Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 213)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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20.07.23 · Business Wire (engl.)  |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8000 | +45,45 | |
| 1,0000 | +42,86 | |
| 3,0000 | +42,18 | |
| 6,2500 | +24,75 | |
| 0,9600 | +18,93 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,3200 | -16,98 | |
| 23,700 | -19,52 | |
| 28,60 | -24,06 | |
| 1,3500 | -25,62 | |
| 0,7800 | -29,73 |
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Antwort auf Beitrag Nr.: 37.825.712 von VaJo am 21.08.09 13:33:43Du vergleichst immer Provenge mit den SPPI Produkten und wirst es hoffentlich mal checken, daß Provenge einmalig ist und kein second-line Produkt etc.....
Ich bin selber mit 1000 Stück in SPPI drin und trotzdem wird SPPI in naher Zukunft nie daß erreichen was Dendreon schon erreicht hat bzw. noch erreichen wird!
Ich bin selber mit 1000 Stück in SPPI drin und trotzdem wird SPPI in naher Zukunft nie daß erreichen was Dendreon schon erreicht hat bzw. noch erreichen wird!
Antwort auf Beitrag Nr.: 37.831.318 von Ville7 am 22.08.09 10:44:59Pusher hin Pusher her, Spectrum kam ohne gepushe nach oben weil seit 2008 Erfolge geschrieben werden. Während andere Bio's noch "wenn" in ihre Bewertung schreiben verdient Spectrum echtes Geld. Und mit den beiden kommenden Zulassungen wirds nicht weniger 
Apropos J.M.Hall - schreib ihn doch mal an er solle sich mal Morphosys anschauen, da könnte der Kurs auch mal einen Schub gebrauchen...
Apropos J.M.Hall - schreib ihn doch mal an er solle sich mal Morphosys anschauen, da könnte der Kurs auch mal einen Schub gebrauchen...
Antwort auf Beitrag Nr.: 37.831.120 von Finanzriese am 22.08.09 09:34:01Genau das ist der Oberpumper-Frontrunner: Justin M. Hall. Nachdem er wochenlang auf Yahoo gepusht hatte, hat er Seeking Alpha und BioMed Reports als bessere Medien erkannt. Mir ists egal, aber jeder der hier investiert sollte wissen, dass er ein ziemlicher Pusher ist.
Spectrum Pharma: The Labor Day Catalyst (NASDAQ:SPPI)
M.E. Garza August 21, 2009 This Labor Day, September 7, Spectrum Pharmaceuticals (NASDAQ:SPPI) expects an FDA decision for their non-Hodgkin´s lymphoma (NHL) radio-immunotherapeutic (RIT), Zevalin®.
The consensus held by most investors, analysts and commentators is that Zevalin will be approved as a first-line consolidation therapy for patients with NHL.
Read More It is important to note that Zevalin is already approved for use in the US for refractory NHL. Unfortunately, Zevalin is usually only administered as a last resort treatment.
FIRST-LINE CONSOLIDATION THERAPY
Upon filing a supplemental Biologic License Application (sBLA) in late 2008, SPPI´s aim is to obtain regulatory approval for Zevalin
in a first-line consolidation setting. Under this setting, Zevalin would be approved for first-line use and administered in consolidation with induction therapy.
Induction therapy generally includes a combination of (1) a chemotherapeutic, such as doxorubicin and (2) rituximab. Consolidation
therapy follows induction therapy and is designed to induce remission. Under the consolidation setting, Zevalin would be
administered after induction therapy to those patients who obtain either a partial response (PR) or complete response (CR).
In April 2008, Zevalin was approved in the EU as a first-line consolidation therapy for patients with NHL. Here, it should be noted that outside the US, Zevalin is marketed by Bayer Schering (BYERF.PK).
THE FIT STUDY
In the Phase 3 FIT trial, patients, who received Zevalin following induction therapy, (1) received a progression free survival (PFS)
benefit of three years (an improvement from two years as previously reported here) and (2) regardless if the patient had received
either PR or CR to induction therapy.
During the company´s August 13 conference call Dr. Andrew Sandler, SPPI´s Chief Medical Officer, pointed out, "[A] three year
progression free survival advantage is very significant in this patient population."
Importantly, 77% of the patients, who received a PR following induction therapy, converted to a CR. Here, FIT researchers
noted, "[T]his is one of the highest PR-to-CR conversion rates reported in [all] Phase 3 randomized studies in first-line follicular
lymphoma."
Based on these significant findings, the Phase 3 FIT trial was characterized as a "landmark study" by Dr. Oliver W. Press, chair
for lymphoma research at FredHutchinsonCancerResearchCenter. (Source: NCI Cancer Bulletin, vol.5/no. 21, Oct. 21, 2008.)
ZEVALIN DISUSE
During last week´s conference call, Dr. Sandler touched on Zevalin´s prior disuse:
"Although Zevalin is currently FDA approved in the relapse or refractory setting, for a number of reasons it is unfortunately
currently only used in a salvage setting. Many patients, who should be receiving Zevalin, are not. We hope to change that.
If Zevalin is approved in the first-line setting, we believe it will be an important first step bringing the treatment of
non-Hodgkin´s lymphoma in line with the standard of care in other hematological malignancies."
Consolidation Therapy in Other Cancers
Consolidation therapy is used often to treat other forms of cancers. In the conference call, Dr. Sandler explained how consolidation therapy is used to treat a related cancer, acute leukemia.
"For decades, doctors have been treating acute leukemias with (1) induction therapy to wipe out as much bulky disease as possible; (2) followed by consolidation therapy to further reduce any minimal residual disease and to provide the patient with the best quality of response possible; and (3) maintenance therapy to sustain the consolidation response, thus improving the duration of the response."
ZEVALIN SALES INCREASED 25% IN Q2 2009
On July 14, 2009, I indicated that, ". . . investors should not be shocked to see an up-tick in Zevalin sales during Q2 2009." In Q2, SPPI did, in fact, report an increase of 25% in quarter over quarter sales for Zevalin.
During the recent conference call, Amar Singh, SPPI´s Chief Commercial Officer, provided some insight on the upside surprise achieved with Zevalin sales.
"We are encouraged by the strong signal that we have received from the market after just one full quarter of marketing and sales under Spectrum´s leadership.
(1) Average growth in unit sales over the prior three years when we compare only the first and second quarters, the rates were a -12%. Despite the fact that two out of these three years, the drug was previously sold by a company (Biogen Idec (BIIB)) much larger than Spectrum.
(2) This improvement from a decrease of -12% to an increase of over 20% was achieved in the first full quarter since Spectrum acquired 100% of the rights to Zevalin.
(3) Importantly, we accomplished this at a time of heightened competition from the launch of Treanda® (marketed in the US by Cephalon (CEPH)) in the refractory NHL setting last fall.
(4) We accomplished this in the absence of receiving regulatory approval of Zevalin in the front-line setting."
Singh concluded, "It appears that we are well on our way to achieving our . . . goal of stabilizing [Zevalin] sales."
Since SPPI acquired the rights to Zevalin from Cell Therapeutics (CTIC) in mid March 2009, I agree with Mr. Singh´s sentiment. That Zevalin sales actually rose for the first time in the past three years is very compelling. From my view, the 25% increase is a meaningful improvement and strongly suggests that Zevalin may finally have a promising future.
SALES FORCE MATTERS
In response to my June 29, 2009 article, Michael Becker commented, "t is naive to believe that Zevalin has simply been marketed incorrectly."
In the conference call, Dr. Rajesh Shrotriya, SPPI´s chairman and CEO, revealed that the company´s sales force, responsible for marketing Zevalin, consisted of 40 executives. Dr. Shrotriya also pointed out that the past sales teams from both Biogen Idec (BIIB) and Cell Therapeutics (CTIC), who had previously held the rights to and were responsible for marketing Zevalin, consisted of no more than seven, (7), executives.
One could reasonably argue that the size of SPPI´s sales force may be having an impact on current Zevalin sales and responsible for the respective 25% increase.
CONCLUSION
The recent up-tick in Zevalin sales appears to be much more than a stroke of good luck. Clearly, SPPI appears to be executing a well-designed plan with a right-sized sales force.
It looks like SPPI may have very well identified the correct issues and mistakes made by others in the past. With an early increase in sales, SPPI´s plan seems to be working and the company does not appear to be repeating mistakes made in the past.
This increase implies either: (1) SPPI has assembled the kind of sales force necessary to market Zevalin appropriately; (2) more physicians are beginning to adopt Zevalin; or (3) all of the above. Nevertheless, it's very telling. The previous sentiment may finally be changing in Zevalin´s favor.
For these reasons, I anticipate sales of the drug will likely continue to grow in the coming quarters - especially if it's approved for the first-line consolidation setting by the FDA on (or before) September 7, Labor Day.
Since institutional investors and hedge funds have been slow to catch on, SPPI still remains a hidden gem and an excellent investment opportunity.
With a current price of $6.32 and a market cap of a mere $263 million, I anticipate shares of SPPI will likely see a dramatic rise in the coming weeks and months.
Over the next 6 to 12 months, my price target for SPPI ranges between $23.80 and $26.67 with a market cap from $1.0 to $1.12 billion.
If Zevalin sales continue to improve, then I anticipate that SPPI could likely be acquired within 12 to 18 months.
Disclosure: Justin Long, who contributed this story on BioMedReports is LONG SPPI
For more in-depth information and article links about SPPI, visit BioMedReports.Com
M.E. Garza August 21, 2009 This Labor Day, September 7, Spectrum Pharmaceuticals (NASDAQ:SPPI) expects an FDA decision for their non-Hodgkin´s lymphoma (NHL) radio-immunotherapeutic (RIT), Zevalin®.
The consensus held by most investors, analysts and commentators is that Zevalin will be approved as a first-line consolidation therapy for patients with NHL.
Read More It is important to note that Zevalin is already approved for use in the US for refractory NHL. Unfortunately, Zevalin is usually only administered as a last resort treatment.
FIRST-LINE CONSOLIDATION THERAPY
Upon filing a supplemental Biologic License Application (sBLA) in late 2008, SPPI´s aim is to obtain regulatory approval for Zevalin
in a first-line consolidation setting. Under this setting, Zevalin would be approved for first-line use and administered in consolidation with induction therapy.
Induction therapy generally includes a combination of (1) a chemotherapeutic, such as doxorubicin and (2) rituximab. Consolidation
therapy follows induction therapy and is designed to induce remission. Under the consolidation setting, Zevalin would be
administered after induction therapy to those patients who obtain either a partial response (PR) or complete response (CR).
In April 2008, Zevalin was approved in the EU as a first-line consolidation therapy for patients with NHL. Here, it should be noted that outside the US, Zevalin is marketed by Bayer Schering (BYERF.PK).
THE FIT STUDY
In the Phase 3 FIT trial, patients, who received Zevalin following induction therapy, (1) received a progression free survival (PFS)
benefit of three years (an improvement from two years as previously reported here) and (2) regardless if the patient had received
either PR or CR to induction therapy.
During the company´s August 13 conference call Dr. Andrew Sandler, SPPI´s Chief Medical Officer, pointed out, "[A] three year
progression free survival advantage is very significant in this patient population."
Importantly, 77% of the patients, who received a PR following induction therapy, converted to a CR. Here, FIT researchers
noted, "[T]his is one of the highest PR-to-CR conversion rates reported in [all] Phase 3 randomized studies in first-line follicular
lymphoma."
Based on these significant findings, the Phase 3 FIT trial was characterized as a "landmark study" by Dr. Oliver W. Press, chair
for lymphoma research at FredHutchinsonCancerResearchCenter. (Source: NCI Cancer Bulletin, vol.5/no. 21, Oct. 21, 2008.)
ZEVALIN DISUSE
During last week´s conference call, Dr. Sandler touched on Zevalin´s prior disuse:
"Although Zevalin is currently FDA approved in the relapse or refractory setting, for a number of reasons it is unfortunately
currently only used in a salvage setting. Many patients, who should be receiving Zevalin, are not. We hope to change that.
If Zevalin is approved in the first-line setting, we believe it will be an important first step bringing the treatment of
non-Hodgkin´s lymphoma in line with the standard of care in other hematological malignancies."
Consolidation Therapy in Other Cancers
Consolidation therapy is used often to treat other forms of cancers. In the conference call, Dr. Sandler explained how consolidation therapy is used to treat a related cancer, acute leukemia.
"For decades, doctors have been treating acute leukemias with (1) induction therapy to wipe out as much bulky disease as possible; (2) followed by consolidation therapy to further reduce any minimal residual disease and to provide the patient with the best quality of response possible; and (3) maintenance therapy to sustain the consolidation response, thus improving the duration of the response."
ZEVALIN SALES INCREASED 25% IN Q2 2009
On July 14, 2009, I indicated that, ". . . investors should not be shocked to see an up-tick in Zevalin sales during Q2 2009." In Q2, SPPI did, in fact, report an increase of 25% in quarter over quarter sales for Zevalin.
During the recent conference call, Amar Singh, SPPI´s Chief Commercial Officer, provided some insight on the upside surprise achieved with Zevalin sales.
"We are encouraged by the strong signal that we have received from the market after just one full quarter of marketing and sales under Spectrum´s leadership.
(1) Average growth in unit sales over the prior three years when we compare only the first and second quarters, the rates were a -12%. Despite the fact that two out of these three years, the drug was previously sold by a company (Biogen Idec (BIIB)) much larger than Spectrum.
(2) This improvement from a decrease of -12% to an increase of over 20% was achieved in the first full quarter since Spectrum acquired 100% of the rights to Zevalin.
(3) Importantly, we accomplished this at a time of heightened competition from the launch of Treanda® (marketed in the US by Cephalon (CEPH)) in the refractory NHL setting last fall.
(4) We accomplished this in the absence of receiving regulatory approval of Zevalin in the front-line setting."
Singh concluded, "It appears that we are well on our way to achieving our . . . goal of stabilizing [Zevalin] sales."
Since SPPI acquired the rights to Zevalin from Cell Therapeutics (CTIC) in mid March 2009, I agree with Mr. Singh´s sentiment. That Zevalin sales actually rose for the first time in the past three years is very compelling. From my view, the 25% increase is a meaningful improvement and strongly suggests that Zevalin may finally have a promising future.
SALES FORCE MATTERS
In response to my June 29, 2009 article, Michael Becker commented, "t is naive to believe that Zevalin has simply been marketed incorrectly."
In the conference call, Dr. Rajesh Shrotriya, SPPI´s chairman and CEO, revealed that the company´s sales force, responsible for marketing Zevalin, consisted of 40 executives. Dr. Shrotriya also pointed out that the past sales teams from both Biogen Idec (BIIB) and Cell Therapeutics (CTIC), who had previously held the rights to and were responsible for marketing Zevalin, consisted of no more than seven, (7), executives.
One could reasonably argue that the size of SPPI´s sales force may be having an impact on current Zevalin sales and responsible for the respective 25% increase.
CONCLUSION
The recent up-tick in Zevalin sales appears to be much more than a stroke of good luck. Clearly, SPPI appears to be executing a well-designed plan with a right-sized sales force.
It looks like SPPI may have very well identified the correct issues and mistakes made by others in the past. With an early increase in sales, SPPI´s plan seems to be working and the company does not appear to be repeating mistakes made in the past.
This increase implies either: (1) SPPI has assembled the kind of sales force necessary to market Zevalin appropriately; (2) more physicians are beginning to adopt Zevalin; or (3) all of the above. Nevertheless, it's very telling. The previous sentiment may finally be changing in Zevalin´s favor.
For these reasons, I anticipate sales of the drug will likely continue to grow in the coming quarters - especially if it's approved for the first-line consolidation setting by the FDA on (or before) September 7, Labor Day.
Since institutional investors and hedge funds have been slow to catch on, SPPI still remains a hidden gem and an excellent investment opportunity.
With a current price of $6.32 and a market cap of a mere $263 million, I anticipate shares of SPPI will likely see a dramatic rise in the coming weeks and months.
Over the next 6 to 12 months, my price target for SPPI ranges between $23.80 and $26.67 with a market cap from $1.0 to $1.12 billion.
If Zevalin sales continue to improve, then I anticipate that SPPI could likely be acquired within 12 to 18 months.
Disclosure: Justin Long, who contributed this story on BioMedReports is LONG SPPI
For more in-depth information and article links about SPPI, visit BioMedReports.Com
Antwort auf Beitrag Nr.: 37.829.527 von VaJo am 21.08.09 20:06:09im Yahoo Board ist ein einziger Jubelhaufen, was die eingeworfen haben möchte ich auch mal haben.
Trading Spotlight
Antwort auf Beitrag Nr.: 37.825.884 von Ville7 am 21.08.09 13:56:14In den USA sind sie eher meiner Meinung - und das ist gut so.
- und das ist gut so.
Antwort auf Beitrag Nr.: 37.825.712 von VaJo am 21.08.09 13:33:43Da kann ich auch genau sagen wie sie ausfallen - Endpoint erreicht lachen
Dann tausch am besten deine GPC's in Aeterna Zentaris Aktien um, wenn du das jetzt schon weißt. Damit hättest du dann mindestens nen 5 bagger.
PS: Ich würde allerdings persönlich keinen Cent darauf wetten.
PPS: Zwillingsbruder deswegen, weil das Wirkprinzip identisch ist und die Produkte von derselben Mutter stammen. Ein Scheitern des Bruders ist daher keine gute News.
Dann tausch am besten deine GPC's in Aeterna Zentaris Aktien um, wenn du das jetzt schon weißt.
Damit hättest du dann mindestens nen 5 bagger. PS: Ich würde allerdings persönlich keinen Cent darauf wetten.
PPS: Zwillingsbruder deswegen, weil das Wirkprinzip identisch ist und die Produkte von derselben Mutter stammen. Ein Scheitern des Bruders ist daher keine gute News.
"These findings are unexpected in light of the previous Phase 2 experience. Those data and the strength of the safety data available to date had given us confidence in this potential new treatment for BPH. It is now important to await results of the other placebo-controlled efficacy study Z-036."
Da kommen die Ergebnisse im November. Da kann ich auch genau sagen wie sie ausfallen - Endpoint erreicht
Ist wie bei Provenge
Eine Behandlung ist besser als keine
Da kommen die Ergebnisse im November. Da kann ich auch genau sagen wie sie ausfallen - Endpoint erreicht
Ist wie bei Provenge
Eine Behandlung ist besser als keine
Antwort auf Beitrag Nr.: 37.825.447 von Ville7 am 21.08.09 12:59:00 wenns ein Zwillingsbruder ist wieso dann 2 verschiedene Namen fürs gleiche Präparat?
Cetrorelix:
Cetrorelix is a peptide-based active substance.
(a luteinizing hormone-releasing hormone (LHRH) antagonist)
Ozarelix:
...is a highly modified luteinizing hormone-releasing hormone (LHRH) antagonists. The 4th generation LHRH antagonist.
Für mich klingt das nicht nach Zwilling?
wenns ein Zwillingsbruder ist wieso dann 2 verschiedene Namen fürs gleiche Präparat?Cetrorelix:
Cetrorelix is a peptide-based active substance.
(a luteinizing hormone-releasing hormone (LHRH) antagonist)
Ozarelix:
...is a highly modified luteinizing hormone-releasing hormone (LHRH) antagonists. The 4th generation LHRH antagonist.
Für mich klingt das nicht nach Zwilling?
Antwort auf Beitrag Nr.: 37.825.447 von Ville7 am 21.08.09 12:59:00Keine gute News für Spectrum und deren Nummer 4 in der Pipeline.
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