Spectrum Pharmaceuticals - Glänzende Zukunft!
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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
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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
* U.S. Fusilev sales expected to reach $200 mln/year
* Zevalin sales projected to reach $300 million
* Two other drugs in final stages of human trials
* FDA approves ready-to-use Fusilev, shares rise 2.3 pct (Adds FDA approval of ready-to-use Fusilev, share movement)
By Deena Beasley
LOS ANGELES, April 21 (Reuters) - Spectrum Pharmaceuticals Inc , which has seen its shares rise nearly sixfold in the past three years, is banking on more growth in its oncology franchise this year, including U.S. approval for its drug Fusilev as a treatment for colon cancer.
Spectrum Chief Executive Officer Rajesh Shrotriya expects annual U.S. sales of the drug, Fusilev, to reach $200 million if it is granted expanded approval by the Food and Drug Administration as expected at the end of this month.
In a separate action, the FDA on Thursday approved a "ready-to-use" formulation of the drug for injection, sending Spectrum's shares up 2.3 percent.
Fusilev is currently approved for treatment of osteosarcoma, a type of bone cancer, but the FDA has been recommending since last year that the drug, also known as levoleucovorin, be made available to U.S. colon cancer patients due to a shortage of an older generic drug, leucovorin.
The FDA in 2009 turned down Spectrum's application for levoleucovorin in colon cancer, saying that the company had not shown that its drug worked as well as leucovorin. Spectrum subsequently resubmitted its regulatory filing.
Shrotriya said at least 30,000 U.S. colon cancer patients are being treated with Fusilev "without spending a dime of our own money."
Annual sales outside of the United States, where the drug is marketed by Takeda Pharmaceutical Co <4502.T> , Sanofi-Aventis and Pfizer Inc , total about $180 million to $200 million, according to the Spectrum CEO.
He said leucovorin is a generic drug "priced at rock bottom," while Fusilev is a purified version of the molecule that is given at a lower dose and can be combined with other drugs so it is priced at a premium.
Shrotriya, formerly an executive at Bristol Myers Squibb , SuperGen Inc , and MGI Pharma, specializes in licensing drug candidates.
Spectrum acquired full ownership in 2009 of Zevalin, a "radioimmunotherapy" invented by what is now Biogen Idec , that combines an antibody drug with radiation for targeted treatment of non-Hodgkin's lymphoma.
Use of Zevalin, first launched by Idec nearly 10 years ago, has been hampered by complicated treatment requirements and reimbursement issues. Spectrum's Zevalin sales totaled $29 million last year.
The FDA is slated to decide by Nov. 20 whether to remove a requirement that patients undergo a pre-treatment imaging evaluation, or bioscan, before receiving Zevalin.
"I expect sales of Zevalin should also rise gradually to over $300 million a year in two or three years," Shrotriya said.
He said Spectrum is also studying usage of Zevalin in different types of lymphoma.
The company has two other drugs in the final stages of human testing.
Shrotriya said Spectrum's goal is to begin filing a new drug application with the FDA before the end of this year for belinostat, which is being studied in a pivotal trial as a treatment for peripheral T-Cell lymphoma (PTCL).
Enrollment in the trial is scheduled to finish in the third quarter, with full trial results expected in early 2012.
He said the company will seek a "fast-track" FDA review, which means belinostat, which is also being studied in a range of different cancer types, could be approved in 2012.
The CEO said another drug, apaziquone, could be on the market as a treatment for bladder cancer in 2013.
"Cancer still remains a big challenge -- it will kill more people in 2011 than in 2010," Shrotriya said. "Whether we keep building our business or somebody comes and buys it remains to be seen. So far there are no offers."
Shares up Spectrum, based in Irvine, California, were up 21 cents at $9.29 in afternoon trading on Nasdaq on Thursday. (Reporting by Deena Beasley; Editing by Tim Dobbyn)
.
Share0 Already an attractive pick because of growing revenue and upcoming catalysts, Spectrum Pharmaceuticals (SPPI) announced last week that the FDA has granted approval of a "ready-to-use" formulation of Fusilev, which is already approved by the FDA in its lyophilized form to treat Osteosarcoma.
The new "ready-to-use" formulation "requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation," according to Spectrum CEO Dr. Rajesh C. Shrotriya in comments published in a press release issued on Thursday, and tt the very least will offer Doctors and medical professionals another option for utilizing Fusilev.
The share price and volume of SPPI reacted positively to the news on Thursday, as the stock closed higher by over two percent on more than double the average volume.
The real short term catalyst for Fusilev, however, is the upcoming 29 April decision day for the FDA regarding Spectrums application to have Fusilev approved for the treatment of colorectal cancer.
Fusilev for the colorectal indication has been denied once before by the FDA, but after supplying the regulatory agency with additional data, Spectrum hopes to see a reversal from the FDA's previous decision.
Keep an eye on shares of Spectrum into the new week. Friday is decision day for the FDA's Fusilev decision, but it's not out of the realm of possibility to see news at any point during the week.
Thursday's modest price and volume spike may have been related to the positive approval news for the "ready-to-use" formulation of Fusilev, but it may have also been related to investors getting a head start for the colorectal indication news that is pending this week.
With growing revenues and the upcoming catalysts still expected, SPPI could still be trading in buy territory. If the company receives approval for the colorectal indication, and if the FDA approves the removal of the bioscan criteria that currently accompanies treatment with Spectrum's non-Hodgkins Lymphoma treatment Zevalin, then it's expected that this stock will see some significant price appreciation over the short to mid term.
SPPI could become a high flyer for 2011.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
First Quarter 2011 Product Revenues in Excess of $40 Million as Compared to Approximately $7 Million in the First Quarter of 2010
Anticipate Reporting a Record Quarterly Profit in the First Quarter 2011Second Consecutive Profitable Quarter
FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is Currently Under Review by the FDAPDUFA Action Date – This Week – April 29, 2011
ZEVALIN® Prior Approval Supplement for the Removal of the Bioscan Requirement Currently Under Review by the FDAPDUFA Action Date – November 20, 2011
Belinostat and Apaziquone Clinical Programs on Track for New Drug Application Filings in 2012
Conference Call to be Held on Wednesday, May 4, 2011
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Press Release Source: Spectrum Pharmaceuticals On Wednesday April 27, 2011, 9:00 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, today announced preliminary unaudited first quarter 2011 product revenues and that it anticipates reporting a record quarterly profit in the first quarter.
"We are pleased with our record revenue and profit during the first quarter,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We believe that our strategy of having multiple commercial drugs has been validated, and our ability to respond to market developments has been demonstrated. While we expect ZEVALIN revenues to grow gradually over time as we continue to focus on driving adoption of ZEVALIN as the treatment of choice for appropriate patients, the revenue growth this quarter was driven by FUSILEV. There is great anticipation around several events for Spectrum over the next two years. If approved for colorectal cancer later this week, we believe it could represent a significant growth catalyst for the company. The PDUFA action date for FUSILEV’s use in colorectal cancer is this Friday, April 29th.”
First Quarter 2011 Estimated Revenues (unaudited)
• First Quarter 2011 product revenues in excess of $40 million, a nearly six-fold increase as compared to approximately $7 million in the first quarter 2010
The Company plans to file its 10-Q for the first quarter ended March 31, 2011 on Tuesday, May 3, after the market close, and host a conference call on Wednesday, May 4, 2011.
Conference Call
Wednesday, May 4, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837-3910, Conference ID# 60326117
International: (973) 796-5077, Conference ID# 60326117
2011/2012 Corporate Events and Valuation Catalysts
FUSILEV®
•FUSILEV sNDA for use in advanced metastatic colorectal cancer is currently under review by the FDA • PDUFA Action Date – April 29, 2011
ZEVALIN®
•ZEVALIN bioscan removal is currently under review by the FDA • PDUFA Action Date – November 20, 2011
Belinostat
• Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012.
Apaziquone
• Anticipate data from Phase 3 bladder cancer trials and filing NDA in 2012.
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.
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Wie gehts weiter?
Am Montag werden sich erstmal alle neu sortieren. Die Shorts vom Freitag werden versuchen ihre Stücke einzukaufen und die die Zweifel am weiteren Erfolg von Fusilev haben werden ihre Stücke loswerden wollen.
Fakt ist, Spectrum erzielt mit Fusilev im Moment Rekordumsätze und das obwohl Fusilev bei Mastdarmkrebs nicht zugelassen war.
Solange die Generika Hersteller weiterhin kein generisches Leucovorin produzieren dürfen weil dieses verunreinigt ist, solange kann das pure Levoleucovorin das zehn mal teurer ist und von Spectrum allein in den US vertrieben wird weiter Spitzenumsätze generieren. Und es wird viel davon benötigt!
Am Mittwoch nächste Woche ist der Conference Call von Spectrum und da werde ich erstmal wieder gespannt lauschen wie sich die Umsätze aufgeteilt haben.
Spannende Woche euch allen....
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Das hält aber MV Capital nicht davon ab, ihr neues Kursziel für SPPI vor Börseneröffnung bekannt zu geben. MV Capital stuft Spectrum nun mit kaufen ein und erhöht das Kursziel auf 12 Monatssicht von $12.50 auf $20.50
Das nenne ich mal eine Hausnummer :-)
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