Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 127)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Antwort auf Beitrag Nr.: 41.406.616 von Ville7 am 23.04.11 21:45:58Kann sein muß aber nicht!
Antwort auf Beitrag Nr.: 41.405.744 von Magnetfeldfredy am 23.04.11 07:23:55Wenn Raj so pusht ist die nächste KE nicht weit.
Antwort auf Beitrag Nr.: 41.405.147 von Ville7 am 22.04.11 16:43:05INTERVIEW-UPDATE 1-Spectrum Pharma CEO eyes oncology growth3:55PM ET on Thursday Apr 21, 2011 by Thomson Reuters
* U.S. Fusilev sales expected to reach $200 mln/year
* Zevalin sales projected to reach $300 million
* Two other drugs in final stages of human trials
* FDA approves ready-to-use Fusilev, shares rise 2.3 pct (Adds FDA approval of ready-to-use Fusilev, share movement)
By Deena Beasley
LOS ANGELES, April 21 (Reuters) - Spectrum Pharmaceuticals Inc <SPPI.O>, which has seen its shares rise nearly sixfold in the past three years, is banking on more growth in its oncology franchise this year, including U.S. approval for its drug Fusilev as a treatment for colon cancer.
Spectrum Chief Executive Officer Rajesh Shrotriya expects annual U.S. sales of the drug, Fusilev, to reach $200 million if it is granted expanded approval by the Food and Drug Administration as expected at the end of this month.
In a separate action, the FDA on Thursday approved a "ready-to-use" formulation of the drug for injection, sending Spectrum's shares up 2.3 percent.
Fusilev is currently approved for treatment of osteosarcoma, a type of bone cancer, but the FDA has been recommending since last year that the drug, also known as levoleucovorin, be made available to U.S. colon cancer patients due to a shortage of an older generic drug, leucovorin.
The FDA in 2009 turned down Spectrum's application for levoleucovorin in colon cancer, saying that the company had not shown that its drug worked as well as leucovorin. Spectrum subsequently resubmitted its regulatory filing.
Shrotriya said at least 30,000 U.S. colon cancer patients are being treated with Fusilev "without spending a dime of our own money."
Annual sales outside of the United States, where the drug is marketed by Takeda Pharmaceutical Co <4502.T> , Sanofi-Aventis <SASY.PA> and Pfizer Inc <PFE.N>, total about $180 million to $200 million, according to the Spectrum CEO.
He said leucovorin is a generic drug "priced at rock bottom," while Fusilev is a purified version of the molecule that is given at a lower dose and can be combined with other drugs so it is priced at a premium.
Shrotriya, formerly an executive at Bristol Myers Squibb <BMY.N>, SuperGen Inc <SUPG.O>, and MGI Pharma, specializes in licensing drug candidates.
Spectrum acquired full ownership in 2009 of Zevalin, a "radioimmunotherapy" invented by what is now Biogen Idec <BIIB.O>, that combines an antibody drug with radiation for targeted treatment of non-Hodgkin's lymphoma.
Use of Zevalin, first launched by Idec nearly 10 years ago, has been hampered by complicated treatment requirements and reimbursement issues. Spectrum's Zevalin sales totaled $29 million last year.
The FDA is slated to decide by Nov. 20 whether to remove a requirement that patients undergo a pre-treatment imaging evaluation, or bioscan, before receiving Zevalin.
"I expect sales of Zevalin should also rise gradually to over $300 million a year in two or three years," Shrotriya said.
He said Spectrum is also studying usage of Zevalin in different types of lymphoma.
The company has two other drugs in the final stages of human testing.
Shrotriya said Spectrum's goal is to begin filing a new drug application with the FDA before the end of this year for belinostat, which is being studied in a pivotal trial as a treatment for peripheral T-Cell lymphoma (PTCL).
Enrollment in the trial is scheduled to finish in the third quarter, with full trial results expected in early 2012.
He said the company will seek a "fast-track" FDA review, which means belinostat, which is also being studied in a range of different cancer types, could be approved in 2012.
The CEO said another drug, apaziquone, could be on the market as a treatment for bladder cancer in 2013.
"Cancer still remains a big challenge -- it will kill more people in 2011 than in 2010," Shrotriya said. "Whether we keep building our business or somebody comes and buys it remains to be seen. So far there are no offers."
Shares up Spectrum, based in Irvine, California, were up 21 cents at $9.29 in afternoon trading on Nasdaq on Thursday. (Reporting by Deena Beasley; Editing by Tim Dobbyn)
.
* U.S. Fusilev sales expected to reach $200 mln/year
* Zevalin sales projected to reach $300 million
* Two other drugs in final stages of human trials
* FDA approves ready-to-use Fusilev, shares rise 2.3 pct (Adds FDA approval of ready-to-use Fusilev, share movement)
By Deena Beasley
LOS ANGELES, April 21 (Reuters) - Spectrum Pharmaceuticals Inc <SPPI.O>, which has seen its shares rise nearly sixfold in the past three years, is banking on more growth in its oncology franchise this year, including U.S. approval for its drug Fusilev as a treatment for colon cancer.
Spectrum Chief Executive Officer Rajesh Shrotriya expects annual U.S. sales of the drug, Fusilev, to reach $200 million if it is granted expanded approval by the Food and Drug Administration as expected at the end of this month.
In a separate action, the FDA on Thursday approved a "ready-to-use" formulation of the drug for injection, sending Spectrum's shares up 2.3 percent.
Fusilev is currently approved for treatment of osteosarcoma, a type of bone cancer, but the FDA has been recommending since last year that the drug, also known as levoleucovorin, be made available to U.S. colon cancer patients due to a shortage of an older generic drug, leucovorin.
The FDA in 2009 turned down Spectrum's application for levoleucovorin in colon cancer, saying that the company had not shown that its drug worked as well as leucovorin. Spectrum subsequently resubmitted its regulatory filing.
Shrotriya said at least 30,000 U.S. colon cancer patients are being treated with Fusilev "without spending a dime of our own money."
Annual sales outside of the United States, where the drug is marketed by Takeda Pharmaceutical Co <4502.T> , Sanofi-Aventis <SASY.PA> and Pfizer Inc <PFE.N>, total about $180 million to $200 million, according to the Spectrum CEO.
He said leucovorin is a generic drug "priced at rock bottom," while Fusilev is a purified version of the molecule that is given at a lower dose and can be combined with other drugs so it is priced at a premium.
Shrotriya, formerly an executive at Bristol Myers Squibb <BMY.N>, SuperGen Inc <SUPG.O>, and MGI Pharma, specializes in licensing drug candidates.
Spectrum acquired full ownership in 2009 of Zevalin, a "radioimmunotherapy" invented by what is now Biogen Idec <BIIB.O>, that combines an antibody drug with radiation for targeted treatment of non-Hodgkin's lymphoma.
Use of Zevalin, first launched by Idec nearly 10 years ago, has been hampered by complicated treatment requirements and reimbursement issues. Spectrum's Zevalin sales totaled $29 million last year.
The FDA is slated to decide by Nov. 20 whether to remove a requirement that patients undergo a pre-treatment imaging evaluation, or bioscan, before receiving Zevalin.
"I expect sales of Zevalin should also rise gradually to over $300 million a year in two or three years," Shrotriya said.
He said Spectrum is also studying usage of Zevalin in different types of lymphoma.
The company has two other drugs in the final stages of human testing.
Shrotriya said Spectrum's goal is to begin filing a new drug application with the FDA before the end of this year for belinostat, which is being studied in a pivotal trial as a treatment for peripheral T-Cell lymphoma (PTCL).
Enrollment in the trial is scheduled to finish in the third quarter, with full trial results expected in early 2012.
He said the company will seek a "fast-track" FDA review, which means belinostat, which is also being studied in a range of different cancer types, could be approved in 2012.
The CEO said another drug, apaziquone, could be on the market as a treatment for bladder cancer in 2013.
"Cancer still remains a big challenge -- it will kill more people in 2011 than in 2010," Shrotriya said. "Whether we keep building our business or somebody comes and buys it remains to be seen. So far there are no offers."
Shares up Spectrum, based in Irvine, California, were up 21 cents at $9.29 in afternoon trading on Nasdaq on Thursday. (Reporting by Deena Beasley; Editing by Tim Dobbyn)
.
Antwort auf Beitrag Nr.: 41.404.154 von VaJo am 22.04.11 07:59:49Die RTU Formulierung bringt nur einen spürbaren Benefit, wenn auch die Zulassung in CC kommt. Nächste Woche wird spannend. Vielleicht wird die Entscheidung auch erst am 29.4 abends nach Börsenschluss bzw. am 2.5. veröffentlicht. Eine positive Entscheidung sollte uns in diesen Kursregionen halten, eine negative Entscheidung sollte uns zurück zu mindestens 6 USD bringen. Nur meine Meinung.
Antwort auf Beitrag Nr.: 41.403.590 von Ville7 am 21.04.11 21:41:22So unbedeutend finde ich das nicht. Schließlich ist es doch jetzt viel leichter zu handhaben oder nicht.
Mal schauen was heute Abend noch passiert.
Mal schauen was heute Abend noch passiert.
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Antwort auf Beitrag Nr.: 41.403.590 von Ville7 am 21.04.11 21:41:22Das sagst Du, im Yahoo Board sehen das einige anders:
Just spoke with Oncology Pharmacist at MD A 21-Apr-11 03:54 pm
He said that this is much better news than fully understood by most people. Doctors have requested a simpler means to both dose and deliver and this is exactly what was needed. Company NEVER told us because they didn't want to give the appearance that current means was less than great..
This will explode on Tuesday after FDA approval, that will come early....you heard it here first
Schaun ma moi!
Just spoke with Oncology Pharmacist at MD A 21-Apr-11 03:54 pm
He said that this is much better news than fully understood by most people. Doctors have requested a simpler means to both dose and deliver and this is exactly what was needed. Company NEVER told us because they didn't want to give the appearance that current means was less than great..
This will explode on Tuesday after FDA approval, that will come early....you heard it here first
Schaun ma moi!
Antwort auf Beitrag Nr.: 41.403.590 von Ville7 am 21.04.11 21:41:22Mist.
Handy ersetzt doch keinen Computer.
Vielleicht wars zumindest der Auftakt für eine spannende nächste Woche.
Schönen Abend
Oberlaendler
Handy ersetzt doch keinen Computer.
Vielleicht wars zumindest der Auftakt für eine spannende nächste Woche.
Schönen Abend
Oberlaendler
Antwort auf Beitrag Nr.: 41.403.571 von Oberlaendler am 21.04.11 21:34:58Das war nur die Zulassung der RTU-Formulierung. Nichts bedeutendes. Nicht die bedeutende Colorectal Cancer Indikation! Der Markt kapiert das langsam auch...
Fusilev-Zulassung ist da. 
->Nasdaq
Mal sehn was geht.
Grüße Oberländler
->Nasdaq
Mal sehn was geht.
Grüße Oberländler
aus dem Krebs-Kompass
http://www.krebs-kompass.de/showthread.php?p=1025343
....
In klinischen Studien sprachen 74% der Patienten mit follikulärem Lymphom auf Zevalin® an, die zuvor nicht mehr auf eine alleinige Therapie mit Rituximab angesprochen hatten.
....
Die Gesamtansprechrate nach den Kriterien des "International Workshop NHL" war 80% für Patienten, die mit Zevalin® behandelt wurden und 56% für die Rituximab-Patienten
...
Die Remission (Verkleinerung oder Beseitigung von Tumoren) hielt bei den Zevalin®-Patienten im Median 13,9 Monate an und bei den Rituximab-Patienten 11,8 Monate.
http://www.krebs-kompass.de/showthread.php?p=1025343
....
In klinischen Studien sprachen 74% der Patienten mit follikulärem Lymphom auf Zevalin® an, die zuvor nicht mehr auf eine alleinige Therapie mit Rituximab angesprochen hatten.
....
Die Gesamtansprechrate nach den Kriterien des "International Workshop NHL" war 80% für Patienten, die mit Zevalin® behandelt wurden und 56% für die Rituximab-Patienten
...
Die Remission (Verkleinerung oder Beseitigung von Tumoren) hielt bei den Zevalin®-Patienten im Median 13,9 Monate an und bei den Rituximab-Patienten 11,8 Monate.
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