Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 131)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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Werte aus der Branche Pharmaindustrie
| 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 | |
| 23,700 | -19,52 | |
| 28,60 | -24,06 | |
| 1,3500 | -25,62 | |
| 0,7800 | -29,73 |
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Spectrum Pharmaceuticals Announces Record Revenue Growth in Fourth Quarter and Fiscal Year 2010; Ends Year with $104 Million in Cash, Cash Equivalents and Investments
2010 Estimated Revenues (unaudited)
* Fourth Quarter 2010 product revenues in excess of $30 million, up 500% as compared to approximately $5 million in the fourth quarter 2009
* Fourth Quarter 2010 total revenues in excess of $33 million, up 267% as compared with approximately $9 million in the fourth quarter 2009
* Fiscal Year 2010 product revenues in excess of $60 million, up 114% as compared to approximately $28 million in fiscal year 2009
* Fiscal Year 2010 total revenues in excess of $73 million, up 92% as compared to approximately $38 million in fiscal year 2009
Cash, Cash Equivalents and Investments as of December 31, 2010 aggregated approximately $104 million, as compared to approximately $125 million as of December 31, 2009, a net decrease of $21 million after cash used for an in license of Belinostat of $30 million, offset by cash received from out-license of apaziquone of $17 million. During the fourth quarter Cash, Cash Equivalents and Investments increased from $92 million as of September 30, 2010 to approximately $104 million as of December 31, 2010, reflecting a net increase of approximately $12 million.
The company plans to report full Fourth Quarter and Fiscal Year ended December 31, 2010 financial results in mid-March 2011.
2010 Estimated Revenues (unaudited)
* Fourth Quarter 2010 product revenues in excess of $30 million, up 500% as compared to approximately $5 million in the fourth quarter 2009
* Fourth Quarter 2010 total revenues in excess of $33 million, up 267% as compared with approximately $9 million in the fourth quarter 2009
* Fiscal Year 2010 product revenues in excess of $60 million, up 114% as compared to approximately $28 million in fiscal year 2009
* Fiscal Year 2010 total revenues in excess of $73 million, up 92% as compared to approximately $38 million in fiscal year 2009
Cash, Cash Equivalents and Investments as of December 31, 2010 aggregated approximately $104 million, as compared to approximately $125 million as of December 31, 2009, a net decrease of $21 million after cash used for an in license of Belinostat of $30 million, offset by cash received from out-license of apaziquone of $17 million. During the fourth quarter Cash, Cash Equivalents and Investments increased from $92 million as of September 30, 2010 to approximately $104 million as of December 31, 2010, reflecting a net increase of approximately $12 million.
The company plans to report full Fourth Quarter and Fiscal Year ended December 31, 2010 financial results in mid-March 2011.
Spectrum Pharmaceuticals to Present at the BIO CEO Investor Conference
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 3:30pm Eastern Time on Tuesday, February 15, 2011
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that an overview of the Company's business strategy will be given at the BIO CEO Investor Conference, being held at the Waldorf Astoria hotel in New York City, New York. The Spectrum Pharmaceuticals presentation is at 3:30p.m. Eastern Time on Tuesday, February 15, 2011.
http://www.sppirx.com/
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 3:30pm Eastern Time on Tuesday, February 15, 2011
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that an overview of the Company's business strategy will be given at the BIO CEO Investor Conference, being held at the Waldorf Astoria hotel in New York City, New York. The Spectrum Pharmaceuticals presentation is at 3:30p.m. Eastern Time on Tuesday, February 15, 2011.
http://www.sppirx.com/
Spectrum Pharmaceuticals Submits Data to FDA in Support of Bioscan Removal for ZEVALIN(R)
* ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
o Treatment of Patients With Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
o Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement. This bioscan component currently is required by the FDA as part of the ZEVALIN therapeutic regimen for the treatment of non-Hodgkin's lymphoma. The ZEVALIN therapeutic regimen requires two administrations of ZEVALIN, the Indium-111 bioscan dose, and the Yttrium-90 therapeutic dose administered 7-9 days later. A single administration of each of these doses takes approximately 10 minutes. The purpose of the bioscan is to pre-determine the distribution of ZEVALIN throughout the body prior to the administration of the therapeutic dose of ZEVALIN, and has no therapeutic effect on the patients.
"We have had several discussions and meetings with the FDA over the past several months to determine exactly what data were necessary to remove the bioscan requirement. We believe that the data we submitted should satisfy the FDA," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Removal of the bioscan eases the burden on patients, doctors, and the healthcare system. First and foremost, patients need to make one less trip to a ZEVALIN administration site and do not have to undergo a scan. Secondly, logistical coordination between the referring oncologist and the administering nuclear medicine or radiation oncology specialist is reduced. Third, it reduces the costs to the healthcare system of administering ZEVALIN by eliminating a costly scan."
Spectrum Pharmaceuticals markets ZEVALIN in the United States. ZEVALIN is currently approved in more than 40 countries. Of those countries, only three require the bioscan: the United States, Japan, and Switzerland.
Of the more than eight thousand patients who have been treated with ZEVALIN in the United States since its approval in 2002, less than 1% had a true altered bioscan. Additionally, the data the Company submitted suggests that of those patients who had a true altered bioscan and received ZEVALIN treatment appeared to experience safety and efficacy outcomes that were consistent with patients with a normal bioscan.
FDA has up to 60 days to formally accept the submission.
http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseI…
* ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
o Treatment of Patients With Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
o Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement. This bioscan component currently is required by the FDA as part of the ZEVALIN therapeutic regimen for the treatment of non-Hodgkin's lymphoma. The ZEVALIN therapeutic regimen requires two administrations of ZEVALIN, the Indium-111 bioscan dose, and the Yttrium-90 therapeutic dose administered 7-9 days later. A single administration of each of these doses takes approximately 10 minutes. The purpose of the bioscan is to pre-determine the distribution of ZEVALIN throughout the body prior to the administration of the therapeutic dose of ZEVALIN, and has no therapeutic effect on the patients.
"We have had several discussions and meetings with the FDA over the past several months to determine exactly what data were necessary to remove the bioscan requirement. We believe that the data we submitted should satisfy the FDA," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Removal of the bioscan eases the burden on patients, doctors, and the healthcare system. First and foremost, patients need to make one less trip to a ZEVALIN administration site and do not have to undergo a scan. Secondly, logistical coordination between the referring oncologist and the administering nuclear medicine or radiation oncology specialist is reduced. Third, it reduces the costs to the healthcare system of administering ZEVALIN by eliminating a costly scan."
Spectrum Pharmaceuticals markets ZEVALIN in the United States. ZEVALIN is currently approved in more than 40 countries. Of those countries, only three require the bioscan: the United States, Japan, and Switzerland.
Of the more than eight thousand patients who have been treated with ZEVALIN in the United States since its approval in 2002, less than 1% had a true altered bioscan. Additionally, the data the Company submitted suggests that of those patients who had a true altered bioscan and received ZEVALIN treatment appeared to experience safety and efficacy outcomes that were consistent with patients with a normal bioscan.
FDA has up to 60 days to formally accept the submission.
http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseI…
SPPI dürfte bald wieder über $7 laufen :-)
Trading Spotlight
Spectrum Pharmaceuticals to Present at the 29th Annual J.P. Morgan Healthcare Conference
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 12 p.m. Pacific Time on Thursday, January 13, 2011
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that an overview of the Company's business strategy will be given at the 29th Annual J. P. Morgan Healthcare Conference, being held in at the Westin St. Francis hotel in San Francisco, California. The Spectrum Pharmaceuticals presentation is at 12:00 p.m. Pacific Time on Thursday, January 13, 2011 in the California East room.
The live webcast of Spectrum's corporate presentation will be available at http://www.sppirx.com.
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 12 p.m. Pacific Time on Thursday, January 13, 2011
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that an overview of the Company's business strategy will be given at the 29th Annual J. P. Morgan Healthcare Conference, being held in at the Westin St. Francis hotel in San Francisco, California. The Spectrum Pharmaceuticals presentation is at 12:00 p.m. Pacific Time on Thursday, January 13, 2011 in the California East room.
The live webcast of Spectrum's corporate presentation will be available at http://www.sppirx.com.
Antwort auf Beitrag Nr.: 40.811.879 von VaJo am 06.01.11 15:39:46naja das mit dem bio-similar war doch eine Lachnumer.
1. ist der Partner einfach nur eine "Klitsche"
2. Das Geld und die Zeit für alle Studien sind einfach zu hoch
3. Konkurrenz ist auch nicht ohne (Teva)
Gruss future_trader
PS: Der gestige Kursverlauf war auch sehr sehr seltsam!
1. ist der Partner einfach nur eine "Klitsche"
2. Das Geld und die Zeit für alle Studien sind einfach zu hoch
3. Konkurrenz ist auch nicht ohne (Teva)
Gruss future_trader
PS: Der gestige Kursverlauf war auch sehr sehr seltsam!
SPPI jagt eine neue Meldung nach der anderen raus. Ich bin jedenfalls begeistert das sich was tut.
Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals Announces Initiation of a Required Phase 1 Study of Apaziquone in Japan by Nippon Kayaku
* Apaziquone is in Pivotal Registrational Trials in the United States; NDA Expected to be Filed in 2012
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer. The Phase 1 study is required by the local regulatory authorities and is designed to enroll up to 6 patients and determine the safety and pharmacokinetics of an immediate instillation of apaziquone in the bladder following transurethral resection of bladder tumor (TURBT), followed by 6 weekly instillations of apaziquone in the bladder, starting week 4.
"We are excited that Nippon Kayaku has begun required studies of apaziquone in Japan, a major market for oncology drugs," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
In December 2009, Spectrum Pharmaceuticals licensed to Nippon Kayaku exclusive rights to apaziquone for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China, for an upfront licensing fee of $15 million, plus up to $136 million in milestones, and royalties. Nippon Kayaku will conduct the apaziquone clinical trials pursuant to a development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Nippon Kayaku territory.
About Apaziquone
Apaziquone is a drug currently being investigated for the treatment of non-muscle invasive bladder cancer. Apaziquone, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. Phase 2 data has confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder cancer, as evidenced by 31 of 46 patients (67%) showing a complete response after receiving six weekly treatments with 4 mg of apaziquone instilled into the urinary bladder in a marker lesion study. In another Phase 2 study, apaziquone instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.
About Nippon Kayaku Co., Ltd.
Nippon Kayaku is a general chemical company focused on IT, health care and safety systems. The Company's Pharmaceuticals Group maintains extensive original expertise related to research and development, production, sales, and aftermarket investigations of anti-cancer drugs. The Company's lineup of cancer-fighting drugs and cancer supportive products has reached 28 products. Nippon Kayaku is also strengthening its licensing activities, and is introducing generic products in order to expand its cancer-related business. For more information, please visit the Company's website at www.nipponkayaku.co.jp/english/.
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.
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
Source: Spectrum Pharmaceuticals
Spectrum Pharmaceuticals Announces Initiation of a Required Phase 1 Study of Apaziquone in Japan by Nippon Kayaku
* Apaziquone is in Pivotal Registrational Trials in the United States; NDA Expected to be Filed in 2012
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer. The Phase 1 study is required by the local regulatory authorities and is designed to enroll up to 6 patients and determine the safety and pharmacokinetics of an immediate instillation of apaziquone in the bladder following transurethral resection of bladder tumor (TURBT), followed by 6 weekly instillations of apaziquone in the bladder, starting week 4.
"We are excited that Nippon Kayaku has begun required studies of apaziquone in Japan, a major market for oncology drugs," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
In December 2009, Spectrum Pharmaceuticals licensed to Nippon Kayaku exclusive rights to apaziquone for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China, for an upfront licensing fee of $15 million, plus up to $136 million in milestones, and royalties. Nippon Kayaku will conduct the apaziquone clinical trials pursuant to a development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Nippon Kayaku territory.
About Apaziquone
Apaziquone is a drug currently being investigated for the treatment of non-muscle invasive bladder cancer. Apaziquone, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. Phase 2 data has confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder cancer, as evidenced by 31 of 46 patients (67%) showing a complete response after receiving six weekly treatments with 4 mg of apaziquone instilled into the urinary bladder in a marker lesion study. In another Phase 2 study, apaziquone instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.
About Nippon Kayaku Co., Ltd.
Nippon Kayaku is a general chemical company focused on IT, health care and safety systems. The Company's Pharmaceuticals Group maintains extensive original expertise related to research and development, production, sales, and aftermarket investigations of anti-cancer drugs. The Company's lineup of cancer-fighting drugs and cancer supportive products has reached 28 products. Nippon Kayaku is also strengthening its licensing activities, and is introducing generic products in order to expand its cancer-related business. For more information, please visit the Company's website at www.nipponkayaku.co.jp/english/.
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.
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
Source: Spectrum Pharmaceuticals
Antwort auf Beitrag Nr.: 40.806.815 von Ville7 am 05.01.11 20:36:20Solide sieht es jedenfalls auf den ersten Blick nicht aus, angeblich ist man in Finanzierungsverhandlungen. Ist aber wohl eine Raj -Buddy connection. Und bei diesem mittlerweile 1260% Pump up.... hat man sicherlich was dran verdient, ... wer auch immer Goldman Sachs golden boys haben sich Zusatzboni verdient...
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