Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 161)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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Antwort auf Beitrag Nr.: 38.379.020 von future_trader am 13.11.09 07:56:23Danke für diese wichtige Info. Das sollte nicht untergehen. Bioniche's MCC scheint ein sehr ernsthafter Konkurrent für Eoquin zu sein. Die Daten der Phase I/II sehen sehr gut aus - im relapsed und refractory setting.
In the Phase I/II trial, 55 patients were enrolled. All had been suffering for several years from carcinoma in situ (CIS), one of the most aggressive forms of SBC; their CIS was refractory to the traditional treatments of SBC (BCG and/or chemotherapy). During the study, the patients received one of two doses of MCC - either 4 mg or 8 mg - with evaluation at 3, 6, 12, and 18 months. The complete response at 12 months ranged (depending on the dose) from 43% to 64% of patients having no evidence of disease as demonstrated by cystoscopy, biopsy, and cytology. Only three of the patients in the study had to stop treatment with MCC, which is a much lower proportion than what is normally seen with those receiving BCG treatment, the traditional treatment for CIS.
Also big watch.
Nochmal zur Info: Die bisher von Spectrum veröffentlichten Daten sind minimal und auch gar nicht aussagekräftig. Als ich zu Jahresbeginn gefragt habe wann Phase II Daten zu follow up der Patienten veröffentlicht werden sollen gab es folgende Antwort:
A follow-up manuscript currently is in preparation for the Phase II marker lesion study. We anticipate submission to a journal, peer review, and subsequent publication of the manuscript within the next 12-18 months.
Ich hoffe also, dass wir in 2010 etwas zur Wirksamkeit von Eoquin erfahren werden.
In the Phase I/II trial, 55 patients were enrolled. All had been suffering for several years from carcinoma in situ (CIS), one of the most aggressive forms of SBC; their CIS was refractory to the traditional treatments of SBC (BCG and/or chemotherapy). During the study, the patients received one of two doses of MCC - either 4 mg or 8 mg - with evaluation at 3, 6, 12, and 18 months. The complete response at 12 months ranged (depending on the dose) from 43% to 64% of patients having no evidence of disease as demonstrated by cystoscopy, biopsy, and cytology. Only three of the patients in the study had to stop treatment with MCC, which is a much lower proportion than what is normally seen with those receiving BCG treatment, the traditional treatment for CIS.
Also big watch.
Nochmal zur Info: Die bisher von Spectrum veröffentlichten Daten sind minimal und auch gar nicht aussagekräftig. Als ich zu Jahresbeginn gefragt habe wann Phase II Daten zu follow up der Patienten veröffentlicht werden sollen gab es folgende Antwort:
A follow-up manuscript currently is in preparation for the Phase II marker lesion study. We anticipate submission to a journal, peer review, and subsequent publication of the manuscript within the next 12-18 months.
Ich hoffe also, dass wir in 2010 etwas zur Wirksamkeit von Eoquin erfahren werden.
ASH Symposium Friday Morning Symposium:
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Morning Symposia
December 4, 2009 7:00 AM - 11:00 AM
New Developments in Immunotherapy for Hematologic Malignancies
This program is sponsored by the University of Medicine and Dentistry of New Jersey and supported by Millennium Pharmaceuticals, Inc., and the Leukemia and Lymphoma Society.
Location: Ernest N. Morial Convention Center, Room 393-396
Speakers: Ronald Levy, MD, Stanford University, Stanford, CA
Oliver W. Press, MD, PhD, Fred Hutchinson Cancer Center, Seattle, WA
Carl H. June, MD, Abramson Family Cancer Research Institute at the University of Pennsylvania, Philadelphia, PA
Hyam I. Levitsky, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Michel Sadelain, MD, PhD, Memorial Sloan-Kettering Cancer Center, New York, NY
This symposium will cover topics in the area of immunotherapy, including studies of radio-labeled monoclonal antibodies for hematologic malignancies, immunological checkpoint modulation for lymphoma, adoptive T-cell therapy, and genetically enhanced T-lymphocyte studies. The goal of the program will be to provide hematologists, oncologists, and other health-care professionals with a better understanding of immunotherapy, as well as to improve their ability to select appropriate therapies in this promising area of research and treatment.
For more information, contact Jeanne Fryar, Robert Michael Educational Institute.
Phone: 856-672-3354
Fax: 856-546-7030
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Morning Symposia
December 4, 2009 7:00 AM - 11:00 AM
New Developments in Immunotherapy for Hematologic Malignancies
This program is sponsored by the University of Medicine and Dentistry of New Jersey and supported by Millennium Pharmaceuticals, Inc., and the Leukemia and Lymphoma Society.
Location: Ernest N. Morial Convention Center, Room 393-396
Speakers: Ronald Levy, MD, Stanford University, Stanford, CA
Oliver W. Press, MD, PhD, Fred Hutchinson Cancer Center, Seattle, WA
Carl H. June, MD, Abramson Family Cancer Research Institute at the University of Pennsylvania, Philadelphia, PA
Hyam I. Levitsky, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Michel Sadelain, MD, PhD, Memorial Sloan-Kettering Cancer Center, New York, NY
This symposium will cover topics in the area of immunotherapy, including studies of radio-labeled monoclonal antibodies for hematologic malignancies, immunological checkpoint modulation for lymphoma, adoptive T-cell therapy, and genetically enhanced T-lymphocyte studies. The goal of the program will be to provide hematologists, oncologists, and other health-care professionals with a better understanding of immunotherapy, as well as to improve their ability to select appropriate therapies in this promising area of research and treatment.
For more information, contact Jeanne Fryar, Robert Michael Educational Institute.
Phone: 856-672-3354
Fax: 856-546-7030
Und dann noch was: Spectrum Pharmaceuticals wird ab Montag, 23.11., in den NASDAQ Biotech Index aufgenommen. Sehr schöne Meldung.
Hier der von mir als wichtigster Punkt des CCs genannte Part bestätigt als SEC Filing (und noch besser: "mehr als 2Mio USD Zevalinabsatz in Oktober"):
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Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On November 13, 2009, Spectrum Pharmaceuticals, Inc. reported, during its investor conference call, that sales of its proprietary oncology product, ZEVALIN, in October were in excess of $2 million. The information in this Current Report on Form 8-K is furnished pursuant to Item 7.01 and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
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Bisher also on-track bzw. sogar leicht über meinen Erwartungen (2 Mio USD mal 3 Monate wären 6 Mio USD für Q4):
Q2 2009 / 3,3
Q3 2009 / 4,7
Q4 2009 / 5,9
Q1 2010 / 7,3 / 21,2
Q2 2010 / 9,2 / 27,1
Q3 2010 / 11,5 / 33,9
Q4 2010 / 14,3 / 42,3
Q1 2011 / 15,8 / 50,8
Q2 2011 / 17,4 / 59,0
Q3 2011 / 19,1 / 66,6
Q4 2011 / 21,0 / 73,2
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Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On November 13, 2009, Spectrum Pharmaceuticals, Inc. reported, during its investor conference call, that sales of its proprietary oncology product, ZEVALIN, in October were in excess of $2 million. The information in this Current Report on Form 8-K is furnished pursuant to Item 7.01 and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
--------------------
Bisher also on-track bzw. sogar leicht über meinen Erwartungen (2 Mio USD mal 3 Monate wären 6 Mio USD für Q4):
Q2 2009 / 3,3
Q3 2009 / 4,7
Q4 2009 / 5,9
Q1 2010 / 7,3 / 21,2
Q2 2010 / 9,2 / 27,1
Q3 2010 / 11,5 / 33,9
Q4 2010 / 14,3 / 42,3
Q1 2011 / 15,8 / 50,8
Q2 2011 / 17,4 / 59,0
Q3 2011 / 19,1 / 66,6
Q4 2011 / 21,0 / 73,2
Antwort auf Beitrag Nr.: 38.385.622 von VaJo am 13.11.09 20:24:15Raj klang aggressiv, aber er sollte sich lieber nicht mit der FDA anlegen. Die sitzt am längeren Hebel. Im Prinzip kann SPPI nichts machen, nur hören was die FDA zu sagen hat. Deswegen schweigt Raj auch bis nach dem Meeting.
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Antwort auf Beitrag Nr.: 38.385.604 von Ville7 am 13.11.09 20:22:15Wenn die Oktober Sales wirklich 2 Mio waren, also das erste Drittel von Q4, dann sind wir gut im Plan von mindestens 25% Wachstum der Sales in gesamt Q4. Vielleicht kommt noch zusätzliche Dynamik rein, durch 1st-line Approval, Sales Force, Reimbursement, TheOncologist Artikel und das ASH Symposium.
Antwort auf Beitrag Nr.: 38.385.604 von Ville7 am 13.11.09 20:22:15Ok danke!
Was meinst Du zu Fusilev. Rajesh klang richtig zuversichtlich.
Was meinst Du zu Fusilev. Rajesh klang richtig zuversichtlich.
Antwort auf Beitrag Nr.: 38.385.596 von Ville7 am 13.11.09 20:21:14TarTia hat das auch so verstanden - siehe seine Notes:
Zevalin Sales:
3rd quarter sales achieved in absence of 1st line.
Keep mentioning Heightened competition.
Zevalin Sales:
3rd quarter sales achieved in absence of 1st line.
Keep mentioning Heightened competition.
Antwort auf Beitrag Nr.: 38.385.567 von VaJo am 13.11.09 20:17:11Ich habe diesen Part ganz anders verstanden. Ich habe es so verstanden, dass sie die 80% plus auf Q-Sicht (Q3 zu Q2) ohne die Wirkung des 1st-line approvals erreicht haben.
Antwort auf Beitrag Nr.: 38.385.553 von VaJo am 13.11.09 20:15:30Ich habe das so verstanden das die 80% mehr innerhalb der 3 wochen nach dem 1st line approval zustande kamen.
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