Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 229)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Antwort auf Beitrag Nr.: 37.606.991 von Finanzriese am 20.07.09 15:48:18JA 200% sind schon nee menge Holz an einem Tag, VW hats auch vorgemacht, aber auf eine andere Weise
Antwort auf Beitrag Nr.: 37.606.789 von VaJo am 20.07.09 15:29:19heute schon mit Human Genome Sciences 200% geschlagen -- da wirds doch mit Spectrum Pharmaceuticals nicht viel schwerer werden!! 
Antwort auf Beitrag Nr.: 37.605.909 von blb am 20.07.09 13:43:15Wird ein heißer Herbst!
Holla!
Ich hoffe schon auf einen heißen Sommer
Holla!
Ich hoffe schon auf einen heißen Sommer
FDA Accepts for Review Spectrum's Response on ZEVALIN as a Class 1 Submission, and Establishes September 7, 2009 as Decision Date
Press Release
Source: Spectrum Pharmaceuticals, Inc.
On Monday July 20, 2009, 7:00 am EDT
Buzz up! 0 Print
Companies:Spectrum pharmaceuticals, inc.
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), a commercial stage biotechnology company with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company’s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.
Related Quotes
Symbol Price Change
SPPI 5.55 0.00
{"s" : "sppi","k" : "c10,l10,p20,t10","o" : "","j" : ""} ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin’s Lymphoma.
About ZEVALIN®
ZEVALIN® (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company’s website at www.spectrumpharm.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of ZEVALIN, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. ZEVALIN is a registered trademark of RIT Oncology, LLC, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Press Release
Source: Spectrum Pharmaceuticals, Inc.
On Monday July 20, 2009, 7:00 am EDT
Buzz up! 0 Print
Companies:Spectrum pharmaceuticals, inc.
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), a commercial stage biotechnology company with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company’s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.
Related Quotes
Symbol Price Change
SPPI 5.55 0.00
{"s" : "sppi","k" : "c10,l10,p20,t10","o" : "","j" : ""} ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin’s Lymphoma.
About ZEVALIN®
ZEVALIN® (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company’s website at www.spectrumpharm.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of ZEVALIN, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. ZEVALIN is a registered trademark of RIT Oncology, LLC, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
FDA Accepts For Review Spectrum Pharmaceuticals, Inc.\'s Response On ZEVALIN As Class 1 Submission 
7:00am EDT
Spectrum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company`s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin`s Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin`s Lymphoma.
7:00am EDT
Spectrum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company`s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin`s Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin`s Lymphoma.
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Antwort auf Beitrag Nr.: 37.602.426 von Finanzriese am 19.07.09 19:43:56Wird ein heißer Herbst!
FDA Accepts for Review Spectrum's Response on ZEVALIN as a Class 1 Submission, and Establishes September 7, 2009 as Decision Date
IRVINE, Calif., Jul 20, 2009 (BUSINESS WIRE) -- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company's supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.
ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin's Lymphoma.
FDA Accepts for Review Spectrum's Response on ZEVALIN as a Class 1 Submission, and Establishes September 7, 2009 as Decision Date
IRVINE, Calif., Jul 20, 2009 (BUSINESS WIRE) -- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company's supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.
ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin's Lymphoma.
Spectrum Pharmaceuticals (Nasdaq: SPPI): Betsy de Parry’s Story, Video, and More
Written by Justin M. Hall
Saturday, 18 July 2009 05:48
Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals (Nasdaq: SPPI) regarding Zevalin®. As of March 16, 2009, Zevalin® is now manufactured and sold in the US by Spectrum Pharmaceuticals (Nasdaq: SPPI). Zevalin® is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin® as a first-line consolidation therapy for NHL. A FDA decision on Zevalin® is expected by September 8, 2009.
ZEVALIN® APPROVAL IS IMPORTANT FOR PATIENTS WITH NHL.
If Zevalin is approved under the first-line consolidation setting, the drug is more likely to have a better shot at becoming the standard of care for NHL. Some patients, who have received Zevalin® or a comparable radioimmunotherapeutic (RIT), Bexxar®, would likely argue that Zevalin deserves to be approved and made available for early-stage patients. The current standard of care is Rituxan® in combination with chemotherapy. Rituxan® is marketed by partners Roche (RHHBY.PK) and Biogen Idec (Nasdaq: BIIB). Bexxar® is marketed by GlaxoSmithKline (NYSE: GSK).
For more details on SPPI, Zevalin®, and the company’s late-stage pipeline, including Fusilev® and Eoquin®, please refer to my previous articles.
BETSY DE PARRY
Betsy de Parry’s story is one with a happy ending. Betsy is a NHL survivor, one of few patients in the US who has actually received a RIT for the treatment of her NHL. While Betsy’s story ended positively, more importantly it exemplifies why patients should be made aware of the Zevalin® option. Please make it a point to check out Betsy’s site. Investors should consider purchasing her book, The Roller Coaster Chronicles©, which is available for sale on her site.
OTHER RESOURCES
New York Times article July, 14 2007 which also features Betsy de Parry as well as other NHL survivors.
On July 16, 2007, a blogger responds to the July 14 New York Times article, infra. Here, I found Betsy de Parry’s comments after the article more valuable than the article itself.
New York Times article December 7, 2007 on Medicare reimbursement challenges. SPPI is working with the CMS to correct reimbursement issues. According to a recent presentation at JMP Securities Conference on May 20, 2009, the company appears to be making headway on these issues.
On April 28, 2008, Zevalin® was approved in Europe as a first-line consolidation therapy for NHL. Bayer Schering markets Zevalin® in Europe as well as other countries except the US.
Bexxar® versus Zevalin®, a factual comparison of the two RITs, Bexxar® and Zevalin®, approved for refractory NHL at Lymphomation.org
CONCLUSION
From my view, these resources make the case – Zevalin® is an extraordinarily effective treatment for NHL.
Regarding other issues: (1) SPPI is working closely with CMS (Medicare) to alleviate the reimbursement issue which has, in part, led to Zevalin’s disuse. (2) SPPI is also working with the FDA to modify the existing scanning requirements.
If approved under the first-line setting, I believe Zevalin® sales will ramp up much faster than other analysts and commentators are expecting. In a recent article, I point out that SPPI’s leadership has the experience and know-how to make it happen for Zevalin®. I believe they will.
As some have implied, I do not believe it is responsible to say the pending Zevalin® approval will NOT prove to be that important. For patients with NHL, Zevalin’s approval is important. Patients need to be aware of the Zevalin® option. Please do NOT take my word for it. Just ask Betsy de Parry. With the first-line approval, I expect more doctors will adopt the treatment and begin treating their patients with it. In time, I anticipate that Zevalin® will become the standard of care for NHL in addition to the current treatments. Under this same reasoning, I foresee sales of Zevalin® increasing over the next 12-18 months and maybe even beyond.
Here, I think it is appropriate to quote a statement engraved on a paperweight that set atop President Ronald Reagan’s desk throughout the eight years he served in the White House, “It CAN Be Done.”
Zevalin® should be made available to early-stage NHL patients.
It’s the right thing to do.
http://biomedreports.com/articles/most-popular/2246-spectrum…
Written by Justin M. Hall
Saturday, 18 July 2009 05:48
Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals (Nasdaq: SPPI) regarding Zevalin®. As of March 16, 2009, Zevalin® is now manufactured and sold in the US by Spectrum Pharmaceuticals (Nasdaq: SPPI). Zevalin® is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin® as a first-line consolidation therapy for NHL. A FDA decision on Zevalin® is expected by September 8, 2009.
ZEVALIN® APPROVAL IS IMPORTANT FOR PATIENTS WITH NHL.
If Zevalin is approved under the first-line consolidation setting, the drug is more likely to have a better shot at becoming the standard of care for NHL. Some patients, who have received Zevalin® or a comparable radioimmunotherapeutic (RIT), Bexxar®, would likely argue that Zevalin deserves to be approved and made available for early-stage patients. The current standard of care is Rituxan® in combination with chemotherapy. Rituxan® is marketed by partners Roche (RHHBY.PK) and Biogen Idec (Nasdaq: BIIB). Bexxar® is marketed by GlaxoSmithKline (NYSE: GSK).
For more details on SPPI, Zevalin®, and the company’s late-stage pipeline, including Fusilev® and Eoquin®, please refer to my previous articles.
BETSY DE PARRY
Betsy de Parry’s story is one with a happy ending. Betsy is a NHL survivor, one of few patients in the US who has actually received a RIT for the treatment of her NHL. While Betsy’s story ended positively, more importantly it exemplifies why patients should be made aware of the Zevalin® option. Please make it a point to check out Betsy’s site. Investors should consider purchasing her book, The Roller Coaster Chronicles©, which is available for sale on her site.
OTHER RESOURCES
New York Times article July, 14 2007 which also features Betsy de Parry as well as other NHL survivors.
On July 16, 2007, a blogger responds to the July 14 New York Times article, infra. Here, I found Betsy de Parry’s comments after the article more valuable than the article itself.
New York Times article December 7, 2007 on Medicare reimbursement challenges. SPPI is working with the CMS to correct reimbursement issues. According to a recent presentation at JMP Securities Conference on May 20, 2009, the company appears to be making headway on these issues.
On April 28, 2008, Zevalin® was approved in Europe as a first-line consolidation therapy for NHL. Bayer Schering markets Zevalin® in Europe as well as other countries except the US.
Bexxar® versus Zevalin®, a factual comparison of the two RITs, Bexxar® and Zevalin®, approved for refractory NHL at Lymphomation.org
CONCLUSION
From my view, these resources make the case – Zevalin® is an extraordinarily effective treatment for NHL.
Regarding other issues: (1) SPPI is working closely with CMS (Medicare) to alleviate the reimbursement issue which has, in part, led to Zevalin’s disuse. (2) SPPI is also working with the FDA to modify the existing scanning requirements.
If approved under the first-line setting, I believe Zevalin® sales will ramp up much faster than other analysts and commentators are expecting. In a recent article, I point out that SPPI’s leadership has the experience and know-how to make it happen for Zevalin®. I believe they will.
As some have implied, I do not believe it is responsible to say the pending Zevalin® approval will NOT prove to be that important. For patients with NHL, Zevalin’s approval is important. Patients need to be aware of the Zevalin® option. Please do NOT take my word for it. Just ask Betsy de Parry. With the first-line approval, I expect more doctors will adopt the treatment and begin treating their patients with it. In time, I anticipate that Zevalin® will become the standard of care for NHL in addition to the current treatments. Under this same reasoning, I foresee sales of Zevalin® increasing over the next 12-18 months and maybe even beyond.
Here, I think it is appropriate to quote a statement engraved on a paperweight that set atop President Ronald Reagan’s desk throughout the eight years he served in the White House, “It CAN Be Done.”
Zevalin® should be made available to early-stage NHL patients.
It’s the right thing to do.
http://biomedreports.com/articles/most-popular/2246-spectrum…
Guter Anfang für nächste Woche....
+6% ist doch nicht zu verachten?
Antwort auf Beitrag Nr.: 37.595.065 von future_trader am 17.07.09 17:07:12Bröckelt auch wieder runter. Denke es dauert noch einige Zeit. August Kurs 3 - 3,50 Euro. Meine Meinung.
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