Drug Administration approves Qutenza pain patch

By AP November 17th, 2009

NeurogesX shares rise following FDA approval


NEW YORK — Shares of biotechnology company NeurogesX Inc. jumped Tuesday after the company received Food and Drug Administration approval for its Qutenza pain patch.

The stock rose 51 cents, or 6.2 percent, to $8.75 in afternoon trading. Shares have traded between 89 cents and $9.20 over the last 52 weeks.

The FDA approved Qutenza as a treatment for postherpetic neuralgia, a type of nerve pain condition that results from shingles. The company plans to launch the drug in the U.S. in the first half of 2010. The patch is already approved in Europe for peripheral nerve pain in non-diabetic adults.

Lazard Capital Markets analyst William Tanner reaffirmed a “Buy” rating and $9 price target, saying the approval seemed likely. He forecast sales of $88 million in 2011, which will also likely be the company’s first profitable year. U.S. sales could peak over $350 million annually by 2015.


mfg ipollit
Antwort auf Beitrag Nr.: 38.769.508 von ipollit am 20.01.10 00:44:48danke für den artikel - hört sich in der tat interessant an diese firma.

allzulange dürfte der cash nicht reichen, da man wohl zunächst von steigendem cashburn ausgehen kann (sales force etc.). aber dann sollten es ja die ersten produktumsätze wieder richten wenn alles glatt geht.

werd mir wohl demnächst ein paar ins körbchen tun. market cap aktuell USD 125,8 mio.
Hallo, klasse Thread!

Mein absoluter Favorit ist Isis Pharmaceuticals. Isis sind sozusagen die Pioniere in der Antisense/RNAI-Technologie mit einer marktbeherrschenden Patentlage.
Die Pipeline ist mit aktuell 23 Medikamenten-Kandidaten mehr als vielversprechend. Die Antisense-Technologie macht es möglich die Pipeline jährlich um 3-5 Medikamente zu erweitern(allein in den letzten 6 Wochen um 3 Stück!) und das zu einem Bruchteil der Kosten traditioneller Technologien.
Pipeline
http://www.isispharm.com/Pipeline/index.htm

Isis hat allerdings den Makel mit der 1. Generation von Antisensemedikamenten kläglich gescheitert zu sein!

Mittlerweile wurde die Antisensetechnologie allerdings erheblich weiterentwickelt und befindet sich in Generationen 2 und 2.2 . Die Generation 2.5 ist für 2010 angekündigt mit der die orale Verabreichung möglich sein wird.

Was noch fehlt ist die Validierung der Technologie, d.h. es muss das erste Blockbustermedikament die Zulassung erhalten.

Mit Mipomersen hat Isis dabei ein sehr vielversprechendes Medikament. Dabei handelt es sich um ein Herz-Kreislauf-Mittel, welches helfen soll, den Cholesterinspiegel im Blut zu senken.
Mipomersen wird zurzeit in verschiedenen Patientengruppen (unterschiedliche Risikogruppen) in Phase III getestet. Die riskanteste Phase III-Studie mit 34 Patienten der höchsten Risikogruppe (allerdings kleinsten Marktpotential) wurde mit herausragenden Ergebnissen abgeschlossen. Die Ergebnisse der Phase-III mit 124 Patienten der zweithöchsten Risikogruppe sind noch in diesem (01.Quartal 2010) fällig und zwei weitere Phase-III Ergebnisse (3. und 4.höchste Risikogruppe) sind im Sommer 2010 fällig. Zulassungsanträge in USA und EU sind für Anfang 2011 geplant.

Wer sich für Isis interessiert sollte sich unbedingt folgende Slides vom R&D DAY ansehen !!!

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9M…


Besonders interessant ist auch das Transcript vom R&D DAY welches man allerdings erst nach Anmeldung (anonyme Einträge reichen auch)
herunterladen kann.
http://ir.isispharm.com/phoenix.zhtml?c=222170&p=IROL-Guestb…


Grüße cristrader:)
Antwort auf Beitrag Nr.: 38.778.590 von cristrader am 21.01.10 01:21:27wurde mit herausragenden Ergebnissen abgeschlossen.

das hat der markt aber absolut nicht so gesehen...

ISIS ist auch auf meiner watchlist; was ich vom konzept dieser satellite-companies halten soll, weiß ich nicht so recht. mag vorteile haben, bietet aber auch viel platz für schindluder mmn.
Antwort auf Beitrag Nr.: 38.786.098 von PathFinder2 am 21.01.10 21:12:39
Was meinst Du mit satellite-companie?

Ich finde ISIS eigentlich auch spannend, aber bisher war ja alles noch nicht so ermutigend und ipollit hat ja auch gleich ganz am Anfang geschrieben:

"Zwar konnte in der ersten PIII Mipomersen bei Hochrisiko-Patienten das Cholesterin senken, doch gab es auch bei einem Teil der Patienten erhöhte Leberwerte, ein Anzeichen von möglicher Leberschädigung. Die Frage ist nun, in wie weit Mipomersen dafür verantwortlich ist und ob dies auch bei Patienten, die keine lebensgefährlichen Cholesterinwerte aufweisen, auftritt, denn nur damit kann Mipomersen zu einem Blockbuster werden. Daher ist der Kurs zuletzt gefallen."


Tja, ich denke, ich bleib zunächst mal an der Seitenlinie, hoffe aber, dass ISIS hier immer wieder diskutiert werden wird.
Antwort auf Beitrag Nr.: 38.778.590 von cristrader am 21.01.10 01:21:27hallo cristrader!

Danke für die Links!

ja, Isis ist recht gut und ich denke, da steckt einiges an Potential drin. Ein Problem gäbe es nur, wenn RNAi insgesamt so nicht funktionieren würde... der große Durchbruch fehlt bisher ja noch. Zudem ist der Cashburn ist relativ gering... und mit 600 Mio USD noch reichlich vorhanden.

Andererseits gibt es eben noch gewisse Unsicherheiten bezügl. Mipomersen (Entwicklungs-Verzögerungen, potentiell gravierende Nebenwirkungen), weshalb wohl schon seit einiger Zeit der Kurs unter Druck ist. In der R&D-Präsentation stellt es Isis ja auch so da, dass Mipomersen von großer Bedeutung ist... mehr als 1/3 des zukünftige Umsatzes soll dadurch generiert werden. Gibt es mit Mipomersen Probleme, dann schlägt es trotz der breiten Pipeline auf den Kurs durch.

Langfristig steht Isis aber dank des Geschäftsmodells wohl gut da.

mfg ipollit
Antwort auf Beitrag Nr.: 38.786.170 von SLGramann am 21.01.10 21:21:55satellite-companies... ich würde sagen Ausgründungen oder Partnerschaften, bei denen andere die Weiterentwicklung übernehmen.

Isis hat ähnlich wie z.B. MOR das Geschäftsmodell, ihre Pipeline alleine maximal bis in PII zu bringen. Danach werden Partnerschaften oder Ausgründungen gesucht, die dann das weitere Risiko und die anfallenden Entwicklungskosten übernehmen. Isis partizipiert dann an den Royalties oder an Unternehmensanteilen... siehe z.B. die R&D-Präsentation. Dies soll den Vorteil haben, dass Isis nicht von einem Medikamentenkandidaten abhängig ist und solange es wenigstens ein paar auf den Markt schaffen, sie irgendwann relativ sicher Gewinne machen. Teilweise hat Isis jetzt schon Cashflow positive Quartale gehabt.

mfg ipollit
eine Sache, die ich im Blog http://www.pharmastrategyblog.com/ gefunden habe...

Antisoma hört sich langsam recht interessant an. Anscheinend ist ASA-404, das Novartis von Antisoma lizensiert hat, ein guter Ansatz... eine Mischung aus Chemo und Avastin ("a kind of hybrid cross between an anti-angiogenic such as bevacizumab (Avastin) and a taxane such as paclitaxel or docetaxel.") Bei einem Erfolg stehen Antisoma einiges an Meilensteinzahlungen und Royalties zu. Zu der Höhe der Royalties habe ich nichts definitives gefunden... an einer Stelle wird es allerdings auf 25% geschätzt, was sehr viel wäre, zumal, wenn ASA-404 ein potentieller Blockbuster bei einem BigPharma wäre.

das ganze für ca. 350 Mio USD MK bietet reichlich Kurspotential, oder?




aus http://www.pharmastrategyblog.com/2010/01/aacr-personalized-…

Today's topic is about a new generation flavanoid, ASA-404, from Novartis. Of course, under FTC guidelines, I should disclose that as many of you know, I'm a former employee and have also done consulting work for the company, but not on this particular product.

ASA-404 is an interesting agent in phase III development. It's a vascular disrupting agent (VDA) with a tubulin dependent mechanism of agent. Unlike taxanes, which target the microtubulin in DNA, this agent is also part anti-angiogenic agent because it selectively disrupts the tumour vasculature with both direct and indirect effects. In simple terms, I think of it as a kind of hybrid cross between an anti-angiogenic such as bevacizumab (Avastin) and a taxane such as paclitaxel or docetaxel.

Dr Mark McKeage presentation at the AACR lung cancer meeting was focused on the phase II that has been published to date, including a publication in the British Journal of Cancer (see bottom of article).

The drug was well tolerated in phase I trials, achieving an MTD of 3700 mg/m2.

In a phase II trial, paclitaxel and carboplatin (pc) therapy was used as the reference arm, and ASA-404 added to the standard chemotherapy in the other arm to determine if the agent added any extra benefit for newly diagnosed patients with non-small cell lung cancer (NSCLC) with either a squamous or non-squamous histology. They looked at 2 different doses of ASA-404 - 1200mg/m2 was used in the randomised comparison with carbo-tax and 1800mg/m2 with out the comparator arm but in combination as before. 36 patients were accrued into the reference pc arm, 37 in the lower dose ASA-404 arm and 31 in the higher dose ASA-404 arm. This gave a total of 104 patients in the pooled phase II study.

Overall, similar rates of adverse events (AE's) were seen in the squamous and non-squamous patients, except for a slight increase in AE's related to blood/lymphatic effects. No serious AE's associated with vascular effects of bleeding, hemorrhage or hemoptysis were seen. There was an increase in hematologic toxicities (anemia, neutropenia and thrombocytopenia) but these were not significant and none rose above 20%. There was no apparent increase in neutropenia related sepsis.

In terms of efficacy and median overall survival, McKey reported:

PCA vs. PC

14.0 vs. 8.8 mos for 1200mg/m2

14.9 for 1800mg/m2

Thus we can clearly see that adding ASA-404 to standard carboplatin-paclitaxel therapy improved median overall in frontline NSCLC by 5 months.

Recently, the FDA has approved several therapies in NSCLC in different histologies, due to either issues with side effects (bevacizumab and bleeding issues) or lack of efficacy (pemetrexed), while others such as erlotinib have been shown to be particularly effective in non-smoking female asians with an adenocarcinoma histology, although the approval is not based on histology.

Let's take a look at the ASA-404 histology data:

Squamous: Non-Squamous: Overall:

PCA PC PCA PC PCA PC

ORR (%) 40.0 14.3 31.7 25.0 34.4 22.2

One third of the patients had a squamous histology, but experienced no bleeding issues seen with VEGF agents.

While the results are higher for those with a squamous histology, there was also a trend towards higher efficacy in the non-squamous patients. The positive results provided support and evidence for the drug's effectiveness and rationale for beginning the phase III triala, ATTRACT-1 in first line and ATTRACT-2 in second line NSCLC without restriction on histology.

To put the 5 months improvement in median OS with ASA-404 in context, I checked out the PI for other therapies. Bevacizumab was approved on the basis of 12.3 months vs. 10.3 months, ie a 2 month improvement, while pemetrexed was approved on the basis of non-inferiority when comparing pemetrexed plus cisplatin to gemcitabine plus cisplatin (ie 10.3 months of overall survival in each arm).

The front-line trial has completed accrual and is ongoing, but the ATTRACT-2 trial for patients who have had prior chemotherapy is still enrolling. You can find it here: ATTRACT-2.

Of course, these are early days yet and positive phase II data does not always translate to phase III success, but they are a hopeful sign of good things to come. If the data are repeated, it will be good news for patients with NSCLC.


mfg ipollit
eine zweite Sache ebenfalls aus diesem Blog gezieht sich auf ARQL...

hier stehen genau die im folgenden beschriebenen c-Met + EGFR Daten in Form der PII von ARQ-197 in Kombination mit Tarceva bei NSCLC in diesem Halbjahr an. Theoretisch scheint diese Kombination anscheinend ja sehr sinnvoll und vielversprechend zu sein.

http://www.pharmastrategyblog.com/2010/01/aacr-personalized-…

January 20, 2010
#AACR Personalized therapy in lung cancer - part 4

It's been a bit of a long week on lung cancer articles and while I was planning on talking about something else today, this new article in my database caught my eye:

.
.
.

Part of the reason is nostalgia - it's 20 years ago since I finished my doctorate on early detection of preclinical lung disease and while I was interested in the methods of detecting changes in breathing patterns associated with smoking, part of me wished I'd done research on molecular biology at the time rather than applied physiology.

The reason is that I realised while doing the literature search is that biochemical and physiological changes in the airways would ultimately tell us more about early detection.

In the article above, the researchers suggest a potential mechanism by which the tobacco-specific carcinogen NNK promotes lung tumour formation and development. Now, bearing in mind that most solid tumours take years to develop from hyperplasia to full aggressive carcinoma, finding how it actually happens and why is still an inexact science, as are methods for early detection given not all smokers get lung cancer and non-smokers are not immune from the disease.

Lin et al., suggest that NNK induces the accumulation of a protein known as DNMT1 in the nucleus and that this protein silences genes that suppress tumour formation. They offered evidence to support their hypothesis, including the observation that DNMT1 accumulates in both lung adenomas from NNK-treated mice and tumours from lung cancer patients that were smokers. DNMT1 overexpression in lung cancer patients who smoked continuously correlated with poor prognosis.

However, the interesting part of their abstract to me was:

"We determined that in a human lung cell line, glycogen synthase kinase 3β (GSK3β) phosphorylated DNMT1 to recruit β-transducin repeat–containing protein (βTrCP), resulting in DNMT1 degradation, and that NNK activated AKT, inhibiting GSK3β function and thereby attenuating DNMT1 degradation."


Ah, our friend AKT.

The potential role of AKT in lung cancer came up repeatedly at last week's AACR lung cancer meeting. The researchers there had begun to realise that blocking EGFR or IGF-1R and c-MET or AKT (either directly or indirectly via PI3K inhibition) might cut off an escape route for the cancer cell and reduce drug resistance:



Drs Jeffrey Engelman (MGH) and David Carbone (Vanderbilt) covered excellent quick reviews at AACR on the latest findings related to EGFR inhibition relating to c-MET and proteomics respectively. As our knowledge of various mutations and biologic pathways improves, so does our understanding of how we can better target aberrations and treat patients with NSCLC more effectively.

Engelman's group has just published a paper on c-MET and EGFR inhibition (see references). They noticed that rare MET-amplified cells exist in some EGFR-mutant lung cancers before treatment. What makes the research relevant to this overview is that MET amplification activates ERBB3/PI3K/AKT signaling in EGFR mutant lung cancers and causes resistance to EGFR kinase inhibitors. They demonstrated that MET activation by its ligand, HGF, induces drug resistance through GAB1 signaling. Using high-throughput FISH analyses in both cell lines and in patients with lung cancer, they identified subpopulations of cells with MET amplification prior to drug exposure.

The concept that HGF induces resistance to tyrosine kinase inhibitors in EGFR-addicted cancers is a novel one. They saw that HGF accelerates MET amplification by expanding preexisting MET-amplified cells. What was particularly relevant though was that analysis of pretreatment cancers identified those poised to become MET amplified, thereby offering a way to segment NSCLC patients for more personalised treatment, increasing the chances of better response rates, longer overall survival and improved patient outcomes.

Then came the killer statement:

"EGFR kinase inhibitor resistance, due to either MET amplification or autocrine HGF production, was cured in vivo by combined EGFR and MET inhibition."

Oh my. This leaves us seriously wondering what will happen in practice by combining erlotinib (Tarceva) or gefitinib (Iressa) with a MET inhibitor in patients with NSCLC?

I can't wait for ASCO this year to find out!


mfg ipollit
CBST... zwar schon etwas her, aber noch zur Calixa-Übernahme

Das dabei erworbene CXA-201 könnte recht aussichtsreich sein... zumindenst waren die Gründer von Calixa zuvor mit Antibiotika bereits sehr erfolgreich.


http://www.pharmacychoice.com/news/article.cfm?Article_ID=36…

3/30/09 - Calixa Pushes Anti-Pseudomonal Antibiotic Toward Phase II for UTI

With $30 million of Series A financing in its coffers, Calixa Therapeutics Inc. is gearing up for a Phase II trial of CXA-101, a broad-spectrum cephalosporin antibiotic that has shown potent anti-pseudomonal activity.

San Diego-based Calixa was founded in late 2007 by antibiotic expert James Ge and serial entrepreneur Eckard Weber. The two have a long history of working together at antibiotic firms funded by Domain Associates, where Weber serves as a partner.

In the early part of the decade, Ge and Weber teamed up at Peninsula Pharmaceuticals Inc., where Ge headed drug development and Weber served as chairman. Peninsula was acquired by Johnson & Johnson in 2005 for $245 million, giving the big pharma control of Peninsula's broad-spectrum carbapenem antibiotic Doribax (doripenem). (See BioWorld Today, April 20, 2005.)

Doribax gained approval for complicated intra-abdominal and urinary tract infections although, like many antibiotics, it has hit regulatory hurdles in hospital-acquired pneumonia. (See BioWorld Today, July 18, 2008.)

While J&J focused on Doribax, the Peninsula team spun out Cerexa Inc. to develop the Phase I broad-spectrum cephalosporin antibiotic ceftaroline, which was licensed from Takeda Chemical Industries Ltd. Again, Ge headed drug development and Weber served as chairman until Cerexa was acquired by Forest Laboratories Inc. in late 2006 for $480 million. (See BioWorld Today, Dec. 15, 2006.)

While Forest moved ceftaroline through Phase III, Ge and Weber had their sights on FR264205, a preclinical broad-spectrum cephalosporin antibiotic in development at Tokyo-based Astellas Pharma Inc. Cerexa had done "extensive due diligence" on the compound, but it hadn't been licensed prior to the Forest acquisition, and Forest wasn't interested in pursuing such an early-stage program, Ge said.

So Ge and Weber founded Calixa, raised $30 million and licensed FR264205 - now known as CXA-101.

The Series A round came from Domain as well as Canaan Partners and Frazier Healthcare Ventures. The money should carry Calixa "into 2010," Ge told BioWorld Today.

What differentiates CXA-101 from other antibiotics on the market or in development is its potent activity against Pseudomonas aeruginosa, Ge explained.

The bacteria ranks alongside Escherichia coli and Streptococcus pneumoniae as one of the most common causes of hospital-acquired infections and can lead to hospital-acquired pneumonia, urinary tract infections, wound infections and sepsis.


P. aeruginosa infections commonly are treated with broad-spectrum antibiotics such as the cephalosporin antibiotics ceftazidime or cefepime, or the carbapenem antibiotic imipenem.

In a paper published in the March 2007 issue of Antimicrobial Agents and Chemotherapy, Astellas' researchers demonstrated that the concentration of CXA-101 needed to inhibit 90 percent of 193 P. aeruginosa isolates was eight times to 16 times lower than that needed for ceftazidime, cefepime or imipenem. CXA-101 also demonstrated activity against strains resistant to the existing drugs and showed evidence that it may be less prone to resistance.

In murine models, CXA-101 showed superior or comparable efficacy to ceftazidime and imipenem.

Calixa filed an investigational new drug application for CXA-101 in mid-2008 and completed two Phase I studies.

CXA-101 was well tolerated with no dose-limiting toxicities and a safety profile similar to that of marketed cephalosporin antibiotics.

With Phase I data in hand, Calixa is now gearing up for a Phase II trial, slated to start in the second quarter. Ge said the double-blind study will compare intravenous CXA-101 to an existing antibiotic for complicated urinary tract infections. Data are expected within a year.

Behind CXA-101, Calixa is developing CXA-201, which combines CXA-101 with a beta-lactamase inhibitor to provide even broader activity. If the data with CXA-201 pan out, Ge said Calixa will focus all of its resources on that program rather than CXA-101.

A similar approach is being pursued by Paris-based Novexel SA, which is conducting a Phase II trial combining its broad-spectrum beta lactamase inhibitor, NXL 104, with ceftazidime for complicated intra-abdominal infections. But Ge noted that CXA-101 has shown better anti-pseudomonal activity than ceftazidime.

He added that CXA-101 has the potential to be "best-in-class" as far as its anti-pseudomonal activity, based on in vitro and in vivo data.

Calixa also is developing an inhaled form of CXA-101 for P. aeruginosa infections in cystic fibrosis patients. The program, dubbed CXA-301, is in preclinical, with formulation work under way.

As of now, the only inhaled antibiotic for CF infections is TOBI (tobramycin solution for inhalation, Novartis AG), but Gilead Sciences Inc. is in regulatory discussions with the FDA regarding its inhaled aztreonam, and Phase II programs include Bayer AG's ciprofloxacin inhaled powder, Aradigm Corp.'s inhaled liposomal ciprofloxacin, Transave Inc.'s Arikace (liposomal amikacin for inhalation) and Mpex Pharmaceuticals Inc.'s MP-376, an aerosol formulation of levofloxacin.

Preclinical data have shown CXA-101 to be more potent than tobramycin and aztreonam, Ge noted


mfg ipollit
Antwort auf Beitrag Nr.: 38.786.872 von ipollit am 21.01.10 22:52:08Antisoma...

ein umfangreicherer Analysten-Report:
http://www.oxbio.com/pressreleases/030609_Antisoma.pdf

mfg ipollit
Antwort auf Beitrag Nr.: 38.786.637 von ipollit am 21.01.10 22:20:52@SL

siehe hier zu satellite companies:
http://www.isispharm.com/Strategic-Alliances/Satellite-Compa…

also ich find solche konstrukte (von unternehmen A gehören ISIS ein paar prozent, von B ein paar, dort ein Joint Venture mit so und so) u.a. aufgrund transparenzgründen nicht so wahnsinnig toll.

nicht falsch verstehen: ich bin absolut für strategische partnerships. gutes beispiel EXEL: ordentliche partnerdeals, EXEL mit kernfunktion research & frühe entwicklung, big pharma (allem voran BMS) mit kernfunktion späte entwicklung und vermarktung. spielen kann man das in mehreren varianten von voller auslizenzierung in früher phase bis hin zu co-development.

der sinn, warum ein biotech von etlichen anderen biotechs equity-stakes haben sollte, erschließt sich mir nicht ganz, bzw. kann auch risiken bergen. risikostreuung kann man mmn besser mit obigen deals umsetzen (sofern man partner findet...)
Antwort auf Beitrag Nr.: 38.769.508 von ipollit am 20.01.10 00:44:48zu NGSX...

ebenfalls ein umfangreicherer Analysten-Report
(Link zum pdf in google anklicken, sonst klappt der Zugriff nicht)
http://www.google.de/search?hl=de&rlz=1R2GGLL_deDE334&q=zer_…

mfg ipollit
Antwort auf Beitrag Nr.: 38.786.637 von ipollit am 21.01.10 22:20:52Hallo!

Die Mipomersenergebnisse werden sicherlich kurzfristig gesehen entscheidend für den Kursverlauf sein. Bezüglich der Mipomersen- Phase III-Studien bin allerdings mehr als zuversichtlich. An mangelnder Wirksamkeit wird Mipomersen den bisherigen Studien zufolge sicherlich nicht scheitern das Nebenwirkungsprofil wird entscheidend sein. Erhöhte Leberwerte gehören insbesondere bei Beginn der Medikamentenverabreichung auch bei allen anderen Standardtherapien zu den häufigen Nebenwirkungen. Die Nebenwirkungen von Mipomersen bewegen sich bisher im vergleichbaren Rahmen, nur das halt ein völlig neuer Therapieansatz bzw. eine neue Medikamententechnologie angewendet wird, wo es bisher einfach keine langfristigen Erfahrungswerte gibt.


S. Crooke
"Of course, we had three patients in this study that had elevated liver transaminases. We reported this at the AHA. Importantly,
what we've seen as we've developed this drug, and just to let you know, as it was presented by [Professor Rawls], these biochemical
changes in liver enzymes occur with all lipid lowering therapies. What we're seeing is, so far in our safety database, is no liver
toxicity. And that's important, no Hy's Law.
We've dosed through a number of -- many of these and they -- and in all cases in this study the transaminases returned to entry
criteria by the end of the planned clinical observation
. So, of course additional analysis is being conducted in this, but we're
very comfortable with the safety of this drug and the profile that we're seeing."

Nachfolgend noch ein Auszug eines Research-Berichtes von "Zacks"

Carlsbad, California-based Isis Pharmaceuticals, Inc. is a drug discovery and development company that
focuses on the development of products using ribonucleic acid (RNA)-based technologies, such as
antisense. Antisense technology is a direct route from genomics to drugs. Antisense drugs are the first
class of drugs targeted to control expression of genes through interactions with RNA. Beyond antisense,
Isis scientists have created another technology that exploits their knowledge of RNA. The company has
about 1,600 issued patents worldwide and controls one of the largest antisense and RNA patent estates
in the pharmaceutical industry.
The company discovers new drugs and out-licenses them to partners for license fees, milestone
payments, and royalties. Isis has partnership agreements with leading pharmaceuticals companies like
Bristol-Myers Squibb, Genzyme, Eli Lilly, and Johnson & Johnson among others. The company also has
a collaboration agreement with biotech company, Alnylam Pharmaceuticals. Both companies have joined
hands to form Regulus Therapeutics, Inc., a company that is focused on microRNA (mRNA) therapeutics.
Isis focuses its research and development efforts primarily in cardiovascular, metabolic and
neurodegenerative diseases and cancer while its partners are involved in the development of antisense
drugs in these and other areas, including inflammatory disease.
In 2008, Isis recognized $107 million in total revenues from licensing its intellectual property, satellite
companies, and from forming collaborations with larger partners in developing antisense drug
candidates. Earlier this year, Isis sold its Ibis Biosciences subsidiary to Abbott Molecular, Inc. for $215
million and an earn out on the sales of assay kits and services. As a result, Ibis financial results are
considered discontinuing operations.
Antisense Technology Represents Enormous Potential: We are big fans of antisense technology and
believe that the number of potential therapeutic applications is enormous. Antisense drugs may have
significant potential to treat a number of diseases where small molecules and biologic compounds
have failed. Although still early stage, antisense technology with mechanisms such as small
interfering RNA (siRNA), RNA interference (RNAi), alternate splicing, and microRNA (mRNA) have
the potential to change how we treat disease in the next decade. We see antisense technology
today where biologics were ten years ago. The promise of biologic drugs is finally delivering with
blockbuster compounds such as Rituxan, Herceptin, Avastin, Aranesp, Synagis, and Humira. We
think in ten years the same will be said for antisense.
Antisense drugs have several specific advantages over traditional protein or small-molecule derived
therapeutics. Firstly, antisense drugs are highly specific and bind to only the complimentary mRNA
strain that codes for the specific protein being targeted. This has the potential to greatly reduce
unwanted side-effects that occur through secondary mechanisms of action. Secondly, since all
proteins are coded by mRNA, antisense drugs have the potential to work on a broad number of
diseases including cardiovascular, metabolic, inflammatory, ocular, viral, neurodegenerative
disease, and cancer. Finally, because all antisense drugs start with the basic hybridization of mRNA
targets, development timelines are shortened and response is often predictable in the early-stage of
development. Scientists need only choose a specific protein to target and then create a small
antisense molecule to bind to the transcribed mRNA. This creates efficiency in drug discovery and
time to market.
Isis is pioneering the effort into antisense research. The company has already commercialized the
first antisense drug in 1998 with Vitravene and has several proprietary compounds in clinical
development as well as partnered programs with large pharmaceutical companies such as Bristol-
Myers, Eli Lilly, Merck, J&J, Genzyme and Glaxo. We think that by 2012 two to three additional
antisense drugs developed by Isis could be on the market.
Mipomersen - The Blockbuster in Phase III: Isis Pharmaceuticals lead pipeline candidate,
mipomersen (formerly ISIS-301012), is a second generation compound currently in a multitude of
phase III trials for familial hypercholesterolemia (FH). Mipomersen is an antisense drug that targets
apolipoprotein B (apoB) -100, which is critical to the synthesis and transport of low density
lipoprotein (LDL) or bad cholesterol. By potentially knocking out the apoB-100 protein via antisense
technology, Isis scientists believe they can effectively lower the cholesterol of patients and reduce
the risk of serious cardiovascular disease. Given the novel mechanism and narrow initial market
focus of homozygous (Ho) FH, the U.S. Food and Drug Administration (FDA) granted mipomersen
orphan drug status in June 2006.
Meanwhile, highly encouraging phase II data helped Isis strike one of the largest biotechnology
deals in history in early 2008 with Genzyme. As per the terms of the deal, Isis will not only receive
commercialization and development milestones, it will also split net profits with Genzyme on
mipomersen (70% Genzyme, 30% - Isis) until worldwide sales eclipse $2 billion. Thereafter,
Genzyme and Isis will split profits on mipomersen 50/50. This deal is a homerun collaboration for
Isis, in our view. It has not only provided a guaranteed $325 million in up-front funding that allows
Isis the opportunity to grow and expand its internal pipeline, but it provides for the future success of
mipomersen as Genzyme has worldwide blockbuster capabilities.
Isis recently reported positive phase III results on mipomersen from a study that was conducted in
patients with homozygous familial hypercholesterolemia (hoFH). Isis and Genzyme announced that
the trial met its primary endpoint, with a 25% reduction in LDL cholesterol (LDL-C) after 26 weeks of
treatment, vs. only a 3% reduction for placebo (p<0.001). The study also met each of its three
secondary endpoints of reduction in apolipoprotein B, total cholesterol and non-high density
lipoprotein (HDL) cholesterol (all p<0.001). What is even more encouraging is that all patients were
failing maximally tolerated statins and other lipid-lowering therapies the average LDL-C at baseline
was greater than 400 mg/dL so these reductions were in addition to those achieved with the
patients' existing therapeutic regimen. Data from this phase III study in patients with hoFH will form
the basis of Genzyme's initial regulatory filing for marketing approval, which is anticipated in the
second half of 2010. The European filing is scheduled to take place soon thereafter. According to
Genzyme, about 25,000 to 30,000 patients in the U.S. and Europe would be candidates for the use
of mipomersen with this indication.
Management is testing once weekly doses of the drug, but the potential exists to have bi-weekly
doses in future. This would be a big convenience over once daily statins. We believe mipomersen
has blockbuster potential. Cholesterol lowering agents such as statins are the largest selling
pharmaceutical products in the world. The potential to improve the efficacy of these drugs with more
convenient dosing creates a large and exciting opportunity.
Partnering Opportunities with ISIS-113715: Another important proprietary candidate at Isis is ISIS-
113715, a second generation compound for type II diabetes. ISIS-113715 is an antisense compound
that targets protein tyrosine phosphatase-1B (PTP-1B). PTP-1B is an enzyme that has been shown
to play a key role in reducing the ability of insulin to regulate blood sugar levels by inactivating the
insulin receptor. By knocking out PTP-1B, the body s insulin receptors may stay active longer and
thus allow for more glucose uptake. Similar to mipomersen in hyperlipidemia, this is a completely
new mechanism of action for type II diabetes and allows for the combination of therapy with currently
approved medications such as metformin, glitazones, and sulfonylurea.
In June 2006, Isis reported positive phase II results in patients with type II diabetes treated with ISIS-
113715 as a single-agent. An intent-to-treat analysis of all patients enrolled in the trial treated with
200 mg/wk for three months showed statistically significant improvement in multiple measures of glucose control such as lowering HbA1C levels and fasting glucose levels. Additionally, important
safety data was observed in the trial. ISIS-113715 did not cause hypoglycemia (low blood sugar)
and weight gain and was well tolerated throughout.
Isis recently presented positive top-line results from a phase II study evaluating the safety and
efficacy of ISIS-113715 in patients with type II diabetes on stable doses of sulfonylurea. In addition
to lowering blood glucose, ISIS-113715 caused statistically significant and clinically meaningful
reductions in LDL cholesterol. Importantly, a tendency towards weight loss was observed even in
this short-term study without strict dietary control. ISIS-113715 demonstrated a favorable safety
profile with no exacerbation of sulfonylurea-induced hypoglycemia or other clinically significant
adverse effects.
These positive phase II results should help ISIS-113715 strike a lucrative partnership deal for the
candidate. The company s strategy of striking partnership deals has helped strengthen its financial
position. Given the company s cash balance of $637.5 million as of June 30, 2009, we believe Isis
has enough cash to fund operations for at least the next five years. A partnership deal for ISIS-
113715 would solidify the cash position further.





Bezüglich zu den Satelitte Companies:

Die Antisense-Technologie ist so ziemlich in allen medizinischen Indikationen einsetzbar. Isis kann als kleines Unternehmen mit 300 Mitarbeitern nicht das ganze Spektrum abdecken, deshalb werden Medikamente oder Therapiebereiche die nicht zur Kernkompetenz passen auslizensiert. Isis will in allen Bereichen ein Stück vom Kuchen abhaben. In den letzten Jahren hat Isis durch die "Satelitte Companies" alleine 450 Mio $ an Meilensteinen eingenommen und das ohne Risiko und Kosten.



Grüße cristrader:)
Antwort auf Beitrag Nr.: 38.787.353 von cristrader am 22.01.10 00:50:28ad satellite companies:

mir ist schon klar, was das unternehmen damit bezwecken will. was mir aber nicht gefällt, sind diese eigentümer-verstrickungen.

wenn zb ein unternehmen A von unternehmen B 20% und unternehmen C 50% hält, dann muss ich mir für eine ordentliche analyse alle unternehmen im detail anschauen (sind unternehmen B und C gut geführt? geht alles mit rechten dingen zu?).

reine projektbedingte auslizenzierungsdeals mit upfront/MS/tantieme fänd ich auch ok.
Antwort auf Beitrag Nr.: 38.787.033 von ipollit am 21.01.10 23:21:01also, das haar in der suppe hab ich bei der NGSX-story (noch) nicht gefunden, abgesehen davon, dass man das teil vor nicht all zu langer zeit bei 1 USD bekam...

ein härchen in der suppe gibts aber wohl, was die patentlage betrifft - siehe auszug aus dem research paper:

Intellectual Property & Manufacturing
We think it is important to note that Anesiva (ANSV) is also working on a liquid capsaicin product currently in phase
III trials. However, Anesiva s product, Adlea, is an injection or instilled application, not a topical rub, and designed
for post-surgical applications such as total knee or hip arthroscopy (TKA / THA) and bunionectomy. As of now, the
two companies seem content stay within their respective market. However, the mention of Anesiva s Adlea brings
up an important discussion on intellectual property. NeurogesX licensed method of use patents in the U.S. and
Europe that covers the delivery of high-concentration capsaicin for the treatment of neuropathic pain from the
University of California (Cal). The license with Cal is exclusive to NeurogesX. NeurogesX will owe a 5% royalty to
Cal on all up-front and backend milestones, as well as sales of the product.
There were three inventors of the patent however, two of the three inventors of the patent did not assign the rights
of this patent to Cal, so NeurogesX license is non-exclusive with respect to the use of capsaicin to treat pain.
Anesiva has licensed the rights to this same patent for the development and commercialization of pain, including
injection or infiltration of capsaicin for post-surgical pain, osteoarthritis or interdigital neuroma. Anesiva has also
licensed the rights for use of capsaicin from Dr. Pappagallo for neuropathic pain.


das wäre durchaus nähere recherche wert
Antwort auf Beitrag Nr.: 38.797.282 von PathFinder2 am 23.01.10 12:23:37ich weiß nicht, ob das Patent ein Problem ist... der von dir zitierte Abschnitt geht ja noch etwas weiter. Soweit ich es verstehe, hat NGSX das alleinige Recht, Capsaicin über die Haut anzuwenden, während z.B. das von Anesiva intravenös wäre. Für die Indikationen von Qutenza scheint die direkte Anwendung auf der Haut optimaler zu sein. Im Prinzip ist es ja nur ein Aufkleben einer Art Pflaster unter leichter örtlicher Betäubung für vielleicht eine Stunde... und das bei Bedarf alle 3 Monate, um die Schmerzen dauerhaft zu reduzieren.

Der Research-Report ist ja schon etwas älter... inzwischen ist beispielsweise dieser potentielle Konkurrent Anesiva pleite, was deren Entwicklung von Adlea sicherlich hemmt.

mfg ipollit
Antwort auf Beitrag Nr.: 38.797.282 von PathFinder2 am 23.01.10 12:23:37hier ist auch noch etwas zu den Patenten...

http://www.babybiotechs.com/biotech-investment-reports/ngsx/…

Intellectual Property

Low doses of capsaicin cream have long been used successfully for relief of neuropathic pain. However the first published study to use high doses (5-10%) in combination with regional anesthesia (to numb the normal burning sensation accompanying such high dose) was published in 1998 from UCSF. This study showed that at these levels of capsaicin, 90% of patients (N=10) were relieved from neuropathic pain from 1 to 18 weeks. Interestingly, in 1996, prior to the publication, three of the authors of the study patented the use of high percentage capsaicin with the Regents of the University of California as an assignee on the patent. Subsequently, the first author on the above study, Dr Wendye Robbins, was issued another patent in 1997 (again UC Regents were the assignee) whereby local anesthetic was administered through the use of a transdermal patch containing the high concentration of capsaicin. Dr. Robbins founded NeurogesX in 2000, licensing the patents from the University of California.

That pretty much brings us up to speed on the intellectual property with one final important caveat. The first patent outlining the use of high concentration capsaicin was issued to three authors, and two of the three were not UCSF faculty and so did not assign their patent rights to the University of California. Anesiva, a company focused on the development and commercialization of treatments for pain, including injection or infiltration of a capsaicin derivative for post-surgical pain, osteoarthritis or interdigital neuroma, has licensed from one of the non-assigning inventors the right to use the technology under the method patent.

So NeurogesX has the worldwide exclusive license for a high concentration capsaicin transdermal patch. The use of high-concentration capsaicin itself is not exactly in the public domain but neither does NeurogesX have exclusive worldwide rights. Therefore, it goes without saying any investment in NeurogesX is banking on the utility of the transdermal patch method of capsaicin delivery. As it turns out the only current alternatives to a transdermal patches are a topical creams which of course have the drawback of wildly inaccurate dosing (FDA won’t approve) and injection such as Anesiva is developing for post surgical pain.


mfg ipollit
ipollit, hast du links zu research reports von SGEN und EXEL?
auf welchen sieten suchst du normal?

danke
danke - das heißt für mich auf den ersten blick

Qutenza - gute IP-position

NGX-1998 - kaum IP-schutz

was denkst du?
bei NGSX stellt sich für mich die hauptfrage, zu welchem zeitpunkt von hier weg ein einstieg sinn machen kann.

rein charttechnisch ist der kurs am unteren ende eines trading-bandes zwischen ca. 7 und 9 USD. von demher ganz ok bei ca. 7.

andererseits, zulassung ist geschehen (da hätt man dabei sein müssen vom niedrigen dollarbereich weg...), und jetzt heißt's auf relevante umsätze warten. 2010 wird's da kaum was geben, 2011, 2012...

was denkt ihr?
Antwort auf Beitrag Nr.: 38.797.527 von PathFinder2 am 23.01.10 13:55:32sorry, richtige Research Reports hab ich auch nicht. Nach den meisten Sachen google ich einfach nur.

zu SGEN und EXEL finden sich einige gute Beiträge im Blog von Ohad Hammer... http://www.hammerstockblog.com/

ansonsten lese ich hin und wieder in den Boards...
ihub http://investorshub.advfn.com/boards/board.aspx?board_id=141…
si http://siliconinvestor.advfn.com/forum.aspx?forumid=62
oder die yahoo-Boards. Viel brauchbares lässt sich da allerdings meist nicht finden.

sonst vielleicht noch
http://www.pharmastrategyblog.com/
http://www.fiercebiotech.com/
http://www.thestreet.com/author/1352996/AdamFeuerstein/all.h…

gibt es sonst noch was?

die letzten SGEN und EXEL JPM-Webcasts sind vielleicht auch interessant...
http://metameetings.com/webcasts/jpmorgan/healthcare10/welco…

mfg ipollit
Antwort auf Beitrag Nr.: 38.797.548 von PathFinder2 am 23.01.10 14:00:21NGX-1998 ist zwar flüssig... allerdings ebenfalls nur zur äußeren Anwendung über die Haut. Durch eine bessere Aufnahme soll die Zeit der Anwendung von einer Stunde gesenkt werden.

mfg ipollit
Antwort auf Beitrag Nr.: 38.797.623 von ipollit am 23.01.10 14:33:58danke!

===
übrigens, wirklich interessant waren die aussagen von Exelixis-CEO Scangos auf deren R&D-day Ende letzten Jahres:

"We know that this goal of building a profitable company we may never get to see because other things might happen, if they do, thats fine, right?"
Antwort auf Beitrag Nr.: 38.797.627 von ipollit am 23.01.10 14:36:09aber NGX-1998 hat nix mit dem patch zu tun, oder? von daher meinte ich kaum IP-schutz. oder hab ich das nicht ganz richtig verstanden?
Antwort auf Beitrag Nr.: 38.797.573 von PathFinder2 am 23.01.10 14:09:43
bei NGSX stellt sich für mich die hauptfrage, zu welchem zeitpunkt von hier weg ein einstieg sinn machen kann.


Hi PathFinder und ipollit,

zunächst mal vielen Dank für eure NGSX-Diskussion, die sehr einsichtsvoll war und mich in meiner Positionierung deutlich bestärkt hat. Besonderen Dank an ipollit für das Ausgraben des Research-Reports.

PathFinder, was Deine Frage angeht: Ich muss bei diesem Investment davon ausgehen, dass Qutenza prinzipiell ein Erfolg wird. Das ist zwar nicht sicher, aber wenn ich davon nicht ausgehe, muss ich eh nicht weiter nachdenken. Was hieße Erfolg konkret? Ich würde es als Erfolg verstehen, wenn sie bis 2015 einen Umsatz aus Royalties und Eigenvertrieb in Höhe von 300 Millionen Dollar generieren würden. Bei "üblichen" Margen und Umsatzmultiplen und ansonsten unfallfrei agierendem Management ließe sich daraus meiner Meinung nach in 2015 eine Marktkapitalisierung irgendwo zwischen 500 und 1.000 Milliarden Dollar ableiten, was also ca. Faktor 4 bis 8 wäre.

Weiteres upside bis 2020 dürfte vorhanden sein.

Ich finde das hinreichend, wenn man das relativ(!) begrenzte Risiko mit berücksichtigt.

So in etwa geht meine Investmentidee und natürlich ist das nur eine Meinung.
Antwort auf Beitrag Nr.: 38.799.166 von SLGramann am 24.01.10 09:55:34
500 und 1.000 Milliarden Dollar

Millionen bitte, Millionen ;):laugh:
Antwort auf Beitrag Nr.: 38.799.166 von SLGramann am 24.01.10 09:55:34ja ich finde das risiko auch relativ begrenzt - und trotzdem einiges an upside-potenzial.

wieso NGSX allerdings nicht gleich nach zulassung von Qutenza übernommen wurde, ist mir nicht so recht klar (wäre zb für Astellas mit sicherheit wesentlich günstiger gewesen).

wie ist die IR von NGSX? bekommt man antworten; sind sie bemüht?

was ist eigentlich mit Japan, sind für Qutenza neue studien notwendig, oder werden vorliegende studien (teilweise) anerkannt?
da wir gerade von microcaps sprechen: kennt jemand
http://www.biodeliverysciences.com/
(siehe auch piplinechart)

market cap 80 Mio. USD
Antwort auf Beitrag Nr.: 38.799.377 von PathFinder2 am 24.01.10 11:35:38BioDelivery Sciences (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet needs in the areas of pain management and oncology supportive care. BDSI’s pain franchise currently consists of two products utilizing the Company’s patented BEMA buccal soluble film technology: ONSOLIS (fentanyl buccal soluble film) which was approved by FDA on July 16, 2009, for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain, and BEMA Buprenorphine, an analgesic in Phase 2 clinical development with at least one potential target indication for the treatment of moderate to severe pain. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting and migraine. The Company is also working with its patented Bioral cochleate technology to facilitate oral dosing of drugs otherwise given by intravenous administration. The first product under development using the technology is Bioral Amphotericin B. The Company’s headquarters is located in Raleigh, North Carolina. For more information please visit www.biodeliverysciences.com.
Antwort auf Beitrag Nr.: 38.799.382 von PathFinder2 am 24.01.10 11:37:07präsentation, die einen recht guten überblick gibt:
http://www.biodeliverysciences.com/media/documents/BDSIInves…
Antwort auf Beitrag Nr.: 38.799.377 von PathFinder2 am 24.01.10 11:35:38BDSI kenne ich leider nicht. Wenn ich es aber so überfliege, so geht es ja im Prinzip um eine andere Art der Verabreichung von Medikamenten... z.B. sich so etwas in den Mund zu kleben. D.h. die Medikamente sind nicht von BDSI, sondern von jemand anderen. Dann müssen sie doch bereits generisch sein, wenn BDSI sie für ihr Produkt verwenden will, oder? Sie treten also mit ihren Produkten immer gegen andere etablierte und generische Produkte an mit der Differenzierung einer anderen Art der Verabreichung. Kann man da wirklich vorhersehen, wie der Markt dies dann annimmt? Bei soetwas habe ich ein wenig Bedenken, dass die zwar ihre Produkte auf den Markt bringen, diese sich dann aber kaum verkaufen lassen. Oder verstehe ich da etwas nicht richtig?

mfg ipollit
Antwort auf Beitrag Nr.: 38.656.864 von ipollit am 03.01.10 16:49:57Während im letzten Jahr Dax, Nasdaq usw große Gewinne einbrachten, hat sich mein Biotech-Depot Thread 1147459 leider nur sehr durchwachsen entwickelt, was ein wenig entäuschend ist... am Ende blieb es bei einem kleinen Minus.

also 2009 mit einem minus abzuschliessen find ich schon
extrem sportlich...2009 war ein extrem gutes biotech jahr.

ich hatte einige misstrades im biotechbereich mit rel.
hohem risikopotential, da sollte ich dran
arbeiten:cool:, aber unterm strich war es doch recht
ordentlich in 2009...

damit dein depot mal bessere zeiten sieht:
Labopharm inc. PDUFA date: 11. febr. 2010 - keine kaufempfehlung

aber warum auf irgendwelche p2 daten warten, wenn zulassung
und partner vor der türe stehen;)
Antwort auf Beitrag Nr.: 38.800.235 von Gustl24 am 24.01.10 16:40:32ja... das war extrem sportlich! :laugh: :cool:

dass es so ein extrem gutes Biotech(!)-Jahr war, fand ich eigentlich nicht. Gemessen an dem, was der Nasdaq oder der gewöhnliche Dax gebracht hat, war es alles andere als gut. Und so ein Jahr (der NBI war währungsbereinigt 13% im Plus) kann man halt auch schonmal im Minus abschließen, wenn man z.B. eine Genmab mit 20% bis 25% gewichtet, die dann fast 2/3 abgibt statt ein kleines Plus zu generieren. Und mussten z.B. CBST oder ONXX in einem extrem guten Biotech-Jahr deutlich zweistellig ins Minus gehen? Und auch so große Biotech-Nrn wie eine AMGN, CELG, GILD oder GENZ haben 2009 nichts abgeworfen, teilweise sogar kräftig abgegeben. Wenn man 100% mit einer HGSI oder VNDA dabei war, kann man natürlich immer lachen... aber auch nur hinterher, denn es hätte für diese beiden auch das Aus kommen können. Dieses Hopp oder Top wollte ich eigentlich nicht mehr spielen.

Daher halte ich mich auch bei Labopharm zurück... die Wahrscheinlichkeit einer glatten Zulassung ist im Schnitt normalerweise deutlich geringer als die Ablehnung. Aber dir viel Spaß damit... vielleicht gehörst du ja zu den Glücklichen und hast dann die Rendite für 2010 bereits im Sack.

mfg ipollit
naja... zumindest der Start in dieses Jahr war bisher nicht so schlecht:

(währungsbereinigt auf EUR-Basis und mit aktueller Gewichtung)

+5,7% Depot
+4,1% NBI
-4,4% Dax
+2,1% USD

+25,6% ViroPharma ( 2,5% )
+22,0% Genmab ( 9,2% )
+21,6% Micromet ( 5,9% )
+20,3% Allos ( 6,7% )
+9,7% Regeneron ( 12,4% )
+9,6% Cubist ( 7,5% )
+7,2% Seattle Genetics ( 3,9% )
+6,2% Incyte ( 10,3% )
+5,1% Progenics ( 1,2% )
+3,3% Onyx ( 5,9% )
+2,5% Isis ( 5,2% )
+0,3% NicOx ( 1,7% )
+0,3% Medigene ( 3,4% )
-5,3% NeurogesX ( 3,5% )
-6,0% Rigel ( 5,4% )
-6,2% Arena ( 2,0% )
-6,8% Addex ( 1,1% )
-8,4% Array ( 2,9% )
-8,7% Sucampo ( 0,9% )
-11,6% Exelixis ( 5,2% )
-12,0% ArQule ( 3,1% )

wenn es so weitergehen würde, wäre ich leicht zufrieden - dann wird es hoffentlich nicht ganz so sportlich ausfallen wie letztes Jahr ;)

mfg ipollit
und die Jahres-Charts vielleicht ein wenig schöner als am Anfang vom Thread...























mfg ipollit
Genmab dürfte bald auch die Zulassung von Arzerra gegen CLL in Europa erhalten. Einen großen Einfluss auf den Kurs hat das nicht. Spannender werden die in nächster Zeit erwarteten Zalutumumab PIII-Daten. Offen ist, ob sich Zalutumumab irgendwie von z.B. Erbitux absetzen kann. Die Erwartungen sind eher negativ.

http://www.reuters.com/article/idUSLDE60L0WE20100122

UPDATE 1-Glaxo, Genmab win EU backing for leukaemia drug

* EMEA recommends Arzerra for chronic lymphocytic leukaemia

* Move follows U.S. FDA approval in October

* Genmab shares up 5 pct, Glaxo flat (Updates with details on drug, sales forecast, shares)

LONDON, Jan 22 (Reuters) - GlaxoSmithKline (GSK.L) and Genmab (GEN.CO) won European backing for their leukaemia drug Arzerra on Friday, following a green light for the medicine from U.S. regulators in October.

Arzerra is the first drug to reach the market from the labs of Genmab and shares in the Danish biotech rose 5 percent on the news. Glaxo stock was flat.

The European Medicines Agency said it was recommending Arzerra, or ofatumumab, as a treatment for chronic lymphocytic leukaemia in patients who do not respond to Genzyme's (GENZ.O) Campath or the chemotherapy drug fludarabine.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Glaxo bought global rights to Arzerra in December 2006 in a deal worth up to $2.1 billion, a record sum for a biotech product agreement at the time.

The world's second biggest drugmaker is also banking on Arzerra working in other diseases beyond CLL.

But hopes for its use in patients with another blood cancer called non-Hodgkin's lymphoma (NHL) were dealt a blow in August when it failed to help patients as much as expected in a clinical trial.

Current consensus analyst forecasts for Arzerra, which is also being developed for rheumatoid arthritis, suggests annual sales will reach $465 million in 2013, according to Thomson Pharma.

Genmab and Glaxo aim to position Arzerra as a rival to Roche (ROG.VX) and Biogen Idec's (BIIB.O) blockbuster treatment Rituxan. Both Arzerra and Rixtuxan belong to a class of medicines known as anti-CD20 antibodies.


mfg ipollit
Genmabs Arzerra ist übrigens mit ca. 100.000 USD pro Behandlungszyklus von 6 Monaten extrem teuer. Entsprechendes gilt auch für Allos Folotyn. Ein wenig liegt es daran, dass die Patientengruppe jeweils relativ klein ist und es keine Alternativen gibt. Irgendwann wird sich aber auch die Frage stellen, ob das ganze noch bezahlbar ist... ich denke aber, dass der Preis automatisch sinkt, wenn diese Therapien breiter eingesetzt werden.

http://www.nytimes.com/2009/12/05/health/05drug.html?pagewan…

Questioning a $30,000-a-Month Cancer Drug

Published: December 4, 2009

A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs.

The price of the new drug, called Folotyn, is at least triple that of other drugs that critics have said are too expensive for the benefits they offer to patients. The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer. The price of Folotyn “seems way higher than I heard of before,” Robert L. Erwin, president of the Marti Nelson Cancer Foundation, a patient advocacy group. “I can’t imagine there not being a backlash against the pricing.”

Drug makers in general have been raising prices sharply in advance of the possible passage of health care overhaul legislation, according to various studies. But the price of cancer drugs has been an issue for several years.

Critics, including many oncologists, say that patients and the health system cannot afford to pay huge prices for drugs that, on average, provide only a few extra months of life at best.

And Folotyn has not even been shown to prolong lives — only to shrink tumors. The drug was approved by the Food and Drug Administration in late September as a treatment for peripheral T-cell lymphoma, a rare and usually aggressive blood cancer that strikes an estimated 5,600 Americans each year. It is available for sale, but its manufacturer, Allos Therapeutics, does not plan to start actively promoting it until January.

Allos defends the price, saying it made a significant investment to develop the first approved drug for this type of cancer.

“It’s a very aggressive disease, and patients right now have no options,” said James V. Caruso, the chief commercial officer for Allos, a 17-year-old publicly traded company based in Westminster, Colo., that has no other drugs on the market.

Mr. Caruso also said the price of Folotyn was not out of line with that of other drugs for rare cancers. Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said. So the total cost of using Folotyn will be less than for many other drugs with lower monthly prices.

“We believe we are fairly priced,” he added, “and we’re benchmarked” against other drugs. In a conference call with analysts last month, Mr. Caruso said Allos had “not had pushback of any type at this point” from insurers.

Some drugs for rare cancers are close to Foltyn’s price. Genzyme’s Clolar for pediatric leukemia costs about $34,000 a week, though the company says that only two weeks of treatment are typically needed. Genzyme’s drug Campath, for chronic lymphocytic leukemia, costs about $5,000 a week for several weeks.

GlaxoSmithKline is charging up to $98,000 for a six-month treatment course of Arzerra, a drug approved in late October for chronic lymphocytic leukemia, which strikes about 15,000 Americans a year. About $60,000 of the cost would be incurred in the first eight weeks, when the drug is given more frequently.

Gloucester Pharmaceuticals, which won approval in November for a drug to treat cutaneous T-cell lymphoma, another rare cancer, declined to discuss what it would charge when that treatment, called Istodax, goes on sale in January.

Despite such comparisons, Dr. Lee N. Newcomer, senior vice president for oncology at the big insurer UnitedHealthcare, called the price of Folotyn “unconscionable.” He said that Folotyn alone would cost as much as UnitedHealthcare now typically spends in total to treat a lymphoma patient from diagnosis until death. That median expenditure now, he said, is $87,000 for a little over a year of treatments.

But Dr. Newcomer said insurers would be obligated to pay for Folotyn because there were no alternatives.

Folotyn has not yet shown an effect on longevity. In the clinical trial that led to approval of the drug, 27 percent of the 109 patients experienced a reduction in tumor size. The reductions lasted a median of 9.4 months.

But considering all the patients in the trial, only 12 percent had a reduction in tumor size that lasted for more than 14 weeks. The trial did not compare Folotyn to another drug or a placebo.

“This drug is not a home run,” Dr. Brad S. Kahl, a lymphoma specialist at the University of Wisconsin, said during a meeting of an advisory committee to the F.D.A. on Sept. 2. “It’s not even a double. It’s a single.”

Saying that even a single was helpful, Dr. Kahl was part of a majority on the panel that recommended approval of the drug, 10 to 4.

But after recently learning what Allos planned to charge for Folotyn, Dr. Kahl said he was “disappointed” by the “excessive” price.

“It dampens my enthusiasm for using that drug,” he said. “It creates these huge ethical quandaries about trying a drug that has a modest benefit for the average patient at enormous expense.”

Folotyn is given by a rapid intravenous procedure once a week for six weeks out of every seven. Even to try the drug for the first seven-week cycle to see if it works would cost over $50,000. In the clinical trial, the median duration of use was 70 days, which would cost roughly $70,000 to $80,000. But some patients used the drug for many months.

In a note to clients in October, Joshua Schimmer, an analyst at Leerink Swann, estimated that a typical treatment would last 3.5 months and cost $126,000, or about $36,000 a month.

For investors, a high price is usually a good thing. Mr. Schimmer’s note was entitled “Folotyn Prices High, Reiterate Outperform.” He estimated annual sales of the drug in the United States reaching about $300 million by 2014.


Patient advocacy groups say that while they wish prices were lower, high prices might be needed to encourage companies to develop new drugs.

“It’s a two-edged sword that we have to live with and deal with,” said Louis J. DeGennaro, chief scientific officer of the Leukemia and Lymphoma Society, which has received donations from Allos and other companies. “A peripheral T-cell lymphoma patient,” he said, “at first blush will see this therapy as a very good thing.”

Allos, which is still unprofitable, has lost $350 million since its founding in 1992 and failed to win approval of a previous drug.

“Every dime that goes into the company supports Folotyn,” Mr. Caruso said.

At the time Folotyn was approved in September, stock in Allos briefly peaked above $8.50 but has slipped since then, closing up 16 cents at $6.62, or an increase of nearly 2.5 percent, on Friday.

After the approval, Allos raised $93 million in a secondary stock offering. In the prospectus for that offering, the company said that one of the risks for investors was “the relative price of Folotyn as compared to alternate treatment options.” It said there was a risk it might have to lower the price or offer discounts to successfully market Folotyn.

Like many other companies with high-priced drugs, Allos has established a program to help patients arrange insurance reimbursement. It says it will give the drug free to uninsured patients who cannot pay for it any other way.

And because a patient’s out-of-pocket co-payments alone — Medicare’s is 20 percent — could be thousands of dollars a month for Folotyn, Allos is financing a co-payment assistance program run by the National Organization for Rare Disorders, a patient advocacy group.

While this helps patients, it also helps the company sell more of its drug. If the 20 percent Medicare co-payment is made, then Medicare will pay the other 80 percent of the drug’s price — or about $24,000 a month.


mfg ipollit
Antwort auf Beitrag Nr.: 38.679.580 von ipollit am 06.01.10 22:31:19nochmals zu mologen: die kursentwicklung nach der bekanntgabe der erfolgreich plazierten ke ist beeindruckend.
ich bin bei inlands biotechwerten bei mologen wilex und 4 sc investiert.
Antwort auf Beitrag Nr.: 38.800.950 von pokemon am 24.01.10 20:01:42
Kurzfristige Kursentwicklungen sind irrelevant. Bei Biotechs schon gar.

Wie bist Du auf Mologen gekommen? Hast Du bspw. eine Interpretation folgender Aussage:

"Die im Rahmen der aktuellen klinischen Studie der Phase 1b durchgeführte vorläufige Bewertung der Wirksamkeit sowie das positive Sicherheitsprofil lassen das hohe Potenzial von MGN1703 erkennen. Selbst bei Patienten mit weit fortgeschrittenen metasta­sierten Tumor-Erkrankungen, wie sie für die Phase 1b Studie ausgewählt wurden, konnte zumindest eine Stabilisierung der Erkrankung erreicht werden. Insgesamt wurden 15 Patienten in verschiedenen Dosierungs­gruppen über einen Zeitraum von 6 Wochen mit MGN1703 behandelt.

Bei sechs Patienten wurde nach Abschluss der 6-wöchigen Therapie ein stabiler Erkrankungs­zustand festgestellt. Zudem zeigten bislang zwei Patienten dieser sechs Patienten auch nach 12 Wochen Behand­lungsdauer einen stabilen Krankheitsverlauf."


Ich kann das nicht interpretieren, weil ich ein Laie bin, aber es liest sich zunächst nicht so wahnsinnig aufregend. Eine stable disease von 40% nach 6 Wochen bzw. 13% nach 12 Wochen dürfte doch mehr oder weniger im Rahmen des "normalen" Krankheitsverlaufs liegen. Das sage ich jetzt allerdings mit ganz großem Vorbehalt, weil mir da die wirklichen Kenntnisse fehlen.

Auf die Schnelle war bspw. das zu finden:

"Beim ersten planmäßigen Arztbesuch (Woche 8) betrug die
progressionsfreie Überlebensrate 45,5% bei Vectibix plus BSC (BSC = Best Supportive Care, ohne Chemotherapie) und 24,6% bei alleiniger BSC; ein Unterschied von 20,9% (95% KI: 12,4; 29,4). Es wurde kein Unterschied im Gesamtüberleben
beobachtet."

oder das:

"Eine retrospektive Analyse zeigte, dass das progressionsfreie Überleben bei Patienten mit nicht-mutiertem KRAS-Gen unter Panitumumab durchschnittlich bei 12,3 Wochen lag, im Vergleich zu 7,3 Wochen bei alleiniger BSC. Patienten mit KRAS-Mutationen hatten keinen Vorteil von der Antikörpertherapie."


Vectibix gilt offensichtlich nicht gerade als Erfolg, hat aber bessere Daten als der Kandidat von Mologen gezeigt. PFS nach 12 Wochen lag bspw. bei über 40%.

Siehe dazu hier auf Seite 10:

http://www.ema.europa.eu/humandocs/PDFs/EPAR/vectibix/H-741-…


Jetzt will ich mal die Daten dieser 15-Patienten-1b-Studie nicht überbewerten. Allein da Prozente auszurechnen ist schon etwas komisch. Aber so richtig positiv liest sich das für mich nicht.

Oder sehe ich das falsch, was sehr gut sein kann? Dann bitte ich um Richtigstellung.
ISIS - Barclays assessment:

ISIS Pharmaceuticals
Key Issues
"Mipomersen opportunity in homozygous FH - positive phase III data establish statistically significant 25% LDL reduction in most difficult to treat population failing statins and multi-drug combinations. Liver enzyme elevations without bilirubin rise is acceptable in very high risk population. Unmet need should support approval. Actual clinical use by lipidologists and reimbursement by payers unlikely to be constrained
by genotype and more likely to follow phenotype and actual CV risk.
Additional phase III data in heterozygous FH and high risk populations should be even better - LDL reduction with mipomersen in phase II was greatest in patients with lower baseline LDL levels. Responsiveness of HeFH and high risk patients to ApoB100 inhibition is greater than for HoFH patients and expect more significant LDL reductions in upcoming phase III trials
Theoretical concerns regarding fatty liver with mipomersen appear overdone - initial liver imaging study suggests no excess
accumulation of liver fat. Preclinical primate models suggest actual regression of fatty liver. Alternate pathways for lipid oxidation activated along with ApoB100 inhibition. No Hy's law criteria met in very sick HoFH patients in phase III. Further liver imaging data expected in 2010
and should better establish liver safety profile.
Antisense Platform Supports Substantial Pipeline opportunity – Complete ownership of antisense platform and royalty rights to RNAi therapeutics should support platform beyond $1.1B purchase price for 2nd tier RNAi player SIRNA by Merck. Phase II PTP-1B inhibitor ISIS- 113715 for type II diabetes has demonstrated statistically significant reductions in fasting blood sugar (FBS), weekly average fasting blood
sugar, glycated albumin and modest weight loss over a short period of 13 weeks with 6 weeks required to achieve steady state drug levels.
Phase III clusterin inhibitor OGX-011 has demonstrated a clinically meaningful 6.9 month improvement in overall survival (OS) in a randomized phase II study in castrate resistant prostate cancer (CRPC) with 39% reduction in risk of death (HR=0.61). Feedback on OGX- 011 from prostate CA experts has been highly positive. Phase II VLA-4 inhibitor ATL1102 has demonstrated Tysabri-like efficacy in RRMS.
Survivin inhibitor LY2181308 could yield phase II data in leukemia for partner LLY in 2010."

The stock has not recovered from the drop when the hoFH results were released, but that should change when heFH results are reported in 1st qtr.

Grüße cristrader
Antwort auf Beitrag Nr.: 38.801.191 von SLGramann am 24.01.10 21:06:57wenn ich das richtig verstanden habe, waren die patienten bei der mologen studie austherapiert, d.h. sämtliche bestehenden möglichkeiten der behandlung halfen nicht mehr. da sind diese ergebnisse doch ausser gewöhnlich gut. oder? wird das bestätigt in der phase II, so hat das medikament großes potential? habe ich da einen denkfehler?

war das bei den erwähnten bsp. auch solche patienten, für die es keine behandlungsmöglichkeit mehr gab?
Vectibix ist als Monotherapie indiziert zur Behandlung des metastasierten, EGFR-exprimierenden, kolorektalen Karzinoms mit nicht-mutiertem (Wildtyp-) KRAS-Gen bei Patienten, bei denen Fluoropyrimidin-, Oxaliplatin- und Irinotecan-haltige Chemotherapieregime versagt haben.

In der bescheibung wird auch von massiven nebenwirkungen gewarnt. das mgn1703 ist laut ad hoc nebenwirkungsfrei.


beide produkte sind aber auch ganz unterschiedlich im ansatz.
im gegensatz zu dem antikörper ist das mgn1703 ein dna basierter wirkstoff im bereich der tlr9 therapeutik.
siehe dazu mologen.com
Antwort auf Beitrag Nr.: 38.801.475 von pokemon am 24.01.10 22:42:42"mgn1703 ist laut ad hoc nebenwirkungsfrei"

es gibt kein Medikament ohne Nebenwirkungen... selbst Placebos haben Nebenwirkungen. Die Nebenwirkung kommt automatisch mit der Wirkung... keine Nebenwirkung bedeutet eigentlich auch keine Wirkung. Aber vielleicht meinst du keine gravierende Nebenwirkung.

mfg ipollit
Antwort auf Beitrag Nr.: 38.801.475 von pokemon am 24.01.10 22:42:42
beide produkte sind aber auch ganz unterschiedlich im ansatz.


Ich weiß. Mir ging es um die Frage, ob die bekannt gegebenen stable disease-Daten wirklich ein brauchbarer Hinweis auf Wirksamkeit sind. Ich habe da Zweifel, kann es aber letztlich nicht beurteilen. Deshalb war die Frage, ob Du zu diesem Punkt Einschätzungen hast oder kennst, die nicht vom Unternehmen stammen.

Aber immerhin wird es ja in ca. einem Jahr bereits Zwischendaten der P II geben. Ich bin sehr skeptisch, Du bist optimistisch. Ahnung haben wir - unterstelle ich mal - beide nicht wirklich. Warten wirs einfach bis dahin ab. ;)
seit langem habe ich NeuroSearch auf meiner Watchliste... jetzt versuche ich es mal mit einer kleinen Position. REGN habe ich dagegen leicht reduziert.

Die NeuroSearch Position ist recht spekulativ und riskant... in Kürze stehen die ersten PIII-Daten zu Huntexil (ACR16) gegen Huntington an. Huntexil sieht eigentlich recht vielversprechend aus, weshalb ich mal auf positive Daten setze... im negativen Fall ist der Schaden einigermaßen begrenzt. Bisher gibt es nichts derartiges bei Huntington, eine Erkrankung, die schwerwiegend und eher selten ist mit jeweils ca. 35.000 Patienten in Europa und den USA. Die PII sah gut aus und das Mittel basiert immerhin auf der Arbeit des Nobelpreis-Trägers Arvid Carlsson (aus der Übernahme von Carlsson Research).




http://www.jyskebank.dk/_Jb/ASP/Apps/redirect.asp?ShadowID=2…

Huntexil bodes well

We expect that NeuroSearch will publish results from the MermaiHD and HART studies in the course of 2010, and the first results from the six-monthly blinded treatment process under the MermaiHD study are anticipated in early 2010. The results from the HART study are expected to be accessible around mid-2010 and will be followed by the results from the six-month extension study to MermaiHD. In previous clinical studies, Huntexil has shown promising effects against a number of serious symptoms associated with Huntington's disease. Particularly, improvement has been seen in connection with patients’ ability to perform voluntary movements and of their way of walking so they do not experience as many incidents of falling, resulting in improved functionality and quality of life. In phase II, Huntexil managed to demonstrate significant improvement of the voluntary movement by -2.8 points measured as a change from the baseline in modified Motor Score (mMS) against -0.8 point for the placebo group. Also, in phase II, Huntexil demonstrated a significant effect on soft parameters such as depression and anxiety. If NeuroSearch is able to repeat the same effect in the MermaiHD study, the primary endpoint will be reached, and this will pave the way for a product launch in 2011.
...

The disease occurs at a rate of about one in every 10,000 of European descent, and therefore it is estimated that the total number of patients with Huntington’s disease in North America amounts to about 34,000 and in Europe to about 37,000. We estimate that about 33.3% of these will experience a mild degree of the disease, 33.3% a moderate degree and 33.3% a severe degree of the disease, and therefore they will be difficult to treat. We assess that only patients with a mild and moderate degree of the disease will benefit from treatment with Huntexil, i.e. two out of three patients. This results in a total target group of 47,333 patients of which 22,668 are in North America and 24,665 in Europe.
...


mfg ipollit
Antwort auf Beitrag Nr.: 38.800.415 von ipollit am 24.01.10 17:39:17würde an deiner stelle schnell mal die medigene gegen mologen umstauschen.

medigene wird den tec dax bald verlassen müssen, mologen wird bald im tech dax sein dürfen!
SCHAU DIR DEN TREND AN!!

schau dir nur mal beide charts an!
1 jahr und
5 jahre

mologen war vor 5 jahren bei 3! jetzt 9!
medigene war vor 5 jahren bei über 11! und jetzt bei unter 4!

mologen war vor einem jahr bei 6 jetzt bei 9!!!!!!
medigene war vor einem jahr bei 4,2 jetzt bei 3,8!!!!!!

Börsenkapitalisierung bei Mologen knapp 100 mio
Börsenwert bei Medigene knapp 130 mio

was meinst du?
Antwort auf Beitrag Nr.: 38.818.463 von ipollit am 26.01.10 23:14:03http://www.investindk.com/visNyhed.asp?artikelID=22787

NeuroSearch prepares to manufacture and sell its first drug
(2009.10.21)

Danish biopharmaceutical company NeuroSearch is changing its business to handle production and sales of its first drug Huntexil
Danish biopharmaceutical company NeuroSearch is changing its business to handle production and sales of its first drug Huntexil, which is currently in phase III development, reports financial daily newspaper Børsen. Huntexil is for the treatment of Huntington's disease, a neurodegenerative genetic disorder that affects muscle coordination and cognitive functions. NeuroSearch expects the final approval of the drug to be given in about one year.

Carsten Lønborg Madsen, analyst at investment bank Carnegie comments: "It is a very interesting drug which has the potential to make a transformation of NeuroSearch, but one should not underestimate the risk in late stage studies of diseases in the central nervous system. There are still some obstacles that need to be cleared."

CEO of NeuroSearch Flemming Pedersen says that forecasts from analysts indicate the market value of Huntexil to be around DKK 5bn (USD 1bn). The company will need between 30 and 50 sales representatives to cover both the European and the US markets. Pedersen expects sales of the drug to quickly reach its maximum potential since doctors and patients are showing great interest in the drug.

Huntexil was adopted into the pipeline a few years ago in association with a company acquisition. When the final stages have been completed, NeuroSearch will have invested approx. DKK 500m (USD 100m) in the drug.

Headquartered in Ballerup on the outskirts of Copenhagen, NeuroSearch’s core business covers the development of novel drugs, based on a discovery platform focusing on ion channels and CNS disorders. A substantial share of the activities is partner-financed through strategic alliances with Eli Lilly and Company, Janssen Pharmaceutica and GlaxoSmithKline (GSK), and a license collaboration with Abbott. The company is listed on Nasdaq OMX Copenhagen and has approximately 220 employees.


mfg ipollit
Antwort auf Beitrag Nr.: 38.826.700 von MrRipley am 27.01.10 21:36:48Repros? Sorry, kenne ich nicht. Die sind zwar heute ziemlich gestiegen, aber von der MK mit 23 Mio und dem Cash mit 2 Mio USD (wenn das richtig ist) sehr klein. Bei dieser Größe kann es natürlich spekulativ zu großen Kursbewegungen kommen, aber dazu braucht es schon recht viel Glück, denke ich. Genauso gut können da in absehbarer Zeit die Lichter ausgehen. Aber im Prinzip kann ich nichts dazu sagen, da ich den Wert wie gesagt nicht kenne.

mfg ipollit
die 26 Neuzulassungen der FDA in 2009...

http://www.fiercebiotech.com/slideshows/fda-approvals-2009

1. Savella - Forest Labs
2. Uloric - Takeda
3. Afinitor - Novartis
4. Coartem - Novartis
5. Ulesfia - Sciele Pharma
6. Simponi - Johnson & Johnson
7. Dysport - Ipsen, Medicis
8. Fanapt - Vanda Pharma
9. Samsca - Otsuka Pharma
10. Besivance - Bausch & Lomb
11. Ilaris - Novartis
12. Multaq - Sanofi-Aventis
13. Effient - Eli Lilly, Daiichi Sankyo
14. Onglyza - AstraZeneca, BMS
15. Livalo - Kowa Research
16. Saphris - Merck's Organon USA
17. Extavia - Novartis
18. Sabril - Lundbeck
19. Bepreve - Ista Pharma
20. Vibativ - Theravance, Astellas
21. Folotyn - Allos Therapeutics
22. Stelara - Johnson & Johnson
23. Votrient - GSK
24. Arzerra - GSK
25. Istodax - Gloucester Pharma
26. Kalbitor - Dyax Corp

zwei davon sind hier direkt relevant... Folotyn von Allos und Arzerra von Genmab



Drug: Folotyn
Indication: Relapsed peripheral T-cell lymphoma
Company: Allos Therapeutics
Date Approved: Sept. 24

Scoop: Folotyn is the first and only drug approved for PTCL, a rare form of blood cancer that has a poor prognosis and a high relapse rate. An expert panel backed the treatment despite questions about the drugmaker's clinical data and the safety profile. Allos has faced some criticism of the drug due to it's $30,000-per-month price tag, but the company says it's priced similarly to other rare disease drugs and adds that patients only receive Folotyn for a few months.



Drug: Arzerra
Indication: chronic lymphocytic leukemia
Company: GlaxoSmithKline
Date Approved: Oct. 26

Scoop: Arzerra is designed to attach to the CD20 molecule found on B cells, which are vulnerable to leukemia. It flags the cells for destruction, much like Rituxan does, though it uses a different mechanism. Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin's lymphoma, but produced underwhelming results for that indication. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.

und zwei weitere sind indirekt relevant... Ilaris wurde zusammen mit REGN entwickelt... REGN erhält Royalties. Und CBST besitzt die Rechte zur Entwicklkung von Kalbitor gegen Blutungen.



Drug: Ilaris (canakinumab)
Indication: CAPS
Company: Novartis
Approval Date: June 17

Scoop: The FDA approved Ilaris for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders, last June. Only 300 cases of CAPS have been diagnosed in the U.S., but there are potentially many more undiagnosed patients with the condition due to poor disease recognition. The approval marks one of the first solid commercial successes for CEO Daniel Vasella's long quest to overhaul the pharma company's pipeline.




Drug: Kalbitor (ecallantide)
Indication: Sudden attacks of hereditary angioedema
Companies: Dyax
Approval Date: Nov. 27

Scoop: Last November the FDA approved Kalbitor for patients with hereditary angioedema, a rare and often lethal genetic disease characterized by pain and swelling in the face, lungs and upper airway. The approval marked a big win for Dyax, which has gone $335 million in the red as it pursued clinical development work. Kalbitor will be the 14-year-old biotech company's first marketed therapy. Dyax also licenses out its phage display technology to researchers.

mfg ipollit
ein paar infos rund um den SGEN/Millenium-deal für brentuximab-v.

Millennium, In a New Role, Flexes Global Muscle to Cut Deal With Seattle Genetics
http://www.xconomy.com/boston/2010/01/26/millennium-in-a-new…
ARNA... trotz der nur schwachen Einzel-Wirkung könnte der Pluspunkt von Lorcaserin das niedrige Risiko von Nebenwirkungen und die relativ große Datenmenge aus der PIII sein. Bei einer Zulassung dürfte hier mittelfristig auch die klassische Fen-Phen Kombi - also Locaserin+Phentermine ausprobiert werden, die vielleicht dann auch zu einer höheren Effektivität führt.

http://www.signonsandiego.com/news/2010/jan/31/dash-for-diet…

Dash for diet drug

If the FDA approves, three biotech firms — two in San Diego — say they will change how obesity is treated
By Thomas Kupper, UNION-TRIBUNE STAFF WRITER

Sunday, January 31, 2010 at 1:04 a.m.

For decades, the pharmaceutical industry has chased an elusive target, a drug that will make you lose weight without putting your health at risk.

For a brief period in the 1990s, the two-drug combo known as Fen-phen achieved blockbuster status — before potentially fatal side effects knocked it off the market. More recently, the risk-benefit profile of the leading diet drug Meridia has come under scrutiny, with European authorities deciding to ban it this month.

Now, three California biotechnology companies are trying to convince the U.S. Food and Drug Administration that they’ve found drugs that are effective and safe. Not only that, they say the drugs can help with conditions that often accompany obesity, such as high cholesterol or blood pressure.

If the companies are right, it could bring about a sweeping change in the treatment of obesity while also bringing in blockbuster profits for the companies — San Diego’s Arena Pharmaceuticals and Orexigen Therapeutics, along with Vivus in the San Francisco Bay Area.

“The stage is set for obesity, to finally make some paradigm changes in the way the condition is thought about and treated,” said Michael Narachi, chief executive of Orexigen.

Narachi pointed to new drugs that have dramatically improved the treatment of conditions like high cholesterol or hypertension while creating multibillion-dollar markets for drug companies. Obesity, he said, offers the same kind of potential for advance.

Nothing will alter the traditional prescription for weight loss — diet and exercise. But the companies say their drugs could give physicians an additional tool to treat excess weight as a medical condition with potentially serious consequences.

All three announced study data last year that showed significant numbers of patients losing 5 percent or more of their weight. Arena and Vivus have since filed with the FDA for clearance to sell their drugs, while Orexigen says it will do so in the coming months.

Donna Ryan, a researcher who leads the Obesity Society in Maryland, said the data suggest all three are effective enough to win the FDA’s blessing when it rules late this year or in 2011. Ryan said safety, the other factor the agency looks at, is harder to judge.

While there are a few drugs doctors prescribe for weight loss, Ryan said it is important to have new options that might prove more effective.

“It’s a great thing,” Ryan said of the potential for multiple drugs to win approval. “In terms of what tools physicians have to manage weight loss, we haven’t gotten any drugs out to help us in a decade.”

Of the three drugs, the only truly new one comes from Arena. Its approach was to design a drug, known as lorcaserin, that would hit the same molecular “receptor” the fenfluramine component of Fen-phen targeted for weight loss, without hitting other receptors that caused side effects.

The other two companies have combination drugs. Orexigen’s Contrave combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained-release version of naltrexone, which is used to treat alcoholism and other addictions.

Vivus’ Qnexa combines a generic form of the appetite suppressant phentermine, the other component of Fen-phen, with the anticonvulsant drug topiramate.

Other companies, including San Diego’s Amylin Pharmaceuticals, have weight-loss drugs in earlier stages of development. Orexigen also has a second drug in development.

With two-thirds of Americans qualifying as overweight, according to the Obesity Society, there appears to be room for multiple drugs in the market.

“There’s room for 13, or 30, new drugs,” Arena chief executive Jack Lief said. “I’d like to see all three of them be approved, because I think that will open up the market very significantly. Patients will go to their physicians and want to do something about their weight.”

Ted Tenthoff, a biotech analyst who follows Arena for investment bank Piper Jaffray & Co., said the drugs could end up addressing distinct segments of the market.

Tenthoff said Vivus’ Qnexa, which showed the most dramatic weight loss in trials, would likely would end up being prescribed for the heaviest patients — though the company also has lower-dose formulations it says will address a broad range of patients.

Tenthoff said a better safety profile could provide a niche for Arena’s lorcaserin with less-obese patients, despite the drug’s weaker data on weight loss. The company believes this also could make it the drug doctors try first.

Orexigen, whose drug Tenthoff described as falling somewhere between the other two, plays up Contrave’s potential to help patients with other conditions that often accompany obesity. For example, Narachi said one-third of obesity patients also suffer from depression and therefore might want a weight-loss drug that includes an antidepressant.

Many patients also might try more than one approach.

“What typically happens in markets like this is that there’s quite a bit of churn,” Narachi said. “There might be somebody who tries a product and decides to stop, either because it’s not effective for them or because some patients are more sensitive to certain tolerability aspects than others. Or people may lose a certain amount of weight on one product and then switch to another one and see if they can lose a little bit more.”

As the FDA considers whether to approve the drugs, a big question is likely to be safety. Past problems with obesity drugs could be one reason investors have been slow to embrace the three companies’ stocks, all of which trade in single digits.

Inevitably, regulators will think back to the Fen-phen fiasco, which led drugmaker Wyeth to set aside $21 billion to resolve litigation related to Fen-phen’s links to heart damage and lung disease.

Tenthoff said more recent experience with Meridia could make the FDA that much more conservative. Data that linked that drug to strokes, heart attacks and other cardiovascular problems led European regulators to suspend sales of the drug this month while the FDA asked for a stronger warning label.

“These drugs are going to be used in millions of patients,” Tenthoff said. “That is going to be on the mind of the FDA.”

Questions about safety also could make some patients hesitant, even if the FDA approves all three drugs.

The companies point to substantial pent-up demand in the market, given the lack of new weight-loss drugs in recent years. When Fen-phen was on the market, prescriptions tripled in one year to hit 20.6 million in 1996.

Right now, a major activity for all three companies is seeking large pharmaceutical company partners with sales forces to help market the drugs if they get on the market. Narachi said multiple potential product launches around the same time also could help speed acceptance.

“There will be three companies, perhaps with three partners, all trying to convince people that pharmacotherapy approaches should be more heavily considered as a treatment for obesity,” Narachi said.

The Obesity Society’s Ryan said doctors and patients are eager for new tools.

“They are clamoring for aids to help with their patients,” Ryan said. “Just telling people to eat less and exercise more is not going to slow the obesity epidemic.”


mfg ipollit
Hi ipollit

Ich sehe du hast hauptsächlich nur Mid-Large Caps Biotechs im Depot du solltest auch mal in Kleine Unternehmen investieren da steckt das große geld .
Antwort auf Beitrag Nr.: 38.850.447 von BrauchGeld am 31.01.10 12:30:58Mid-Large Caps? Was verstehst du darunter. Ich denke, ich habe quer von allem etwas zwischen Mid- und Smallcaps. Aber warum soll die größe des Unternehmens etwas mit den Erfolg der Anlage zutun haben? Je kleiner das Unternehmen, umso riskanter ist es in der Regel, da es einfach nicht so breit aufgestellt sein kann und auch nicht soviel Geld zur Verfügung hat, um etwas zu bewegen. Bei den Positionen in meinem Depot ist es eher so, dass die Erfolgreichen steigen und damit teuer aussehen und die Flops fallen und damit billig aussehen. Zum Beispiel eine Addex muss wieder ganz neu beginnen... das spiegelt sich in der niedrigen Bewertung wieder und man sollte dies nicht mit "billig" oder "preiswert" verwechseln. Ich fand die Mittelgroßen bisher jedenfalls nicht schlecht.

die MKs in Mio USD...

2.150 Regeneron
1.799 Onyx
1.270 Incyte
1.190 Cubist
1.100 Isis
1.040 Seattle Genetics
825 Genmab
765 ViroPharma
755 Allos
712 Exelixis
565 NicOx
536 Micromet
425 Rigel
378 NeuroSearch
289 Arena
178 Medigene
151 Sucampo
144 ArQule
142 Progenics
125 NeurogesX
118 Array
69 Addex

mfg ipollit
Was haltet ihr von ISIS?
Die zweite Generation von Antisensemolekülen scheint zu funktionieren!?! Oder?
zu CBST...

http://www.xconomy.com/boston/2010/01/25/cubist-maintains-gr…

Cubist Maintains Growth Streak, As Investors Fear Generic Threat, Thin Pipeline

Ryan McBride 1/25/10

Cubist Pharmaceuticals has grown into one of the big success stories in biotech industry of the past few years, based almost entirely on the sales of a single product. The Lexington, MA-based company’s big hit is an intravenous antibiotic for deadly infections called daptomycin (Cubicin). Even though this has propelled Cubist into profitable territory, the company’s (NASDAQ:CBST) stock price has been flat for more than four years amid concerns on Wall Street about potential threats to its antibiotics franchise.

Last week, I visited the company’s headquarters and met with CEO Michael Bonney and discussed the successes and challenges he faces at Cubist. This month the company announced 2009 revenue of $562.1 million, a 30-percent jump from the year before. Revenues have grown rapidly every year since the market debut of daptomycin in 2003. But Bonney was clear that the company doesn’t plan to rest on its laurels, and the firm is taking more aggressive measures than in previous years to bring a second commercial product to market. (The company also sells an antibiotic called meropenem on behalf of AstraZeneca in the U.S., but that agreement brought Cubist only $22.5 million in revenue last year.)

Indeed, analysts have criticized the company’s lack of an encore to its success with daptomycin. Bonney acknowledged that the company’s critics have a point, and that he’s tackling it now.

“I think we could have been a little more aggressive at pipeline building earlier than we started to,” Bonney said. “It’s always a fine balancing act between [profitability] and how much you are going to spend, and there’s no formula that I’ve found in any textbook that says this is how you do it. But I do think, with the benefit of hindsight, that is something we could have done differently.”

Cubist has more than just its pipeline to worry about. It generates 93 percent of its revenue from daptomycin, a compound used in hospitals to treat lethal MRSA (Methicillin-resistant Staphylococcus aureus) infections and other bugs. And while analysts say daptomycin has potential to reach $1 billion in peak annual sales, that is no sure thing. Generic drug maker Teva Pharmaceutical has plans to market a cheaper generic copy of the drug before Cubist’s patents for the product expire between 2016 and 2019. Cubist plans to prove in its pending lawsuit against Teva that its patents protect its lead antibiotic from generic competition.

Cubist’s problem isn’t exactly unique in the biotech game; there are a number of mid-sized drug developers whose success hinges largely on one product. A couple of those companies include Cheshire, CT-based Alexion Pharmaceuticals (NASDAQ:ALXN), which gets all of its sales revenue from one product, eculizumab (Soliris), a treatment for a rare blood disorder called paroxysmal nocturnal hemoglobinuria, as well as Emeryville, CA-based Onyx Pharmaceuticals (NASDAQ:ONXX), which has an anti-tumor drug called sorafenib (Nexavar) that it develops and markets with the help of Bayer .

Though Cubist may not have another drug in its pipeline to bring to the market within the next two years, the company completed several deals in 2009 to broaden its portfolio of drug candidates. Last month, the firm bought San Diego-based Calixa Therapeutics for $92.5 million up front and an additional $310 million in potential payments. The buyout gave Cubist most of the commercial rights to Calixa’slead antibiotic treatment, a combination of anti-bacterial agents, that has the potential of being a top seller on par with daptomycin. That’s because it may be able about to treat a life-threatening bug called P. aeruginosa better than existing antibiotics on the market, Bonney says. That promising treatment is in mid-stage clinical trials, and Cubist predicts that it could be seeking U.S. approval for the product in 2013.

Cubist also revealed separate deals last year with a trio of Massachusetts-based biotechs with products in various stages of development: Alnylam Pharmaceuticals, Forma Therapeutics, and Hydra Biosciences. Perhaps the most high profile of those deals was with the RNA-interference (RNAi) drug developer Alnylam (NASDAQ:ALNY), from which Cubist licensed rights to Alnylam’s gene-silencing technology for treating respiratory syncytial virus (RSV), which sends about 125,000 children to the hospital in the U.S. every year, according to Alnylam. Alnylam is in mid-stage clinical development of a first-generation RNAi therapy for RSV. Bonney told me that his company is keenly interested in a newer version of the treatment specifically for children. Yet the therapy hasn’t reached human clinical trials, meaning that its potential commercial impact on the firm is both many years away and highly uncertain.

Another big question mark in Cubist’s pipeline is the future of its experimental drug ecallantide. The company put the brakes on a mid-stage clinical trial of the drug, which it is developing as an anti-bleeding agent for heart surgeries, after more patients who were treated with the drug died compared with those who didn’t take it. (Ecallantide is a protein drug that was discovered by Cambridge, MA-based Dyax (NASDAQ:DYAX), which has licensed the drug to Cubist for use in heart surgeries.) Cubist is expected to provide an update on what happened in its trial with ecallantide sometime in the first half of this year.

Still, what perhaps keeps the company’s stockholders up at night is the near-term challenge Teva has brought to the daptomycin patents. Cubist mounted a lawsuit against Teva early last year in response to Teva’s notice that it planned to start seek FDA approval of generic version of the antibiotic, before the expiration of Cubist’s patents on the treatment between 2016 and 2019. Bonney said that his company had been ready for such a case since 2007, expecting that Teva or another generic drug-maker would challenge its patents.

Cubist filed two of the three patents in question in the case, Bonney said, after the company acquired rights to daptomycin from the company that discovered the molecule, Indianapolis-based drug giant Eli Lilly (NYSE:LLY). Daptomycin is used in hospitals mostly to treat infections in the skin and tissue just beneath the skin. Cubist is credited with discovering how best to administer the antibiotic to patients at certain dose levels, something that Eli Lilly wasn’t able to figure out. (In fact, Bonney told me that the agreement that brought daptomycin to Cubist required the company to pay Eli Lilly an upfront fee of about $1 million and royalty payments to Lilly—an amazingly small amount considering that the antibiotic now generates more than half a billion dollars in annual revenue.)

Despite the rapid growth in Cubist’s sales of daptomycin, the price of the company’s common stock has been lingering in the $15 to $25 range since mid-2005. Wall Street analysts have cited the potential approval of a generic version of daptomycin, competition from new antibiotics such as South San Francisco-based Theravance’s telavancin, and Cubist’s lack of a late-stage product candidate in its pipeline, as reasons to be concerned about the company’s future.

“I think it’s generally recognized by everybody that the key thing for Cubist is to continue to build the pipeline and find a follow on to Cubicin. That’s relevant whether or not Teva is successful,” says Alan Carr, a biotech analyst for the investment bank Needham & Company in New York. Carr, who is a bit more optimistic about Cubist’s prospects than some of his fellow analysts, has a “buy” rating for the company’s stock.

Bonney said that building the company’s pipeline, including staying in the market for acquisitions that would give the company a new product to bring to market, is one of his top three priorities. However, he said that he isn’t willing to spend too much to acquire new products, especially at the expense of his other big priorities, which are to continue boosting daptomycin sales and to increase the company’s operating profits.

Massachusetts officials are also rooting for Cubist to continue growing in the state. As part of state’s 10-year plan to invest about $1 billion to boost its life sciences industry, Cubist garnered $1.74 million in tax incentives last year tied to its commitment to add jobs in the commonwealth. Cubist employed 362 people in Lexington and 227 more workers outside of the town as of late last month, company spokesman Francis McLoughlin says. He noted that the firm has budgeted for 87 new hires in 2010.

The company is also planning an 110,000-square-foot expansion to its facilities in Lexington. There are still some permitting requirements before construction begins, McLoughlin says, but the project could break ground before the end of this year.


mfg ipollit
Antwort auf Beitrag Nr.: 38.851.355 von bussibaer12 am 31.01.10 17:46:09zu ISIS wurde doch hier schon ein wenig gepostet...

mfg ipollit
ONXX - neben der möglichen Zulassung von Carfilzomib aufgrund der ausstehenden PII-Daten wird bald auch eine PIII gestartet

http://www.prnewswire.com/news-releases/onyx-pharmaceuticals…

Onyx Pharmaceuticals Announces Agreement with the FDA on a Special Protocol Assessment for Planned Phase 3 Carfilzomib Combination Trial in Relapsed Multiple Myeloma
EMERYVILLE, Calif., Feb. 2 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enroll patients with relapsed multiple myeloma following treatment with one to three prior regimens. It is designed to evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone.

"The SPA enables us to initiate this carfilzomib Phase 3 combination trial in the first half of this year with increased clarity on the full approval pathway," said Michael Kauffman, M.D., Ph.D., chief medical officer at Onyx. "In the Phase 2b data (from the "006" trial) reported at the American Society of Hematology meeting last December, carfilzomib showed promising response rates and good tolerability with this three-drug combination in patients with relapsed or refractory myeloma."

Dr. Kauffman continued, "This planned Phase 3 study complements and builds upon the encouraging single-agent carfilzomib data reported earlier in heavily pretreated patients with relapsed and refractory multiple myeloma. Despite the established use of existing therapies, over time virtually all multiple myeloma patients relapse and succumb to their disease, meaning new innovative agents are needed. As a medical community, we have made important strides in extending the life of myeloma patients and need to continue to identify new ways we can benefit those who have this disease."

Carfilzomib Development Strategy

Based on carfilzomib's efficacy and tolerability profile demonstrated to-date, Onyx is pursuing a broad approach to advancing this therapy for multiple myeloma patients. In the advanced relapsed refractory setting, carfilzomib is currently being evaluated in a Phase 2b study that could support a new drug application filing by the end of 2010. In addition to this potential accelerated approval pathway and for patients earlier in the course of their disease, Onyx is evaluating the combination of carfilzomib, Revlimid® and low-dose dexamethasone in a Phase 3 study, as covered by this SPA, which is expected to begin in the first half of 2010.

About Special Protocol Assessments

A Special Protocol Assessment is a written agreement with the FDA on the design and planned analysis for a clinical trial. It is intended to form the basis for a marketing application and may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new public health concerns.

About the Phase 3 Trial

The Phase 3 ("009") trial is a 700 patient, randomized, open-label, global multi-center study comparing two treatment regimens for patients with relapsed multiple myeloma and will be conducted in approximately 200 centers worldwide. This study is designed to demonstrate the clinical benefit of carfilzomib in combination with lenalidomide and dexamethasone based on a primary endpoint of progression-free survival. Patients will be randomized to receive carfilzomib (20mg/m2 on days 1 and 2 of cycle 1 only, then 27mg/m2 subsequently) or matching placebo, in addition to a standard dosing schedule of lenalidomide (25mg qd 21 days on, 7 days off) and low-dose dexamethasone (40mg q week).

About Carfilzomib

Carfilzomib is a selective, next-generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study (known as "003-A1") in patients with relapsed, refractory multiple myeloma, which could support a new drug application (NDA) filing by the end of 2010. Carfilzomib is also being evaluated in advanced solid tumors.

About Multiple Myeloma

Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually(i). Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually(ii).


mfg ipollit
Neurosearch - puh... noch rechzeitig dabei und Glück gehabt! :)

erste Huntexil PIII war erfolgreich... somit ist der Weg frei. Wegen fehlender Alternativen bei Huntington ist sogar ein potentieller Blockbuster drin, den Neurosearch wegen der relativ geringen Anzahl an Patienten auch selber vermarkten kann.

03.02.2010 10:18
UPDATE 1-Neurosearch shares leap on Huntington's drug study

COPENHAGEN, Feb 3 (Reuters) - Shares in Danish biopharmaceuticals firm Neurosearch A/S surged as much as 74 percent after it announced positive results from a Phase III trial with a candidate Huntington's disease drug.

If approved, the drug, Huntexil, could become Neurosearch's first product on the market.

'This could pave the way for a launch in the near future, possibly in early 2011 or even late 2010, and turn Neurosearch into a profitable company,' Jyske Bank analyst Frank Andersen said.

The shares hit a one-year high to trade up 49 percent at 126.50 crowns by 0850 GMT, against the trend of a 0.9 percent fall in the DJ Stoxx European healthcare index.

'Huntexil significantly improves motor functions in Huntington patients,' Neurosearch said in a statement.

It said positive effects were observed in both voluntary and involuntary motor symptoms and Huntexil was very well tolerated with adverse effects similar to placebo.

Neurosearch said it is now starting talks with scientific advisors and regulatory agencies in Europe and the United States to discuss the outcome of the study and plans for submitting applications for market authorisation for for Huntexil.

'This supports our 'buy' recommendation on the shares. This is very good news,' Andersen said.

He said the drug would likely be launched in Europe first since the Phase III study was conducted in Europe.

Huntington's disease is a highly disabling, hereditary neurodegenerative genetic disorder which leads to damage of the nerve cells in certain areas of the brain.




mfg ipollit
Antwort auf Beitrag Nr.: 38.869.634 von ipollit am 03.02.10 10:29:48dieser Jyske Bank Analyst ist echt eine ziemliche Pfeife... ich verstehe manchmal nicht, was die so treiben, wenn sie ihre Analysen schreiben. Die Zahlen von denen sind kaum etwas wert. :rolleyes:

z.B. heute: Jyske Bank analyst Frank Andersen raised his target price on Neurosearch twice in one day, first to 260 crowns from 165 crowns and then to 380 crowns, and repeated a "buy" recommendation on the back of the news.
...
He said he had raised his target price on Neurosearch shares for the second time in one day because the treatment price with Huntexil should be higher than his previous estimate and in line with the treatment price for patients using Danish drug maker Lundbeck's (LUN.CO) Huntington's drug Xenazine.

http://www.reuters.com/article/idUSLDE6120GC20100203?type=ma…

in seiner letzten Analyse schrieb er noch vor wenigen Monaten: "We assess that Huntexil will be priced in line with other Orphan drugs, and hence we will in the US see a treatment price of DKK 75,000, while we assess that in Europe the price will come to DKK 60,000." 75k DDK sind 14k USD

dabei schreibt Neurosearch in ihrer letzten Präsentation selber, dass Huntexil als Orphan Drug mindestens vergleichbar mit Xenazine im Preis liegen sollte, den sie mit 40k USD angeben: "Attractive value increment in orphan pricing (Xenazine (chorea symptoms only); ~ 40000 $ p.a."

und heute fällt diesem Analysten plötzlich auf, dass Huntexil ja vielleicht genauso teuer sein könnte... und muss sich innerhalb eines Tages auch nochmal korrigieren :rolleyes:

woanders stand ein möglicher Preis im Bereich von 40-45k EUR, was schon eher hinkommen dürfte... also ca. 60k USD für die Therapie pro Jahr.

An Huntington leiden angeblich in den USA und in Europa zusammen etwa 70.000 Menschen... 2/3 davon sollen für Huntexil in Frage kommen. In der Summe steckt in dem Mittel, das eigentlich in der Form keine Konkurrenz hat und bei dem sehr hoher Bedarf besteht, also eine Menge Potential. Vor allen Dingen wird die Vermarktung von NeuroSearch alleine bewältigt werden können... und NeuroSearch ist dagegen noch ein relativ kleines Unternehmen.

Zwar soll die Zulassung erst Ende des Jahres beantragt werden, doch soll vorher schon Huntexil einem begrenzten Patientenkreis zugänglich gemacht werden.

mfg ipollit
Antwort auf Beitrag Nr.: 38.851.197 von ipollit am 31.01.10 16:56:25nimm zu deinen medigene, deren börsenwert (178 mio $) kontinuierlich fällt, doch mologene (136 mio $), deren wert kontinuierlich steigt, dazu! :)
Antwort auf Beitrag Nr.: 38.875.174 von pokemon am 03.02.10 20:47:10@pokemon: sorry, auch wenn ich jetzt riskiere, von dir geschlagen zu werden, aber mologen!? ich gönne dir ein paar hundert prozent, aber befürchte gegenteiliges ;)

@ipollit: gratulation zum jüngsten trade! das zahlt sich im wahrsten sinne aus :)
Antwort auf Beitrag Nr.: 38.875.591 von PathFinder2 am 03.02.10 21:47:08danke... gehört aber einiges an Glück dazu, hätte auch schief gehen können.

mfg ipollit
Genmab... doch leider ein ziemlicher Problemfall geworden. Rückblickend ist es eine klare Fehlinvestition gewesen.

Heute kamen die ersten Zahlen zu Arzerra. Außerdem wurde das wenig aussichtsreiche Zanolimumab noch für ein paar Mios verscherbelt.


4 Feb, 2010 13:09 CET

Genmab A/S Company Announcement Arzerra 2009 Net Sales Figures

Summary: Net sales of Arzerra™ for the fourth quarter of 2009 wereapproximately DKK 29 million, with an expected royalty payment to Genmab of DKK6 million. Copenhagen, Denmark; February 4, 2010 - Genmab A/S (OMX: GEN) announced todaythat the U.S. net sales for Arzerra (ofatumumab) during the fourth quarter of2009 were approximately DKK 29 million (approximately USD 5.5 million). Underthe terms of the collaboration with GlaxoSmithKline (GSK), Genmab expects to receive a royalty payment of approximately DKK 6 million (approximately USD 1.1million). “We are very pleased to see the first sales figures for Arzerra and we believethat they reflect the need for new treatment options for patients withrefractory CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer ofGenmab. Arzerra was approved by the FDA in October, 2009, for the treatment of patientsin the U.S. with chronic lymphocytic leukemia (CLL) that is refractory tofludarabine and alemtuzumab, and was launched by GSK in mid-November, 2009. Arzerra is a monoclonal antibody that causes the body's immune response tofight against normal and cancerous B-cells. Arzerra attaches to the small andlarge loop epitopes - on a molecule called CD20, which is found on the surfaceof B-cells, the type of cell that becomes cancerous in CLL.



************

4 Feb, 2010 17:48 CET

Genmab A/S Investor News Genmab Outlicenses Zanolimumab to TenX Biopharma

Summary: Genmab has licensed zanolimumab to TenX Biopharma, Inc. Copenhagen, Denmark; February 4, 2010 - Genmab A/S (OMX: GEN) announced today that it has closed a license agreement under which Genmab has granted exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4(R)) to TenXBiopharma, Inc. Under the terms of the agreement, Genmab receives a payment of USD 4.5 million and will be entitled to milestones and royalties on sales of zanolimumab. TenX Biopharma will be responsible for all future costs of developing, manufacturing and commercializing zanolimumab. “Genmab is pleased to find a partner who wishes to take zanolimumab forward in development,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer. “This is good news for patients who may one day benefit from treatment with zanolimumab.”“Zanolimumab has promise for treatment of patients with T cell cancers, and potential in other cancer types for which existing therapies are inadequate”, said Gardiner F.H. Smith, Chief Executive Officer of TenX Biopharma. “We are building a pipeline of new medicines for high unmet need, with a focus on the patient through business efficiency.” Asher Nathan, Managing Partner of Zoticon Bioventures, and lead investor in TenX, said “TenX and zanolimumab represent the fourth late stage drug funding which we've led in the past two years. I'm delighted that this important product will be available in the future, and look forward to the management teamat TenX continuing to build value with novel cancer therapeutics.”


mfg ipollit
Antwort auf Beitrag Nr.: 38.883.581 von ipollit am 04.02.10 20:06:20hier noch ein Artikel, der den Problemfall Genmab ganz gut wiedergibt. Seitdem ist es eher noch schlechter geworden durch das Ende der Entwicklung von Roche's RG1507.

http://www.europharmatoday.com/2009/11/genmabs-star-falls-am…

November 23, 2009

Genmab's Star Falls Amid Setbacks, Cuts And Manufacturing Fire-Sale

What a difference a year makes. In October 2008, Genmab's leaders were being applauded for their prudent strategic review as they cut 101 staff and axed the development of Phase III HuMax-CD4 (zanulimumab) plus a handful of earlier-stage programs, to concentrate instead on the potentially far larger Arzerra (ofatumumab) and zalutumumab, a late-stage EGFR-inhibitor. But now management credibility is being questioned, following the Nov. 5 announcement of a further 300 headcount reduction, setbacks to both remaining key programs, plus the fire-sale of its U.S. manufacturing unit acquired only 18 months earlier.

Genmab was becoming that rare beast in European biotech - a company with home-grown, innovative, late-stage antibody drugs, and significant cash ($333 million at the end of 2008).

As well as securing significant Big Pharma partnerships with GlaxoSmithKline (which paid over $100 million upfront for global rights to ofatumumab in 2006) and Roche (which signed an antibody discovery partnership back in 2001), Genmab had manufacturing capability and, back then, the real possibility of co-promoting its own products in some markets (1 See 'GSK/Genmab: An Impressive Display of Biotech's Increased Leverage,' IN VIVO, Jan. 2007).

On Oct. 27, 2009, the company earned yet another star when FDA approved CD-20 targeting antibody Arzerra for chronic lymphocytic leukaemia (CLL) under an accelerated process (2 'The Pink Sheet' DAILY, Oct. 27, 2009).

A Series of Setbacks

But the full significance of that landmark event was lost in discussions about what has gone wrong at Genmab. Some analysts are even questioning the sustainability of this one-time biotech star.

Granted, Arzerra's approval was anticipated following a positive FDA advisory committee meeting in June and the fact that few treatments are available in this setting. As such, the share price had little movement. And although Arzerra's development and approval path hasn't been smooth, that's hardly unique to Genmab. It's as likely a sign of tougher regulatory hurdles across the board.

Still, Genmab appears - whether through mismanagement, or just bad luck - to have driven itself into a tight corner at a time when investors have minimal appetite for risk.

First, FDA now wants more data from an ongoing CLL study to show that the drug does indeed slow disease progression. And the compound has already stumbled in other indications such as non-Hodgkin's Lymphoma and autoimmune diseases (such as rheumatoid arthritis), both key to the drug's achieving its full potential, yet both highly competitive fields. Some analysts were forecasting peak sales for Arzerra (across all indications) at over $1 billion, although most have cut these forecasts significantly since.

Phase III data in NHL patients refractory to Roche/Genentech's Rituxan (rituximab), released over the summer, showed a disappointingly low response rate - 10 percent versus company expectations of around 20 percent. Thus Genmab was denied the milestone payment from partner GSK and the share price plummeted to a three-year low (3 'The Pink Sheet,' Aug. 24, 2009).

In RA, a market where Arzerra aims to compete against the anti-TNFa drugs (such as Abbott's Humira (adalimumab), neither Genmab nor GSK are clear about which formulation will move forward in trials -intravenous or subcutaneous.

Strategic Errors?

Analysts had been expecting Genmab to react to the Arzerra NHL setback, possibly with a fundraising, but not with a fire-sale. The acquisition of the Brooklyn Park manufacturing site in March 2008 for $240 million now looks to some like a strategic error, which, coupled with the additional headcount reduction, is making many question why Genmab management didn't adequately foresee, during the October 2008 review, the need for these further cuts so soon afterwards. Many point to poor contingency planning and over-optimism.

At the time of the Brooklyn Park purchase, Genmab stated the need to secure "significant manufacturing capacity." Yet Arzerra manufacturing is GSK's responsibility, according to the 2006 deal terms, so Brooklyn Park was in any case used only for producing zalutumumab and the now-shelved HuMax-CD4. To make things worse, antibody manufacturing has since very rapidly shifted from a state of under-capacity to overcapacity, reducing the need for a proprietary facility and, more crucially, making any manufacturing asset hard to sell. Genmab says it hopes to get $145 million for the unit (after $5 million in selling costs) and will take an $83 million impairment charge this quarter.

Chairman and CEO Lisa Drakeman argues that the drastic changes affecting both the financial markets and biologics manufacturing capacity could not have been foreseen.

"We made the best decision we could with all the information we had at the time," she said. "Things changed in a way no one could have predicted and I think that none of us are to be blamed for the world economic climate that has resulted in the kind of actions companies such as Genmab are taking. What we have to do is manage for the world that we live in."

She also acknowledges, however, that most of the company's resources and attention over the past 12 months have been - quite reasonably - focused on Arzerra. "We had a significant role to play in the filing and approval of Arzerra. We had the heaviest workload of any period, especially in terms of the importance of the work. Now that workload has changed dramatically and we are now looking forward, hence the reorganization. This is a major shift, a transformation."

Development Costs Still Significant

Whether or not that's the case, Genmab's about-face on the manufacturing site will at least help it pay what will continue to be hefty development costs, including for its 50 percent share of an Arzerra-Rituxan head-to-head trial in diffuse large B-cell lymphoma (DLBCL), the most common form of NHL, announced Nov. 9. Piper Jaffray analysts estimate that the sale will buy Genmab another two years of operations.

The randomized NHL trial, whose primary endpoint will be progression-free survival, is highly risky. But Arzerra needs to show superiority to Rituxan in order to get any kind of foothold in this indication. The study will also take several years to complete: recruitment alone of 380 patients who are refractory to or have relapsed following first-line treatment with Rituxan plus chemotherapy could take up to two years.

Meanwhile, Genmab's other key drug, zalutumumab, has been hit by a delay in pivotal data on head and neck cancer. Expected before year-end, this will now be released in Q1 2010 - pushing out further partnering revenues. And securing the right partner will be crucial to expand the range of indications (which Genmab narrowed down during its 2008 strategic review) and establish zalutumumab in the already crowded anti-EGFr market, where it will be up against the likes of AstraZeneca's Iressa (gefitinib), Amgen's Vectibix (panitumumab), Roche's Tarceva (erlotinib) and Bristol's Erbitux (cetuximab). Given the relatively small refractory head and neck cancer market and lack of data in any of the larger indications, Piper Jaffray analysts recently slashed their peak sales forecast for this candidate to $150 million from $500 million.

Drakeman, who has been at the company's helm since inception, is putting on a brave face. Perhaps she has some justification: after all, GSK has not returned Arzerra, as no Big Pharma would hesitate to do these days, but is instead pushing ahead with the lengthy and costly Rituxan head-to-head trial.

Yet Genmab's ambition to share in both the costs, and thus more fully in the rewards, of its drug assets worries some investors. "I would rather see GSK take the product in-house, [and] assume all costs in a return for a reduced royalty rate to Genmab. That would make me happier," declares one analyst.

And that's the rub: in this economic environment, risk-taking is being punished, not rewarded. Indeed, Europe's investors have a reputation for being risk-averse at the best of times. Most investors would now much rather Genmab had settled for less upside from its drugs, and faced less financial exposure along the way, whatever their views may have been at the time the GSK deal was signed.

Genmab may yet come through the latest round of setbacks; it has further assets in its pipeline, including three Roche-partnered development-stage programs and a handful of antibodies available for licensing. And Drakeman's right: it's impossible for any biotech CEO to predict the future economic context and thus tailor its deal-terms accordingly.

But deal-terms can be changed, and biotech leaders need big contingencies - they can go for the stars, but need to acknowledge that failures and delays are more likely, and thus plan for those eventualities.


mfg ipollit
Antwort auf Beitrag Nr.: 38.883.581 von ipollit am 04.02.10 20:06:20hi ipollit,

ja, glück gehört einfach dazu, gerade im biotech-bereich.

was hältst du eigentlich vom daratumumab-programm von Genmab?
ARRY...

Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2010

BOULDER, Colo.--(BUSINESS WIRE)--Array BioPharma Inc. (Nasdaq: ARRY - News) today reported financial results for the second quarter of fiscal 2010.

Array reported revenue of $9.6 million for the second quarter of fiscal 2010, compared to revenue of $7.7 million for the same period in fiscal 2009. Array spent $19.1 million for proprietary research and development during the quarter to advance its wholly-owned drugs in clinical development and select discovery programs. This compares to $23.7 million spent for research and development during the second quarter of fiscal 2009. Array reported a net loss of $21.8 million, or ($0.44) per share, for the second quarter, compared to a net loss of $37.8 million, or ($0.79) per share, for the second quarter in fiscal 2009. Array ended the second quarter of fiscal 2010 with $115 million in cash, cash equivalents and marketable securities.

Array reported revenue of $17.5 million for the six-month period ended December 31, 2009, compared to revenue of $13.4 million for the same period in fiscal 2009. Net loss for the six months ended December 31, 2009, was $46.6 million, or ($0.96) per share, compared to a net loss of $71.5 million, or ($1.50) per share, reported in the same six-month period in fiscal 2009.

“We are delighted to partner with Amgen on our type 2 diabetes program, including AMG 151 / ARRY-403, which provided a $60 million up-front payment with additional potential milestones of $666 million and a double-digit royalty,” said Robert E. Conway, Chief Executive Officer. “We continued to implement our partnering strategy with our Amgen deal, which significantly added to our cash balance and reduced our burn. Our partnerships, which include seven Array-invented drugs in clinical trials, provide Array with significant upside of $1.9 billion in potential milestones and royalties that range up to 15 percent. As a result of our partnering efforts, we are revising our guidance for the second half of the fiscal year, increasing our revenue and reducing our loss per share.”

SUMMARY OF RECENT PROGRESS

Array Partners with Amgen in Type 2 Diabetes:

AMG 151 / ARRY-403 – GK activator for type 2 diabetes: Array entered into an agreement with Amgen Inc. for Array’s small-molecule glucokinase activator program, including AMG 151 / ARRY-403, which is currently being tested in a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes.

Under the terms of the agreement, Array received an upfront payment of $60 million and additional contingent payments up to $666 million if clinical and commercial milestones are achieved for AMG 151 and at least one back-up compound. Amgen is responsible for future clinical development and commercialization for AMG 151 and any resulting back-up compounds, with Array having an option to co-promote in the United States. Array will receive double digit royalties on sales of AMG 151. In addition, Amgen is providing research funding over the next two-years to identify and advance second-generation glucokinase activators.

Five clinical programs advanced for the treatment of cancer:

ARRY-162 – MEK inhibitor for cancer: Array completed enrolling four cohorts and reached the maximum tolerated dose in a Phase 1 clinical trial in cancer patients with its most advanced wholly-owned MEK inhibitor, ARRY-162. ARRY-162 is now advancing into an expansion phase of the trial in biliary tract cancer patients at ten clinical sites in North America. The Phase 1 dose escalation study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of ARRY-162 in patients with advanced solid tumors.

ARRY-520 – KSP inhibitor for AML and MM: Array continued a Phase 1 trial of ARRY-520, a novel KSP inhibitor, in patients with solid tumors and two Phase 1/2 trials in patients with acute myelogenous leukemia and multiple myeloma.

ARRY-614 - p38/Tie-2 Inhibitor for MDS: Array continued dosing patients with myelodysplastic syndromes (MDS) in a Phase 1 trial with ARRY-614 to determine the safety, maximum tolerated dose, pharmacokinetics and preliminary estimates of efficacy of the compound in this patient population.

ARRY-543 - ErbB family inhibitor for solid tumors: Array completed a Phase 1 dose-escalation study with tablet formulation in patients with solid tumors and continued three Phase 1b trials in combination with Xeloda® (capecitabine), Taxotere® (docetaxel) and Gemzar® (gemcitabine), respectively.

ARRY-380 – HER2 oral, selective inhibitor for cancer: Array continues dose escalation in a Phase 1 trial with ARRY-380. The trial is designed to evaluate the safety, maximum tolerated dose and pharmacokinetics of ARRY-380 in patients with advanced cancer.

Array announced positive interim results of this trial at the 2009 San Antonio Breast Cancer Symposium. These results showed that ARRY-380 at doses greater than or equal to 200 mg BID demonstrated evidence of tumor regression in eight out of ten heavily pre-treated patients with HER2 expressing cancers. Of these eight patients, four had prolonged stable disease for 16 weeks or longer. ARRY-380 has been well-tolerated; the predominant adverse events have been Grade 1 and included nausea, rash and fatigue. In completed cohorts, no Grade 3 or 4 treatment-related adverse events and no cardiac adverse events have been observed.


mfg ipollit
Antwort auf Beitrag Nr.: 38.883.680 von ipollit am 04.02.10 20:15:57und noch ein paar Anmerkungen zur ARRY CC... von iHub...

http://investorshub.advfn.com/boards/read_msg.aspx?message_i…

ARRY - Notes on 2Q10 Call

1. ARRY anticipates milestones from existing collaborations to total about $10M for this year and to double to about $20M in 2011.

2. ARRY anticipates 1 or more significant partnering deals in calendar 2010. There is significant partnering interest around ARRY-162 and ARRY-380, but discussions are also ongoing with respect to ARRY-543 and ARRY-520, in addition to discovery assets. ARRY may prefer to get additional clinical data on 380 before partnering the compound to increase the economics of the deal.

3. The 2010 calendar milestones remain largely unchanged from what was posted in #msg-45521735 .

4. ARRY-162 has moved into biliary cancer patients in Phase 1 trials, because biliary cancers have high IL-6, TNF, angiogenesis, and BRAF mutations. AZD6244 showed success in this indication before with 3 PRs, prolonged PFS, and a quality of life benefit (weight gain in a tumor type that is cachexic) in a prior trial, so ARRY is hopeful that 162 will be successful. Japan has over 78,000 biliary cancer patients.

5. Trial design for 162 in biliary tract cancer will look at biomarkers (BRAF and others) to assess activity of the drug. ARRY wants to see the relationship between mutation status and response and see if 162 spurs weight gain and adds to patient pain relief.

****

ARRY also expects to present data on 162, 543 and 380 by the 1st half of the year.


http://seekingalpha.com/article/186072-array-biopharma-inc-f…

mfg ipollit
Antwort auf Beitrag Nr.: 38.883.657 von PathFinder2 am 04.02.10 20:12:52daratumumab... hab ich bisher noch nicht viel zu gefunden. Zieht sich ja auch schon länger hin... sind aber damit immerhin weiter als MOR ;)

mfg ipollit
Durch den Anstieg ist Neurosearch nun doch zu einer größeren Position geworden. Huntexil bietet meiner Meinung nach weiter Potential. Einen kleinen Rückschlag wird es wohl noch geben, da Glaxo angekündigt hat, generell aus der Indikation Depressionen auszusteigen, zu der sie auch einige Projekte mit NeuroSearch haben.

aktuelle Positionen im Depot...
10,5% Incyte http://finance.yahoo.com/q?s=INCY
10,1% Regeneron http://finance.yahoo.com/q?s=REGN
8,3% Genmab http://finance.yahoo.com/q?s=GEN.CO
8,1% NeuroSearch http://finance.yahoo.com/q?s=NEUR.CO
7,1% Cubist http://finance.yahoo.com/q?s=CBST
5,8% Micromet http://finance.yahoo.com/q?s=MITI
5,8% Allos http://finance.yahoo.com/q?s=ALTH
5,5% Onyx http://finance.yahoo.com/q?s=ONXX
5,1% Rigel http://finance.yahoo.com/q?s=RIGL
4,9% Isis http://finance.yahoo.com/q?s=ISIS
4,9% Exelixis http://finance.yahoo.com/q?s=EXEL
3,5% NeurogesX http://finance.yahoo.com/q?s=NGSX
3,3% Seattle Genetics http://finance.yahoo.com/q?s=SGEN
3,1% Medigene http://finance.yahoo.com/q?s=MDG.DE
2,9% ArQule http://finance.yahoo.com/q?s=ARQL
2,7% Array http://finance.yahoo.com/q?s=ARRY
2,3% ViroPharma http://finance.yahoo.com/q?s=VPHM
1,9% Arena http://finance.yahoo.com/q?s=ARNA
1,5% NicOx http://finance.yahoo.com/q?s=COX.PA
1,1% Progenics http://finance.yahoo.com/q?s=PGNX
0,9% Addex http://finance.yahoo.com/q?s=ADXN.SW
0,8% Sucampo http://finance.yahoo.com/q?s=SCMP

das Depot hält sich Dank NeuroSearch und der EUR-Schwäche bisher noch ganz gut... YTD Jahres-Entwicklung auf EUR-Basis:
+12,5% Depot
+5,5% NBI
-8,8% Dax
+5,2% USD

+190,8% NeuroSearch ( 8,1% )
+30,8% Micromet ( 5,8% )
+21,2% ViroPharma ( 2,3% )
+18,9% Genmab ( 8,3% )
+17,7% Incyte ( 10,5% )
+12,9% Allos ( 5,8% )
+12,4% Cubist ( 7,1% )
+12,0% Regeneron ( 10,1% )
+5,2% Progenics ( 1,1% )
+4,6% Isis ( 4,9% )
+4,4% Onyx ( 5,5% )
+1,1% NeurogesX ( 3,5% )
-0,3% Medigene ( 3,1% )
-2,7% Seattle Genetics ( 3,3% )
-3,7% Rigel ( 5,1% )
-5,0% NicOx ( 1,5% )
-6,0% Arena ( 1,9% )
-7,5% Array ( 2,7% )
-10,7% ArQule ( 2,9% )
-11,2% Sucampo ( 0,8% )
-11,2% Exelixis ( 4,9% )
-15,0% Addex ( 0,9% )

mfg ipollit
auch eine meiner Meinung interessante Long-Position gewesen... idealerweise gestern: AMAG. Leider habe ich dafür im Moment nichts frei, zumal es ja gerade auch generell abwärts geht.

Feraheme ist gerade am Markt und lag bisher über den Erwartungen... die Sicherheitsbedenken scheinen unbegründet zu sein und vielleicht nur gestreut, um den Kurs zu drücken



http://www.reuters.com/article/idCAN0516236520100205?rpc=44

UPDATE 2-AMAG safety update on anemia drug lifts shares

* AMAG says adverse event rate in line with drug label

* AMAG does not believe single death related to Feraheme

* Shares rise 4.5 pct

By Bill Berkrot and Ransdell Pierson

NEW YORK, Feb 5 (Reuters) - AMAG Pharmaceuticals Inc (AMAG.O), whose shares fell 16 percent on Thursday on concerns about the safety of its Feraheme anemia treatment, said the number of serious adverse events seen with the product was in line with what would be expected from the intravenous drug.

AMAG, whose shares rose 4.5 percent after the company issued its safety update late Friday, said 40 serious adverse events had been reported since the iron replacement drug was introduced in the United States in July 2009. That represents a rate of 0.1 percent of the 35,000 "patient exposures" to date, AMAG said.

"A single reported death occurred in a patient two days post-Feraheme treatment, which the company does not believe was the result of Feraheme," the company said in a statement.

"Since the infusion was well tolerated we don't think it (the death) was related to the drug," AMAG's Chief Medical Officer Lee Allen later said on a conference call.

Feraheme is approved for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

Analysts said they believe the AMAG share sell-off earlier in the week, which was triggered by a research note suggesting there had been a higher-than-expected rate of serious adverse events from the drug, was unfounded.

"Every drug has beneficial effects and unwanted side effects," Needham & Co analyst Mark Monane said, adding that he believes Feraheme has a desirable benefit/risk ratio that favors use of the drug.

Monane said he still expects Feraheme will eventually garner $500 million to $1 billion in annual sales once it gains broader approval for use in a wider variety of patients.

The company said the rate of serious side effects, such as a potentially dangerous drop in blood pressure or allergic reaction "was consistent with that contained in the U.S. package insert."

A drug's label, or package insert, typically includes results from clinical trials as well as adverse events seen with the medicine's use in studies.

Robert W Baird analyst Christopher Raymond said in a note that Friday's safety update "provides a big sigh of relief."

"With safety rumors completely dispelled, we continue to recommend purchase of AMAG shares into the low $50 range," Raymond said.

AMAG shares rose to $39.50 after hours from their Nasdaq close on Friday at $37.77.

Summer Street Research analyst Carol Werther also believes the recent sell-off was "overdone," but she was not quite ready to write off safety concerns as completely dispelled.

"The clinicians I spoke to are going to use the drug more cautiously until they have more information. Whether the information that came out today is enough, I have no idea," she said.


mfg ipollit
Antwort auf Beitrag Nr.: 38.869.634 von ipollit am 03.02.10 10:29:48hier auch nochmal zu dem Erfolg von NeuroSearch... genau genommen ein großer Erfolg der Arbeit von Arvid Carlsson.

http://www.thelocal.se/24818/20100205/

Swedes develop Huntington's medicine
Published: 5 Feb 10 13:48 CET

A Swedish biotechnology firm has developed a new medicine which provides hope for sufferers of Huntington's disease, according to a report in Göteborgs-Posten.

The new medicine, based on the findings of Nobel prize winning scientist Arvid Carlsson, is set to replace the only other treatment for the disease.

Huntexil is the name given to the new medicine which has been found to relieve the disease's tension and tremors without the secondary side-effects of existing drugs.

The next stage in the development of Huntexil is to have it approved as a medicine with its prospects to date reported to be bright.

The company responsible for the research is called Neurosearch, a Denmark-based firm with a subsidiary in Gothenburg. The firm emerged from the group of research scientists working with Arvid Carlsson.

Arvid Carlsson is a Swedish scientist who is best known for his work to develop a method for measuring the amount of dopamine in brain tissues and it effects on Parkinson's disease.

Carlsson was awarded the Nobel prize in Physiology or Medicine in 2000.


mfg ipollit
zu ISIS:

Genzyme Corporation and Isis Pharmaceuticals Say Cholesterol Drug Met Trial Goal-Reuters
9:07am EST
Reuters reported that Genzyme Corporation and Isis Pharmaceuticals said that their drug to treat a subset of patients with high cholesterol met the main goal of a late stage clinical trial. The drug is being tested in patients with severe, inherited high cholesterol, known as familial hypercholesterolemia, in which patients are unable to properly metabolize LDL due to dysfunctional LDL receptors, which are responsible for clearing LDL from plasma. The companies said elevated liver enzymes were seen in some patients, at about the same rate as in previous trials. The Company, which is handling the regulatory filings for the drug, will first seek approval for patients with hoFH. A late stage study of the drug previously met its main goal of a 25% average reduction in LDL cholesterol. The Company expects to file for U.S. and European approval for the drug in the first half of 2011. - - - - - (repeated)


----------

Kurs ist nach der Meldung 15% im Minus... Liegts am gefetteten Satz?
Antwort auf Beitrag Nr.: 38.920.147 von SLGramann am 10.02.10 17:37:07Genau ...

The companies spooked Wall Street by noting that elevated levels of liver enzymes called transaminases were observed in the study that were similar in magnitude and duration to those seen in earlier studies.

Such elevated enzymes are considered to be a marker of potential liver toxicity and are seen with standard "statin" pills used to treat cholesterol and with many other medicines.

But elevated enzymes have torpedoed approvals of some promising drugs .
Antwort auf Beitrag Nr.: 38.920.175 von BrauchGeld am 10.02.10 17:40:21http://www.thestreet.com/story/10678655/1/isis-genzyme-fall-…

(...) On a conference call Wednesday morning, Isis CEO Stanley Crooke downplayed the mipomersen safety worries, stating that "no new concerns" were raised in this study that were not detected in previous studies. Furthermore, Crooke said none of the patients treated with mipomersen experienced liver dysfunction.

Yet, at the same time, Crooke, in reply to a question, conceded that MRI scans of mipomersen patients in the study detected fat deposits on their livers -- a safety signal that wasn't found in prior mipomersen studies.

"We're still analyzing the data," said Crooke of the liver-fat findings, adding that it's consistent with what's been shown when mipomersen was tested in animals.

Isis and Genzyme previously conducted a phase III study of mipomersen in patients with homozygous familial hypercholesterolemia (HoFH) -- a rarer and much more severe form of the same disease in which patients inherit two defective genes that can cause fatal levels of cholesterol elevation. In that study, mipomersen lowered cholesterol levels by 25% but patients also experienced elevated liver enzymes.

HeFH patients are less sick than HoFH patients, so expectations going into Wednesday results were that mipomersen would cause less liver toxicity in HeFH patients. But in its announcement Wednesday and on the conference call, Isis described the liver safety data as being "similar" between the two patient groups. (...)
Hallo - bin neu hier.
Frage an Euch Bio-Freaks.
Schon was von Sino European Biotechnology AG, ISIN CH0042354727
gehört??
Antwort auf Beitrag Nr.: 38.929.203 von raphel am 11.02.10 19:59:51hallo,

nein, aber der name klingt echt unseriös ;)
Noch mal zu ISIS und mipomersen:


A Wonder Drug With Not-So-Wonderful Side Effects


Brian Orelli, Ph.D.
February 11, 2010

Side effects may not kill Isis Pharmaceuticals (Nasdaq: ISIS) and Genzyme's (Nasdaq: GENZ) cholesterol drug mipomersen, but they could severely diminish the potential patient population that would be willing to take it.

News of the side effects dampened Isis' shares yesterday, which fell more than 18%. As marketing partner Genzyme already has several drugs on the market, its shares were hardly touched by the news.

Let's start with the good news about the drug's great efficacy data. In patients who have a genetic disorder that results in high cholesterol levels even while taking cholesterol-lowering drugs -- like Pfizer's (NYSE: PFE) Lipitor, AstraZeneca's (NYSE: AZN) Crestor, Merck's (NYSE: MRK) Zetia, and Abbott Labs' (NYSE: ABT) Niaspan -- mipomersen was able to reduce cholesterol by 28%. Patients taking placebo saw their cholesterol levels go up 5%.

The bad news is that increased liver enzymes continue to plague mipomersen -- 14% of patients taking mipomersen saw liver enzyme levels at least three-times the normal level. Elevated liver enzymes are a sign of liver toxicity and a reason that many drugs die in clinical trials. Most of the patients only had one measurement that was high and there weren't other signs of liver damage, which puts the companies in an awkward position. The side effects may not be severe enough to keep mipomersen from getting approved, but only the most severe patients may be willing to roll the dice given the side effect signal.

We should know a little more when the full data set is presented at a medical meeting. Here are the two most important things to look out for:

* The number of patients that rolled over to the open label study. After completion of the 26-week trial, both patients that got mipomersen and those on placebo are given the option of taking mipomersen, so the company can get long-term safety data from the patients. For investors, a high rollover rate indicates that doctors and patients think the benefits outweigh the risk.

* The results of MRIs looking at fat build up in the liver. Management said that there was an initial build up of fat, but they're hoping images from later in the study show that the fat decreases over time like it does with other cholesterol drugs.

After the first trial, I said that investors might be overreacting. Now that we've had two trials with increased liver enzymes, I'd say a little paranoia is justified. The data to date is likely good enough to get past the FDA, but if mipomersen can only be used on the most severe patients, sales will be limited.

-----------------

Tja... ISIS wird jetzt noch mit 850 Mio. bewertet. Zieht man die 550 Mio. Cash ab (was auch nicht ganz sauber ist), dann kostet das Unternehmen jetzt noch ganze 300 Mio. Dollar.

Was sagt uns das jetzt? Keine Ahnung. Leider.