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    Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 422)

    eröffnet am 31.08.08 11:55:05 von
    neuester Beitrag 10.08.23 11:06:43 von
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      Avatar
      schrieb am 02.10.08 12:21:04
      Beitrag Nr. 19 ()
      Spectrum hat heute die neue Präsentation Stand Oktober veröffentlicht duch auch in den Webcasts besprochen wurde.

      Hier ein paar Seiten:


      [/url]

      Avatar
      schrieb am 01.10.08 13:46:04
      Beitrag Nr. 18 ()
      Ein super Beitrag eines Users aus dem Krebsforum.at zum Thema EOquin das im englischen ohne Fachkenntnisse nur sehr schwer zu verstehen ist.
      ******
      EOquin als dritte Alternative zu BCG und Mitomycin kurz vor dem Start

      EOquin (für intravesikale Instillation) ist ein Wirkstoff, der derzeit zur Behandlung von nicht-invasivem Blasenkrebs entwickelt wird. Der Antikrebswirkstoff EOquin wird durch das in den Krebszellen vorhandene Reduktase-Enzym aktiviert und ist zur direkten Verabreichung in die Harnblase vor- gesehen.

      In einer Pilotstudie der Phase 2, zu der die Patientenaufnahme im letzten Jahr abgeschlossen wurde, wurde das nach einer transurethralen Resektion des Blasentumors in die Blase eingebrachte EOquin gut vertragen.
      Dabei konnte im Blut keinerlei Absorption durch die Blasenwand nachgewiesen werden,
      sodass das Risiko der systemischen Toxizität sehr gering ist.

      Spectrum Pharmaceuticals konnte in Europa bereits eine multizentrische klinische Studie der Phase 2 abschliessen.
      Die Ergebnisse dieser Studie zeigten, dass EOquin gut vertragen wird und
      bei 67 % der teilweise mehrfach vorbehandelten Patienten zu einem vollständigen Ansprechen (CR, Complete Response) führte.
      Die Ergebnisse der Studie wurden der FDA im Frühjahr 2006 vorgelegt.

      Jetzt wurde an 55 Zentren in den USA eine Phase 3 Studie begonnen.
      Bei positivem Ausgang steht auch in Deutschland eine 3. Möglichkeit bald zur Verfügung.

      Ob besser als BCG bleibt abzuwarten.

      ****
      Hier der Original Text:
      http://www.krebsforum.at/forum/index.php?topic=1626.0
      Avatar
      schrieb am 01.10.08 09:23:39
      Beitrag Nr. 17 ()
      Pfizer reorganizing research efforts, focusing on biotech drugs, unmet needs such as cancer

      TRENTON, N.J. (AP) -- Pfizer Inc. is shifting its research focus to diseases that have high potential for big profits and for treatment improvements, such as cancer and Alzheimer's disease.

      The world's biggest drugmaker also is ending new research on conditions from obesity to heart disease, but research on drugs already in late-stage human testing will continue, spokeswoman Liz Power said Tuesday.

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      Experts said such tweaking of research strategy is standard in the pharmaceutical industry -- and needed periodically as new competition and other factors affect revenue.

      Pfizer expects to spend up to $7.5 billion on research and development this year, a huge budget for the industry.

      "Even though it is very large, it is finite," Power said.

      Like most of its competitors, Pfizer has been reorganizing and cutting costs to deal with looming generic competition and a lack of blockbusters in its pipeline.

      Power said Pfizer needs to focus research, particularly costly late-stage human testing, on areas where patient needs aren't met by existing treatments, where there's a sizable commercial market and where the company has expertise and a good chance for scientific success.

      The New York-based company has identified six high-priority areas for future research: cancer, pain, inflammation, diabetes, Alzheimer's disease and schizophrenia.

      "They're basically looking at the largest-margin, largest-market indications," said analyst Steve Brozak of WBB Securities.

      Pfizer has increasingly been investing in cancer research and probably now will move into treatments for pain and inflammation that work through different mechanisms than its blockbuster Celebrex, he said. The focus on diabetes likely will be on the type linked to the Western obesity epidemic, and Alzheimer's also will be a huge market, given the aging population. And there are "no satisfactory cures whatsoever" for schizophrenia, Brozak added.

      Areas where the company is ending research, much of it still in early stages, include anemia, bone health, gastrointestinal disorders, muscle diseases, obesity and some approaches to osteoarthritis. The company also is dropping early research in four areas of cardiac disease: hardening of the arteries, high cholesterol, heart failure and peripheral arterial disease.

      Deutsche Bank pharmaceuticals analyst Barbara Ryan noted Pfizer has been among the top few drug companies that develop heart drugsa huge market given the aging population in developed countries.

      Pfizer markets the world's top-selling drug, cholesterol fighter Lipitor, which generates about $12 billion a year in revenue. However, it will lose its U.S. patent late in 2011, and there's already a generic version of a cholesterol drug from the same class, Zocor.

      Many heart drugs in other categories also have significant generic competition that is eroding sales of brand-name medicines.

      "We have a large number of highly effective (cardiovascular) drugs, and it's very difficult to demonstrate a big improvement above and beyond what exists, and that's really what the FDA and payers demand," said Ryan.

      Meanwhile, Pfizer on Tuesday gave its semiannual update for investors on its research pipeline. It now has 114 human studies of drugs in process and said that since its last update in February, the number in final human testing has grown from 16 to 25 -- 19 of them in its high-priority areas. Testing of 13 drugs, including four for rheumatoid arthritis, has been stopped since February.

      Biotechnology drugs, which generally are extremely profitable and so far have been insulated from generic competition by their complexity, will be a big part of that pipeline, particularly in cancer research.

      Pfizer shares rose 79 cents, or 4.5 percent, to close at $18.44, near their 52-week low and at about the same level where they traded in the summer of 1997.
      Avatar
      schrieb am 30.09.08 06:54:30
      Beitrag Nr. 16 ()
      10% runter und damit im Einklang mit der Nasdaq. News und Ergebnisse gibt es keine. Wir befinden uns aktuell auf dem Niveau vor dem Fusilev Verkaufsstart. Nächster Termin ist der Antrag zur 2 Indikation von Fusilev.

      Wenn die Kurse in den USA den Boden gefunden haben, sollte es auch mit SPPI wieder normal weitergehen. Im Moment ist Land unter :)
      Avatar
      schrieb am 23.09.08 07:03:03
      Beitrag Nr. 15 ()
      Biotech Informer:

      Let’s continue with our analysis of Spectrum Pharmaceuticals (SPPI), specifically reviewing their pipeline of drugs in development for readers that are interested in biotech stock investing.

      Levoleucovorin (Fusilev):

      Fusilev was approved in March 2008 as rescue therapy for osteosarcoma patients after receiving high-dose methotrexate (chemotherapy). Osteosarcoma is a malignant bone cancer afflicting individuals under the age of 30. High-dose methotrexate is the most commonly used regimen in treating osteosarcoma. Fusilev neutralizes the toxic effects from methotrexate therapy in order to prevent serious side effects. Although the osteosarcoma market is small at 900 new cases a year, approximately 1/3 of these patients die each year.

      Spectrum plans to file a supplemental New Drug Application (sNDA) with the FDA for treating colorectal cancer (CRC) with patients receiving 5-fluorouracil (5-FU) regimens (another chemotherapeutic agent) by October of this year.

      Unlike Fusilev’s indication for osteosarcoma patients, in CRC patients Fusilev enhances the effectiveness and binding of 5-FU to an enzyme inside cancer cells called Thymidilate Synthetase, thereby prolonging the life span of 5-FU within cancer cells. Note that the life span of 5-FU in tissue cells is normally very short therefore limiting it’s anti cancer effects.

      The company does not anticipate conducting additional clinical trials for the indication in CRC. Approval timeline for this indication would be about a year which would be October 2009. Approximately 150,000 patients are diagnosed each year with CRC and the estimated market for Fusilev is in the range of $100 million.

      Management is hesitant in responding to any questions pertaining to revenue projections from sales of Fusilev until the FDA responds to their sNDA filing for CRC. I suspect this is because any sales generated from the osteosarcoma market would be miniscule, at most helping to reduce the company’s burn rate and preserving their cash position.

      EOquin:

      EOquin is a novel chemotherapy drug that represents a therapeutic advancement in treating superficial bladder cancer (SBC) in an important area in which there’s an unmet medical need. EOquin is currently being tested in two phase-3 double-blinded, placebo controlled, randomized trials. The majority of all bladder cancers are of the SBC type, or tumors which have not yet invaded the mucous membrane of the muscle tissue of the bladder. The recurrence rate in SBC is high resulting in the need for additional surgeries for patients.

      EOquin is considered a more selective or targeted treatment approach because it’s a prodrug that is not activated until a certain enzyme found within bladder cancer cells activates EOquin. Since EOquin is a large molecule, it cannot pass through the bladder lining, therefore no detectable levels are found in systemic circulation. Because this is a targeted therapy, the side effect profile is much more favorable relative to other chemotherapeutic agents. EOquin is administered immediately following a surgical procedure called “transurethral resection” or TUR in which the tumor is first removed.

      Current treatment for SBC consists of surgical removal of the tumor followed by the administration of mitomycin C or bacillus Calmette-Guerin, an immunotherapeutic vaccine. Recurrence rates are expected in 50%-70% of cases in which tumors flare up again after a short period of time so this is considered nothing more than a maintenance therapy to delay the next recurrence. So, there is a great need for new therapies that prolong the recurrence of tumors.

      The prevalence of bladder cancer in the U.S. is 50,000-60,000new cases per year in which 70-80% are non-invasive or of the type superficial tumors. Internationally, the incidence varies substantially with the highest rates in Europe and North America. Smoking is the strongest risk factor associated with the development of bladder cancer.

      EOquin trials should be fully enrolled by the end of 2009 and Spectrum should be announcing some form of partnership for by the end of this year. According to management, there are several potential partners interested in this drug.

      Ozarelix:

      Ozarelix is being developed for the treatment of benign prostatic hypertrophy (BPH) or enlarged prostate. As mentioned earlier, their phase-2 clinical trial released disappointing data from their U.S. trial. The previous Eastern Europe trial results were more favorable as the data point called IPSS (measures strength and frequency of urination) produced a score of 8. Spectrum states that some irregularities in the conduct of the trial resulted in removing various clinical trial sites therefore leaving the number of patients in the protocol group at a total of 44, which is a number totally meaningless as it’s too small of a number to draw any conclusions from. Spectrum will now have to conduct another phase-2 trial and is currently writing a new protocol before starting which is expected to commence again before the end of this year.

      The market for BPH is huge at approximately $4 billion per year. Current treatments are once-a-day pills such as Flomax or Avodart. Ozarelix is an injection that is administered twice a year which offers freedom from having to take a daily oral medication. Although the time-lines on this program have been delayed, the potential is still there.

      Stock catalysts over the next 12 months:

      * FDA review of Spectrum’s sNDA for Fusilev in treatment of CRC
      * Any meaningful revenue from sales of Fusilev in osteosarcoma market
      * Signing of partnership for EOquin
      * No need for raising capital in the near future

      There are additional early stage programs that Spectrum is developing as well, but the ones I’ve mentioned are the ones that will impact the company’s valuation over the next couple of years. For investors that aren’t patient enough to allow the company to move forward and develop their programs, you may want to move on to another company.

      My thesis for investing in Spectrum is twofold. First being that the company has several mid to late stage programs in development in significantly unmet markets, and secondly because the technology value of the company has zero value assigned to it by investors. I like the fact that no expectations are priced into the stock. This provides a relatively low risk profile for investors while providing significant upside potential on any positive news for any of the company’s various drug programs. Any revenue generated from Fusilev will significantly impact the company’s valuation as the current market cap of the company is only $53 million (the stock has increased over 20% since the first post). A partnership announcement for EOquin in SBC would probably amount to more than the entire value of the company today.

      Closing comments:
      Valuations such as this are not commonly found even with small cap biotechs that burn millions of dollars per year. Future companies I write about will doubtfully have a profile like Spectrum. I will continue to update and give you my thoughts on Spectrum as developments unfold.

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      Avatar
      schrieb am 20.09.08 10:12:56
      Beitrag Nr. 14 ()
      Antwort auf Beitrag Nr.: 35.194.285 von reaggy26 am 19.09.08 23:28:35Hallo reaggy26

      Es wird wohl niemanden geben der mit SPPI nicht im Minus ist. Es sei den jemand ist in den letzten Tagen eingestiegen.
      Die Chancen überwiegen aber im Moment die Risiken.

      Spectrum:

      - hat 60 Mio Dollar Cash
      - die Marktkapitalisierung liegt bei 45 Mio Dollar
      - hat 1 Krebsmedikament am Markt (Fusilev)
      - weitere Indikationen folgen
      - 9 Wirkstoffe in der Pipeline
      - 2 davon mit Blockbusterpotential (EOquin und Ozarelix)
      - sucht eine strategische Partnerschaft für EOquin

      Der Markt muss das halt nur noch berücksichtigen, dann steigen die Kurse auch wieder ;)
      Avatar
      schrieb am 19.09.08 23:28:35
      Beitrag Nr. 13 ()
      vajo,
      ein stiller Mitleser ist auch investiert, leider dick im minus,
      glaube aber ebenfalls hier eine Biotechfirma (nach etlichen flops)
      gefunden zu haben, die Potential hat, danke für deine Infos
      Avatar
      schrieb am 19.09.08 11:54:10
      Beitrag Nr. 12 ()
      Antwort auf Beitrag Nr.: 35.182.074 von orfmen am 19.09.08 09:03:36Für die Handlungsweise von GPC und das was mit Satraplatin passiert ist kann Spectrum doch nichts? Mir ist diese Sippenhaft schleierhaft ;), den Spectrum hat Satraplatin seinerzeit von Johnsonn einlizensiert und GPC wiederum von Spectrum.
      Avatar
      schrieb am 19.09.08 09:03:36
      Beitrag Nr. 11 ()
      Antwort auf Beitrag Nr.: 35.172.464 von VaJo am 18.09.08 18:07:24Hallo VaJo,
      danke für deine Ausführungen!!!
      Ich bleibe an der Sache dran.
      Das sie geschlampt haben ist schlecht und sicher auch ein Grund für die miesen Kurse, neben dem Satradebakel.
      Das sie zugeben geschlampt zu haben und noch eine 2.PII starten werte ich erstmal positiv.
      Die geringe MK ist gut aber auch schlecht. So bleiben sie vorerst ein "Spielball", aber wie gesagt sehr interessant.
      Ich melde mich wieder.
      Grüße!
      Avatar
      schrieb am 18.09.08 20:57:45
      Beitrag Nr. 10 ()
      So soll es mal bei SPPI aussehen ;)



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      Spectrum Pharmaceuticals - Chancen und Risiken?