Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 135)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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| TitelBeiträge |
|---|
20.07.23 · Business Wire (engl.)  |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8000 | +33,33 | |
| 323,60 | +17,59 | |
| 9,4900 | +16,58 | |
| 5,3700 | +15,98 | |
| 449,10 | +15,09 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 8,1200 | -13,53 | |
| 2,1000 | -16,00 | |
| 7,1900 | -20,02 | |
| 0,9500 | -22,76 | |
| 80,22 | -23,42 |
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Antwort auf Beitrag Nr.: 38.259.691 von Ville7 am 27.10.09 11:27:26Eigenkritik: Ich war mit dem erhofften Exit beim Kauf meiner Tradingposition vor mehr als einem Jahr etwas zu optimistisch was den Zeithorizont des Exits angeht, musste bis heute ein Jahr länger warten als erhofft (siehe meine Grafik in USD von letztem Jahr).
Grundsätzlich wird heute der obere Teil meines Tradingziels erreicht und wahrscheinlich das Gap, das nach dem Fusilev-Zulassungsdebakel aufgemacht wurde geschlossen. Mein Tradingziel damals: 6,02 bzw. 6,03 USD - obere Gapkante. Diese Stelle wurde gestern nachbörslich erreicht und könnte auch zur Eröffnung heute das Ziel sein.
Ein dennoch erfolgreicher Trade - mit 40% Rendite vor Steuern.
Grundsätzlich wird heute der obere Teil meines Tradingziels erreicht und wahrscheinlich das Gap, das nach dem Fusilev-Zulassungsdebakel aufgemacht wurde geschlossen. Mein Tradingziel damals: 6,02 bzw. 6,03 USD - obere Gapkante. Diese Stelle wurde gestern nachbörslich erreicht und könnte auch zur Eröffnung heute das Ziel sein.
Ein dennoch erfolgreicher Trade - mit 40% Rendite vor Steuern.
Wer zahlt um 9:47Uhr denn 4,538 in Frankfurt, wenn er in Stuttgart die Dinger für 4,40 haben kann? Tststs...
So, der Zeitpunkt zum Verkauf meiner Tradingposition ist gekommen, habe nun heute morgen 4800 Stück via zwei Tranchen über Börse Stuttgart zu 4,37 Euro und 4,35 Euro direkt ins Bid hinein verkauft (EK ca. 3,10 Euro vor Gebühren Ende 2009). Zudem biete ich gerade weitere 2300 Stück zu 4,40 Euro in Stuttgart an (mein EK hier Anfang 2010: 3,26 Euro vor Gebühren). Wer die also kaufen möchte ist herzlich eingeladen, wenn nicht, dann halte ich auch die gerne bis Ende nächstes Jahr und nehme vielleicht 6 Euro oder mehr. (Also nicht, dass ich es mir noch anders überlege 
)
)
Antwort auf Beitrag Nr.: 40.658.804 von future_trader am 07.12.10 00:05:53Die Ergebnisse von 84% Respones Rate bei alleiniger Therapie mit Zevalin in einer einzigen Dosis in Spätstadium Patienten sind schon mehr als beeindruckend. Das sollte den Zevalin Verkäufen etwas Schub geben, da die Akzeptanz dadurch gefördert werden könnte.
Zevalin als Monotherapie bei NHL. Damit könnte man auf Rituxan verzichten und die Behandlung würde deutlich billiger. Jetzt noch der Scan weg und ab gehts.
Ich bin gespannt wie es weiter geht.
Ich bin gespannt wie es weiter geht.
Trading Spotlight
Schöne News :-)
* Mid-stage trial sees 84 pct response rate
* Late-stage study shows 35 months progression-free survival
* Mid-stage trial sees 84 pct response rate
* Late-stage study shows 35 months progression-free survival
After hour trades $6,10
Ganz neue Möglichkeiten!
http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=535301
Single Dose ZEVALIN in First-Ever Phase 2 Monotherapy Trial for Non-Hodgkin's Lymphoma Shows Significant and Durable Clinical Responses
ORLANDO, Fla.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin's lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy. This trial differed from earlier ZEVALIN trials in NHL in that patients were treated with ZEVALIN first-line, without the use of upfront chemotherapy. The data were presented at an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Antonio Pezzutto, M.D., Professor of Hematology and Oncology at Charité Hospital, Berlin and principal investigator for the study, designed it to assess whether any chemotherapy is necessary before administering ZEVALIN for patients with Stage III and IV follicular NHL. The preliminary results from this 60-patient, single-arm study show that treatment-naïve patients who received a single dose of ZEVALIN alone achieved a one-year overall clinical response rate of 84% (53% complete response and 31% partial response). This response is of similar magnitude to responses reported in previous trials evaluating standard chemotherapy alone, or chemotherapy followed by ZEVALIN, in NHL. Because no chemotherapy was used in the current trial, patients were not exposed to the often serious adverse events associated with it. Professor Pezzutto and colleagues concluded the absence of infectious episodes and limited severity of side effects compare extremely well with the toxicity of the standard regimens.
"The strongest argument in favor of ZEVALIN is the patients' acceptance: most patients do not have the impression of being treated for cancer," said Professor Pezzutto of Charité Hospital, Humboldt University, Berlin.
Longer follow-up of the same patient cohort will yield data on the duration of response (progression-free survival). In the trial, hematological toxicity was modest: 24 patients exhibited thrombocytopenia, neutropenia and/or anemia. To date, progression to high-grade lymphoma occurred in three patients. The safety profile was comparable to that seen with ZEVALIN's use in approved indications, but patients in this trial were spared the side effects associated with upfront chemotherapy.
ZEVALIN is currently indicated for untreated NHL, in patients 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 NHL.
"The first-ever data suggesting strong clinical activity of ZEVALIN as a monotherapy in the first-line setting for selected lymphoma patients gives us a green light to pursue a clinical program as part of our strategy to expand the label of FDA-approved uses of the radioimmunotherapy," said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "We plan to make this potential indication a part of our long-term strategy to expand commercial use of ZEVALIN. We are currently consulting leading hematologists and regulatory advisors to create a development plan."
Professor Pezzutto's ASH presentation is titled 90Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma: First Results from an International Phase II Clinical Trial. ASH abstract # 593.
About ZEVALIN®
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use 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.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
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.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x 216
Source: Spectrum Pharmaceuticals, Inc.
News Provided by Acquire Media
Ganz neue Möglichkeiten!
http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=535301
Single Dose ZEVALIN in First-Ever Phase 2 Monotherapy Trial for Non-Hodgkin's Lymphoma Shows Significant and Durable Clinical Responses
ORLANDO, Fla.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin's lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy. This trial differed from earlier ZEVALIN trials in NHL in that patients were treated with ZEVALIN first-line, without the use of upfront chemotherapy. The data were presented at an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Antonio Pezzutto, M.D., Professor of Hematology and Oncology at Charité Hospital, Berlin and principal investigator for the study, designed it to assess whether any chemotherapy is necessary before administering ZEVALIN for patients with Stage III and IV follicular NHL. The preliminary results from this 60-patient, single-arm study show that treatment-naïve patients who received a single dose of ZEVALIN alone achieved a one-year overall clinical response rate of 84% (53% complete response and 31% partial response). This response is of similar magnitude to responses reported in previous trials evaluating standard chemotherapy alone, or chemotherapy followed by ZEVALIN, in NHL. Because no chemotherapy was used in the current trial, patients were not exposed to the often serious adverse events associated with it. Professor Pezzutto and colleagues concluded the absence of infectious episodes and limited severity of side effects compare extremely well with the toxicity of the standard regimens.
"The strongest argument in favor of ZEVALIN is the patients' acceptance: most patients do not have the impression of being treated for cancer," said Professor Pezzutto of Charité Hospital, Humboldt University, Berlin.
Longer follow-up of the same patient cohort will yield data on the duration of response (progression-free survival). In the trial, hematological toxicity was modest: 24 patients exhibited thrombocytopenia, neutropenia and/or anemia. To date, progression to high-grade lymphoma occurred in three patients. The safety profile was comparable to that seen with ZEVALIN's use in approved indications, but patients in this trial were spared the side effects associated with upfront chemotherapy.
ZEVALIN is currently indicated for untreated NHL, in patients 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 NHL.
"The first-ever data suggesting strong clinical activity of ZEVALIN as a monotherapy in the first-line setting for selected lymphoma patients gives us a green light to pursue a clinical program as part of our strategy to expand the label of FDA-approved uses of the radioimmunotherapy," said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "We plan to make this potential indication a part of our long-term strategy to expand commercial use of ZEVALIN. We are currently consulting leading hematologists and regulatory advisors to create a development plan."
Professor Pezzutto's ASH presentation is titled 90Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma: First Results from an International Phase II Clinical Trial. ASH abstract # 593.
About ZEVALIN®
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use 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.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
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.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x 216
Source: Spectrum Pharmaceuticals, Inc.
News Provided by Acquire Media
Antwort auf Beitrag Nr.: 40.655.973 von VaJo am 06.12.10 18:27:11BIg news + weekly chartbreakout!!
charttechnical analysis here:
http://www.privattraders.com/
Press Release Source: Spectrum Pharmaceuticals, Inc. On Monday December 6, 2010, 4:00 pm
ORLANDO, Fla.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News) today announced that updated data from the ZEVALIN (ibritumomab tiuxetan) injection for intravenous use Phase 3 First-line Indolent Trial (FIT) released in an oral presentation at the 52nd American Society of Hematology (ASH) Annual Meeting by independent researchers demonstrated that after a median follow-up of 66.2 months, patients with previously untreated follicular non-Hodgkin’s lymphoma treated with a standard, single-dose infusion of ZEVALIN as part of the ZEVALIN Therapeutic Regimen after partial or complete response to first-line chemotherapy had a nearly three-year advantage in median progression-free survival (PFS) compared to patients treated with either chemotherapy alone or chemotherapy plus rituximab (49 months versus 14 months).
“ZEVALIN is in my opinion the most effective single drug available with an acceptable hematological toxicity profile for the treatment of patients with low-grade malignant follicular non-Hodgkin's lymphoma,” said Anton Hagenbeek, M.D., Ph.D., Professor of Hematology, Academic Medical Center, Amsterdam and principal investigator of the FIT trial who presented the updated data in an oral presentation at ASH. “Hematologists should seriously consider this cost-effective treatment modality, which is relatively easy to administer, for their patients in first remission.”
“The compelling five-year follow-up FIT data underscore the strong clinical utility of ZEVALIN for its approved indication of consolidation of first remission in patients with non-Hodgkin’s lymphoma,” said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Since obtaining commercial rights to ZEVALIN over a year ago, we have made great strides in broadening the utilization of ZEVALIN, including securing FDA approval as first-line consolidation therapy, establishment of full reimbursement, and inclusion in the National Comprehensive Cancer Network treatment guidelines. These accomplishments further strengthen the ZEVALIN brand and its growth potential,” Dr. Shrotriya continued.
Spectrum Pharmaceuticals plans to submit data for consideration to the U.S. Food and Drug Administration to remove the bioscan requirement prior to ZEVALIN administration. Spectrum believes removal of the requirement will further improve the convenience of ZEVALIN administration and thereby further facilitate its adoption as the standard of care in first-line consolidation setting for follicular non-Hodgkin’s lymphoma.
Second Follow-Up Data from FIT – Oral Session, ASH Abstract #594
90-Y-Ibritumomab Tiuxetan (ZEVALIN) Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin's Lymphoma: Updated Results After a Median Follow-up of 66.2 Months From the International, Randomized, Phase III First-Line Indolent Trial (FIT) in 414 Patients
As published in 2008, results from the first extended follow-up of the FIT trial after a median of 42 months revealed a significant improvement in PFS from the time of randomization with ZEVALIN consolidation compared with control (36.5 versus 13.3 months, respectively; p<0.0001; Morschhauser et al. JCO. 2008; 26:5156-5164).
The multinational, randomized, open-label Phase 3 FIT trial evaluates clinical benefit and safety of a single infusion of ZEVALIN in 414 patients with CD20-positive follicular non-Hodgkin’s lymphoma who had achieved a partial response or a complete response after receiving one of the standard first-line chemotherapy regimens.
Patients were randomly assigned to either ZEVALIN treatment (n=207) or observation (n=202) within three months of completing induction chemotherapy (chemotherapy only: 86%; rituximab in combination with chemotherapy: 14%).
FIT-study results at 66.2 months median follow-up (5.5 years)
ZEVALIN Control P-value
(Months) (Months)
Median Progression-Free Survival (PFS) in all patients randomized 49 14 <0.001
PFS Among Patients with Complete Response after Chemotherapy Induction Median not yet reached at 92 months 32 0.011
PFS Among Patients with Partial Response after Chemotherapy Induction 30 6 <0.001
Time to Next Treatment/Time without need for further treatment Median not yet reached at 99 months 35 <0.0001
At the 66.2 month analysis, five-year PFS was 47% in the ZEVALIN group and 29% in the control group (p<0.0001). Median PFS in the ZEVALIN group was 49 months versus 14 months in the control group (p<0.001). For all patients, the time to next treatment (as calculated from the date of randomization) differed significantly between the two groups; the median was not reached at 99 months in the ZEVALIN group versus 35 months in the control group (p<0.0001). At current follow-up, no significant difference in incidence of secondary malignancies has been observed, with 16 malignancies reported in the ZEVALIN group versus nine in the control group (P=0.19). Six cases of myelodysplastic syndrome (MDS)/acute myelogenous leukemia (AML) were reported in the ZEVALIN group versus one case in the control group (P=0.062). Following disease relapse on study, patients were treated at the discretion of the investigator with treatments that included, besides chemotherapy, autologous (n=44) or allogeneic (n=4) stem cell transplantation, or ZEVALIN for patients originally assigned to the control group (n=12). Use of ZEVALIN upfront in this study did not appear to affect responses to subsequent treatments given for relapsed disease. The toxicity profile in this study is reflected in currently approved product labeling, which is based on results from this trial.
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.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
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.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
charttechnical analysis here:
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Press Release Source: Spectrum Pharmaceuticals, Inc. On Monday December 6, 2010, 4:00 pm
ORLANDO, Fla.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News) today announced that updated data from the ZEVALIN (ibritumomab tiuxetan) injection for intravenous use Phase 3 First-line Indolent Trial (FIT) released in an oral presentation at the 52nd American Society of Hematology (ASH) Annual Meeting by independent researchers demonstrated that after a median follow-up of 66.2 months, patients with previously untreated follicular non-Hodgkin’s lymphoma treated with a standard, single-dose infusion of ZEVALIN as part of the ZEVALIN Therapeutic Regimen after partial or complete response to first-line chemotherapy had a nearly three-year advantage in median progression-free survival (PFS) compared to patients treated with either chemotherapy alone or chemotherapy plus rituximab (49 months versus 14 months).
“ZEVALIN is in my opinion the most effective single drug available with an acceptable hematological toxicity profile for the treatment of patients with low-grade malignant follicular non-Hodgkin's lymphoma,” said Anton Hagenbeek, M.D., Ph.D., Professor of Hematology, Academic Medical Center, Amsterdam and principal investigator of the FIT trial who presented the updated data in an oral presentation at ASH. “Hematologists should seriously consider this cost-effective treatment modality, which is relatively easy to administer, for their patients in first remission.”
“The compelling five-year follow-up FIT data underscore the strong clinical utility of ZEVALIN for its approved indication of consolidation of first remission in patients with non-Hodgkin’s lymphoma,” said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Since obtaining commercial rights to ZEVALIN over a year ago, we have made great strides in broadening the utilization of ZEVALIN, including securing FDA approval as first-line consolidation therapy, establishment of full reimbursement, and inclusion in the National Comprehensive Cancer Network treatment guidelines. These accomplishments further strengthen the ZEVALIN brand and its growth potential,” Dr. Shrotriya continued.
Spectrum Pharmaceuticals plans to submit data for consideration to the U.S. Food and Drug Administration to remove the bioscan requirement prior to ZEVALIN administration. Spectrum believes removal of the requirement will further improve the convenience of ZEVALIN administration and thereby further facilitate its adoption as the standard of care in first-line consolidation setting for follicular non-Hodgkin’s lymphoma.
Second Follow-Up Data from FIT – Oral Session, ASH Abstract #594
90-Y-Ibritumomab Tiuxetan (ZEVALIN) Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin's Lymphoma: Updated Results After a Median Follow-up of 66.2 Months From the International, Randomized, Phase III First-Line Indolent Trial (FIT) in 414 Patients
As published in 2008, results from the first extended follow-up of the FIT trial after a median of 42 months revealed a significant improvement in PFS from the time of randomization with ZEVALIN consolidation compared with control (36.5 versus 13.3 months, respectively; p<0.0001; Morschhauser et al. JCO. 2008; 26:5156-5164).
The multinational, randomized, open-label Phase 3 FIT trial evaluates clinical benefit and safety of a single infusion of ZEVALIN in 414 patients with CD20-positive follicular non-Hodgkin’s lymphoma who had achieved a partial response or a complete response after receiving one of the standard first-line chemotherapy regimens.
Patients were randomly assigned to either ZEVALIN treatment (n=207) or observation (n=202) within three months of completing induction chemotherapy (chemotherapy only: 86%; rituximab in combination with chemotherapy: 14%).
FIT-study results at 66.2 months median follow-up (5.5 years)
ZEVALIN Control P-value
(Months) (Months)
Median Progression-Free Survival (PFS) in all patients randomized 49 14 <0.001
PFS Among Patients with Complete Response after Chemotherapy Induction Median not yet reached at 92 months 32 0.011
PFS Among Patients with Partial Response after Chemotherapy Induction 30 6 <0.001
Time to Next Treatment/Time without need for further treatment Median not yet reached at 99 months 35 <0.0001
At the 66.2 month analysis, five-year PFS was 47% in the ZEVALIN group and 29% in the control group (p<0.0001). Median PFS in the ZEVALIN group was 49 months versus 14 months in the control group (p<0.001). For all patients, the time to next treatment (as calculated from the date of randomization) differed significantly between the two groups; the median was not reached at 99 months in the ZEVALIN group versus 35 months in the control group (p<0.0001). At current follow-up, no significant difference in incidence of secondary malignancies has been observed, with 16 malignancies reported in the ZEVALIN group versus nine in the control group (P=0.19). Six cases of myelodysplastic syndrome (MDS)/acute myelogenous leukemia (AML) were reported in the ZEVALIN group versus one case in the control group (P=0.062). Following disease relapse on study, patients were treated at the discretion of the investigator with treatments that included, besides chemotherapy, autologous (n=44) or allogeneic (n=4) stem cell transplantation, or ZEVALIN for patients originally assigned to the control group (n=12). Use of ZEVALIN upfront in this study did not appear to affect responses to subsequent treatments given for relapsed disease. The toxicity profile in this study is reflected in currently approved product labeling, which is based on results from this trial.
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.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
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.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
52nd annual American Society of Hematology (ASH)/Orlando, Florida
Spectrum erregt Aufmerksamkeit, Übernahme im Gespräch
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Es bleibt spannend!
FDA Accepts for Review Spectrum's Response on FUSILEV® as a Class 2 Submission, and Establishes April 29, 2011 as PDUFA Action Date
* FUSILEV® Supplemental New Drug Application (sNDA) is Under Review by the FDA for Use in Combination Chemotherapy in Advanced Metastatic Colorectal Cancer
* FUSILEV is Currently FDA Approved and Marketed by Spectrum For:
o Rescue After High-Dose Methotrexate Therapy in Osteosarcoma;
o To Diminish the Toxicity and Counteract the Effects of Impaired Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid Antagonists
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGM: SPPI), 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 filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
The FDA considers the submission a Class 2 response, therefore, the PDUFA Action Date is April 29, 2011.
FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Important FUSILEV® (levoleucovorin) for Injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
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, and 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 financial results, 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, the safety and efficacy of ZEVALIN, FUSILEV, apaziquone, and belinostat, 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 trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Source: Spectrum Pharmaceuticals
News Provided by Acquire Media
Es bleibt spannend!
FDA Accepts for Review Spectrum's Response on FUSILEV® as a Class 2 Submission, and Establishes April 29, 2011 as PDUFA Action Date
* FUSILEV® Supplemental New Drug Application (sNDA) is Under Review by the FDA for Use in Combination Chemotherapy in Advanced Metastatic Colorectal Cancer
* FUSILEV is Currently FDA Approved and Marketed by Spectrum For:
o Rescue After High-Dose Methotrexate Therapy in Osteosarcoma;
o To Diminish the Toxicity and Counteract the Effects of Impaired Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid Antagonists
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGM: SPPI), 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 filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
The FDA considers the submission a Class 2 response, therefore, the PDUFA Action Date is April 29, 2011.
FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Important FUSILEV® (levoleucovorin) for Injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
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, and 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 financial results, 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, the safety and efficacy of ZEVALIN, FUSILEV, apaziquone, and belinostat, 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 trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Source: Spectrum Pharmaceuticals
News Provided by Acquire Media
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