Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 359)
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
Neuigkeiten
20.07.23 · Business Wire (engl.) |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
Wertpapier | Kurs | Perf. % |
---|---|---|
2,25 | +63,04 | |
0,8000 | +45,45 | |
1,0000 | +42,86 | |
6,2500 | +24,75 | |
15,348 | +19,53 |
Wertpapier | Kurs | Perf. % |
---|---|---|
114,60 | -13,61 | |
23,700 | -19,52 | |
28,60 | -24,06 | |
1,3500 | -25,62 | |
0,7800 | -29,73 |
Beitrag zu dieser Diskussion schreiben
Fusilev entwickelt sich genau so wie ich es letztes Jahr im Herbst vorausgesagt habe. Es wird Off Label in allen Indikationen eingesetzt in denen zuvor Leucovorin verwandt wurde. Der Shortage pusht zwar diese Entwicklung aber mit der Zeit werden immer mehr Onkologen Fusilev einsetzten und der Preis für Fusilev wird im Gegenzug deutlich sinken.
Nochmal - Fusilev ist kein Nischenprodukt wie vielfach behauptet. Die Indikationen in denen Fusilev verwandt werden kann sind zahlreich.
Nochmal - Fusilev ist kein Nischenprodukt wie vielfach behauptet. Die Indikationen in denen Fusilev verwandt werden kann sind zahlreich.
Fusilev wird bereits häufig Off-Label eingesetzt.
27.01.2009
Clinicians, Cooperative Groups Work through Leucovorin Shortage
A shortage of the chemotherapy drug leucovorin is raising some concern about patient care and the conduct of clinical trials, researchers and patient advocates have reported in recent weeks.
Although it is used to treat several cancers, leucovorin in combination with another chemotherapy drug, fluorouracil (often called 5-FU), is particularly important as part of the first-line therapy in patients with metastatic colorectal cancer and adjuvant therapy for earlier stage disease, explained Dr. Meg Mooney, head of Gastrointestinal and Neuroendocrine Cancer Therapeutics in NCI's Division of Cancer Treatment and Diagnosis.
It's unclear whether the shortage has had a demonstrable impact on patient care across the country. According to Kate Murphy from the Colorectal Cancer Coalition, the organization has not received many calls from patients reporting problems with their care because of lack of access to the drug.
“We've been hearing it more from the people in the clinical trials who are concerned about amending protocols,” Ms. Murphy said. Even so, she added, that is no guarantee that more wide-spread issues won't arise.
Managing the Shortage
NCI's Cancer Therapy Evaluation Program (CTEP) has provided general instructions to Cooperative Groups conducting CTEP-supported clinical trials on how to address the leucovorin shortage with regard to their specific protocols.
At Fox Chase Cancer Center in Philadelphia, the shortage initially “caused a fair amount of scrambling,” said Dr. Steven J. Cohen, a lead investigator on colorectal cancer trials at the center. The Eastern Cooperative Oncology Group, which runs a large number of colorectal cancer trials, quickly got word to facilities about the shortage, Dr. Cohen noted, so the staff worked with the pharmacy to secure enough levoleucovorin (Fusilev), an alternative form of leucovorin, to meet patient demand. Although levoleucovorin is not approved by the FDA for the treatment of colorectal cancer, it is often used off-label to treat it, according to a clinical alert issued by the American Society of Clinical Oncology.
“We wanted to make sure that for patients coming in to receive standard therapy, we had something for them,” he said. Sometimes that means alternating between standard leucovorin and levoleucovorin. Although dosing differences are an issue with levoleucovorin, the larger concern may be its vastly higher price tag, which is approximately 60 times higher than the generic leucovorin, Dr. Cohen said.
The experience differs from facility to facility, though. At Swedish Cancer Institute in Seattle, the leucovorin supply has been stable to date and has not had an impact on patient care or clinical trials, said Dr. Philip Gold, program leader of gastrointestinal cancers at that institute.
What's Behind It?
The shortage appears to have been brought on by manufacturing interruptions. Two companies produce leucovorin, Bedford Laboratories and Teva Pharmaceuticals. According to the most recent statement from Bedford, released nearly 5 weeks ago, supply interruptions of its leucovorin product are due to ongoing efforts at its Ohio manufacturing facility to expand production capacity.
“We anticipate resolution of these issues in the near future. Until such time, we will work diligently to fulfill our order commitments,” the December 18 statement said.
Teva has had no manufacturing issues that would slow production of its leucovorin product, according to a company spokesperson. However, in response to the shortage it has ramped up production and is releasing product as frequently as it can, the spokesperson said.
27.01.2009
Clinicians, Cooperative Groups Work through Leucovorin Shortage
A shortage of the chemotherapy drug leucovorin is raising some concern about patient care and the conduct of clinical trials, researchers and patient advocates have reported in recent weeks.
Although it is used to treat several cancers, leucovorin in combination with another chemotherapy drug, fluorouracil (often called 5-FU), is particularly important as part of the first-line therapy in patients with metastatic colorectal cancer and adjuvant therapy for earlier stage disease, explained Dr. Meg Mooney, head of Gastrointestinal and Neuroendocrine Cancer Therapeutics in NCI's Division of Cancer Treatment and Diagnosis.
It's unclear whether the shortage has had a demonstrable impact on patient care across the country. According to Kate Murphy from the Colorectal Cancer Coalition, the organization has not received many calls from patients reporting problems with their care because of lack of access to the drug.
“We've been hearing it more from the people in the clinical trials who are concerned about amending protocols,” Ms. Murphy said. Even so, she added, that is no guarantee that more wide-spread issues won't arise.
Managing the Shortage
NCI's Cancer Therapy Evaluation Program (CTEP) has provided general instructions to Cooperative Groups conducting CTEP-supported clinical trials on how to address the leucovorin shortage with regard to their specific protocols.
At Fox Chase Cancer Center in Philadelphia, the shortage initially “caused a fair amount of scrambling,” said Dr. Steven J. Cohen, a lead investigator on colorectal cancer trials at the center. The Eastern Cooperative Oncology Group, which runs a large number of colorectal cancer trials, quickly got word to facilities about the shortage, Dr. Cohen noted, so the staff worked with the pharmacy to secure enough levoleucovorin (Fusilev), an alternative form of leucovorin, to meet patient demand. Although levoleucovorin is not approved by the FDA for the treatment of colorectal cancer, it is often used off-label to treat it, according to a clinical alert issued by the American Society of Clinical Oncology.
“We wanted to make sure that for patients coming in to receive standard therapy, we had something for them,” he said. Sometimes that means alternating between standard leucovorin and levoleucovorin. Although dosing differences are an issue with levoleucovorin, the larger concern may be its vastly higher price tag, which is approximately 60 times higher than the generic leucovorin, Dr. Cohen said.
The experience differs from facility to facility, though. At Swedish Cancer Institute in Seattle, the leucovorin supply has been stable to date and has not had an impact on patient care or clinical trials, said Dr. Philip Gold, program leader of gastrointestinal cancers at that institute.
What's Behind It?
The shortage appears to have been brought on by manufacturing interruptions. Two companies produce leucovorin, Bedford Laboratories and Teva Pharmaceuticals. According to the most recent statement from Bedford, released nearly 5 weeks ago, supply interruptions of its leucovorin product are due to ongoing efforts at its Ohio manufacturing facility to expand production capacity.
“We anticipate resolution of these issues in the near future. Until such time, we will work diligently to fulfill our order commitments,” the December 18 statement said.
Teva has had no manufacturing issues that would slow production of its leucovorin product, according to a company spokesperson. However, in response to the shortage it has ramped up production and is releasing product as frequently as it can, the spokesperson said.
Re: Look at the netsales! 27-Jan-09 05:02 pm
According to the numbers you mentioned in another message board it seems to bei selling @ a $ 5.000.000 per month pace as long as the shortage exists. My the shortage be forever!
ville_9
Ich würde mal sagen Du kittest Deinen Post im Yahoo Board selbst, ich habe das nicht geschrieben
According to the numbers you mentioned in another message board it seems to bei selling @ a $ 5.000.000 per month pace as long as the shortage exists. My the shortage be forever!
ville_9
Ich würde mal sagen Du kittest Deinen Post im Yahoo Board selbst, ich habe das nicht geschrieben
Antwort auf Beitrag Nr.: 36.470.969 von Ville7 am 29.01.09 08:39:37Fundamentals
In Millions of U.S. Dollars
As of 01/28/09
Income Statement
Net Sales 7.67
Gross Profit 7.67
Income Before Taxes -34.06
Net Income -34.04
In Millions of U.S. Dollars
As of 01/28/09
Income Statement
Net Sales 7.67
Gross Profit 7.67
Income Before Taxes -34.06
Net Income -34.04
Lies nochmal was ich geschrieben habe. Sie haben mich auf die Fundamentals verwiesen. Da stehen die aktuellen netsales. Jetzt aktualisiert 7,67 mio. Was das mit AdHoc zu tun hat weis ich nicht.
Antwort auf Beitrag Nr.: 36.469.415 von VaJo am 28.01.09 21:14:14Bitte auf yahoo zu den von dir genannten Saleszahlen Stellung nehmen. Haben sie dir wirklich den Betrag 7.68Mio genannt? Wenn ja ist das Insiderinfo und könnte einen Shareholderlawsiut nach sich ziehen, weil von Spectrum gegen das amerikanische AdHoc Gesetz verstossen wurde.
Info-Update:
Kleine Rechnung zu den vermuteten NetSales von Fusilev.
Ich hoffe es ist verständlich.
Leucovorin:
Preis für 10 mg = 69,53 EUR = 70 EUR
Levoleucovorin:
der Preis ist laut Aussage von Dr. Chandler NCI 60 x höher
70 EUR x 60 = 4200 EUR für 10 mg Levoleucovorin / 2 da wir nur die Hälfte (5mg) für eine Dosis benötigen.
macht 2100 EUR entspricht ca. 2751 US-Dollar.
Teilen wir die angenommenen 5 Mio NetSales/ $2751 = 1817 Anwendungen im Monat.
Jährlich werden in den USA 500 Mio Milligram Leucovorin verbraucht. Das bedeutet bei 10mg Einheiten das 50 Mio Einheiten jedes Jahr in den USA benötigt werden. Durch 12 Monate geteilt ergibt das einen Bedarf von 4,2 Mio Einheiten Leucovorin. Wenn Spectrum im Shorage bisher 1817 Einheiten/Monat verkauft, sind das 0,04% Anteil am Bedarf.
Betrachtet man das Gesundheitssystem in den USA werden sich die Menschen die dringend Leucovorin benötigen sich das teure Levoleucovorin leisten, weil sie es sich leisten können.
Also ich bin der Meinung die Zahl ist sehr wahrscheinlich.
Kleine Rechnung zu den vermuteten NetSales von Fusilev.
Ich hoffe es ist verständlich.
Leucovorin:
Preis für 10 mg = 69,53 EUR = 70 EUR
Levoleucovorin:
der Preis ist laut Aussage von Dr. Chandler NCI 60 x höher
70 EUR x 60 = 4200 EUR für 10 mg Levoleucovorin / 2 da wir nur die Hälfte (5mg) für eine Dosis benötigen.
macht 2100 EUR entspricht ca. 2751 US-Dollar.
Teilen wir die angenommenen 5 Mio NetSales/ $2751 = 1817 Anwendungen im Monat.
Jährlich werden in den USA 500 Mio Milligram Leucovorin verbraucht. Das bedeutet bei 10mg Einheiten das 50 Mio Einheiten jedes Jahr in den USA benötigt werden. Durch 12 Monate geteilt ergibt das einen Bedarf von 4,2 Mio Einheiten Leucovorin. Wenn Spectrum im Shorage bisher 1817 Einheiten/Monat verkauft, sind das 0,04% Anteil am Bedarf.
Betrachtet man das Gesundheitssystem in den USA werden sich die Menschen die dringend Leucovorin benötigen sich das teure Levoleucovorin leisten, weil sie es sich leisten können.
Also ich bin der Meinung die Zahl ist sehr wahrscheinlich.
!
Dieser Beitrag wurde moderiert. Grund: Postings von Doppel-IDs
Wer fragte hier nach den Satraplatin Rechten? Die hält GPC Biotech. Spectrum erhält Royalties wenn Satraplatin jemals als Produkt verkauft wird. Es waren um die 6% netto Royalties. Dazu Meilensteine.
Schaut aber eher so aus als wird Satraplatin bald eingestellt. Diesbezügliche Hinweise finden sich auf der HV Präsentation von GPC Biotech vom Dezember 08.
Schaut aber eher so aus als wird Satraplatin bald eingestellt. Diesbezügliche Hinweise finden sich auf der HV Präsentation von GPC Biotech vom Dezember 08.
10 Mill. kommen mir sehr viel vor. Aber andererseits haben wir diese Hochrechnungen ja nicht vorliegen. Tja mich würde diese Rechnung auch sehr interessieren und wieso das so viel sein soll. Naja um mich jetzt näher damit zu beschäftigen ist die von mir bei Spectrum eingegangene Position eh zu klein und mir die Mühe nicht wert, aber nichts desto trotz ist das eine sehr interessante Aktie. Der Kursverlauf, das Unternehmen, die Bewertung und Aussichten. Einfach alles irgendwie packend.
20.07.23 · Business Wire (engl.) · Spectrum Pharmaceuticals |
30.06.23 · Business Wire (engl.) · Spectrum Pharmaceuticals |