Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 129)
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Noch ein Artikel zur Shortage:
FDA works to avert cancer drug shortage
March 9, 2011 — 6:59pm ET | By George Miller
A recent example of the FDA stepping in to help alleviate a drug shortage involves high-flying Spectrum Pharmaceuticals and its anticancer drug, Fusilev (levoleucovorin, in 50-mg single-use vials). Given the ongoing shortage of both levoleucovorin and its cousin leucovorin, the agency has given the drugmaker a temporary OK to import levoleucovorin 100-mg powder for injection for U.S. distribution.
In addition to Spectrum, Teva Pharmaceuticals, Bedford Labs and APP currently appear in the short supply notification referencing leucovorin. Its shortage traces back to at least 2008. Explanations have been sketchy and currently include the oft-cited "manufacturing delays." Bedford Labs in 2009 said a facility expansion interrupted supply. Reuters says contamination problems affected the suppliers, and Teva had to close one of its plants last April.
Despite the number of suppliers, Spectrum stands alone in implementing the import fix. "There have not been any other firms so far willing and able to import," says FDA spokesperson Shelly Burgess in an email. "However[,] FDA continues to explore additional supplies to help with the shortage."
Spectrum may have a greater interest than its competitors in the levoleucovorin supply. Reuters notes that Fusilev contributes the majority of the drugmaker's revenue. And the news outlet cites an industry analyst who says that if the manufacturing issues for other suppliers continue, Fusilev is likely to continue helping Spectrum prosper. Furthering its dependence on the drug, Spectrum says it anticipates an FDA decision next month on an application for supplemental use.
...
Read more: FDA works to avert cancer drug shortage - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-works-ave…
Grüße Oberländler
FDA works to avert cancer drug shortage
March 9, 2011 — 6:59pm ET | By George Miller
A recent example of the FDA stepping in to help alleviate a drug shortage involves high-flying Spectrum Pharmaceuticals and its anticancer drug, Fusilev (levoleucovorin, in 50-mg single-use vials). Given the ongoing shortage of both levoleucovorin and its cousin leucovorin, the agency has given the drugmaker a temporary OK to import levoleucovorin 100-mg powder for injection for U.S. distribution.
In addition to Spectrum, Teva Pharmaceuticals, Bedford Labs and APP currently appear in the short supply notification referencing leucovorin. Its shortage traces back to at least 2008. Explanations have been sketchy and currently include the oft-cited "manufacturing delays." Bedford Labs in 2009 said a facility expansion interrupted supply. Reuters says contamination problems affected the suppliers, and Teva had to close one of its plants last April.
Despite the number of suppliers, Spectrum stands alone in implementing the import fix. "There have not been any other firms so far willing and able to import," says FDA spokesperson Shelly Burgess in an email. "However[,] FDA continues to explore additional supplies to help with the shortage."
Spectrum may have a greater interest than its competitors in the levoleucovorin supply. Reuters notes that Fusilev contributes the majority of the drugmaker's revenue. And the news outlet cites an industry analyst who says that if the manufacturing issues for other suppliers continue, Fusilev is likely to continue helping Spectrum prosper. Furthering its dependence on the drug, Spectrum says it anticipates an FDA decision next month on an application for supplemental use.
...
Read more: FDA works to avert cancer drug shortage - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-works-ave…
Grüße Oberländler
Ein Risiko 2011: Raj wird wahrscheinlich um 10 USD wieder eine Kapitalerhöhung durchführen.
Nach Anhören des CCs sieht es so aus als sei die Levo Shortage noch voll bestehend und Spectrum kann dank FDA-Unterstützung und Einkauf bei Pfizer/Wyeth in Europa voll davon profitieren. Daher kann man wohl in Q1 mit möglicherweise noch höheren Umsätzen von Fusilev rechnen als in Q4. Das wird ein interessantes Jahr werden.
Zevalin ist im Wachstum etwas enttäuschend, wuchs in Q4 nur mit 3% gegenüber Q3. Allerdings hätten sie angeblich eine Menge Aufmerksamkeit durch ASH erhalten und gehen von einem weiter anhaltenden Wachstum aus. Sie wissen meist schon Monate vorab wie hoch die Anzahl Patienten sein werden, da diese Monate voraus eingeplant werden.
Bald sind auch Ergebnisse eines Trials in Non Small Lung Cancer zu erwarten. PCTL Ergebnisse dann im Laufe des Jahres und auch die CUP Daten brauchen mindestens 6 Monate, werden aber noch in 2011 erwartet.
Diese Shortages in Leucovorin ist das beste was diesem Investment passieren konnte. Und nun kann man möglicherweise gar die Zulasssung erhalten, 29.4. ist der magische Termin.
Meine ags-freien 10.900 Stück bleiben drin. Für einen Exit wären 10 Euro je Stück ein Traum. Mal sehen, ob das in den nächsten zwei Jahren machbar ist.
Zevalin ist im Wachstum etwas enttäuschend, wuchs in Q4 nur mit 3% gegenüber Q3. Allerdings hätten sie angeblich eine Menge Aufmerksamkeit durch ASH erhalten und gehen von einem weiter anhaltenden Wachstum aus. Sie wissen meist schon Monate vorab wie hoch die Anzahl Patienten sein werden, da diese Monate voraus eingeplant werden.
Bald sind auch Ergebnisse eines Trials in Non Small Lung Cancer zu erwarten. PCTL Ergebnisse dann im Laufe des Jahres und auch die CUP Daten brauchen mindestens 6 Monate, werden aber noch in 2011 erwartet.
Diese Shortages in Leucovorin ist das beste was diesem Investment passieren konnte. Und nun kann man möglicherweise gar die Zulasssung erhalten, 29.4. ist der magische Termin.
Meine ags-freien 10.900 Stück bleiben drin. Für einen Exit wären 10 Euro je Stück ein Traum. Mal sehen, ob das in den nächsten zwei Jahren machbar ist.
Antwort auf Beitrag Nr.: 41.165.669 von Magnetfeldfredy am 08.03.11 16:36:17Spectrum Pharmaceuticals Reports Profitable Fourth Quarter and Record Revenue Growth for 2010
Strong Financial Results Include a Nearly Five-Fold and Two-Fold Increase in Fourth Quarter and Fiscal 2010 Product Revenue Vs. Fourth Quarter and Fiscal Year 2009, Respectively
Three and 12-Month 2010 Consolidated Revenues Approximately $34 Million and $74 Million, Respectively
Three and 12-Month 2010 Product Revenues Approximately $31 Million and $61 Million,
ZEVALIN® Fourth Quarter and Fiscal Year 2010 Sales Up 54% and 84% Vs. Fourth Quarter and Fiscal Year 2009, Respectively
FUSILEV® Fiscal Year 2010 Sales Up 156% Vs. Fiscal Year 2009
Approximately $104 Million In Cash, Cash Equivalents and Investments as of December 31, 2010, Up From $92 Million as of September 30, 2010
ShareretweetEmailPrintCompanies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 6.90 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals On Thursday March 10, 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, today reported financial results for the three and 12-months ended December 31, 2010.
“We are proud of our many accomplishments in 2010, especially the record revenue growth of both of our proprietary, marketed, anti-cancer drugs, FUSILEV® and ZEVALIN®, and the licensing of belinostat, a late-stage, potentially best-in-class HDAC inhibitor for potentially multiple indications,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “We remain committed to lymphoma. The cash generated by the record product sales provides us greater opportunity to help cancer patients by initiating additional studies for ZEVALIN, such as in Diffuse Large B-Cell Lymphoma, and for our other pipeline drugs.”
Fourth Quarter Results Ended December 31, 2010 (All #s are approximates)
Consolidated revenue of $34 million was comprised of product sales of $31 million ($8 million from ZEVALIN, $23 million from FUSILEV) and $3 million from licensing fees. This represents a more than three-fold increase over the $9 million in consolidated revenue in the fourth quarter of 2009, which was comprised of $5 million from product sales and the balance from licensing and milestone fees. The Company recorded net income of $4 million, or $0.09 per basic and $0.08 per diluted share, compared to net income of $10 million, which includes income of $20 million from the change in the fair value of common stock warrant liability, or $0.21 per basic and $0.20 per diluted share, in the fourth quarter of 2009. Total research and development expenses were $7 million, as compared to $4 million in the same period of 2009, primarily due to in-licensing of compounds and continued investment in clinical trials. Selling, general and administrative expenses were $13 million compared to $11 million in the same period in 2009, an increase primarily attributable to sales and marketing expenses, including payroll costs and non cash stock compensation costs incurred with the sales of ZEVALIN and FUSILEV.
12-Month Results Ended December 31, 2010 (All #s are approximates)
Consolidated revenue of $74 million was comprised of product sales of $61 million ($29 million from ZEVALIN, $32 million from FUSILEV) and $13 million from licensing fees. This represents a nearly two-fold increase from $38 million in consolidated revenue recorded in 2009, which was comprised of $28 million from product sales ($16 million from ZEVALIN, $12 million from FUSILEV) and $10 million from milestone and licensing fees. The Company recorded a net loss attributable to stockholders’ of $49 million, or ($0.99) per basic and diluted share, compared to a net loss attributable to stockholders’ of $19 million, or ($0.48) per basic and diluted share, in the same period of 2009. Total research and development expenses were $57 million, as compared to $21 million in the same period of 2009, primarily due to the $30 million upfront payment for the licensing of belinostat, and a one-time charge of $3 million, representing the fair value of 751,956 shares of our common stock issued as consideration for the acquisition and licensing of compounds. Selling, general and administrative expenses were $49 million compared to $34 million in the same period in 2009 an increase primarily due to the $14 million increase attributable to sales and marketing expenses, including payroll costs, incurred with the increase in sales of ZEVALIN and FUSILEV.
Cash, cash equivalents and investments as of December 31, 2010 aggregated $104 million, as compared to $125 million as of December 31, 2009, a net decrease of $21 million including the $30 million used for the in-licensing of belinostat.
There are approximately 51 million shares of common stock issued and outstanding at December 31, 2010. Approximately 7 million warrants expired unexercised in 2010.
2011/2012 Corporate Events and Potential Valuation Catalysts
FUSILEV®
FDA PDUFA Action date in metastatic colorectal cancer by April 29, 2011.
ZEVALIN®
Anticipate FDA decision on bioscan removal before the end of 2011;
Initiation of a Diffuse Large B-Cell Lymphoma trial in 2011.
Belinostat
Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012.
Apaziquone
Anticipate filing NDA for bladder cancer in 2012.
Conference Call
Thursday, March 10, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837 - 3910
International: (973) 796 - 5077
Webcast and replays: www.sppirx.com
Audio replays will be available through April 1, 2011
Domestic: (800) 642-1687, passcode 43097899
International: (706) 645-9291, passcode 43097899
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) 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.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials for injection 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 (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Three Months Ended Years Ended
December 31, December 31,
(unaudited)
2010 2009 2010 2009
Net revenues $ 33,946 $ 8,620 $ 74,113 $ 38,025
Operating expenses:
Cost of product sales(excludes amortization of purchased intangibles) 6,813 2,446 17,439 8,148
Selling, general and administrative 12,475 11,069 48,550 33,607
Research and development 6,986 3,525 57,301 21,058
Amortization of purchased intangibles 930 870 3,720 3,720
Total operating costs and expenses 27,204 17,910 127,010 66,533
Income (loss) from operations 6,742 (9,290 ) (52,897 ) (28,508 )
Change in fair value of common stock warrant liability (3,300 ) 19,834 2,731 8,075
Other Income, net 1,034 61 1,279 662
Income (loss) before provision for income taxes 4,476 10,605 (48,887 ) (19,771 )
Provision for income taxes (36 ) (421 ) 43 (421 )
Net loss attributable to non-controlling interest — — — 1,146
Net income (loss) attributable to Spectrum Pharmaceuticals, Inc. stockholders $ 4,440 $ 10,184 $ (48,887 ) $ (19,046 )
Net income (loss) per share:
Basic $ 0.09 $ 0.21 $ (0.99 ) $ (0.48 )
Diluted $ 0.08 $ 0.20 $ (0.99 ) $ (0.48 )
Weighted average shares outstanding:
Basic 50,344,177 48,425,486 49,502,854 39,273,905
Diluted 52,268,739 49,704,126 49,502,854 39,273,905
SUMMARY CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31,
2010 2009
Cash, cash equivalents and investments $ 95,674 $ 113,341
Accounts receivable, net 21,051 8,658
Inventories, net 4,234 3,230
Prepaid expenses and other current assets 906 1,028
Total current assets 121,865 126,257
Bank certificates of deposit & treasuries 8,569 11,438
Property and equipment, net 3,158 1,928
Zevalin related intangible assets, net 29,605 33,325
Other assets 434 185
Total Assets $ 163,631 $ 173,133
Current liabilities $ 63,322 $ 39,499
Deferred revenue and other credits – less current portion 25,495 24,943
Other long-term liabilities 338 367
Total liabilities 89,155 64,809
Total stockholders’ equity 74,476 108,324
Total liabilities and stockholders’ equity $ 163,631 $ 173,133
Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company’s on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Company’s core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company’s financial results in the way that management views the financial results.
The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company’s business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
NON-GAAP INCOME (LOSS) RECONCILIATION
(In thousands)
Three Months Ended Years Ended
December 31, December 31,
(unaudited)
2010 2009 2010 2009
GAAP net income (loss) $ 4,440 $ 10,184 $ (48,844 ) $ (19,046 )
Stock-based compensation 2,018 1,410 8,285 7,423
Change in fair value of common stock warrant liability 3,330 (19,834 ) (2,731 ) (8,075 )
Non-GAAP income (loss) $ 9,788 $ (8,240 ) $ (43,290 ) $ (19,698 )
Contact:
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700x216
Strong Financial Results Include a Nearly Five-Fold and Two-Fold Increase in Fourth Quarter and Fiscal 2010 Product Revenue Vs. Fourth Quarter and Fiscal Year 2009, Respectively
Three and 12-Month 2010 Consolidated Revenues Approximately $34 Million and $74 Million, Respectively
Three and 12-Month 2010 Product Revenues Approximately $31 Million and $61 Million,
ZEVALIN® Fourth Quarter and Fiscal Year 2010 Sales Up 54% and 84% Vs. Fourth Quarter and Fiscal Year 2009, Respectively
FUSILEV® Fiscal Year 2010 Sales Up 156% Vs. Fiscal Year 2009
Approximately $104 Million In Cash, Cash Equivalents and Investments as of December 31, 2010, Up From $92 Million as of September 30, 2010
ShareretweetEmailPrintCompanies:Spectrum Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SPPI 6.90 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals On Thursday March 10, 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, today reported financial results for the three and 12-months ended December 31, 2010.
“We are proud of our many accomplishments in 2010, especially the record revenue growth of both of our proprietary, marketed, anti-cancer drugs, FUSILEV® and ZEVALIN®, and the licensing of belinostat, a late-stage, potentially best-in-class HDAC inhibitor for potentially multiple indications,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “We remain committed to lymphoma. The cash generated by the record product sales provides us greater opportunity to help cancer patients by initiating additional studies for ZEVALIN, such as in Diffuse Large B-Cell Lymphoma, and for our other pipeline drugs.”
Fourth Quarter Results Ended December 31, 2010 (All #s are approximates)
Consolidated revenue of $34 million was comprised of product sales of $31 million ($8 million from ZEVALIN, $23 million from FUSILEV) and $3 million from licensing fees. This represents a more than three-fold increase over the $9 million in consolidated revenue in the fourth quarter of 2009, which was comprised of $5 million from product sales and the balance from licensing and milestone fees. The Company recorded net income of $4 million, or $0.09 per basic and $0.08 per diluted share, compared to net income of $10 million, which includes income of $20 million from the change in the fair value of common stock warrant liability, or $0.21 per basic and $0.20 per diluted share, in the fourth quarter of 2009. Total research and development expenses were $7 million, as compared to $4 million in the same period of 2009, primarily due to in-licensing of compounds and continued investment in clinical trials. Selling, general and administrative expenses were $13 million compared to $11 million in the same period in 2009, an increase primarily attributable to sales and marketing expenses, including payroll costs and non cash stock compensation costs incurred with the sales of ZEVALIN and FUSILEV.
12-Month Results Ended December 31, 2010 (All #s are approximates)
Consolidated revenue of $74 million was comprised of product sales of $61 million ($29 million from ZEVALIN, $32 million from FUSILEV) and $13 million from licensing fees. This represents a nearly two-fold increase from $38 million in consolidated revenue recorded in 2009, which was comprised of $28 million from product sales ($16 million from ZEVALIN, $12 million from FUSILEV) and $10 million from milestone and licensing fees. The Company recorded a net loss attributable to stockholders’ of $49 million, or ($0.99) per basic and diluted share, compared to a net loss attributable to stockholders’ of $19 million, or ($0.48) per basic and diluted share, in the same period of 2009. Total research and development expenses were $57 million, as compared to $21 million in the same period of 2009, primarily due to the $30 million upfront payment for the licensing of belinostat, and a one-time charge of $3 million, representing the fair value of 751,956 shares of our common stock issued as consideration for the acquisition and licensing of compounds. Selling, general and administrative expenses were $49 million compared to $34 million in the same period in 2009 an increase primarily due to the $14 million increase attributable to sales and marketing expenses, including payroll costs, incurred with the increase in sales of ZEVALIN and FUSILEV.
Cash, cash equivalents and investments as of December 31, 2010 aggregated $104 million, as compared to $125 million as of December 31, 2009, a net decrease of $21 million including the $30 million used for the in-licensing of belinostat.
There are approximately 51 million shares of common stock issued and outstanding at December 31, 2010. Approximately 7 million warrants expired unexercised in 2010.
2011/2012 Corporate Events and Potential Valuation Catalysts
FUSILEV®
FDA PDUFA Action date in metastatic colorectal cancer by April 29, 2011.
ZEVALIN®
Anticipate FDA decision on bioscan removal before the end of 2011;
Initiation of a Diffuse Large B-Cell Lymphoma trial in 2011.
Belinostat
Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012.
Apaziquone
Anticipate filing NDA for bladder cancer in 2012.
Conference Call
Thursday, March 10, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837 - 3910
International: (973) 796 - 5077
Webcast and replays: www.sppirx.com
Audio replays will be available through April 1, 2011
Domestic: (800) 642-1687, passcode 43097899
International: (706) 645-9291, passcode 43097899
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) 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.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials for injection 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 (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Three Months Ended Years Ended
December 31, December 31,
(unaudited)
2010 2009 2010 2009
Net revenues $ 33,946 $ 8,620 $ 74,113 $ 38,025
Operating expenses:
Cost of product sales(excludes amortization of purchased intangibles) 6,813 2,446 17,439 8,148
Selling, general and administrative 12,475 11,069 48,550 33,607
Research and development 6,986 3,525 57,301 21,058
Amortization of purchased intangibles 930 870 3,720 3,720
Total operating costs and expenses 27,204 17,910 127,010 66,533
Income (loss) from operations 6,742 (9,290 ) (52,897 ) (28,508 )
Change in fair value of common stock warrant liability (3,300 ) 19,834 2,731 8,075
Other Income, net 1,034 61 1,279 662
Income (loss) before provision for income taxes 4,476 10,605 (48,887 ) (19,771 )
Provision for income taxes (36 ) (421 ) 43 (421 )
Net loss attributable to non-controlling interest — — — 1,146
Net income (loss) attributable to Spectrum Pharmaceuticals, Inc. stockholders $ 4,440 $ 10,184 $ (48,887 ) $ (19,046 )
Net income (loss) per share:
Basic $ 0.09 $ 0.21 $ (0.99 ) $ (0.48 )
Diluted $ 0.08 $ 0.20 $ (0.99 ) $ (0.48 )
Weighted average shares outstanding:
Basic 50,344,177 48,425,486 49,502,854 39,273,905
Diluted 52,268,739 49,704,126 49,502,854 39,273,905
SUMMARY CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31,
2010 2009
Cash, cash equivalents and investments $ 95,674 $ 113,341
Accounts receivable, net 21,051 8,658
Inventories, net 4,234 3,230
Prepaid expenses and other current assets 906 1,028
Total current assets 121,865 126,257
Bank certificates of deposit & treasuries 8,569 11,438
Property and equipment, net 3,158 1,928
Zevalin related intangible assets, net 29,605 33,325
Other assets 434 185
Total Assets $ 163,631 $ 173,133
Current liabilities $ 63,322 $ 39,499
Deferred revenue and other credits – less current portion 25,495 24,943
Other long-term liabilities 338 367
Total liabilities 89,155 64,809
Total stockholders’ equity 74,476 108,324
Total liabilities and stockholders’ equity $ 163,631 $ 173,133
Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company’s on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Company’s core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company’s financial results in the way that management views the financial results.
The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company’s business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
NON-GAAP INCOME (LOSS) RECONCILIATION
(In thousands)
Three Months Ended Years Ended
December 31, December 31,
(unaudited)
2010 2009 2010 2009
GAAP net income (loss) $ 4,440 $ 10,184 $ (48,844 ) $ (19,046 )
Stock-based compensation 2,018 1,410 8,285 7,423
Change in fair value of common stock warrant liability 3,330 (19,834 ) (2,731 ) (8,075 )
Non-GAAP income (loss) $ 9,788 $ (8,240 ) $ (43,290 ) $ (19,698 )
Contact:
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700x216
Antwort auf Beitrag Nr.: 41.161.952 von Ville7 am 08.03.11 06:45:08Vielleicht wissen wir da mehr:
Spectrum Pharmaceuticals Announces Date and Time for Fourth Quarter and Fiscal 2010 Corporate Update Conference Call
ShareretweetEmailPrintPress Release Source: Spectrum Pharmaceuticals, Inc. On Monday March 7, 2011, 7:00 am EST
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced the date and time for its fourth quarter and fiscal year 2010 corporate update conference call.
Conference Call
Thursday, March 10, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837-3910
International: (973) 796-5077
Webcast and replays: www.sppirx.com
Audio replays will be available through April 1, 2011
Domestic: (800) 642-1687, passcode 43097899
International: (706) 645-9291, passcode 43097899
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.
Spectrum Pharmaceuticals Announces Date and Time for Fourth Quarter and Fiscal 2010 Corporate Update Conference Call
ShareretweetEmailPrintPress Release Source: Spectrum Pharmaceuticals, Inc. On Monday March 7, 2011, 7:00 am EST
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced the date and time for its fourth quarter and fiscal year 2010 corporate update conference call.
Conference Call
Thursday, March 10, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837-3910
International: (973) 796-5077
Webcast and replays: www.sppirx.com
Audio replays will be available through April 1, 2011
Domestic: (800) 642-1687, passcode 43097899
International: (706) 645-9291, passcode 43097899
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.
Trading Spotlight
Scheint so als bekäme SPPI seit Februar Fusilev von Pfizer (mit Segen der FDA). D.h. man kann weiter von der Shortage profitieren, zwar bestimmt mit stark verminderter Marge, aber immerhin. Sehr gute (indirekte) News.
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.…
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.…
Dieses Bildchen hier ist in Plagiat des Charts von Waxweazle (ob er den Chart auch nur "geklaut" hat weiß ich nicht). Interessant ist, dass hier ein Doppeltop gesehen wird. Falls sich dieses wirklich so ausgeht würde die gesamt Anlegerschaft auf dem falschen Fuß erwischt werden und man würde noch mal deutlich tiefere Kurse sehen. Seid bereit, falls es so kommt!
Spectrum Pharmaceuticals to Present at the RBC Capital Markets 2011 Health Care Investor Conference
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 2:00pm Eastern Time on Thursday, March 3, 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 RBC Capital Markets Healthcare Conference, being held in at the New York Palace Hotel in New York City, New York. The Spectrum Pharmaceuticals presentation is at 2:00p.m. Eastern Time on Thursday, March 3, 2011.
The live webcast of Spectrum's corporate presentation will be available at http://www.sppirx.com .
Spectrum Pharmaceuticals Appoints Steven M. Fruchtman, MD, an Industry Veteran, as Vice President of Clinical Development
* Dr. Fruchtman Is a Hematologist/Oncologist With a Proven Track Record in Clinical Research
* Joins Spectrum From Allos Therapeutics, Where He Led Development of FOLOTYN® For Hematologic and Oncologic Indications; Leading to FDA Approval of FOLOTYN in Relapsed and Refractory Peripheral T-Cell Lymphoma
* Previously, Dr. Fruchtman Was At Novartis, Where He Was Responsible For The Development of Panobinostat For Hematologic and Oncologic Indications, and Proleukin For Renal Cell and Melanoma; and Ortho Biotech Products, a Division of Johnson & Johnson, Where He Led The Development of Doxil® and Others
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 the appointment of Steven M. Fruchtman, MD, to the position of Vice President of Clinical Development. Dr. Fruchtman will report directly to George Tidmarsh, MD, PhD, the Company's Chief Scientific Officer and Head of Research and Development Operations, and will provide the strategic planning and leadership necessary for managing the Company's clinical development of belinostat, ZEVALIN® and its other pipeline products.
"We are pleased to announce the appointment of Dr. Fruchtman as our Vice President of Clinical Development," said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Steve comes to us from Allos Therapeutics, where he spearheaded the development of FOLOTYN. He was instrumental in the presentation of the FOLOTYN data to the ODAC panel that recommended and ultimately received FDA approval in relapsed/refractory Peripheral T-Cell Lymphoma. He is a board certified hematologist, and will be intimately involved with the development of belinostat and ZEVALIN in new indications including large B-cell lymphoma."
"I am extremely excited to join Spectrum Pharmaceuticals. Spectrum has a very exciting and diversified lineup of drugs both on the market and in late-stage clinical development," said Dr. Fruchtman. "Belinostat has the potential to be an effective treatment for not only Peripheral T-Cell lymphoma, but several other indications as well. Data from the most recent ASH 2010 Meeting shows ZEVALIN® provides durable remission rates in patients with B-Cell lymphomas. I am looking forward to bringing these potential life saving treatments to cancer patients as quickly as possible."
Dr. Fruchtman comes to Spectrum from Allos Therapeutics, where he led the development of pralatrexate for Hematologic and Oncologic indications. After a successful academic career at Mount Sinai Hospital and Medical School in New York, where he was Chief of the Stem Cell Transplantation Program, and prior to joining Allos, Dr. Fruchtman was Senior Director of US Clinical Development and Medical Affairs for Novartis Pharmaceuticals. At Novartis, he was responsible for the development of LBH589 (Panobinostat) for hematologic and oncologic indications, and was responsible for registration trials in the United States for CML, MM, and CTCL; lead development of post marketing trials for Proleukin (IL-2) in renal cell and melanoma; and lead development of RAD001 (Afinitor) for hematological indications. Prior to his tenure at Novartis, he was the Medical Director of Hematology and Oncology Therapeutics and Clinical Affairs at Ortho Biotech Products (OBI), L.P., a division of Johnson and Johnson Pharmaceuticals. At OBI, he was responsible for the clinical development of DOXIL® Phase 4 trials in Hematological Malignancies, (Multiple Myeloma and NHL), Velcade and DOXIL® for 2nd line Multiple Myeloma, Zarnestra® (tipifarnib) Phase 1 and 2 trials in MDS and AML, Procrit® for MDS, and Yondelis® (trabectedin) Trials in Soft Tissue Sarcoma and Ovarian Cancer.
Dr. Fruchtman has served as an external reviewer for the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, European Journal of Hematology, Leukemia, and served on the editorial board of The Mount Sinai Journal of Medicine. Dr. Fruchtman is an author of more than 170 lectures, presentations, books, chapters, and abstracts. Dr. Fruchtman received his Bachelor of Arts with Honors from Cornell University, and his MD from New York Medical College.
http://www.sppirx.com
* Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, to Present at 2:00pm Eastern Time on Thursday, March 3, 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 RBC Capital Markets Healthcare Conference, being held in at the New York Palace Hotel in New York City, New York. The Spectrum Pharmaceuticals presentation is at 2:00p.m. Eastern Time on Thursday, March 3, 2011.
The live webcast of Spectrum's corporate presentation will be available at http://www.sppirx.com .
Spectrum Pharmaceuticals Appoints Steven M. Fruchtman, MD, an Industry Veteran, as Vice President of Clinical Development
* Dr. Fruchtman Is a Hematologist/Oncologist With a Proven Track Record in Clinical Research
* Joins Spectrum From Allos Therapeutics, Where He Led Development of FOLOTYN® For Hematologic and Oncologic Indications; Leading to FDA Approval of FOLOTYN in Relapsed and Refractory Peripheral T-Cell Lymphoma
* Previously, Dr. Fruchtman Was At Novartis, Where He Was Responsible For The Development of Panobinostat For Hematologic and Oncologic Indications, and Proleukin For Renal Cell and Melanoma; and Ortho Biotech Products, a Division of Johnson & Johnson, Where He Led The Development of Doxil® and Others
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 the appointment of Steven M. Fruchtman, MD, to the position of Vice President of Clinical Development. Dr. Fruchtman will report directly to George Tidmarsh, MD, PhD, the Company's Chief Scientific Officer and Head of Research and Development Operations, and will provide the strategic planning and leadership necessary for managing the Company's clinical development of belinostat, ZEVALIN® and its other pipeline products.
"We are pleased to announce the appointment of Dr. Fruchtman as our Vice President of Clinical Development," said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Steve comes to us from Allos Therapeutics, where he spearheaded the development of FOLOTYN. He was instrumental in the presentation of the FOLOTYN data to the ODAC panel that recommended and ultimately received FDA approval in relapsed/refractory Peripheral T-Cell Lymphoma. He is a board certified hematologist, and will be intimately involved with the development of belinostat and ZEVALIN in new indications including large B-cell lymphoma."
"I am extremely excited to join Spectrum Pharmaceuticals. Spectrum has a very exciting and diversified lineup of drugs both on the market and in late-stage clinical development," said Dr. Fruchtman. "Belinostat has the potential to be an effective treatment for not only Peripheral T-Cell lymphoma, but several other indications as well. Data from the most recent ASH 2010 Meeting shows ZEVALIN® provides durable remission rates in patients with B-Cell lymphomas. I am looking forward to bringing these potential life saving treatments to cancer patients as quickly as possible."
Dr. Fruchtman comes to Spectrum from Allos Therapeutics, where he led the development of pralatrexate for Hematologic and Oncologic indications. After a successful academic career at Mount Sinai Hospital and Medical School in New York, where he was Chief of the Stem Cell Transplantation Program, and prior to joining Allos, Dr. Fruchtman was Senior Director of US Clinical Development and Medical Affairs for Novartis Pharmaceuticals. At Novartis, he was responsible for the development of LBH589 (Panobinostat) for hematologic and oncologic indications, and was responsible for registration trials in the United States for CML, MM, and CTCL; lead development of post marketing trials for Proleukin (IL-2) in renal cell and melanoma; and lead development of RAD001 (Afinitor) for hematological indications. Prior to his tenure at Novartis, he was the Medical Director of Hematology and Oncology Therapeutics and Clinical Affairs at Ortho Biotech Products (OBI), L.P., a division of Johnson and Johnson Pharmaceuticals. At OBI, he was responsible for the clinical development of DOXIL® Phase 4 trials in Hematological Malignancies, (Multiple Myeloma and NHL), Velcade and DOXIL® for 2nd line Multiple Myeloma, Zarnestra® (tipifarnib) Phase 1 and 2 trials in MDS and AML, Procrit® for MDS, and Yondelis® (trabectedin) Trials in Soft Tissue Sarcoma and Ovarian Cancer.
Dr. Fruchtman has served as an external reviewer for the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, European Journal of Hematology, Leukemia, and served on the editorial board of The Mount Sinai Journal of Medicine. Dr. Fruchtman is an author of more than 170 lectures, presentations, books, chapters, and abstracts. Dr. Fruchtman received his Bachelor of Arts with Honors from Cornell University, and his MD from New York Medical College.
http://www.sppirx.com
6 Events der nächsten zwei Jahre, die sehr wichtig für den Preis sind:
1. Fusilev Zulassung -> recht sicher positiv -> aktuell schon eingepreist.
2. BioScan Removal Zevalin -> sehr wahrscheinlich positiv -> notwendig für Wachstum der Jahresverkaufszahlen auf mehr als 50Mio USD.
3. Belinostat Daten PTCL -> Glücksspiel, ob die unverblindete Studie mit der geringen Patientenzahl signifikante Ergebnisse liefert. Ich denke eher nicht, dass die Daten einen NDA ermöglichen.
4. Kapitalerhöhung -> sehr wahrscheinlich bei Kursen um 10 USD oder darüber -> negativer Effekt auf Preis, wenn nicht durch andere Events überlagert.
5. Einlizensierung eines weiteren Produkts -> sehr wahrscheinlich -> Effekt auf Preis abhängig von deal.
6. Apaziquone Daten -> Glücksspiel, ob Daten positiv. Chance m.E. 50%:50%. Wenn ja, dann positiv enormes Upside.
1. Fusilev Zulassung -> recht sicher positiv -> aktuell schon eingepreist.
2. BioScan Removal Zevalin -> sehr wahrscheinlich positiv -> notwendig für Wachstum der Jahresverkaufszahlen auf mehr als 50Mio USD.
3. Belinostat Daten PTCL -> Glücksspiel, ob die unverblindete Studie mit der geringen Patientenzahl signifikante Ergebnisse liefert. Ich denke eher nicht, dass die Daten einen NDA ermöglichen.
4. Kapitalerhöhung -> sehr wahrscheinlich bei Kursen um 10 USD oder darüber -> negativer Effekt auf Preis, wenn nicht durch andere Events überlagert.
5. Einlizensierung eines weiteren Produkts -> sehr wahrscheinlich -> Effekt auf Preis abhängig von deal.
6. Apaziquone Daten -> Glücksspiel, ob Daten positiv. Chance m.E. 50%:50%. Wenn ja, dann positiv enormes Upside.
Antwort auf Beitrag Nr.: 41.068.566 von Ville7 am 18.02.11 18:57:29Ich habe eine Idee: So könnte die orale Form von Belinostat heissen.
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