Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 128)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8000 | +45,45 | |
| 1,0000 | +42,86 | |
| 3,0000 | +42,18 | |
| 6,2500 | +24,75 | |
| 0,9600 | +18,93 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,9300 | -17,52 | |
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| 28,60 | -24,06 | |
| 1,3500 | -25,62 | |
| 0,7800 | -29,73 |
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http://www.fiercepharmamanufacturing.com/story/fda-works-ave…
sieht jedenfalls so aus als ob der kommende Quartalsbericht der Knaller wird
http://www.fiercepharmamanufacturing.com/story/fda-works-ave…
sieht jedenfalls so aus als ob der kommende Quartalsbericht der Knaller wird
Mir solls recht sein. Ich habe meinen Bestand heute ein wenig reduzieren müssen (Betongold) ;-)
Heute über 9 USD?
Vor Zulassung dann um die 10 und bei Zulassung kurz 10-30% hochgap'en und dann wieder der Schwerkraft folgend?
Wir werden sehen...
Vor Zulassung dann um die 10 und bei Zulassung kurz 10-30% hochgap'en und dann wieder der Schwerkraft folgend?
Wir werden sehen...
Antwort auf Beitrag Nr.: 41.266.831 von Magnetfeldfredy am 25.03.11 14:43:53Good news:
Independent Data Monitoring Committee Recommends Continuation of Spectrum Pharmaceuticals’ Pivotal Registrational Study of Belinostat in Peripheral T-Cell Lymphoma
Independent Data Monitoring Committee (DMC) Recommends That the BELIEF Study Continue According to Protocol Until 100 Evaluable Patients Enrolled
No Safety Concerns Raised Based on DMC Safety Analysis
Companies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 8.58 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals On Monday March 28, 2011, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the independent Data Monitoring Committee (DMC), per protocol, has performed a safety and futility analysis and has recommended that the pivotal, registrational study for belinostat in relapsed or refractory Peripheral T-Cell Lymphoma, the “BELIEF” Study, continue according to protocol until 100 evaluable patients are enrolled.
“We are pleased that the DMC found through their independent review that the data supports continuation of this pivotal trial,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in cancer therapy in a variety of indications. It has activity as a single agent and in combination at full-doses with other chemotherapy drugs in multiple cancer clinical trials, has a favorable tolerability and safety profile, and is being studied via intravenous or oral administration. We continue to enroll patients into the pivotal registrational BELIEF study.” Spectrum expects to file a rolling New Drug Application for Peripheral T-Cell Lymphoma in 2011/2012.
The interim futility analysis and safety assessments were performed after the first 45 patients were entered into the study and have received at least one dose of belinostat and had the opportunity to be followed for at least two cycles. Following its analysis of the data, the DMC recommended that the study should continue.
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
Belinostat is currently in a registrational trial, the BELIEF Study, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.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, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum
Independent Data Monitoring Committee Recommends Continuation of Spectrum Pharmaceuticals’ Pivotal Registrational Study of Belinostat in Peripheral T-Cell Lymphoma
Independent Data Monitoring Committee (DMC) Recommends That the BELIEF Study Continue According to Protocol Until 100 Evaluable Patients Enrolled
No Safety Concerns Raised Based on DMC Safety Analysis
Companies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 8.58 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals On Monday March 28, 2011, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the independent Data Monitoring Committee (DMC), per protocol, has performed a safety and futility analysis and has recommended that the pivotal, registrational study for belinostat in relapsed or refractory Peripheral T-Cell Lymphoma, the “BELIEF” Study, continue according to protocol until 100 evaluable patients are enrolled.
“We are pleased that the DMC found through their independent review that the data supports continuation of this pivotal trial,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in cancer therapy in a variety of indications. It has activity as a single agent and in combination at full-doses with other chemotherapy drugs in multiple cancer clinical trials, has a favorable tolerability and safety profile, and is being studied via intravenous or oral administration. We continue to enroll patients into the pivotal registrational BELIEF study.” Spectrum expects to file a rolling New Drug Application for Peripheral T-Cell Lymphoma in 2011/2012.
The interim futility analysis and safety assessments were performed after the first 45 patients were entered into the study and have received at least one dose of belinostat and had the opportunity to be followed for at least two cycles. Following its analysis of the data, the DMC recommended that the study should continue.
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
Belinostat is currently in a registrational trial, the BELIEF Study, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.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, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum
Antwort auf Beitrag Nr.: 41.257.710 von VaJo am 24.03.11 09:05:53Spectrum Pharmaceuticals, Inc. (SPPI) Rated at “Outperform” by RBC Capital Mkts
By FavStocks Staff on 03/25/2011 – 5:28 am PDT
Analysts Coverage
Share Equities research analysts at RBC Capital Mkts Rated shares of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) a “Outperform” rating in a research note released to investors today.
Spectrum Pharmaceuticals, Inc. is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) are trading up 0.36% as of Mar 24, 4:00PM EDT, hitting 8.39. Spectrum Pharmaceuticals, Inc. has a 52 week low of 3.67 and a 52 week high of 8.43. The companies last released earnings were -1.00 per share. were The company has a market cap of 433.19M and a price-to-earnings ratio of .
By FavStocks Staff on 03/25/2011 – 5:28 am PDT
Analysts Coverage
Share Equities research analysts at RBC Capital Mkts Rated shares of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) a “Outperform” rating in a research note released to investors today.
Spectrum Pharmaceuticals, Inc. is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) are trading up 0.36% as of Mar 24, 4:00PM EDT, hitting 8.39. Spectrum Pharmaceuticals, Inc. has a 52 week low of 3.67 and a 52 week high of 8.43. The companies last released earnings were -1.00 per share. were The company has a market cap of 433.19M and a price-to-earnings ratio of .
Trading Spotlight
URGENT: LEVOLEUCOVORIN UPDATE
Dear Healthcare Professional:
Due to the ongoing critical shortage of Leucovorin Calcium for Injection in the United States
market, Spectrum Pharmaceuticals, Inc. (Spectrum) is working with the United States Food and
Drug Administration (FDA) to increase the availability of levoleucovorin products.
Levoleucovorin is the levo isomeric form of racemic d,l-leucovorin, present as the calcium salt,
and is the pharmacologically active isomer of leucovorin [(6-S)-leucovorin]. Levoleucovorin is
dosed at one-half the usual dose of leucovorin.
Due to the shortage of both leucovorin and FUSILEV® (levoleucovorin) for Injection, the FDA
has authorized Spectrum to import Levoleucovorin 100 mg Powder for Injection manufactured
by Pfizer Inc. (previously known as Wyeth) into the US market from Italy. Pfizer
Levoleucovorin 100 mg Powder for Injection is manufactured in an FDA-inspected facility
(Pfizer in Catania, Italy). This facility has been in compliance with FDA manufacturing
standards.
No other entity except for Spectrum is authorized by FDA to import or distribute Pfizer
Levoleucovorin 100 mg Powder for Injection in the United States. Any sales of Pfizer
Levoleucovorin 100 mg Powder for Injection from any entity other than Spectrum will be
considered a violation of the Federal Food, Drug and Cosmetic Act and will be subject to
enforcement by FDA.
Dear Healthcare Professional:
Due to the ongoing critical shortage of Leucovorin Calcium for Injection in the United States
market, Spectrum Pharmaceuticals, Inc. (Spectrum) is working with the United States Food and
Drug Administration (FDA) to increase the availability of levoleucovorin products.
Levoleucovorin is the levo isomeric form of racemic d,l-leucovorin, present as the calcium salt,
and is the pharmacologically active isomer of leucovorin [(6-S)-leucovorin]. Levoleucovorin is
dosed at one-half the usual dose of leucovorin.
Due to the shortage of both leucovorin and FUSILEV® (levoleucovorin) for Injection, the FDA
has authorized Spectrum to import Levoleucovorin 100 mg Powder for Injection manufactured
by Pfizer Inc. (previously known as Wyeth) into the US market from Italy. Pfizer
Levoleucovorin 100 mg Powder for Injection is manufactured in an FDA-inspected facility
(Pfizer in Catania, Italy). This facility has been in compliance with FDA manufacturing
standards.
No other entity except for Spectrum is authorized by FDA to import or distribute Pfizer
Levoleucovorin 100 mg Powder for Injection in the United States. Any sales of Pfizer
Levoleucovorin 100 mg Powder for Injection from any entity other than Spectrum will be
considered a violation of the Federal Food, Drug and Cosmetic Act and will be subject to
enforcement by FDA.
Antwort auf Beitrag Nr.: 41.201.577 von Magnetfeldfredy am 14.03.11 19:44:29FDA Accepts for Review Spectrum Pharmaceuticals’ ZEVALIN® Submission for the Removal of the Bioscan
Establishes November 20, 2011 as the Prescription Drug User Fee Act (PDUFA) Action Date
Prior Approval Supplement, Submitted on January 20, 2011, Provides for the Removal of the Bioscan Requirement
ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
Treatment of Patients With Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Companies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 7.91 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals, Inc. On Tuesday March 22, 2011, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the “bioscan” requirement. A decision is expected by November 20, 2011.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.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, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700 x 216
Establishes November 20, 2011 as the Prescription Drug User Fee Act (PDUFA) Action Date
Prior Approval Supplement, Submitted on January 20, 2011, Provides for the Removal of the Bioscan Requirement
ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
Treatment of Patients With Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Companies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 7.91 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals, Inc. On Tuesday March 22, 2011, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the “bioscan” requirement. A decision is expected by November 20, 2011.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.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, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700 x 216
Antwort auf Beitrag Nr.: 41.201.248 von Magnetfeldfredy am 14.03.11 19:06:00Spectrum Pharm upgraded to Buy from Hold at Capstone (TheFlyOnTheWall)
Spectrum Pharm upgraded to Buy from Hold at Capstone (TheFlyOnTheWall)
Mar 11, 2011 7:09:00 AM
Close Ad
Email story | Discuss on ZenoBank | View more ads Capstone upgraded Spectrum citing the better than expected Q4 report that was driven by generic Leucovorin shortages. Price target is $10.
Spectrum Pharm upgraded to Buy from Hold at Capstone (TheFlyOnTheWall)
Mar 11, 2011 7:09:00 AM
Close Ad
Email story | Discuss on ZenoBank | View more ads Capstone upgraded Spectrum citing the better than expected Q4 report that was driven by generic Leucovorin shortages. Price target is $10.
Antwort auf Beitrag Nr.: 41.192.799 von Ville7 am 13.03.11 12:48:08Sppi bärenstark im schwachen Börsenumfeld!
Antwort auf Beitrag Nr.: 41.185.943 von Oberlaendler am 11.03.11 14:37:44Das ist ja das geile, SPPI macht derzeit das vollständige Leucovorin-USA Geschäft mit ihrem hochpreisigem Medikament. Sollte das alles ein ganzes Quartal andauern und Pfizer genug liefern können, so wird Spectrum möglicherweise in Q1 über 50Mio USD Fusilev Umsätze melden. Einziger Wehrmutstropfen: SPPI's Marge wird aufgrund des Imports und der Shortage ihres einzigen Lieferanten nicht so hoch sein.
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