Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 418)
eröffnet am 31.08.08 11:55:05 von
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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. % |
|---|---|---|
| 1,8550 | +147,33 | |
| 0,5700 | +55,23 | |
| 5,4500 | +41,56 | |
| 150,47 | +38,68 | |
| 1,0000 | +33,33 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,7300 | -19,34 | |
| 18,280 | -21,55 | |
| 2,1400 | -24,11 | |
| 1,5100 | -24,12 | |
| 2.849,50 | -83,34 |
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Antwort auf Beitrag Nr.: 35.779.503 von suomi3 am 31.10.08 17:14:58Ein bisschen verärgert bin ich trotzdem. Der Kurs ist zwar nett anzuschauen, aber spiegelt nicht einmal den aktuellen Cashbestand wieder.
Ich frage mich, warum der Kurs nicht vorgestern schon sofort in den Bereich um 3 Dollar gesprungen ist.
Wenigstens sollte man sich trauen den Bargeldbestand zu bewerten wenn man sich in Zeiten einer Finanzkrise schon nicht an zukünftige Einnahmen herantraut.
Ich frage mich, warum der Kurs nicht vorgestern schon sofort in den Bereich um 3 Dollar gesprungen ist.
Wenigstens sollte man sich trauen den Bargeldbestand zu bewerten wenn man sich in Zeiten einer Finanzkrise schon nicht an zukünftige Einnahmen herantraut.
Antwort auf Beitrag Nr.: 35.778.817 von VaJo am 31.10.08 16:14:36Danke, einverstanden, dem gibts von meiner Seite nichts hinzuzufügen!
Im Moment macht der Markt zwar noch nicht so mit, aber es sieht wirklich gut aus für die Zukunft.
Wir beliben dabei!
Im Moment macht der Markt zwar noch nicht so mit, aber es sieht wirklich gut aus für die Zukunft.
Wir beliben dabei!
Was haben wir bis jetzt erreicht!
Verkauf von Sumatriptan im November 2007 für 21 Mio Dollar.
Zulassung von Isovorin durch die FDA -> neuer Name Fusilev im März 08
Verkaufsstart von Fusilev in den USA und Kanada im August 08
Rajesh spricht offen von einer finanziellen Unabhängigkeit für Spectrum und davon, das man von nun an nicht nur forscht und entwickelt, sondern auch verkauft.
Erkündigt die 2.Indikation für Fusilev an.
Er spricht davon entweder einen starken Partner für Eoquin zu finden oder Eoquin im Alleingang zu entwickeln.
Rajesh hat wie ich meine aller Kritik getrotzt. Er hat eine super Arbeit gemacht und Wort gehalten.
Nun sollte auch das Vertrauen zurückkehren, den ab heute werden wir das wirklich im Kurs sehen.
Verkauf von Sumatriptan im November 2007 für 21 Mio Dollar.
Zulassung von Isovorin durch die FDA -> neuer Name Fusilev im März 08
Verkaufsstart von Fusilev in den USA und Kanada im August 08
Rajesh spricht offen von einer finanziellen Unabhängigkeit für Spectrum und davon, das man von nun an nicht nur forscht und entwickelt, sondern auch verkauft.
Erkündigt die 2.Indikation für Fusilev an.
Er spricht davon entweder einen starken Partner für Eoquin zu finden oder Eoquin im Alleingang zu entwickeln.
Rajesh hat wie ich meine aller Kritik getrotzt. Er hat eine super Arbeit gemacht und Wort gehalten.
Nun sollte auch das Vertrauen zurückkehren, den ab heute werden wir das wirklich im Kurs sehen.
Ja ist den heute schon Montag!
Damit beginnt die 10 Monatsfrist für die 2. Indikation.
Die Chancen auf Zulassung stehen nicht schlecht, den die Wirksamkeit und Verträglichkeit wurden ja bereits mit der 1. Indikation geprüft.
Das ist ein Markt mit mehr als 100 Mio Dollar.
Damit beginnt die 10 Monatsfrist für die 2. Indikation.
Die Chancen auf Zulassung stehen nicht schlecht, den die Wirksamkeit und Verträglichkeit wurden ja bereits mit der 1. Indikation geprüft.
Das ist ein Markt mit mehr als 100 Mio Dollar.
Antwort auf Beitrag Nr.: 35.773.866 von VaJo am 31.10.08 07:44:39News:
Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for FUSILEV(TM) in Colorectal Cancer
Friday October 31, 7:00 am ET
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI - News) today announced that it has filed with the FDA the supplemental NDA for FUSILEV™ (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. FUSILEV is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
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“Ninety percent of the more than 500 million milligrams of leucovorin used in the United States is for colorectal cancer,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009. We continue to expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved.”
Earlier this year, the Company completed its filing of an amendment to the New Drug Application (NDA) for FUSILEV™ Tablets. The Oncologic Drugs Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate.
About FUSILEV (levoleucovorin) for injection
FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. 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 comprised only of the pharmacologically active isomer of leucovorin.
Important FUSILEV (levoleucovorin) for injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.fusilev.com.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus, and; leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.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, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the safety and efficacy of FUSILEV™, that assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009, that we expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved, the Company's promising pipeline, 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.
FUSILEV ™, SPECTRUM PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.
© 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for FUSILEV(TM) in Colorectal Cancer
Friday October 31, 7:00 am ET
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI - News) today announced that it has filed with the FDA the supplemental NDA for FUSILEV™ (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. FUSILEV is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
ADVERTISEMENT
“Ninety percent of the more than 500 million milligrams of leucovorin used in the United States is for colorectal cancer,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009. We continue to expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved.”
Earlier this year, the Company completed its filing of an amendment to the New Drug Application (NDA) for FUSILEV™ Tablets. The Oncologic Drugs Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate.
About FUSILEV (levoleucovorin) for injection
FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. 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 comprised only of the pharmacologically active isomer of leucovorin.
Important FUSILEV (levoleucovorin) for injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.fusilev.com.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus, and; leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.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, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the safety and efficacy of FUSILEV™, that assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009, that we expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved, the Company's promising pipeline, 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.
FUSILEV ™, SPECTRUM PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.
© 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Trading Spotlight
Fundstück:
David Pyott, chairman of the board and CEO of Allergan, said: "Allergan looks forward to working with Spectrum in developing novel treatments for bladder cancer, and we believe apaziquone, if approved, has the potential to represent a meaningful advancement to urologists and patients in the current bladder cancer treatment paradigm."
Ende 2009 wird mit dem Abschluß der PIII gerechnet. Bis zum Abschluß und zur Zulassung erhält SPPI insgesamt 302 Mio Dollar zusätzlich zu den 41 Mio Upfrontzahlungen.
Sollte Eoquin scheitern stehen immer noch 7 weitere Wirkstoffe auf der Liste. Die Gefahr eines Totalverlusts ist damit bei SPPI mehr als Gering.
Ende 2009 könnte SPPI auf einem Cashbestand von über 300 Mio Dollar sitzen. Bei einer aktuellen Marktkapitalisierung von aktuell 51 Mio erscheint der Kurs geradezu lächerlich.
Streicht man Fusilev als Einnahmequelle, das mit der 2 Indikation nochmals +100 Mio bringen könnte, dann sollte der Kurs rein rechnerisch bei 6 Dollar je Aktie stehen.
Was der Markt daraus macht ist eine andere Sache. Die Chancen stehen aber nicht schlecht.
Interessant werden auf jeden Fall die ersten Zahlen zu Fusilv.
David Pyott, chairman of the board and CEO of Allergan, said: "Allergan looks forward to working with Spectrum in developing novel treatments for bladder cancer, and we believe apaziquone, if approved, has the potential to represent a meaningful advancement to urologists and patients in the current bladder cancer treatment paradigm."
Ende 2009 wird mit dem Abschluß der PIII gerechnet. Bis zum Abschluß und zur Zulassung erhält SPPI insgesamt 302 Mio Dollar zusätzlich zu den 41 Mio Upfrontzahlungen.
Sollte Eoquin scheitern stehen immer noch 7 weitere Wirkstoffe auf der Liste. Die Gefahr eines Totalverlusts ist damit bei SPPI mehr als Gering.
Ende 2009 könnte SPPI auf einem Cashbestand von über 300 Mio Dollar sitzen. Bei einer aktuellen Marktkapitalisierung von aktuell 51 Mio erscheint der Kurs geradezu lächerlich.
Streicht man Fusilev als Einnahmequelle, das mit der 2 Indikation nochmals +100 Mio bringen könnte, dann sollte der Kurs rein rechnerisch bei 6 Dollar je Aktie stehen.
Was der Markt daraus macht ist eine andere Sache. Die Chancen stehen aber nicht schlecht.
Interessant werden auf jeden Fall die ersten Zahlen zu Fusilv.
Antwort auf Beitrag Nr.: 35.768.093 von VaJo am 30.10.08 19:13:39Hallo allerseits,
Erwartungen erfüllt für gestern Donnerstag?
Denke schon.
Bin ja so was von gespannt auf Montag und die kommende Woche!
Sounds good!
Viel Glück allen die noch/oder wieder dabei sind!
Suomi
P.S;
PROGNOSEN?
Erwartungen erfüllt für gestern Donnerstag?
Denke schon.
Bin ja so was von gespannt auf Montag und die kommende Woche!
Sounds good!
Viel Glück allen die noch/oder wieder dabei sind!
Suomi
P.S;
PROGNOSEN?
Antwort auf Beitrag Nr.: 35.767.755 von Magnetfeldfredy am 30.10.08 18:46:23Hallo Fredy,
ja Rajesh hat einiges gut zu machen!
Schaun wir mal wie es weitergeht.
ja Rajesh hat einiges gut zu machen!
Schaun wir mal wie es weitergeht.
Antwort auf Beitrag Nr.: 35.763.918 von VaJo am 30.10.08 14:34:45Bin auch wieder mit dabei!
Jedoch hat SPPI in der Vergangenheit "viel Porzellan zerschlagen" und muß sich erst das Vertrauen der Aktionäre durch hieb und stichfähige Verträge erarbeiten!
Perspektiven sind ja da!
Jedoch hat SPPI in der Vergangenheit "viel Porzellan zerschlagen" und muß sich erst das Vertrauen der Aktionäre durch hieb und stichfähige Verträge erarbeiten!
Perspektiven sind ja da!
Hier mal ein Beitrag aus dem Ami Board
I keep wiping them trying to reconcile the $50 Million market cap with:
$100 million in cash
No debt
300 + Million in potential milestones
65% of dev costs paid for Eoquin
200 + Million in sales milestones
mid teen royalty and profit sharing arrangements
Other value drivers like Fusilev and the rest of the pipeline
It just doesn't match up. Why is this stock's valuation not $200 or $300 million at least?
Occam's razor says the simplest explanation is the most likely. THIS STOCK IS RIDICULOUSLY UNDERVALUED. It is hard to see how you wouldn't get at least a 100% return on this in the next year. Ok, ok, I understand that cash is king right now. Oh wait, they have $100 Million!
Unbelievable.
Sentiment : Strong Buy
I keep wiping them trying to reconcile the $50 Million market cap with:
$100 million in cash
No debt
300 + Million in potential milestones
65% of dev costs paid for Eoquin
200 + Million in sales milestones
mid teen royalty and profit sharing arrangements
Other value drivers like Fusilev and the rest of the pipeline
It just doesn't match up. Why is this stock's valuation not $200 or $300 million at least?
Occam's razor says the simplest explanation is the most likely. THIS STOCK IS RIDICULOUSLY UNDERVALUED. It is hard to see how you wouldn't get at least a 100% return on this in the next year. Ok, ok, I understand that cash is king right now. Oh wait, they have $100 Million!
Unbelievable.
Sentiment : Strong Buy
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