Neues aus der Welt der Antikörper und Immunother.

Oder geht es hier nur um konkrete Medikamente in Indikationen?
Will ja keinen Fehler hier machen in deinem schönen Sammelthread.  

@eck, kannst hier posten was du  willst, primär sicher Antikörpermedikamente und
Entwicklungsrichtung und Strategien, aber  Hauptsache irgendwie Bezug zu Ak's,
also Cat-Übernahme  hätte sicher reingehört,  da es einen unabhängigen Player weniger bedeutet, noch dazu einen, der ohne Mouse-Technology arbeitet, genau  wie  Morphosys.  

also : Cat (Cambridge Antibody Technology) wurde übernommen von
Astra-Zeneca
http://de.biz.yahoo.com/15052006/36/...nen-pfund-bar-uebernehmen.html

dpa-afx
AstraZeneca will CAT für 702 Millionen Pfund in bar übernehmen
Montag 15. Mai 2006, 08:30 Uhr


LONDON (dpa-AFX) - Der britisch-schwedische Pharmakonzern AstraZeneca will das Biotech-Unternehmen Cambridge Antibody Technology (CAT) für 702 Millionen britische Pfund (1,03 Mrd Euro) in bar übernehmen. Die Führungsgremien beider Firmen hätten sich auf die Bedingungen geeinigt, teilte AstraZeneca (London: AZN.L - Nachrichten) am Montag in London mit. Der Kauf werde keine Auswirkungen haben auf die Prognose für den Gewinn je Aktie oder das Aktienrückkaufprogramm bei Astrazeneca in diesem Jahr./ari/sk  
 

http://de.biz.yahoo.com/03062006/217/...lassung-europa-empfohlen.html

BASEL, Schweiz, June 3 /PRNewswire/ --


- Erstes selektiv auf die B-Zellen wirkendes Medikament bietet Patienten
eine wahre Alternative bei der Behandlung dieser beeinträchtigenden Krankheit



Roche gab heute bekannt, dass der Ausschuss für Humanarzneimittel (CHMP)
eine Zulassungsempfehlung für MabThera (Rituximab) zur Behandlung von
rheumatoider Arthritis (RA) in Europa erliess. Dies bringt MabThera, die
erste und einzige selektiv auf B-Zellen wirkende Therapie, einen Schritt
näher für RA-Patienten, die auf die gegenwärtigen Behandlungsoptionen
(einschliesslich TNF-Inhibitoren) ANZEIGE
 
mit einer unzureichenden Ansprechrate oder
Unverträglichkeit reagierten. Die B-Zellen spielen in der Entzündungskaskade,
welche letztlich zu den für rheumatoide Arthritis typischen Knochen- und
Knorpelschäden in den Gelenken führt, eine wichtige Rolle.



Professor Paul Emery, University of Leeds, GB, einer der leitenden
Prüfärzte in der REFLEX(1) Studie kommentierte: "Dies ist ein wichtiger
Moment - MabThera wird für die RA-Patienten in Europa, die durch die derzeit
verfügbaren Therapien keine ausreichende Linderung erfahren oder diese
Therapien nicht vertragen, erhebliche Vorteile bringen. Dieser neue Ansatz
verspricht mit jedem kurzen Behandlungszyklus alle 6 bis 12 Monate
nachhaltigen klinischen Nutzen."



"Die positive Stellungnahme des CHMP ist ein grosser Meilenstein für
MabThera - das erste Medikament für rheumatoide Arthritis in unserem
Produkteportfolio im Bereich der Autoimmunkrankheiten. Wir freuen uns, dass
MabThera bald vielen an dieser beeinträchtigenden Krankheit leidenden
Menschen als neue Behandlungsalternative zur Verfügung stehen wird," sagte
Eduard Holdener, Leiter von Pharma Development bei Roche.



Die positive Stellungnahme des CHMP gilt für MabThera in Kombination mit
Methotrexat zur Behandlung von erwachsenen Patienten mit schwerer aktiver
rheumatoider Arthritis (RA), die zuvor nicht ausreichend auf andere
krankheitsmodifizierenden Antirheumatika (einschliesslich eines oder mehrerer
Tumornekrosefaktor(TNF)-Inhibitoren) angesprochen oder diese Medikamente
nicht vertragen hatten. Bis zu 40 % der RA-Patienten, die mit derzeit
verfügbaren Biotherapeutika behandelt werden, sprechen nur ungenügend auf die
Behandlung an und haben wenig andere Behandlungsalternativen. Daher besteht
ein dringender Bedarf an neuen wirksamen Behandlungsoptionen für Patienten,
deren tägliches Leben durch diese schwerwiegende Krankheit beeinträchtigt
wird.



Die Bekanntmachung des CHMP kam nach den positiven Ergebnissen der
Phase-III-REFLEX-Studie, die zeigten, dass MabThera ein hochwirksames
Präparat zur Symptomlinderung bei RA-Patienten ist und eine nachhaltige
Verbesserung nach nur zwei Infusionen pro Behandlungszyklus bringt. Die
Studie zeigte insbesondere, dass MabThera beeindruckende Ergebnisse bei der
Reduzierung von Schwellungen und Schmerzen der Gelenke erzielte und somit die
Abgeschlagenheit und Lebensqualität der Patienten verbesserte. Eine
detaillierte Analyse der REFLEX-Studie einschliesslich der röntgenologischen
Daten über einen Zeitraum von einem Jahr sowie der Wirkung von wiederholten
Behandlungszyklen wird im Juni 2006 auf dem EULAR-Kongress (European League
Against Rheumatism) präsentiert.



MabThera wird in den USA von Genentech unter dem Namen Rituxan vertrieben
und erhielt vor kurzem nach einem beschleunigten Verfahren die Zulassung der
amerikanischen Gesundheitsbehörde FDA für die Behandlung von mittelschwerer
bis schwerer RA.



Die rheumatoide Arthritis stellt eine der häufigsten Autoimmunkrankheiten
dar und betrifft mit bis zu 2 Millionen Erkrankten allein in Europa mehr als
21 Millionen Menschen weltweit.



MabThera wird bereits als bewährte Behandlung von Non-Hodgkin-Lymphom
(NHL), einer Form von Lymphdrüsenkrebs, eingesetzt. Über 730.000 Patienten
wurden in den letzten 7 Jahren mit MabThera behandelt, ohne grösseren Anlass
zu Bedenken bezüglich der Sicherheit zu geben.



Über die REFLEX-Studie



Die REFLEX-Studie (Randomised Evaluation oF Long-term Efficacy of
Rituximab in RA) ist eine randomisierte, doppelblinde, placebokontrollierte
Phase-III-Studie an mehreren Zentren. Bei Patienten, die im Rahmen dieser
Studie einen einzigen Behandlungszyklus von nur zwei Infusionen MabThera in
Kombination mit einer gleich bleibenden Dosis Methotrexat (MTX) erhielten,
wurde nach 24 Wochen eine statistisch signifikante Besserung der Symptome im
Vergleich zur Patientengruppe mit Placebo plus MTX gemessen. Bei den meisten
Patienten, die weitere Behandlungszyklen erhielten, erfolgten diese jeweils
24 Wochen nach dem vorhergehenden Behandlungszyklus. Eine vorläufige Analyse
der REFLEX-Daten lieferten keine unerwarteten Erkenntnisse hinsichtlich der
Medikamentensicherheit. Die Unternehmen kontrollieren weiterhin die
langfristige Sicherheit von MabThera in allen klinischen Studien.



Signifikante Verbesserungen aller Symptomparameter



Die Ergebnisse der 6-Monatsanalyse zeigten, dass MabThera in Kombination
mit Methotrexat (MTX), einer Standardbehandlung von RA, hoch wirksam war und
verglichen mit MTX plus Placebo statistisch signifikant höhere Ansprechraten
erzielte: 51 % der Patienten verzeichneten eine 20-prozentige Verbesserung
der Anzeichen und Symptome (ACR20(2)), verglichen mit 18 % bei MTX allein.
Der Unterschied zwischen den beiden Gruppen war nach 8 Wochen ersichtlich und
wurde für die gesamte Dauer der Studie nach nur einem Behandlungszyklus von 2
Infusionen von MabThera im Abstand von 2 Wochen aufrechterhalten. Im Verlauf
der sechs Monate erzielten mehr als fünfmal so viel Patienten in der
MabThera-Gruppe eine 50-prozentige Verbesserung der Anzeichen und Symptome
verglichen mit MTX allein (ACR50: 27 % vs. 5 %), und zwölfmal so viele
MabThera-Patienten erzielten eine 70-prozentige Verbesserung (ACR70: 12 % vs.
1 %). Bei den meisten Patienten, die weitere Behandlungszyklen erhielten,
erfolgten diese 6 Wochen nach dem vorhergehenden Behandlungszyklus.



Über MabThera und rheumatoide Arthritis



MabThera zielt selektiv auf eine Untergruppe der B-Zellen ab, die CD20
exprimieren. Die Stamm-, Pro-B- und Plasmazellen bleiben dabei unangetastet.
Dieser Untergruppe der B-Zellen kommt im Autoimmunprozess bei rheumatoider
Arthritis eine zentrale Rolle zu; MabThera wirkt auf eine Unterbrechung
dieser Abfolge von Reaktionen hin, die zur Entzündung der Gelenkinnenhaut und
schliesslich zu dem für diese Krankheit typischen Knorpelschwund und
Knochenabbau führen. Mehr als 1000 Patienten mit RA wurden bisher in
klinischen Studien mit MabThera behandelt. Ein umfangreiches klinisches
Phase-III-Entwicklungsprogramm prüft derzeit den potenziellen klinischen
Nutzen von MabThera in früheren Stadien der rheumatoiden Arthritis näher.



Über rheumatoide Arthritis



Bei der rheumatoiden Arthritis handelt es sich um eine progressive
systemische Autoimmunkrankheit, bei der sich die Gelenkinnenhaut entzündet.
Diese Entzündung verursacht einen Verlust der Form und Funktion des Gelenks,
was zu Schmerzen, Steifigkeit und Schwellungen und schliesslich zu einer
irreversiblen Zerstörung des Gelenks und zu Behinderung führt. Zu den
typischen Symptomen der rheumatoiden Arthritis zählen Schwellungen, Schmerzen
und eingeschränkte Beweglichkeit der Gelenke an Händen, Füssen, Ellenbogen,
Knien und im Nacken. Rheumatoide Arthritis kann, wenn sie wichtige
Organsysteme beeinträchtigt, die Lebenserwartung verkürzen. Nach 10 Jahren
sind weniger als 50 % der Patienten noch in der Lage, einer Arbeit oder ihren
gewohnten Alltagsaktivitäten nachzugehen.



Über Roche



Roche mit Hauptsitz in Basel, Schweiz, ist ein global führendes, auf
Forschung fokussiertes Healthcare-Unternehmen in den Bereichen Pharma und
Diagnostics. Mit innovativen Produkten und Dienstleistungen, die der
frühzeitigen Entdeckung, Prävention, Diagnose und Behandlung von Krankheiten
dienen, trägt das Unternehmen auf breiter Basis zur Verbesserung der
Gesundheit und Lebensqualität von Menschen bei. Roche ist ein global
führendes Unternehmen auf dem Diagnostikmarkt sowie der führende Anbieter von
Krebs- und Transplantationsmedikamenten und nimmt in der Virologie eine
Spitzenposition ein. 2005 erzielte die Division Pharma einen Umsatz von 27,3
Milliarden Franken und die Division Diagnostics Verkäufe von 8,2 Milliarden
Franken. Roche beschäftigt rund 70.000 Mitarbeitende in 150 Ländern und führt
strategische Allianzen sowie Forschungs- und Entwicklungskooperationen mit
zahlreichen Partnern. Hierzu gehören auch die Mehrheitsbeteiligungen an
Genentech und Chugai. Weitere Informationen zur Roche-Gruppe finden sich im
Internet (www.roche.com).



Alle in dieser Pressemitteilung erwähnten Markennamen sind gesetzlich
geschützt.



Literaturhinweise:



1. Die REFLEX-Studie (Randomised Evaluation oF Long-term Efficacy of
Rituximab in RA) ist eine randomisierte, doppelblinde, placebokontrollierte
Phase-III-Studie an mehreren Zentren.



2. Die ACR-Response ist ein vom American College of Rheumatology (ACR)
entwickelter Massstab zur Beurteilung des Therapieerfolgs bei rheumatoider
Arthritis. Dabei müssen sich bei einem Patienten die Anzahl Symptome und die
Krankheitswerte um einen bestimmten prozentualen Anteil reduzieren. Eine
Verminderung um 20 %, 50 % oder 70 % (prozentuale Verbesserung der
RA-Symptome) wird beispielsweise als ACR20, ACR50 oder ACR70 ausgewiesen.
Eine ACR70-Response wird von den bestehenden Therapien nur in Ausnahmefällen
erreicht und bedeutet eine signifikante Verbesserung des Gesundheitszustandes
eines Patienten.


Roche


 
 


Über Thema diskutieren   Per  


 

Hier geht es nicht um Antikörper sondern um einen neuen Ansatz des Pharmariesen Novartis. Artikel enthält auch einige interessante Aussagen zur Zukunftstrategie des Pharma-Konzerns.  


http://de.biz.yahoo.com/03062006/345/...zwingt-konzerne-umdenken.html

Samstag 3. Juni 2006, 21:15 Uhr


Die Zukunft von Novartis (Virt-X: NOVN.VX - Nachrichten) schwimmt zu Tausenden in kleinen Aquarien. Während man sonst in der Pharmaforschung auf die typischen Labormäuse zählt, sind in das neue Forschungszentrum des Schweizer Pharmakonzerns in Boston Zebrafische eingezogen.

Die durchsichtigen Organismen stehen seit zehn Jahren Modell für Grundlagenforscher, die verstehen wollen, wie sich komplexe Organe wie das Herz entwickeln. Novartis will mit ihnen in seinem Institute of Biomedical Research (NIBR) Wissen und Inspirationen Anzeige
 
für die Medikamenten-Entwicklung sammeln.

Ein großer, 1 Mrd. $ teurer Schritt in Richtung Grundlagenforschung - Terrain, auf das sich bisher meist nur Biotech (Brüssel: BIOT.BR - Nachrichten) -Unternehmen wagten.

"Die pure Ausrichtung auf angewandte Forschung, die man sich in den 80er und 90er Jahren leisten konnte, weil es genügend Therapieansätze gab, kann man sich heute nicht mehr leisten", sagt Jörg Reinhardt, einst Entwicklungschef von Novartis, heute Chef der von Novartis übernommenen Impfstofffirma Chiron. Während in den 90er Jahren jährlich Dutzende neuartige Medikamente auf den Markt kamen, waren es 2002 nur noch 17.

Immer häufiger genügen Neuentwicklungen den strengen Zulassungsstandards nicht. Ein "Produktivitätsloch", sagt Reinhardt. Gleichzeitig stiegen aber die Kosten von Entwicklung und Vermarktung auf bis zu 1,7 Mrd. $ pro Medikament. Und es sanken die Einnahmen: Die Verkaufsschlager der 90er verlieren den Patentschutz, bis zu 80 Prozent des Umsatzes gehen an Nachahmerpräparate verloren.Von Mäusen, Fischen und Fliegen"Die Pharmaforschung kann so nicht weitermachen", sagt Marc Fishman. Der Mediziner, der dem Zebrafisch zum Durchbruch verhalf, leitet die weltweite Forschung von Novartis in seinem Büro im NIBR. "Es gibt so viele Patienten, die wir noch immer nicht behandeln können. Die Medikamenten-Entwicklung ist einfach zu langsam."

Fishmans Vision für eine neue Pharmaforschung beruht auf Mäusen, Fischen, Fliegen und Hefezellen. Denn diese Arbeitstiere der biomedizinischen Forschung sind die Werkzeuge, das das Zusammenspiel der Gene in normalen und kranken Zellen verstehen und eventuell beeinflussen hilft.

So wissen Forscher inzwischen, dass grundlegende entwicklungsbiologische Mechanismen sich bei verschiedenen Organismen kaum unterscheiden. Die Evolution hat nicht nur einzelne Gene, sondern auch die Interaktionen zwischen ihnen, die so genannten Signalketten, jahrmillionenlang beibehalten.

Ein klassisches Beispiel ist die fast identische Signalkette, die sowohl beim Säugetier als auch bei der Fruchtfliege Drosophila die Augenentwicklung anstößt. Die Gene sind derart identisch, dass mit dem Gen der Maus der Ausfall des Fliegen-Pendants ersetzt werden kann. Und das Herz des Menschen wird von den gleichen Genen gebaut, die auch beim Zebrafisch aktiv sind.In der Zebrafisch-Arbeitsgruppe von Fabrizio Serluca am NIBR untersuchen die Forscher beispielsweise, welche Gene die Darmbewegungen der Fische kontrollieren. Diverse menschliche Erkrankungen hängen damit zusammen.

"Bei Mäusen lässt sich das schlecht untersuchen, aber der Zebrafisch ist durchsichtig, man kann direkt in den Darm sehen." Bestimmte Mutationen an Genen des Signalwegs lassen den Transport stocken. Diese neuralgischen Punkte will Novartis nutzen, um in die Regulation einzugreifen.

Dennoch sind die Zebrafische ungewöhnlich für Pharmafirmen, die so anwendungsferne Forschung in meist über Kooperationen mit Biotech-Unternehmen oder Universitäten regeln. Das ließ die Biotechbranche zunächst nervös werden, aus Angst, Kooperationen mit Novartis könnten wegbrechen.Den Signalweg erkennenAus den Novartis-Aktivitäten lasse sich kein allgemeiner Trend ableiten, meint Ralf Kindervater, Geschäftsführer des baden-württembergischen Biopro-Netzwerks: "Eine Trendwende zum kooperationsaversen Verhalten der Pharma-Unternehmen sehen wir nicht." Allerdings sind Firmen wie Novartis und auch GlaxoSmithKline (London: GSK.L - Nachrichten) mit ihren Forschungseinheiten auf die Grundlagenforscher zugegangen.

Die Biotech-Unternehmen müssen nun der Pharmabranche entgegenkommen. "Für Unternehmen, die mit ihren Entwicklungen den ,Proof of Concept? geliefert haben, stehen die Chancen gut", sagt Kindervater. "Wirkstoffe, für die eine Phase-IIb-Studie erfolgreich abgeschlossen wurde, sind interessant für Pharma."

Dass das Konzept "Mehr Forschung wagen" aufgehen kann, zeigt Novartis' Krebsmedikament Gleevec. Zwar taugt es nicht zum Kassenschlager, da es nur für etwa 30.000 Patienten im Jahr in Frage kommt. Doch Fishman zuckt nur mit den Schultern: "Wir werden Blockbuster-Signalketten haben, wodurch wir verschiedene Krankheiten ähnlich behandeln können."

Und auch Entwicklungschef Jörg Reinhardt ist sich sicher: "Das ist nur die erste Designermedizin, die wir durch unsere neue Forschungsstrategie, das Ziel und den Signalweg zu kennen, zu entdecken hoffen." Schon heute hat Novartis die Zahl neuer Wirkstoffe in der Pipeline mit 80 im Vergleich zu 1997 verdreifacht.

 

 
http://de.biz.yahoo.com/05062006/85/...isse-leukaemie-medikament.html

finanzen.net
Schering legt positive Forschungsergebnisse für Leukämie-Medikament vor
Montag 5. Juni 2006, 09:59 Uhr


Westerburg, 5. Juni 2006 (aktiencheck.de AG) - Der Pharmahersteller Schering AG (ISIN DE0007172009/ WKN 717200) und die amerikanische Genzyme Corp (NASDAQ: GENZ - Nachrichten) . (ISIN US3729171047/ WKN 871137) haben positive Forschungsergebnisse einer Phase III-Studie für das Medikament MabCampath vorgelegt.
Wie der Konzern am Samstag bekannt gab, hat die vorläufige Analyse des sekundären Studienendpunktes dieser Studie gezeigt, dass Patienten mit chronischer lymphatischer B-Zell-Leukämie (B-CLL), die den monoklonalen Antikörper MabCampath Anzeige
 
erhielten, signifikant höhere Ansprechraten (Gesamtansprechraten - ORR - und Raten der vollständigen Rückbildung der Krankheitssymptome - CRR) aufwiesen als Patienten, die mit Chlorambucil behandelt wurden. Im Rahmen der klinische Phase-III-Studie wurde MabCampath (Alemtuzumab) mit Chlorambucil verglichen.

In der offenen, randomisierten Studie mit 297 Patienten wurden Wirksamkeit und Sicherheit von MabCampath und Chlorambucil verglichen. Chlorambucil wird im Hinblick auf die Sicherheit für nicht vorbehandelte Patienten als weitestgehend gut verträgliche Therapie betrachtet. Als primären Endpunkt untersuchte die Studie das progressionsfreie Überleben. Die sekundären Endpunkte der Studie beinhalten Sicherheit, Ansprechrate und Gesamtüberleben.

MabCampath erhielt 2001 die beschleunigte Zulassung für die Behandlung von B-CLL bei Patienten, die bereits mit alkylierenden Substanzen behandelt worden waren und bei denen eine Fludarabinphosphat-Therapie nicht angeschlagen hatte. Schering besitzt die exklusiven weltweiten Marketing- und Vertriebsrechte für das Produkt, das in den USA von Berlex Oncology, einem Unternehmen der US-Tochter von Schering, Berlex Laboratories, unter der Bezeichnung Campath vertrieben wird. Schering und Genzyme arbeiten gemeinsam an der Entwicklung von MabCampath für onkologische und andere Indikationen.

Die Aktie von Schering notiert aktuell mit einem Minus von 0,01 Prozent bei 85,39 Euro.
 

http://de.biz.yahoo.com/06062006/341/...ng-ms-medikament-tysabri.html

Dow Jones
FDA genehmigt Wiederzulassung von MS-Medikament Tysabri
Dienstag 6. Juni 2006, 07:09 Uhr

Aktienkurse  
Biogen Idec Inc
BIIB
45.39
+0.00%





(korrigierte Fassung)

WASHINGTON (Dow Jones)--Die US-Gesundheitsbehörde FDA hat die Wiederzulassung des Multiple-Sklerose-Medikaments "Tysabri" genehmigt. Tysabri wurde gemeinsam von der Biogen Idec Inc und Elan Corp entwickelt und vermarktet. Die Unternehmen mussten das Medikament im Februar 2005 vom Markt nehmen, nachdem zwei Patienten im Zusammenhang mit der Einnahme des Medikaments an der seltenen Krankheit PML gestorben waren.

Bereits Anfang März hatte ein Beratergremium der FDA eine Wiederzulassung von Tsyabri einstimmig empfohlen. Die US-Gesundheitsbehörde kündigte jedoch Mitte März an, ihre Untersuchung des Medikaments Anzeige
 
um bis zu 90 Tage verlängern. Nach Unternehmensangaben soll das Medikament nun im Juli wieder erhältlich sein. Laut Analystenaussagen vom März hängt die Zukunft des schuldenbeladenen irischen Pharmakonzerns Elan von der Entscheidung der FDA ab.

Die Verwendung wurde jedoch beschränkt. Nach Angaben der FDA soll Tysabri künftig nur bei Multiple-Sklerose-Patienten angewendet werden, bei denen andere Therapien fehlgeschlagen sind. Zudem sollte Tysabri nicht in Kombination mit anderen Medikamenten genommen werden, die das Immunsystem beeinflussen.

-Von Jennifer Corbett Dooren, Dow Jones Newswires, +49 (0)69 - 29725 111, unternehmen.de@dowjones.com DJG/DJN/abe/nas/jhe

 

http://de.biz.yahoo.com/06062006/217/...lt-weiterhin-versprechen.html

PR Newswire
Merck KGaA: Erbitux(R) (cetuximab) hält weiterhin sein Versprechen
Dienstag 6. Juni 2006, 08:43 Uhr



ATLANTA, Georgia, June 6 /PRNewswire/ --


- Kurzreferate: 3085, 3509, 3535, 3549, 3555, 3556, 5537, 7109



- Veranstaltungsort: 42. Jahrestagung der American Society of Clinical
Oncology (ASCO) 2006, Atlanta, Georgia



- Merck KGaA veröffentlicht eine Vielzahl neuer Daten über Erbitux(R)
(cetuximab) anlässlich der ASCO Jahrestagung



Die anlässlich der 42. Jahrestagung der American Society of Clinical
Oncology (ASCO) vorgestellten Daten aus klinischen Versuchen mit 1.147
Patienten, die zuvor nicht mehr auf die auf der Basis von Irinotecan
ANZEIGE
 
durchgeführte Behandlung ihres metastasierenden kolorektalen Karzinoms (mCRC)
angesprochen hatten, lieferten den Beweis einer mittleren Überlebensdauer von
9,2 Monaten durch eine gezielte Krebstherapie mit Erbitux(R) (cetuximab) und
Irinotecan.(1) Diese Ergebnisse der Versuche mit mehr als 1.000 Patienten
bestätigen die Wirksamkeit und Sicherheit von Erbitux plus Irinotecan an
vorbehandelten Patienten und liefern den weiteren Beweis, dass Erbitux sein
Versprechen hält.



"Die hier vorgetragenen Ergebnisse ermutigen uns sehr," sagte Professor
Hansjochen Wilke von den Kliniken Essen Mitte, Essen, Deutschland, der
Versuchsleiter der Studie. "Die Behandlung von Patienten, die auf
Standard-Chemotherapien nicht mehr ansprechen, ist für Ärzte eine
Herausforderung. Die Therapie mit Erbitux plus Irinotecan erweist sich als
hochwirksame Behandlung für diese Patienten und ist zum Behandlungsstandard
von Patienten geworden, deren Behandlung mit einer zuvor durchgeführten auf
Irinotecan basierenden Therapie gescheitert war."



Die Studie unter dem Namen MABEL[a] wurde in 197 Zentren in acht
europäischen Ländern durchgeführt und wertete progressionsfreie
Überlebensraten von Patienten mit mCRC aus, deren Erkrankung auf die zuvor
durchgeführte Therapie mit Irinotecan nicht ansprach. Die Patienten wurden
mit Erbitux in Verbindung mit Irinotecan behandelt. Die progressionsfreie
Überlebensrate betrug 61% bei 12 Wochen und 34% bei 24 Wochen und bestätigte
damit deutlich die bereits in zuvor durchgeführten Studien beobachtete
Wirksamkeit dieser Behandlungsmöglichkeit.(1)



Ferner wurden vorläufige Befunde aus einem klinischen Versuch mit Erbitux
plus Chemotherapie bei zuvor unbehandelten Patienten mit mCRC von Prof. Dr.
med. Alan Venook von der University of California, San Francisco im Namen der
CALGB[b] (Chronic & Acute Leukemia Group) gemeldet. Patienten mit
unbehandeltem mCRC wurden in die Studie aufgenommen und zur Behandlung
entweder durch Chemotherapie (ausgewählt zwischen Irinotecan/5FU/LV [FOLFIRI]
oder Oxaliplatin/ 5FU/LV [FOLFOX]) oder Chemotherapie plus Erbitux
randomisiert. Die Studie, CALGB 80203, wurde im Jahr 2004 initiiert und
sollte ursprünglich ca. 2.200 Patienten aufnehmen. Die Registrierung wurde
nach der Aufnahme von 238 Patienten aufgrund eines sich entwickelnden
Standards bei der Erstbehandlung von mCRC beendet. Der primäre Endpunkt der
Studie war das allgemeine Überleben; die sekundären Endpunkte enthielten
Reaktionsrate, progressionsfreies Überleben und Toxizität. Da die Studie
vorzeitig beendet wurde, kann sie nicht zur statistischen Auswertung des
progressionsfreien und allgemeinen Überlebens verwendet werden und
Folgerungen können daraus unmöglich gezogen werden. Jedoch war die
Reaktionsrate bei Patienten, die durch die Verbindung von Erbitux und
Chemotherapie behandelt wurden, signifikant höher als die bei Patienten,
die nur eine Chemotherapie erhielten (52% respektive 38%, p=0.029).(2)



Untersuchung eines alternativen Dosierungsplans für Erbitux



Weitere auf der ASCO Jahrestagung vorgestellte Daten zeigen, dass die
Verabreichung von Erbitux jede zweite Woche (anstelle der dem gegenwärtigen
Standard entsprechenden wöchentlichen Dosierung) ein alternativer
Dosierungsplan für Patienten sein könnte.(3) Es könnte nachgewiesen werden,
dass die Verabreichung von Erbitux in Dosen von 500 mg/msquared jede zweite
Woche ähnliche pharmakokinetische Ergebnisse liefert, verglichen mit der
aktuellen wöchentlichen Standarddosierung von 250 mg/msquared. Dieses
Ergebnis ist von grosser Wichtigkeit, da es Patienten und Onkologen einen
flexibleren Dosierungsvorteil bietet.



Erbitux Phase-III-Studien werden wie geplant fortgesetzt



Auf der Tagung wurden auch frühe Ergebnisse mehrerer internationaler
klinischer Phase-III-Versuche mit mehr als 4.000 Patienten präsentiert,
die deutlich machten, dass die unabhängigen Data Safety Monitoring Boards
(DSMB) die Fortsetzung der Versuche mit Erbitux empfehlen.(4-7) Diese
klinischen Phase-III-Versuche werden mit schwierigen Krebsarten
durchgeführt, zu denen mCRC, Plattenepithelkarzinom des Kopfes und Halses
(SCCHN) und nicht kleinzelliges Bronchialkarzinom (NSCLC) zählen.(4-7)



Zwei umfangreiche Phase-III-Studien werden zu mCRC durchgeführt:
EPIC[c],(4) (Untersuchung der Anwendung von Erbitux in Verbindung mit
Irinotecan nach Versagen einer auf Oxaliplatin basierenden Chemotherapie an
1.301 Patienten) und CRYSTAL[d],(5) (Untersuchung von Erbitux mit Irinotecan
an 1.221 Patienten als Erstbehandlung). Diese Ergebnisse erlauben die
Fortsetzung der Phase-III-Studien zur weiteren Forschung, aufbauend auf den
bereits aussergewöhnlichen Phase-II-Studien, die beständig hohe
Reaktionsraten von bis zu 81% bei der Erstbehandlung von mCRC zeigten.
Hierdurch konnten die bereits auf die Leber übergegriffenen, zuvor
inoperablen Metastasen bei nahezu einem von vier Patienten chirurgisch
entfernt werden.(8,9,10) Bislang ist bei mCRC der einzige Ansatz mit einer
Hoffnung auf Heilung die Resektion von vorwiegend in der Leber gefundenen
Metastasen.(11,12)



Die Phase-III-Studie mit dem Namen EXTREME [e](6) untersucht die
Erstbehandlung mit Erbitux in Verbindung mit einer Chemotherapie (Cisplatin
plus 5-FU oder Carboplatin plus 5-FU) an 442 Patienten mit rekurrenten
und/oder metastatischen SCCHN.



Die Phase-III-Studie FLEX[f] (7) untersucht die Überlebenschancen einer
Erstbehandlung mit Erbitux plus Chemotherapie (Cisplatin und Vinorelbin) im
Vergleich zu einer ausschliesslich durchgeführten Chemotherapie an 1.125
Patienten mit fortgeschrittenem NSCLC.



"Die anlässlich der diesjährigen ASCO Jahrestagung vorgestellten Daten
über Erbitux bekräftigen die überragende Wirksamkeit bei der Erstbehandlung
und späteren Therapien bei Patienten mit metastatischem kolorektalem Krebs
nach zuvor fehlgeschlagener Chemotherapie," sagte Dr. Wolfgang Wein, Senior
Vice President und Leiter der Global Oncology Commercialization' bei der
Merck KGaA. "Die neuen Daten, die beweisen, dass Erbitux jede zweite Woche
verabreicht werden kann, sind für uns auch sehr ermutigend."



Hinweise für Redakteure



Informationen zu ERBITUX



ERBITUX(R) ist ein erstklassiger und sehr aktiver, auf den epidermalen
Wachstumsfaktor-Rezeptor (EGFR) gerichteter IgG1 monoklonaler Antikörper. Als
monoklonaler Antikörper unterscheidet sich die Wirkungsweise von Erbitux
von standardmässigen, nicht selektiven Chemotherapien dadurch, dass er
spezifisch auf den EGFR gerichtet ist und an den EGFR bindet. Diese Bindung
hemmt die Aktivierung des Rezeptors und des nachfolgenden
Signalübertragungspfads und führt somit zu einer Reduktion der Invasion des
gesunden Gewebes durch Tumorzellen und die Distribution von Tumoren an neuen
Stellen. Man geht auch davon aus, dass das Mittel die Fähigkeit von
Tumorzellen hemmt, den durch Chemotherapie und Radiotherapie verursachten
Schaden zu reparieren und die Bildung von neuen Blutgefässen innerhalb von
Tumoren zu hemmen, was zu einer allgemeinen Unterdrückung des Tumorwachstums
zu führen scheint. Die am häufigsten gemeldete Nebenwirkung von Erbitux ist
ein akneähnlicher Hautauschlag, der mit dem guten Ansprechen auf die Therapie
zusammenzuhängen scheint. Bei etwa fünf Prozent der Patienten kann während
der Behandlung mit Erbitux eine Überempfindlichkeit festgestellt werden; rund
die Hälfte davon ist schwerwiegend.



Erbitux ist in 53 Ländern bereits zur Behandlung von Patienten mit
EGFR-positivem metastasierendem kolorektalem Karzinom, das auf
Irinotecan-Therapien nicht mehr anspricht, zur Anwendung in Kombination mit
Irinotecan zugelassen: der Schweiz, den USA, Mexiko, Argentinien, Chile,
Island, Norwegen, der Europäischen Union, Peru, Australien, Kroatien, Israel,
Bulgarien, Panama, Guatemala, Kolumbien, Singapur, Hongkong, Südkorea,
Kanada, Ecuador, Malaysia, den Philippinen, Taiwan, China, Indien, Libanon,
Venezuela und Nicaragua. In den USA, Argentinien, Chile, Mexiko, Peru,
Singapur, Australien, Panama, Kolumbien, Guatemala, Hongkong, Kanada,
Ecuador, den Philippinen, Libanon, Venezuela und Nicaragua ist Erbitux auch
als Monowirkstoff zugelassen.



Ferner ist Erbitux in Kombination mit einer Radiotherapie zur Behandlung
lokal fortgeschrittener Plattenepithelkarzinome des Kopfes und Halses (SCCHN)
in der Schweiz, Argentinien, Kolumbien, den USA, der Europäischen Union,
Norwegen, Island und den Philippinen zugelassen. In Argentinien, den USA und
den Philippinen ist Erbitux auch als Monotherapie bei Patienten mit
rekurrenten und/oder metastatischen SCCHN zugelassen, die auf frühere
Chemotherapien nicht mehr angesprochen haben.



Informationen zur Merck KGaA



Die Merck KGaA, Darmstadt, hat die Lizenz zur Vermarktung von Erbitux
ausserhalb der USA und Kanada im Jahre 1998 von ImClone Systems Incorporated
of New York erworben. In Japan teilt sich die Merck KGaA das exklusive
Marketing-Recht mit ImClone Systems.



Die Merck KGaA ist dem stetigen Fortschritt der Behandlungsmethoden in
der Onkologie verpflichtet. Derzeit untersucht das Unternehmen neuartige
Therapien in zielgerichteten Bereichen, wie z. B. dem Einsatz von Erbitux
beim kolorektalen Karzinom, Plattenepithelkarzinom im Kopf- und Nackenbereich
und nicht kleinzelligen Bronchialkarzinom. Die Merck KGaA hat auch die Rechte
zur Behandlung von Krebs mit UFT(R) (Tegafur-Uracil) erworben - einer oralen
Chemotherapie, die mit Folinsäure (FA) zur Erstbehandlung von metastatischem
kolorektalem Krebs verabreicht wird.



Die Merck KGaA untersucht zurzeit unter anderen Krebstherapien auch den
Einsatz von Stimuvax(R) (zuvor als BLP25 Liposom-Impfstoff bezeichnet) bei
der Behandlung von nicht kleinzelligem Bronchialkarzinom. Der Impfstoff
befindet sich seit September 2004 im beschleunigten Zulassungsverfahren der
FDA. Merck erwarb die exklusiven weltweiten Lizenzen von Biomira Inc. in
Edmonton, Alberta, Kanada mit Ausnahme von Kanada, wo die Unternehmen sich
die Rechte teilen.



Quellenangaben:



1. Wilke H et al. Poster-Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006; ID-Nummer 3549



2. Venook A et al. Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006; ID-Nummer 3509



3. Tabernero J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 3085



4. Abubakr Y et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006: ID-Nummer 3556



5. Láng I et al. Poster-Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006: ID-Nummer 3555



6. Vermorken J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 5537



7. Von Pawel J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 7109



8. Diaz Rubio E et al. Vortrag auf der ASCO Jahrestagung, Orlando,
Florida, 2005: Abstr. 3535



9. Folprecht G et al. Cetuximab and irinotecan/5-fluorouracil/folinic
acid is a safe combination for the first-line treatment of patients with
epidermal growth factor receptor expressing metastatic colorectal carcinoma.
Ann Oncol 2006; 17: 450-456



10. Peeters M et al. Eur J Cancer 2005; Supplement 3: Abstract 664



11. Macdonald JS. Adjuvant Therapy of Colon Cancer. CA Cancer
J Clin 1999; 49 (4), 202-219.



12. Mineo TC et al. Long term results after resection of
simultaneous and sequential lung and liver metastases from colorectal
carcinoma. J Am Coll Surg 2003; 197: 386-391.



Sämtliche Pressemitteilungen der Merck KGaA werden zeitgleich mit der
Publikation im Internet per eMail versandt. Nutzen Sie bitte die Webadresse
http://www.subscribe.merck.de, um sich online zu registrieren, die getroffene
Auswahl zu ändern oder den Service wieder zu kündigen.



Merck ist ein weltweit tätiges Pharma- und Chemieunternehmen mit einem
Umsatz von EUR 5,9 Mrd. im Jahre 2005. Die Firmengeschichte begann im Jahr
1668 und die Zukunft wird von 29.133 Mitarbeitern in 54 Ländern gestaltet.
Der Erfolg von Merck wird durch Innovationen unternehmerisch denkender
Mitarbeiter geprägt. Merck bündelt die operativen Tätigkeiten unter dem Dach
der Merck KGaA, an der die Familie Merck zu 73% beteiligt ist und freie
Aktionäre den restlichen Anteil von 27% halten. Die einstige
US-Tochtergesellschaft Merck & Co. ist seit 1917 ein von der Merck-Gruppe
vollständig unabhängiges Unternehmen.



[a] Monoclonal Antibody Erbitux in a European Pre-License Study



[b] The Cancer and Leukemia Group B



[c] European Prospective Investigation of Cancer



[d] Cetuximab combined with iRinotecan in first-line therapY for
metaSTatic colorectAL cancer



[e] ErbituX in first-line Treatment of REcurrent or MEtastatic head &
neck cancer



[f] First-line in Lung cancer with ErbituX




Merck

 

 



GPC Biotech : ASCO-Konferenz

GPC Biotech hat auf der ASCO-Konferenz in Atlanta neue Informationen zum Krebsmedikament Satraplatin bekannt gegeben. So ist Satraplatin bei leichter und mittlerer Beeinträchtigung der Leberfunktion gut verträglich. Die häufigsten Nebenwirkungen betreffen das Blutbild. Auch bei Patienten mit fortgeschrittenen Tumoren und eingeschränkter Nierenfunktion soll das Medikament gut verträglich sein.

AktienEinblick.de

06.06.2006 12:52  

Anmerkung zu Posting 58: Satraplatin von GPC ist ein Platinderivat, derzeit in Phase III Studien,
(kleines Molekül ->Chemotherapie) also  kein Antikörper.      GPC hat auch einen Antikörper von Morphosys in der Pipe, allerdings erst in Phase 1 (siehe oben).

 

http://biz.yahoo.com/prnews/060627/sftu075.html?.v=58


Press Release Source: Genentech, Inc.


Phase III Study of Avastin(R) in Advanced Pancreatic Cancer Does Not Meet Primary Endpoint
Tuesday June 27, 1:30 am ET  
Genentech Remains Committed to Broad Avastin Development Program in Multiple Tumor Types and Stages of Disease


SOUTH SAN FRANCISCO, Calif., June 27 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) today announced that a Phase III trial of Avastin® (bevacizumab) in combination with gemcitabine chemotherapy as first-line treatment for advanced pancreatic cancer did not meet its primary endpoint of overall survival. The trial was stopped at the recommendation of an independent data monitoring board based on an interim analysis indicating that it is very unlikely that significant differences in overall survival will be shown between treatment arms as the data mature. The study was not stopped due to safety events and no new safety concerns related to Avastin were observed in this trial. Data from the study will be presented at an upcoming medical meeting.
ADVERTISEMENT


"We are disappointed in these results and will be evaluating the data to understand potential reasons why Avastin did not add a clinical benefit in this trial," said Hal Barron, M.D., senior vice president, Development and chief medical officer for Genentech. "Chemotherapy has had a limited impact in advancing outcomes for patients with pancreatic cancer, and treatments that may improve survival are desperately needed. We will continue to explore novel biologic and targeted therapy approaches that may lead to improved clinical outcomes for patients with pancreatic cancer."

This randomized, controlled study of 602 patients was sponsored by the National Cancer Institute (NCI) and conducted by a network of researchers led by the Cancer and Leukemia Group B (CALGB). The trial was initiated based on results from a single-arm Phase II study combining Avastin with gemcitabine in pancreatic cancer. The Phase II study results were first presented in 2003 at the annual meeting of the American Society of Clinical Oncology.

Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. As part of this program, a randomized Phase III study evaluating the addition of Avastin to a standard regimen of gemcitabine and Tarceva® (erlotinib) in patients with pancreatic cancer is currently being conducted by Roche.

Avastin, in combination with intravenous 5-FU-based chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) in February 2004 for first-line treatment of patients with metastatic colorectal cancer, and received approval in June 2006 for second-line treatment of colorectal cancer. The company recently submitted supplemental Biologics License Applications (sBLA) to the FDA for Avastin in advanced non-small cell lung cancer, other than predominant squamous histology (April 2006), and for locally recurrent or metastatic breast cancer (May 2006).

About the CALGB 80303 Trial

This randomized, placebo-controlled, multi-center trial, known as CALGB 80303, was sponsored by the NCI, part of the National Institutes of Health (NIH), under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB. In this study, 602 patients were enrolled at approximately 200 sites and were randomized to receive treatment with gemcitabine plus Avastin or gemcitabine plus placebo as a first-line therapy. Patients who had received prior chemotherapy for metastatic disease, adjuvant chemotherapy within the previous four weeks or any prior treatment with gemcitabine or Avastin in the adjuvant or metastatic setting were excluded. Patients with a prior history of bleeding events and those who had a surgical procedure, open biopsy, or significant traumatic injury 28 days prior were also excluded from the study. The statistical plan included pre-specified futility analyses that were conducted and reviewed by an independent data monitoring board.

About Avastin

Avastin is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, a process that is thought to be critical to a tumor's growth and metastasis. For full prescribing information and boxed warnings on Avastin and information about angiogenesis, visit http://www.gene.com. For more information on Avastin, visit http://www.avastin.com.

Avastin, in combination with intravenous 5-FU-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum. The FDA first approved Avastin on February 26, 2004 as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Approval was based on data from two trials. The pivotal trial was a large, placebo-controlled, randomized study that demonstrated a prolongation in the median survival of patients treated with Avastin plus the IFL (5-FU/leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). The addition of Avastin to IFL improved overall survival by 52 percent (based on a hazard ratio of 0.66). In addition, this study demonstrated an improvement in progression-free survival of more than four months (10.6 months in the Avastin/IFL arm compared to 6.2 months in the IFL-alone arm).

Avastin Safety Profile

Avastin has a well-established safety profile. In Genentech-sponsored studies, the most serious adverse events associated with Avastin were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome and congestive heart failure. The most common adverse events in receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

About the Avastin Development Program

Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, pancreatic, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. In April 2006, Genentech submitted an sBLA for Avastin plus platinum-based chemotherapy for first-line treatment of advanced non-small cell lung cancer other than predominant squamous histology. In May 2006, Genentech submitted an sBLA for Avastin in combination with taxane chemotherapy for patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer. For further information about Avastin clinical trials, please call 888-662-6728.

About VEGF and Tumor Angiogenesis

Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. The link between angiogenesis and cancer growth has been discussed by many researchers for decades. It wasn't until 1989 that a key growth factor influencing the process, VEGF, was discovered by Napoleone Ferrara, M.D., a staff scientist at Genentech. Dr. Ferrara and his team at Genentech cloned VEGF, providing some of the first evidence that a specific angiogenic growth factor existed. This research was published in the journal Science in 1989. Dr. Ferrara then created a mouse antibody to this protein.

In 1993, in a study published in Nature, Dr. Ferrara and his team demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play a critical role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.

About Pancreatic Cancer

The American Cancer Society estimates 33,730 Americans will be diagnosed with pancreatic cancer and 32,300 will die of the disease in 2006. Pancreatic cancer, characterized by early, distant spread, is the fourth leading cause of cancer death in the United States. For patients with advanced pancreatic cancer, the five-year survival rate across all stages is less than 1 percent, with most patients dying within one year of diagnosis.

About Genentech BioOncology

Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is conducting clinical development programs for Rituxan® (Rituximab), Herceptin® (Trastuzumab), Avastin® (bevacizumab), and Tarceva® (erlotinib), and markets all four products in the United States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan) or OSI Pharmaceuticals, Inc. (Tarceva).

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell death), the HER pathway, and B-cell biology. An investigational antibody directed at the HER pathway is currently in Phase II trials. In early development, are a small molecule directed at the hedgehog pathway and an investigational agent targeting apoptosis.

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

For the full prescribing information for Tarceva and the full prescribing information and Boxed Warnings for Rituxan, Herceptin, and Avastin, please visit http://www.gene.com.


   Media Contact:        Kristina Becker    650-467-6450
   Investor Contact:     Diane Schrick      650-225-1599
   Advocacy Contact:     Kristin Reed       650-467-9831



 

http://www.marketwatch.com/News/Story/...2Fyhoo&dist=yhoo&siteid=yhoo

Genentech's eye treatment gets FDA OK

E-mail | Print |  | Disable live quotes By Carolyn Pritchard, MarketWatch
Last Update: 4:23 PM ET Jun 30, 2006


SAN FRANCISCO (MarketWatch) -- Genentech Inc. on Friday said its treament for wet age-related macular degeneration, the leading cause of blindness in the elderly, was granted approval by the Food and Drug Administration.
Shares of Genentech (DNA : genentech inc com new
News , chart, profile, more
Last: 81.80+1.67+2.08%

4:42pm 06/30/2006

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
DNA81.80, +1.67, +2.1%) finished higher by 2.1%, at $81.80.
The South San Francisco, Calif. biotech company's application was granted priority review by the agency at the end of December, which gave the FDA six months to decide whether or not to approve Lucentis.
The application was based on data from Phase III studies that showed the treatment not only maintained the vision of the majority of wet AMD patients, but in some cases, improved it.
"We are thrilled that after nearly a decade of rigorous study, Lucentis is approved, and we look forward to getting it to patients quickly," company spokeswoman Dawn Kalmar said. Shipments will start today.
Genentech said on a conference call that it has priced Lucentis at $1,950 a vial and is estimating the average dosage will be five to seven times a year. That would bring the average annual cost of the treatment to $9,750 to $13,650 a year.
Lucentis will enter a marketplace that includes Visudyne, an intravenously injected, light-activated treatment made by a QLT Therapeutics (QLTI : qlt inc com
News , chart, profile, more
Last: 7.08-0.10-1.39%

4:31pm 06/30/2006

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
QLTI7.08, -0.10, -1.4%) and Novartis AG (NVS : novartis a g sponsored adr
News , chart, profile, more
Last: 53.92+0.51+0.95%

4:26pm 06/30/2006

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
NVS53.92, +0.51, +1.0%) .
But it is likely to compete more closely with Macugen, made by Pfizer Inc. (PFE : Pfizer Inc
News , chart, profile, more
Last: 23.47+0.23+0.99%

4:41pm 06/30/2006

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
PFE23.47, +0.23, +1.0%) and Eyetech Pharmaceuticals Inc., which was acquired last year by OSI Pharmaceuticals Inc. (OSIP : osi pharmaceuticals inc com
News , chart, profile, more
Last: 32.96-0.52-1.55%

4:47pm 06/30/2006

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
OSIP32.96, -0.52, -1.6%) . Both Macugen and Lucentis are delivered directly into the eye via injection and work by binding to a protein believed to play a critical role in the formation of new blood vessels.
Wet AMD is caused by the growth of abnormal blood vessels that leak and bleed and cause blindness-inducing scar tissue. Serious vision loss by the more common, dry form of AMD is rare.
Lucentis will be also be competing against one of Genentech's own drugs, Avastin, which is approved to treat colorectal cancer but which company executives have acknowledged is increasingly being used by ophthalmologists as an "off-label" treatment for wet AMD.
The company has no plans to seek approval for Avastin to be used to treat the eye condition. "Our interpretation of Avastin use [for AMD] is it tells you how big of an unmet need there is," Genentech's president of product development, Susan Desmond-Hellman, told MarketWatch in an interview back in January. See full story.
Lucentis was developed by Genentech and Novartis AG, which maintains commercial rights to it outside of North America.  
 

 http://biz.yahoo.com/prnews/060629/sfth012.html?.v=55

Press Release Source: Dendreon Corporation


Dendreon Announces Publication of Pivotal Phase 3 Study Highlighting Survival Benefit and Safety Profile of PROVENGE in Men With Advanced Prostate Cancer
Thursday June 29, 6:00 pm ET  
First Cancer Immunotherapy to Demonstrate a Survival Benefit in a Randomized Phase 3 Study
Company Plans to Submit BLA to U.S. Food and Drug Administration Later This Year


SEATTLE, June 29 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the publication of the results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in the July issue of the Journal of Clinical Oncology. The article highlights the significant survival benefit and favorable safety profile of PROVENGE, the Company's investigational active cellular immunotherapy, in men with advanced androgen-independent prostate cancer. The Company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) later this year to obtain approval to market PROVENGE.
ADVERTISEMENT


"This trial is an important milestone in the development of new treatments for prostate cancer patients. The survival benefit that was observed has the potential to offer important benefits to patients, and represents the first time an immunotherapy has provided a survival advantage in prostate cancer," said Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco and lead author of the publication. "In addition to the observed survival benefit, PROVENGE has a very favorable toxicity and safety profile, with the most common side effects being low grade fevers and chills. A favorable benefit-to-risk profile will be appealing to patients with advanced stage prostate cancer who currently have few appealing treatment options available to them."

The double-blind, placebo-controlled Phase 3 Study D9901 showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo. These data will form the basis of the Company's BLA to the FDA for marketing approval, which the Company plans to submit later this year.

Patients in the PROVENGE arm had a 31 percent delay in their time to disease progression compared to patients in the placebo arm (p-value = 0.052; HR = 1.45). Furthermore, patients receiving PROVENGE had an approximately 8-fold increase in their T-cell immunity after treatment compared to the placebo group (p < 0.001).

"The survival benefit demonstrated in this trial, combined with the favorable safety profile of PROVENGE, will form the basis for our BLA submission to the FDA later this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We look forward to making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer."

The D9901 study was conducted at 19 institutions in the United States and enrolled 127 men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer. Patients were randomized in a 2:1 ratio to receive three infusions of PROVENGE (n=82) or placebo (n=45) every two weeks for a total of three infusions over a one month period.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

About PROVENGE (sipuleucel-T)

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95 percent of prostate cancers. PROVENGE is in late-stage development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon's lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre-clinical development, which is over-expressed in breast, prostate, lung and colon cancers. For more information about the Company and its programs, visit www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.




--------------------------------------------------
Source: Dendreon Corporation  

Da beschleicht mich das ungute Gefühl, dass die FDA sich Zeit lässt, bis die AMIS auch soweit sind und die 3. Phase abgeschlossen haben. Gefällt mir überhaupt nicht. Ist das der Grund, warum GPC im Kurs nicht vorankommen und auch PHARMION in USA auf der Stelle treten? Wer weiss Näheres ?  

Buckyball-Antibody Combination Delivers Antitumor Drugs

Combining a monoclonal antibody known to target melanoma tumors with multiple C60 buckyballs, researchers at Rice University and the University of Texas M. D. Anderson Cancer Center have developed a new way to deliver multiple drugs simultaneously to tumors. Unlike other methods that use multiple targeting agents, such as antibodies, to deliver individual drug-loaded nanoparticles to malignant cells, this new approach attaches multiple nanoparticles to an individual tumor-targeting antibody.

In research published in the journal Chemical Communications, Lon Wilson, Ph.D., and colleagues at Rice University, working with Michael Rosenblum, Ph.D., and collaborators at The M. D. Anderson Cancer Center, describe the methods they used to attach as many as 40 water-soluble buckyballs onto a single antibody known as ZME-018. The M. D. Anderson Cancer Center investigators had already shown that ZME-018, which binds to a tumor protein known as gp240, will deliver anticancer drugs into melanoma tumors, while the Rice group has been developing buckyballs as drug delivery agents.

One potential advantage of attaching multiple nanoparticles to a single antibody is that it may be possible to load a different anticancer drug into each nanoparticle. "The idea that we can potentially carry more than one Taxol? per buckyball is exciting, but the real advantage of fullerene immunotherapy over other targeted therapeutic agents is likely to be the buckyball's potential to carry multiple drug payloads, such as Taxol? plus other chemotherapeutic drugs," said Wilson. "Cancer cells can become drug resistant, and we hope to cut down on the possibility of their escaping treatment by attacking them with more than one kind of drug at a time."

While it's possible to attach drug molecules directly to antibodies, researchers have not been able to attach more than a handful of drug molecules to an antibody without significantly changing its targeting ability. That happens, in large part, because the chemical bonds that are used to attach the drugs -- strong, covalent bonds -- tend to block the targeting centers on the antibody's surface. If an antibody is modified with too many covalent bonds, the chemical changes will destroy its ability to recognize the cancer it was intended to attack.

The investigators originally had planned to overcome this limitation by attaching multiple molecules of the anticancer agent paclitaxel to each buckyball, which would then be connected chemically to the antibodies. To the team members' surprise, many more buckyballs than expected attached themselves to the antibody. Moreover, the buckyballs stuck tightly to the antibodies without the need to form chemical bonds, so the increased payload did not significantly change the targeting ability of the antibody.

This work is detailed in a paper titled, "Fullerene (C60) immunoconjugates: interaction of water-soluble C60 derivatives with the murine anti-gp240 melanoma antibody." This paper was published online in advance of print publication. An abstract of this paper is available at the journal's website. View abstract.

http://nano.cancer.gov

http://www.azonano.com/news.asp?newsID=2546  

Da wir grade beim thema 'der Antikörper als Transportvehikel für Tumorzellenkillersubstanzen' sind (voriges Posting) passt vielleicht auch folgendes dazu:

http://www.stock-world.de/news/article.m?news_id=2111562

Biotest schließt Lizenzvereinbarung für Krebsantikörper
11.07.06 14:55

Die Biotest AG hat sich über eine Kooperations- und Lizenzvereinbarung mit der ImmunoGen, Inc., Cambridge, MA (USA), die weltweiten Vermarktungsrechte für die in Entwicklung befindliche Krebstherapie (DM-Toxine) in Verbindung mit dem eigenen monoklonalen Antikörper BT-062 gesichert. Dies gab das Pharma-, Biotherapeutika- und Diagnostikunternehmen am Dienstag bekannt.Im Rahmen der Vereinbarung erhalte Biotest für ein bestimmtes Antigen die exklusiven Nutzungsrechte an der Tumor-Activated-Prodrug (TAP) Technologie von ImmunoGen. Bei dieser Technologie würden Tumorzellen mit Hilfe eines Immunkonjugats bekämpft, das sich aus dem Antikörper von Biotest sowie einem Toxin von ImmunoGen zusammensetzt. Der hochspezifische Antikörper bindet selektiv an Tumorzellen, die dann vom Zellgift zerstört werden. Diese neuartige Therapie soll in der Indikation Multiples Myelom sowie in weiteren Krebserkrankungen entwickelt werden.Im Rahmen der Vereinbarung werde Biotest an ImmunoGen eine Upfront-Zahlung in Höhe von 1 Million US-Dollar leisten (knapp 800.000 Euro). Weitere Zahlungen seien vom Erreichen definierter Meilensteine während der Entwicklung und Zulassung abhängig. Die Meilenstein-Zahlungen können eine Gesamtsumme von maximal 35,5 Millionen US-Dollar (rund 28 Millionen Euro) erreichen, teilte Biotest mit. Darüber hinaus sei ImmunoGen prozentual an den Produktumsätzen beteiligt.Für den US-amerikanischen Markt habe ImmunoGen die Option, sich gegen Zahlung einer Gebühr an Biotest unmittelbar hälftig an der Entwicklung und Vermarktung des Immunkonjugats zu beteiligen. Die Höhe dieser Gebühr betrage abhängig vom Entwicklungsstadium 5 Millionen bzw. 15 Millionen US-Dollar. Im Falle der Ausübung der Option verliert ImmunoGen den Anspruch auf Lizenzzahlungen für den US-amerikanischen Markt und alle weiteren von Biotest noch nicht entrichteten Meilensteinzahlungen. Biotest strebt auch in weiteren Ländern Entwicklungs- und Vertriebspartnerschaften an, um den Forschungs- und Entwicklungsaufwand zu begrenzen und zugleich die zügige weltweite Vermarktung des Biotherapeutikums auf Basis von BT-062 sicherzustellen.
 

 
   http://biz.yahoo.com/ap/060724/britain_drug_trials.html?.v=1

AP
Britain Seeks Tighter Drug Trial Rules
Monday July 24, 9:12 am ET

                    §
British Drug Industry Proposes Stricter Clinical Trial Guidelines
LONDON (AP) -- Britain's pharmaceutical industry on Monday proposed strict new guidelines for testing some experimental drugs after a disastrous trial that left six men in comas.
In March, six healthy volunteers participated in a trial for test drug TGN1412, designed to treat leukemia, autoimmune and inflammatory diseases. Within hours of being given doses of the drug they suffered convulsions, organ failure and ultimately lapsed into comas.

ADVERTISEMENT

A report by the Association of the British Pharmaceutical Industry and the BioIndustry Association, the industry's two largest trade associations, proposed that drugs which stimulate the immune system should be subject to strict new safety standards when they are tested on humans for the first time.
The groups recommended that trials of drugs such as TGN1412 should be staggered, with only one person receiving the drug on the first day.
Their report also said trials should only be carried out at hospitals with intensive care facilities which are able to deal with unforeseen problems.
Martyn Day, a lawyer who represents four of the TGN1412 trial volunteers, said the report "starts the process of learning from this dreadful tragedy which has caused the six young victims to have such a terrible cloud hanging over their lives."
German drug maker TeGenero AG, which produced TGN1412, filed for bankruptcy protection earlier this month.

 

http://biz.yahoo.com/ap/060828/biogen_clinical_trial.html?.v=2
AP
Biogen, Genentech See Solid Rituxan Data
Monday August 28, 11:16 am ET  
Biogen Idec, Genentech Say Rituxan Passes Mid-Stage Trial in Multiple Sclerosis Study


NEW YORK (AP) -- Drug makers Biogen Idec Inc. and Genentech Inc. said Monday a mid-stage study of Rituxan showed it was effective in treating multiple sclerosis.
The Food and Drug Administration originally approved the drug in 1997 for the treatment of cancer. It was developed by Cambridge, Mass-based Biogen and is co-marketed with South San Francisco, Calif-based Genentech in the United States.

ADVERTISEMENT


The companies said the treatment reached its primary endpoint in reducing the number of gadolinium enhancing T1 lesions, or indicators of relapsing forms of MS, in a 104-patient study. The clinical trial compared Rituxan to a placebo and took place over 24 weeks.

Patients involved in the study will be followed for an additional 48 weeks as the companies monitor the long-term safety affects of the treatment.

MS, an autoimmune disease, is the leading cause of neurological disorders in young adults, the companies said, with the relapsing form of the disease accounting for 65 percent of all MS cases.

Shares of Genentech added 11 cents to $80.11 in morning trading on the New York Stock Exchange, while shares of Biogen rose 40 cents to $44.68 on the Nasdaq.


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

http://biz.yahoo.com/prnews/060828/sfm054.html?.v=62

Press Release Source: Genentech, Inc.


Genentech and Biogen Idec Announce Positive Results From a Phase II Trial of Rituxan in Relapsing-Remitting Multiple Sclerosis
Monday August 28, 9:00 am ET


SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., Aug. 28 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) and Biogen Idec, Inc. (Nasdaq: BIIB - News) announced today that a Phase II study of Rituxan® (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
ADVERTISEMENT
 


"These initial results exceeded our expectations," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "Showing a significant benefit at 24 weeks in this small Phase II trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."

"Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec.

Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. Serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis. The overall rates of infection were comparable among the two treatment groups with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections and sinusitis in the Rituxan-treated patients. There were more first infusion-related reactions with Rituxan, the majority of which were mild to moderate and were generally reversible with medical intervention. The companies continue to monitor the long-term safety of Rituxan treatment.

About the Study

This Phase II randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with RRMS. A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo. Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.

About MS and RRMS

MS is a chronic autoimmune disease in which the immune system is thought to attack the body's own myelin, a fatty substance that surrounds and protects the nerve fibers of the brain, optic nerves and spinal cord. There are four types of MS with a wide variety of symptoms and different courses of disease progression.

MS is the leading cause of neurological disability in young adults. Neurological disability typically accumulates over time and includes muscle weakness and spasticity, balance and coordination problems, as well as memory impairment and depression. Other symptoms include numbness, pain, slurred speech and blurred vision. Many patients experience fatigue and problems with bladder, bowel or sexual function.

RRMS is the most common form of MS and accounts for approximately 65 percent of all MS cases. RRMS is characterized by acute exacerbations with full or partial recovery between attacks. The disease does not progress between attacks.

Rituxan Safety Profile in Oncology and Autoimmune Diseases

The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of eight years.

In general, the adverse events observed in patients with RA, an autoimmune disease, were similar in type to those seen in patients with non-Hodgkin's lymphoma (NHL). The most common adverse events observed in patients treated with Rituxan for RA in clinical trials were infusion reactions and infections. No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events or risk of opportunistic infections (including tuberculosis) in Rituxan-treated patients over 24 weeks of treatment. Although 5 percent of Rituxan-treated patients developed human anti-chimeric antibodies (HACA), this was not associated with loss of clinical response or additional safety observations.

The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema, hypotension and hypoxia. These symptoms vary in severity and generally are reversible with medical intervention.

Severe infusion reactions have been reported in patients treated with Rituxan, some with fatal outcomes in patients with NHL. These severe reactions typically occur during the first infusion. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. Patients who develop clinically significant infusion reactions should have their Rituxan infusion discontinued and receive medical treatment. Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of tumor lysis syndrome following treatment with Rituxan. Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Patients experiencing a severe mucocutaneous reaction should not receive any further infusions and seek prompt medical evaluation. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell (DLBCL), CD20-positive, non-Hodgkin's lymphoma. Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include Hepatitis B reactivation with fulminant hepatitis, other viral infections, hypersensitivity reactions, and cardiac arrhythmias.

About Rituxan

Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. In addition to RRMS, Rituxan is being studied in primary progressive MS, for which there is currently no FDA-approved therapy. Rituxan is being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and ANCA-associated vasculitis.

Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. In addition, Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients, as well as in combination with methotrexate to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan has more than 960,000 patient exposures worldwide. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com .

About Genentech

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com .

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com .

This press release contains a forward-looking statement regarding the potential of Rituxan to treat MS. Such statement is a prediction and involves risks and uncertainties such that the actual results may differ materially. Among other things, the potential of Rituxan could be affected by unexpected safety, efficacy or manufacturing issues, additional time requirements for data analysis and decision-making, the need for additional clinical studies, discussions with the FDA, FDA actions, failure to receive FDA approval, competition, reimbursement, intellectual property or contract rights, pricing, the ability to supply product, or product withdrawal. Please also refer to Genentech's and Biogen Idec's periodic reports filed with the Securities and Exchange Commission. Genentech and Biogen Idec disclaim, and do not undertake, any obligation to update or revise this forward-looking statement in this press release.


    Media:     Nikki Levy         650-225-1729
    Investor:  Susan Morris       650-225-6523

    Biogen Idec Contacts:
    Media:     Amy Brockelman     617-914-6524
    Investor:  Eric Hoffman       617-679-2812






 

Erbitux bekommt Konkurrenz. ;)

Link zum Artikel

Press Release Source: Amgen


FDA Approves Vectibix(TM) to Treat Patients with Metastatic Colorectal Cancer
Wednesday September 27, 4:47 pm ET  
First Entirely Human Anti-EGFr Antibody Approved by the FDA and Amgen's First Targeted Cancer Therapeutic


THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Amgen (NASDAQ:AMGN - News) today announced that the U.S. Food and Drug Administration (FDA) has approved Vectibix(TM) (panitumumab) following priority review. Vectibix is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.
ADVERTISEMENT


The FDA approval of Vectibix was based on a progression-free survival endpoint. Vectibix is the first anti-EGFr antibody shown to significantly improve progression-free survival in patients with metastatic colorectal cancer. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix can be conveniently administered intravenously once every two weeks.

Vectibix is expected to be commercially available in early-to-mid October and will be priced at approximately 20 percent less than the other anti-EGFr antibody currently on the market.

"Vectibix is the first entirely human antibody for the treatment of colorectal cancer to be approved by the FDA. It provides another option for patients with metastatic colorectal cancer that have progressed on all available chemotherapy regimens," said J. Randolph Hecht, M.D., director of the UCLA Gastrointestinal Oncology Program and clinical professor of Medicine, UCLA David Geffen School of Medicine, Los Angeles. "In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care."

Epidermal growth factor receptors are proteins that play an important role in cancer cell signaling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGF receptors. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.

"Our goal is to fulfill the promise of biotechnology to improve the way cancer is treated," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of Vectibix allows us to build on our strong foundation in supportive care and move forward with our comprehensive approach to helping patients in their fight against cancer."

"One out of 18 people in this country will develop colorectal cancer in their lifetime and 20 percent of colorectal cancers are found after the disease has spread to distant organs." said Amy Kelly, director and co-founder of the Colon Cancer Alliance. "That means that a person in the U.S. is diagnosed with colorectal cancer every four minutes, heightening the need for new therapeutic options such as Vectibix."

Marketing applications were simultaneously submitted to the European Medicines Agency (EMEA) in April 2006 and Health Canada, Australia and Switzerland in May 2006. Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer. For more information please visit www.amgentrials.com.

Important Product Safety Information

As described below, the Vectibix Prescribing Information includes warning language as part of evolving FDA labeling for the anti-EGFr class:

Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.

Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

Other important safety information includes:

The most common adverse reactions to Vectibix were generally mild to moderate and included skin rash with variable presentations, paronychia, fatigue, abdominal pain, nausea and diarrhea. Hypomagnesemia occurred 6 weeks or longer after the initiation of Vectibix. In some patients, hypomagnesemia was associated with hypocalcemia.

Amgen(TM) Oncology Assistance

Amgen has expanded its patient assistance programs into a comprehensive, multifaceted program with a single gateway - Amgen(TM) Oncology Assistance. Through this program, patients who are uninsured, underinsured, or unable to afford their insurance co-payments can receive financial support for Amgen's cancer medicines, including Vectibix. The Amgen Oncology Assistance program will be available for U.S. cancer patients and will launch in October. For more information, please visit www.amgen.com.

About Colorectal Cancer

Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 146,940 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006. Colorectal cancer is the second leading cause of cancer death among men and women in the United States and Canada (after lung cancer). It has been estimated that 56,370 people will die from colorectal cancer in 2006. That means that one person in the United States dies of colorectal cancer every 9.3 minutes.

About Vectibix

Although EGF receptors normally help regulate the growth of many different cells in the body, these receptors also can stimulate cancer cells to grow. In fact, some cancer cells actually require signals mediated by EGF receptors for their survival. Residing on the surfaces of these tumor cells, EGF receptors are activated when naturally occurring proteins in the body, such as epidermal growth factor (EGF) or transforming growth factor alpha (TGF-alpha), bind to them. This binding changes the shape of the EGF receptors, which, in turn, triggers internal cellular signals that stimulate tumor cell growth. Vectibix binds to EGF receptors, preventing the natural ligands such as EGF and TGF-alpha from binding to the receptors and interfering with the signals that might otherwise stimulate growth and survival of the cancer cell.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statement

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while Amgen routinely obtains patents for Amgen's products and technology, the protection offered by Amgen's patents and patent applications may be challenged, invalidated or circumvented by Amgen's competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for Amgen's products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of Amgen's existing products. Amgen or others could identify side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of Amgen's products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.

EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.



Contact:
Amgen
Christine Regan, 805-447-5476 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)
 

Die (vermutlich) 13. Indikation für diesen AK : Psoriasis

  http://www.jnj.com/news/jnj_news/20060926_155540.htm

FDA Approves REMICADE® (Infliximab) For Treatment Of Chronic Severe Plaque Psoriasis: Marks Major Milestone For Patients With High Disease Burden
Nearly Eight Out of 10 Patients Treated With REMICADE® (Infliximab) Achieved 75 Percent Improvement in Psoriasis at Week 10
Horsham, PA (September 27, 2006) ? Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter. In the Phase 3 clinical trial EXPRESS, eight out of 10 patients receiving REMICADE® 5 mg/kg induction therapy achieved 75 percent improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75) by week 10. Similar results were seen with EXPRESS II, the second Phase 3 study. These results were maintained by every eight-week REMICADE® 5 mg/kg maintenance infusions at six months. The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies. More than 1,200 patients participated in the two Phase 3 clinical trials.

"The rapidity and consistency with which REMICADE® can improve clearance of patients' skin is a major step forward for a patient population where persisting unmet needs in treatment exist," said Alice B. Gottlieb, M.D., Ph.D., dermatologist-in-chief, professor of Dermatology, Tufts-New England Medical Center, and pivotal U.S. study investigator. "As a researcher involved in the clinical investigation of REMICADE® for the treatment of psoriasis, I've seen first-hand its significant results in improving psoriasis in the majority of patients treated."

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and emotional distress. It is estimated that as many as 7.5 million people in the U.S. have psoriasis1, which can present in various forms and can range from mild to severe and disabling. Centocor will expand its educational programs to help dermatologists and their patients achieve the benefits of REMICADE® and to help manage and minimize the potential risks of biologic therapies, like REMICADE®.

Data from two multi-center, randomized, double-blind, placebo-controlled trials ? EXPRESS and EXPRESS II ? served as the primary basis for approval. Both EXPRESS and EXPRESS II showed that a majority of patients treated with REMICADE® achieved clinically significant levels of skin clearance with induction and every eight-week maintenance therapy. At week 10 in EXPRESS, 80 percent of patients receiving REMICADE® 5 mg/kg achieved PASI 75 versus three percent of patients receiving placebo (P < 0.001). At week 10 in EXPRESS II, 75 percent of patients receiving REMICADE® 5 mg/kg achieved PASI 75 versus two percent of patients receiving placebo (P < 0.001).

During the controlled periods in EXPRESS and EXPRESS II, adverse events (AEs) occurred at a higher incidence in the REMICADE® groups compared with the placebo groups. In the EXPRESS study, there were more serious adverse events, including one fatal infection, in the REMICADE® group compared to placebo group. In the EXPRESS II study, serious AE rates were similar in the REMICADE® 5 mg/kg and placebo groups. The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® groups compared with the placebo groups were elevated liver enzyme tests. AEs observed in these studies were generally consistent with those described in the prescribing information, including the risk of serious infections. Please see "Important Safety Information" below.

"New biologic treatment options are needed in our struggle to more effectively manage all patients with this lifelong, chronic condition, particularly those that have severe disease," said Alan Menter, M.D., chairman, Division of Dermatology, Baylor University Medical Center, and lead U.S. study investigator. "The approval of REMICADE® offers dermatologists a treatment option that has been clinically proven to rapidly and dramatically clear the skin of patients with a high disease burden."

Psoriasis is most commonly diagnosed between the ages of 20 and 30, striking in the prime of people's lives, and the extent of skin involvement varies from mild to severe and disabling. People with severe psoriasis may have large areas of their body covered by lesions, which may crack and bleed. The pain and embarrassment associated with such skin lesions may prevent people from participating in social and work-related activities, and the physical and mental effects of psoriasis have been compared to those of other chronic illnesses such as rheumatoid arthritis, hypertension, heart disease, diabetes and depression. Skin lesions associated with psoriasis often result in feelings of sadness, despair, guilt and anger, as well as in low self-esteem. A person?s sense of self-worth can be affected, and in some cases, this emotional turmoil can lead to depression.

"The severity of psoriasis is something that can often be misunderstood. Imagine having psoriatic plaques on the soles of your feet, which makes walking painful and difficult. Or, imagine going through life with your face and arms covered in psoriasis and how that would make you feel. These are just a few examples of what some patients must contend with," said Gail Zimmerman, president and CEO, National Psoriasis Foundation. "The approval of REMICADE® is a much needed addition for patients with severe psoriasis."

REMICADE® is the first and only anti-TNF-alpha treatment to receive 13 FDA approvals across inflammatory diseases in gastroenterology, rheumatology and dermatology, and has now been used to treat more than 800,000 patients worldwide, more than all other anti-TNF agents combined. REMICADE® is an advanced biologic treatment for chronic severe plaque psoriasis, requiring as few as six treatments a year after an initial three treatments.

About EXPRESS

The European Infliximab for Psoriasis [REMICADE®] Efficacy and Safety Study (EXPRESS) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE® induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE® 5 mg/kg or placebo administered at weeks zero, two and six, followed by maintenance treatment every eight weeks. The REMICADE® group continued on maintenance treatments every eight weeks. Beginning at week 24, patients randomized to the placebo group were crossed over to receive REMICADE® therapy through week 46.  

In EXPRESS, through week 24, AEs occurred at a higher incidence in the REMICADE® group (82 percent) compared with the placebo group (71 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (six percent), including one fatal infection, in the REMICADE® group than in the placebo group (three percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About EXPRESS II

The Evaluation of Infliximab for Psoriasis in a [REMICADE®] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE® in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE® 3 mg/kg or 5 mg/kg or placebo at weeks zero, two and six. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive REMICADE® 5 mg/kg at weeks 16, 18 and 22, then every eight weeks through week 46.  

In EXPRESS II, through week 14 (the placebo-controlled period), AEs occurred at a higher incidence in the REMICADE® groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease, which results when skin cells over-produce and accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. It is estimated that two percent of the U.S. population has psoriasis, and about 30 percent of people with psoriasis have cases that are considered moderate to severe.

About REMICADE®

REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is the only anti-TNF-alpha treatment approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE® has demonstrated broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE® have been well established in clinical trials over the past 14 years and with more than 800,000 patients treated worldwide through commercial experience.

In the U.S., REMICADE®, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE® is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE® was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE® was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE® was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE® the first and only biologic approved for the treatment of moderate to severe UC. In addition, on May 19, 2006, REMICADE® was approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. This approval establishes REMICADE® as the first and only biologic therapy approved for the treatment of PCD.

REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), UC (5 mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg), REMICADE® is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE® patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE® is a two-hour infusion administered every six weeks, following a standard induction regimen that requires treatment at weeks zero, two and six.

Important Safety Information

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE®. REMICADE® can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE®, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if, you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE® or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease, may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn's disease with REMICADE® have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6-mercaptopurine. If you take REMICADE® or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE®; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE®. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE®, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever or severe fatigue.  

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE®. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE®.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE®. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands and fever or chills. Tell you doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE® are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE® and discuss it with your doctor.

About Centocor, Inc.

Centocor, Inc., is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor, Inc., has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor, Inc., has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc., is a wholly-owned subsidiary of Johnson & Johnson.

1 National Institute of Arthritis and Musculoskeletal and Skin Disorders. Questions and Answers About Psoriasis. U.S. Department of Health and Human Services, National Institutes of Health; 2003. NIH Publication No. 03-5040.

# # #






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

Last Updated: September 27, 2006  

XOMA and Affimed Sign Antibody Cross-License and Collaboration Agreement

BERKELEY, Calif. and HEIDELBERG, Germany, Oct 2, 2006 (PrimeZone Media Network via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA) and Affimed Therapeutics AG announced today that they have signed a cross-license and collaboration agreement for antibody-related technologies. Financial terms were not disclosed.

The agreement provides XOMA with a license under Affimed\'s antibody library patents for antibody discovery purposes, as well as for the development and commercialization of antibodies. In addition, Affimed has agreed to build two customized patient-derived human antibody phage display libraries according to XOMA specifications.

The agreement provides Affimed with a license to use XOMA\'s Bacterial Cell Expression (BCE) technology for research purposes, with an option to acquire a BCE license for production and commercialization of antibodies, in particular for Affimed\'s proprietary TandAb and Flexibody technologies. XOMA also has agreed to provide Affimed with cell line development and process development services specific to a TandAb therapeutic product candidate that Affimed is currently developing.

"Affimed\'s custom libraries represent a powerful addition to XOMA\'s existing collection of the seven leading commercial human antibody phage display libraries. The advantage of patient-derived libraries is their potential to contain unique antibody candidates for the therapeutic area of interest," said Jack Castello, chairman of the board, president and chief executive officer of XOMA. "This collaboration extends XOMA\'s leadership in therapeutic antibodies, providing a single point of access to an even broader fully-integrated antibody discovery and development platform."

"We are delighted to enter into this broad cross-license and collaboration agreement with XOMA," said Rolf H. Gunther MD PhD, chief executive officer of Affimed. "The access to XOMA\'s state-of-the-art BCE technology represents another very important milestone for Affimed and provides new opportunities for the development of Affimed\'s promising recombinant antibody products. In addition to having the rights to use this technology in our development work, we are particularly pleased to have the benefit of XOMA\'s expertise in the development of cell lines and production systems for our TandAb therapeutic candidate."

About Affimed Therapeutics AG

Affimed is a private biopharmaceutical company based in Heidelberg, Germany and specializing in the development of recombinant antibodies -- the fastest growing segment of the pharmaceutical industry. Affimed was founded in May of 2000 by Professor Melvyn Little as a spin-off of his group "Recombinant Antibodies" at the German Cancer Research Centre in Heidelberg.

The strength of Affimed\'s discovery platform lies in three large distinct antibody libraries that are the source of antibody leads which can be produced in a variety of formats from scFv, diabodies, full length antibodies to proprietary tetravalent formats such as Affimed\'s TandAb or Flexibody.

Affimed\'s existing pipeline comprises several very novel antibody formats targeting some potentially very high value cancer targets. Two cancer products are in advanced pre-clinical development. To learn more about Affimed, please visit www.affimed.com

About XOMA and its Bacterial Cell Expression Technology

XOMA is a leader in the discovery, development and manufacture of therapeutic antibodies, with a therapeutic focus that includes cancer and immune diseases. XOMA has royalty interests in RAPTIVA(r) (efalizumab), a monoclonal antibody product marketed worldwide (by Genentech, Inc. and Serono, SA) to treat moderate-to-severe plaque psoriasis, and LUCENTIS(tm) (ranibizumab injection), a monoclonal antibody product marketed worldwide (by Genentech and Novartis AG) to treat neovascular (wet) age-related macular degeneration.

The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display libraries and XOMA\'s proprietary Human Engineering(tm) and BCE technologies. BCE is an enabling technology used to discover and screen, as well as develop and manufacture, recombinant proteins and antibodies for commercial purposes. BCE is also a key technology used in multiple systems for high throughput screening of antibody domains. XOMA scientists were the first to demonstrate the secretion of antibody domains directly from the bacterial cells as fully functional, properly folded molecules. More than 45 companies have signed BCE licenses.

XOMA\'s development collaborators include Lexicon Genetics Inc., Novartis and Schering-Plough Corporation. With a fully integrated product development infrastructure, XOMA\'s product development capabilities extend from preclinical sciences to product launch. The company\'s pipeline also includes proprietary programs in preclinical and clinical development. In addition, XOMA leverages its recombinant protein and antibody production infrastructure through process development and manufacturing contracts with public and private sector organizations. For more information about XOMA\'s product pipeline and antibody product development capabilities and technologies, please visit XOMA\'s website at http://www.xoma.com/.

Certain statements contained herein concerning product development, customized patient-derived libraries, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); uncertainties regarding the status of biotechnology patents; uncertainties as to the cost of protecting intellectual property; changes in the status of the existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; market demand for products; scale up and marketing capabilities; competition; international operations; share price volatility; XOMA\'s financing needs and opportunities and risks associated with XOMA\'s status as a Bermuda company, are described in more detail in XOMA\'s most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA\'s prospects.

http://investors.xoma.com/releasedetail.cfm?ReleaseID=212966  

die einzige aktiengesellschaft auf der welt die monoklonale antikörper herstellt und auf wunsch der pharmaunternehmen designet heisst morphosys. alles andere ist human- oder mäusebasiert. diese methoden werden bald der vergangenheit angehören. Morphosys ist eines der interessantesten deutschen biotechunternehmen.  

Hoffnung auf den Nobelpreis-Blockbuster
von Martin Virtel

Die mit dem Nobelpreis für Medizin ausgezeichnete Entdeckung hat bereits zu einem Biotech-Gründungsboom geführt. Erste Medikamente werden derzeit an Menschen getestet.

Die Amerikaner Andrew Fire und Craig Mello hatten 1997 bei Fadenwürmern einen Mechanismus entdeckt, mit dem Zellen ihre eigenen Gene und die von Viren blockieren. Sie nutzen dazu kleine Schnippsel aus RNA, einer nahen Verwandten der Erbsubstanz DNA. Es stellte sich heraus, dass die so genannte RNA-Interferenz beim Menschen genau so wie beim Wurm funktioniert.

Krankheitserreger könnten also mit Blockade-Molekülen ausgeschaltet, krank machende Erbinformationen neutralisiert werden - so die Hoffnung von Investoren, die in den acht Jahren seit der Veröffentlichung von Fires und Mellos Milliarden Dollar in die Suche nach RNA-Interferenz-Medikamenten investiert haben. "Das kommerzielle Potenzial dieser Entdeckung ist enorm. Ich glaube schon, dass sich Craig und Fire eine ganze Reihe interessanter Patente gesichert haben", sagte Hans Jörnvall vom Nobelkomitee der Nachrichtenagentur dpa.

Pharmakonzerne wie Merck, GlaxoSmithKline und Novartis gehören mit zu den Investoren in die Forschung. Medikamente sind noch keine auf dem Markt, die Hoffnungen sind trotzdem ungetrübt: "Wir glauben, dass RNA-Interferenz eine grundlegende Technologie für eine breite Palette von Anwendungen ist", sagt Douglas Chow, Analyst der auf Biotech spezialisierten Investmentbank Caris in New York. "Unser Ausblick für Sirna und Alnylam ist positiv."


Beide Unternehmen sind an der Nasdaq notiert und erproben bereits RNA-Interferenz-Medikamente an Menschen. Dabei wird die RNA per Spritze oder Pille an den Krankheitsherd gebracht. Sirna hat ein RNA-basiertes Mittel gegen eine seltene Art der Altersblindheit entwickelt: Gene, die dafür sorgen, dass die Netzhaut mit Blutgefäßen zuwächst, werden durch das Mittel ausschaltet. Alnylam testet ein Medikament gegen das Respiratory Syncytial Virus, einen häufigen und für Erwachsene harmlosen Erreger von Atemwegserkrankungen.

Das Virus nutzt RNA als Träger für die eigenen Erbinformationen, deswegen kann das aus RNA hergestellte Medikament das Erbgut des Erregers direkt blockieren. Die Hoffnung ist, den Mechanismus eines Tages auch gegen zwei sehr viel verheerendere RNA-Viren einzusetzen: den Aids-Erreger HIV und das Grippe-Virus. "Gegen Influenza gibt es sehr gute Resultate, allerdings erst im Reagenzglas und bei Tieren", sagt Chow.
Erste Tests bei Menschen erfolgreich

Alle diese Ansätze gehen allerdings davon aus, dass der Patient ständig RNA-Mittel erhält. Eleganter wäre es, wenn ein kranker oder von einem Virus befallener Kärper selbst in die Lage versetzt wird, die heilenden Erbgutschnippsel herzustellen. "Diese systemische Anwendung von RNAi ist die Hoffnung für die Zukunft", sagt Chow. Allerdings birgt diese Anwendung auch neue Risiken: Ein Versuch an Mäusen zeigte, dass sich Zellen unter Umständen selbst zugrunde richten, wenn sie durch Medikamente allzu stark zur Produktion von Blockade-RNA angeregt werden.  

Auch hier  eine weitere Indikation für einen Ak-KLassiker.

http://www.gene.com/gene/news/press-releases/...ethod=detail&id=10107
Mittwoch, Okt 11, 2006


FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer


-- Avastin Is First Therapy to Extend Survival Beyond One Year in Patients with Advanced Non-Small Cell Lung Cancer  --


-- Genentech Expands Patient Access Programs to Include Annual Expenditure Cap for Avastin  --


South San Francisco, Calif. --  11. Oktober 2006 --  Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), the most common type of lung cancer. The approval is based on a Phase III study (E4599) that showed Avastin in combination with chemotherapy resulted in a 25 percent improvement in overall survival compared to chemotherapy alone (based on a hazard ratio of 0.80).
"Bevacizumab, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA-approved therapy ever to extend survival for these patients beyond one year in a large, randomized clinical study," said Alan Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and lead investigator on the E4599 trial. "With this survival benefit, bevacizumab represents an important therapy for many advanced lung cancer patients fighting this difficult disease."

"Lung cancer is responsible for more than one-third of all U.S. cancer deaths, killing more people than breast, prostate, colon, liver and kidney cancers combined," said Laurie Fenton, president of the Lung Cancer Alliance in Washington, D.C. "The approval of Avastin plus chemotherapy is a significant stride in the right direction, and we are pleased that Genentech continues to make lung cancer a priority."

About E4599
The FDA approval for this new indication was based on results from E4599, a randomized, controlled, multi-center trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Patients with mixed histology were excluded if the predominant cell type was squamous. Results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapy had a 25 percent improvement in overall survival, the trial's primary endpoint, compared to patients who received paclitaxel and carboplatin alone (based on a hazard ratio of 0.80). One-year survival was 51 percent in the Avastin plus chemotherapy arm versus 44 percent in the chemotherapy-alone arm. Median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.

The E4599 trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under a Cooperative Research and Development Agreement between NCI and Genentech. The trial was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).

E4599 Safety Analysis
The most common Grade 3-5 (severe) adverse events in Study E4599 seen in Avastin-treated patients were neutropenia (low white blood cell count), fatigue, hypertension (high blood pressure), infection and hemorrhage.

In Study E4599, the rate of pulmonary hemorrhage requiring medical intervention for the paclitaxel and carboplatin plus Avastin arm was 2.3 percent (10/427), compared to 0.5 percent (2/441) for the paclitaxel and carboplatin-alone arm. There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel and carboplatin-plus Avastin arm, as compared to one in the paclitaxel and carboplatin-alone arm.

In previous clinical experience with Avastin in combination with paclitaxel and carboplatin in NSCLC, patients with a specific type of NSCLC called squamous cell carcinoma had a higher risk of experiencing life-threatening or fatal pulmonary bleeding. Squamous cells are a particular kind of cell that form in the lining of the air ducts in the lung. Because of the risk of bleeding attributed to this population, patients with NSCLC classified as predominantly squamous histology were not included in the E4599 trial.

About the New Avastin Annual Expenditure Cap and Genentech's Access to Care Programs
Genentech also announced today that the company plans to initiate a first-of-its-kind program to cap the overall expense of Avastin to $55,000 per year per eligible patient for any FDA-approved indication. The program will be available for eligible patients regardless of whether they are insured. The company plans to launch the new program in January 2007. In addition, the company announced that it has doubled its contribution to independent charities that provide co-pay assistance to a total of $50 million.

"The clinical development program that led to Avastin's three FDA approvals suggested dose and duration vary depending on tumor type," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "The new expenditure cap on Avastin is a step Genentech is taking to address this variability in current and future FDA-approved indications. This new program, along with the increased contribution to independent charities that provide co-pay assistance to patients, continues our 20-year history of commitment to patient access."

The price of Avastin was established in February 2004 upon the FDA approval of the drug for the treatment of first-line colorectal cancer in combination with 5-FU based chemotherapy. At that time, the monthly price of Avastin was set below the standard of care chemotherapy for metastatic colorectal cancer at approximately $4,400.

In advanced lung cancer, a higher dose of Avastin is indicated. This dose was based on clinical data from a randomized dose-ranging Phase II study of Avastin in combination with chemotherapy. Based on this trial, ECOG and NCI selected the higher dose for the pivotal Phase III trial in NSCLC. The typical monthly cost of Avastin at this dose is approximately $8,800 and, based on median progression-free survival as measured in the E4599 trial, the average cost per course of therapy in NSCLC is approximately $56,000.

Avastin is covered by most insurers and Medicare for its approved indications. Genentech's donation to independent co-pay charities helps provide assistance to eligible patients with higher co-pay burdens. For eligible uninsured patients, the Genentech Access to Care Foundation (GATCF) provides Avastin for free.

Genentech has provided more than $850 million in free drug to patients since 1990. In 2005 alone, GATCF supported over 18,000 patients by providing approximately $200 million of free product. To learn more about the GATCF, independent charities that provide co-pay assistance to patients and potential financial assistance options, patients can speak with an Alternative Funding Specialist from Genentech's Single Point of Contact (SPOC) group by calling 888-249-4918 or visiting http://www.SPOConline.com.

About Lung Cancer
According to the American Cancer Society, lung cancer is the single largest cause of cancer deaths among men and women in the U.S. and is responsible for nearly 30 percent of cancer deaths in this country. The American Cancer Society estimates that more than 170,000 Americans will be diagnosed with lung cancer this year, and 162,000 Americans will die of the disease this year. NSCLC is the most common type of lung cancer.

About Avastin
Avastin, in combination with intravenous 5-fluorouracil (FU)-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; and in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC). For full prescribing information and boxed warnings on Avastin and information about angiogenesis, visit http://www.gene.com. For more information on Avastin, visit http://www.avastin.com.

The FDA first approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The National Comprehensive Cancer Network recommends Avastin plus chemotherapy as a standard treatment for the first- and second-line treatment of metastatic colorectal cancer and as a first-line treatment of advanced non-squamous NSCLC.

Avastin Safety
The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome (RPLS), neutropenia and infection, nephrotic syndrome and congestive heart failure. The most common adverse events in patients receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

About the Avastin Development Program
Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. For further information about Avastin clinical trials, please call 888-662-6728.

About VEGF and Tumor Angiogenesis
Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. The link between angiogenesis and cancer growth has been discussed by many researchers for decades; however it was not until 1989 that a key growth factor influencing the process, vascular endothelial growth factor (VEGF), was discovered by Napoleone Ferrara, M.D., a staff scientist at Genentech. Ferrara and his team at Genentech cloned VEGF, providing some of the first evidence that a specific angiogenic growth factor existed. This research was published in the journal Science in 1989. Ferrara then created a mouse antibody to this protein.

In 1993, in a study published in the journal Nature, Ferrara and his team demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play an important role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.

About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is conducting clinical development programs for Rituxan® (Rituximab), Herceptin® (Trastuzumab), Avastin® (bevacizumab), and Tarceva® (erlotinib), and markets all four products in the United States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan) or OSI Pharmaceuticals, Inc. (Tarceva).

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell death), the HER pathway, and B-cell biology. An investigational antibody directed at the HER pathway is currently in Phase II trials. In early development are a small molecule directed at the hedgehog pathway and an investigational agent targeting apoptosis.

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

For the full prescribing information for Tarceva and the full prescribing information and Boxed Warnings for Rituxan, Herceptin, and Avastin, please visit http://www.gene.com.


# # #

 

Was ist eure Meinung bzgl. der Pipeline von Medarex?

6 Produkte in Phase III (d.h. mit verschiedenen Rechten am Markt).
Da könnte doch kräftig was laufen, wenn eine FDA Zulassung kommt.

Gruss biodani  

MEDX entwickelt sich genau so, wie ich mir das vorgestellt habe. Solange jederzeit eine FDA Zulassung oder positive Testresultate ins Haus flattern können, gehts Richtung Norden.  
Spezielles Augenmerk ist bei den Produkten die mit JNJ zusammen entwickelt wurden angebracht. Solche Riesenkonzerne lassen sich Umsatzmillionen nicht gerne entgehen.
Die Barreserven und die Beteiligung an Genmab wirken sich äusserst positiv auf das Risikopotential aus.