Dendreon - 500 Beiträge pro Seite

[motzi]

Kennt jemand die Firma, wie sind die Aussichten nach Angaben von Taipan v. 18.5.03 Kurspotenzial von 471%

[jethor tull]

Anbei ein paar interessante Meldungen. Sollte die Prognose von Taipan zutreffen, wäre dies eine interessanter Eeinstiegspreis.
Dendreon, Antigenics Bid Up on Cancer-Vaccine Hopes

By TSC Staff
05/23/2003 09:22 AM EDT



Shares of two biotech companies, Dendreon (DNDN:Nasdaq - news - commentary - research - analysis) and Antigenics (AGEN:Nasdaq - news - commentary - research - analysis), were rocketing higher in premarket trading Friday after the companies were mentioned in a published report discussing their work on a potential cancer vaccine.


The Wall Street Journal published a story discussing the positive aspects of dendritic-cell therapy in fighting cancer.

According to the report, some successes have been noted in clinical trials and the therapy has been effective in some patients. Specifically, the Journal indicated that several cancer patients in a Stanford University program have seen positive results from dendritic-cell treatment.

Dendritic cells go through the body looking for pathogens that cause disease, and when they find something, they carry it to a lymph node, where they train other cells to recognize and fight the disease, according to the report.

At least 10 academic and commercial teams are testing dendritic-cell vaccines to treat various cancers, the report said, and suggested the treatment could be considered as an alternative to chemotherapy.

According to the report, dendritic-cell vaccines vary, but most are made by drawing the cells from the patient`s own blood and fusing them with pieces of the patient`s tumor.

Dendreon and Antigenics plan to present new data on their cancer vaccines at the American Society for Clinical Oncology meeting this month, the Journal reported. Genzyme (GENZ:Nasdaq - news - commentary - research - analysis) was also mentioned as another company working with dendritic cells.

Investors liked what they read. Shares of Dendreon were climbing $1.32, or 24%, to $6.89 on Instinet before the opening bell. Antigenics was up $1.20, or 11%, to $11.81.







--------------------------------------------------------------------------------
Write


Die Aktie von Dendreon kletterte am Montag um 22 %, nachdem das Unternehmen im Einvernehmen mit der FDA bekannt gab, dass weiterführende klinische Studien mit Provenge durchgeführt werden. Das Vakzin gegen Prostata-Krebs soll jetzt nur noch an Patienten getestet werden, die an einer weniger aggressiven Ausprägung der Krankheit leiden, da dabei die Wirksamkeit besser ist. Enden die Versuche erfolgreich, wäre Provenge der erste Impfstoff gegen diese bei Männern am häufigsten auftretende Krebsform. Die Phase-III-Studie soll 2004 abgeschlossen werden. Im Jahr darauf spekuliert das Unternehmen auf die Markteinführung. Vorangegangene Testreihen hatten jedoch widersprüchliche Ergebnisse geliefert. So verlor die Aktie im Januar 40 % an Wert, nachdem Testresultate als nicht überzeugend eingestuft worden waren. Die neue Meldung verhalf der Aktie jedoch zu einem Kursplus von 37 % auf 5,49 US-$.

Gruß

Jethor

[meislo]

Da gibt es schon ein Thread zu



Thread: Dendreon mit neuer Krebstherapie inTierversuchen erfolgreich

gruss meislo

[Geheimnisvoller]

Am Sonntag präsentiert Dendreon News auf dem Washingter Kongress!!!

http://investor.dendreon.com/calendar.cfm

[meislo]

Dendreon auf der AACR

Dendreon Announces APC8024 and Provenge Presentations at American Association for Cancer Research Annual Meeting
Tuesday July 8, 8:12 am ET


SEATTLE--(BUSINESS WIRE)--July 8, 2003--Dendreon Corporation (NasdaqNDN - News) today announced that its APC8024 and Provenge® immunotherapies will be highlighted during the American Association for Cancer Research 94th Annual Meeting taking place July 11-14 at the Washington Convention Center in Washington, D.C.
Dendreon will be presenting new data on APC8024, its investigational immunotherapy for the treatment of breast, colon and ovarian cancers, which is completing Phase 1 clinical testing in patients with advanced, metastatic, Her-2-positive breast cancer. Also being presented is an overview of results from the completed double blind, placebo controlled Phase 3 trial, D9901, of Provenge in patients with androgen independent prostate cancer.

[UH1d]

NEWS!
SEATTLE--(BUSINESS WIRE)--July 30, 2003--Dendreon Corporation (NasdaqNDN) today announced that it has completed its acquisition of Corvas International (Nasdaq:CVAS). The acquisition provides Dendreon with an enhanced product pipeline and the financial position to discover, develop and commercialize innovative therapeutic products in oncology.
Under the terms of the transaction, originally announced on February 25, 2003, each share of Corvas common stock will be exchanged for a fixed ratio of 0.45 shares of Dendreon common stock in a tax-free reorganization. Based on Dendreon`s closing share price of $6.38 on July 29, 2003, the transaction is valued at $80.3 million. Dendreon`s cash upon closing of the transaction is estimated at more than $130 million.

"This is a very exciting time for Dendreon, our stockholders and the many cancer patients who could potentially benefit from our therapies," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "We are more committed than ever to treating cancer, and the coming months will be exciting ones for Dendreon as we advance our leading immunotherapy, Provenge(R), closer to registration."

Needham & Company, Inc. and SG Cowen Securities Corporation advised Dendreon, and Lazard Freres and Company advised Corvas on this transaction. Corvas, now a wholly-owned subsidiary of Dendreon, known as Dendreon San Diego, L.L.C., has ceased trading on Nasdaq.

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The company`s lead investigational product candidate, Provenge, is a cancer immunotherapy undergoing a pivotal Phase 3 clinical trial for the potential treatment of androgen independent prostate cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with industry leaders Genentech, Inc., Kirin Brewery Co., Ltd., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks and uncertainties, inherent in an acquisition transaction, including those relating to the inability to achieve planned synergies or execute integration plans and establish management and organizational structure. Other risk factors include the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license; the risk that the FDA will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied; the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial; risks that we may lack the financial resources and access to capital to fund required clinical trials for Provenge; the failure by Dendreon to secure and maintain relationships with collaborators, including a collaborator for the development and commercialization of Provenge; risks associated with completing Dendreon`s clinical trials; reliance on key employees, especially senior management; risks related to Dendreon`s limited operating history; dependence on the efforts of third parties; and dependence on intellectual property. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations are contained in Dendreon`s public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.

[meislo]

On the Twisting Trail of Cancer Vaccines
While success has eluded huge drug companies and small biotechs so far, scientists now have a better idea of what might work


As cancer researcher Dr. Olivera Finn tells it, therapeutic cancer vaccines have a way of confounding scientists. "Once in a while, there`s a response. Once in a while, we see stabilization. Once in a while, a patient lives longer than expected." After nearly 20 years of studying vaccines, Finn says her work is still about "doing everything you can imagine to eek out a little bit of success. That won`t solve the cancer problem."

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Though progress is frustratingly slow, Finn, chief of immunology at the University of Pittsburgh School of Medicine and author of a recent review of cancer-vaccine research in Nature, still believes that cancer vaccines will become a reality. And she`s not alone. Vaccines remain one of the most promising -- and daunting -- areas of cancer research. Even with all the advancements in other cancer treatments in recent years -- like Genentech`s (DNA ) and Idec`s (IDPH ) respective antibodies Herceptin and Rituxan and Novartis` targeted therapy Gleevec -- vaccines intrigue researchers.

In theory, they should cause fewer side effects than traditional cancer drugs. The concept behind cancer vaccines differs from both traditional vaccines and cancer treatments. The goal of a cancer vaccine, unlike prophylactic shots for ailments like flu, isn`t to prevent disease but to trick the immune system, which has already missed the existing cancer cells, to attack them. Unlike traditional chemotherapy drugs, which kill cells unselectively, vaccines aim to help the body kill off cancer cells only.

INCONCLUSIVE RESULTS. Some 13% of all new cancer treatments in development are therapeutic vaccines, according to pharmaceutical-industry consulting firm Decision Resources. Many heavyweights like Genzyme (GENZ ) (through its Genzyme Molecular Oncology unit), Aventis Pasteur (AVE ), and GlaxoSmithKline (GSK ) have ongoing cancer-vaccine projects in early phases. The National Institutes of Health is funding several projects. And a dozen or more biotechs have vaccines at various stages of development, including Cell Genesys (CEGE ), Genitope, and Therion Biologics.

At least eight vaccines are now in late Phase 3 testing. But so far results from large trials have been discouraging. Two years ago, Corixa`s Melacine vaccine didn`t produce the harsh side effects of chemotherapy, but results were inconclusive, except in a subgroup of patients. This summer, Biomira`s (BIOM ) breast-cancer vaccine Theratope, which is being developed with Germany`s Merck, had a similar result.

Finn thinks the trials have been flawed. While informative, none to date, including trials she has been involved in, have merited the broad human testing that has been done, Finn contends. Smaller companies, often with modestly positive data at best, are often under pressure to initiate big trials to keep their investors interested. All of the failed studies then "look like a failure of our science," Finn says.

DUAL PATHS. The best prospects among therapeutic cancer vaccines may ultimately be in earlier-stage research efforts -- projects that began as knowledge of how to construct viable vaccines and became more comprehensive. Vaccines like Melacine represent the best of an early generation of such therapies, says David Fanning, Corixia`s chief operating officer, because they have "greater specificity and cleaner ability to test for immune response."

Cancer-vaccine research falls mainly in two camps: antigen-specific and whole-cell. The first approach tries to increase recognition of antigens -- foreign substances that appear on intruding cells -- known to be related to certain cancers. Whole-cell vaccines are tailored to a patient`s own tumor cells or a combination of other people`s cancer cells. Test details vary -- in terms of the type of patients selected, how the vaccine is delivered (with a virus or a different method), what so-called adjuvant drug is used to prime the immune system to best respond to the vaccines and which specific antigens to go after.

Though many companies are still testing them, whole-cell strategies are beginning to lose some luster while vaccines that target specific antigens seem to be garnering more champions. With whole-cell vaccines, it isn`t clear which elements are having an effect on the cancer. "We have so much knowledge in precision molecules and understanding specificity, then we ignore it to get any kind of immune response," says Finn.

Mitchell Gold, chief executive of Dendreon agrees: "With [whole-cell] vaccines, it`s a potpourri." At least two of the vaccines in late-stage testing are whole-cell: Cancervax`s Canvaxin and Antigenics` Oncophage

RECOGNITION BOOSTER. An antigen-specific treatment with a shot at approval is Seattle-based Dendreon`s Provenge, which targets a prostate-cancer antigen seen in 95% of men with that illness. Provenge also has the added ingredient of a sample of a patient`s so-called dendritic cells, which boost the vaccine by alerting other immune system cells to recognize antigens and mount an immune response.

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Provenge is now in its second Phase 3 trial. In 2001, Dendreon reported, as had others before it, successful results in just a subset of patients. Fortunately, the subset represented some 75% of men with prostate cancer -- those with less aggressive tumors who were no longer responding to hormone treatments.

Patients given Provenge saw their chances of surviving more than double and experienced a significant delay in disease-related pain, says Dendreon`s Gold. "Others are promising, but I think the proof is in our data," he says. All the data from the second Phase 3 trial will be available sometime in 2005.

"THAT`S A CLUE." Earlier-stage anitgen-specific projects at French drugmaker Aventis Pasteur are showing some promise. Dr. Neil Berinstein, assistant vice-president for clinical oncology and cancer program director, says the company has done four Phase 1 trials in colorectal-cancer patients. "We`re eager to move as fast as possible on cancer vaccines," he says.

Aventis is using the CEA antigen, commonly seen in colon-cancer cells, in a gene-therapy treatment. In response to the vaccine, the body is supposed to make the antigen, which is then supposed to stimulate the immune system to attack the antigen. "We`ve shown it`s safe and that most patients have a CTL -- i.e. cyotoxic lymphocycte, or killer T-cell -- response to CEA," says Berinstein. "And in some patients who failed chemo, we`ve seen a stabilization. That`s a clue that something is happening."

Berinstein, naturally, is bullish on the approach. "This will bea big growth area," he predicts. "Sometime in the next decade, almost every patient will receive a cancer vaccine." Not as the only therapy, he hastens to add, but as part of a combination regimen. Aventis-Pasteur is also doing trials in melanoma patients. "We`ve found that the vaccine is safe, and we get high levels of T-cell activation -- and some actual tumor response."

NO ANIMAL TESTING. While cancer vaccines continue to intrigue many reasearchers, some companies are losing patience. Jean Stephenne, president of GlaxoSmithKline`s vaccine unit, said recently: "We have reduced our effort in cancer vaccines. It`s really a gamble." He says one key problem is that no animal models exist, so the only way of getting data is with human trials. Still, Glaxo is working with Corixa on development of vaccines for breast and prostate cancer. Trial data will be available in 2006, says Stephenne.

In the next two years, several companies will unveil results from late-stage trials for cancer vaccines, but if the Phase 3 disappointments of the past are any indication, a real product on the market could still be very far away. Nothing is for sure in drug research, and the field will likely test the patience of investors, the medical community, and cancer sufferers alike for many more years to come.


http://yahoo.businessweek.com/technology/content/aug2003/tc2…

[meislo]

Fast track!!!!!!!!!!!!!

Reuters
UPDATE - Dendreon gets fast track on prostate cancer drug
Thursday September 4, 8:19 am ET


(Adds details paragraphs 2-3, 5-6)
NEW YORK, Sept 4 (Reuters) - Biotechnology company Dendreon Corp. (NasdaqNMNDN - News) on Thursday said U.S. regulators would speed their review of the company`s prostate cancer drug Provenge, currently in late-stage testing.

Shares of the company jumped to $7.70 in pre-market trading on Instinet from a closing price of $6.23 on Wednesday.

The U.S. Food and Drug Adminstration`s "fast-track" designation means the agency will review data from clinical trials before all the company`s data has been submitted. The fast-track status often leads to a "priority," or six-month, review of a drug, compared to the normal 12-month review.

Dendreon in June won another concession from the FDA when the agency ruled the company could exclude prostate cancer patients with the most aggressive tumors from its pivotal Phase III trial.

Previous clinical trials suggested the drug delays progression of the disease and reduces pain from the cancer. Dendreon has previously said it hopes to have Provenge on the market in 2005.

The treatment consists of immune-system cells called "dendrites" that are taken from the body and exposed to a genetically engineered protein, or antigen, found only on prostate cancer cells. They are then re-infused in the body with the task of triggering its immune system to fight foreign invaders such as cancer cells.


gruss meis

lo

[meislo]

Biotechnologie gehört die Gunst der Stunde. Firmen, die Hoffnung gegen Krebs machen, beflügeln die Phantasie der Anleger. Eine Krebsart steht dabei seit drei Tagen besonders im Vordergrund: Prostatakrebs. Wer gedacht hat, der Kursanstieg von MediGene (+25,20 %) wegen der erwarteten deutschen Zulassung für das Mittel Leuprogel wäre fulminant, sollte die Kursentwicklung bei Dendreon unter die Lupe nehmen. Das US-Papier sprang heute um 38,04 % auf 8,60 Dollar an, - und der Grund: schon wieder die Vorsteherdrüse, - die Prostata eben.

Wie sehnsüchtig manch Männerherz auf dieses Medikament wartet, kann man daran ablesen, dass Dendreon heute von der FDA den "Fast Track Status" für sein experimentelles Medikament Provenge erhalten hat.
Die Gesundheitsbehörde gewährt das beschleunigte Prüfungsverfahren „Fast Track Status" nur solchen Arzneimitteln, die zur Behandlung von lebensbedrohlichen Krankheiten dienen, für die es bisher keine Medikamente gibt, oder wenn der Zulassungskandidat eine bedeutende Verbesserung gegenüber bisher verfügbarer Behandlungsmethoden darstellt. Sie wird dann innerhalb von sechs Monaten über den Zulassungsantrag entscheiden, während dies üblicherweise 12 Monate dauert. Dendreon ging erst für das Jahr 2005 von einer Markteinführung des Mittels aus. Wenn das nicht für Dendreon aber gegen Medigene spricht?!

Leuprogel von MediGene (502090) ist nämlich in den USA bereits seit Jahresbeginn zugelassen, hat allerdings bislang nach Angaben von MediGene nur einen Marktanteil von drei Prozent erreicht. MediGene erwartet die Genehmigung innerhalb des dritten Quartals. Nachdem das Präparat in den USA bereits zugelassen ist, gilt die Zulassung in Deutschland als ziemlich sicher. Das Medikament soll MediGene 2003 noch erste Umsätze bringen, wenn nicht Provenge von Dendreon die Freudenfeier stört.

Na denn Prost - ata!

[meislo]

Fast Track" Status für Provenge rückt Zulassung in greifbare Nähe.

Dass die "patienten-maßgeschneiderte" Vakzine gegen einen der häufigsten Tumoren bei Männern, dem Prostatakarzinom, tatsächlich eine signifikante Immunantwort hervorrufen kann, das hat der Erfinder von Provenge, das Biotechunternehmen Dendreon, bereits mehrfach unter Beweis gestellt. Doch erst kürzlich sorgte die US-Gesundheitsbehörde (FDA) dafür, dass die Zulassung von Provenge tatsächlich in greifbare Nähe rückt. Durch die Verleihung des "Fast Track" Status, der eine Überstellung von Zulassungsunterlagen noch vor Beendigung der finalen Phase III Studie ermöglicht, wird sich der Prüfungsprozess entscheidend verkürzen. Zudem geht mit den "Fast Track" Status meist auch noch eine beschleunigte Prüfung der Zulassungsunterlagen von nur sechs Monaten einher.

Der Kursaufschlag von mehr als 30 Prozent, der im Anschluss an diese Meldung erfolgt war, ist mit Sicherheit nicht übertrieben. Geht man davon aus, dass Dendreon die vorläufigen Daten schon demnächst an die FDA überstellen wird, dann wäre mit einer Zulassungsentscheidung der Behörde vielleicht schon im März zu rechnen. Ein Datum, dass sich Investoren und solche die es vielleicht noch werden wollen auf jeden Fall gut einprägen sollten.

Dass die FDA Provenge auf jeden Fall zulassen will, dafür spricht nämlich nicht nur der "Fast Track" Status. Erst vor wenigen Wochen erhielt Dendreon ermutigende Post von der FDA. Laut der Mitteilung erhielt Dendreon die Genehmigung, besonders aggressive Tumoren in der finalen Studie nicht berücksichtigen zu müssen. Eine Maßnahme, die mit Sicherheit zu einer weit höheren Signifikanz von Provenge führen dürfte und damit die Zulassungswahrscheinlichkeit deutlich erhöhen sollte.

Ein Einstieg bei Dendreon sollte noch immer lohnenswert sein, auch wenn die Aktie des Unternehmens jüngst deutlich gestiegen ist. Mit der Zulassung von Provenge gäbe es nämlich erstmalig eine echte Behandlungsalternative für Prostatakrebs-Patienten. Die Zulassung, die gemäß der bisher generierten Studiendaten sehr wahrscheinlich ist, könnte zu einem erneuten Kurssprung bei Dendreon führen.

Nach dem Erhalt des "Fast Track" Status in den USA könnte vielleicht bald schon die nächste kurstreibende Nachricht ins Haus stehen. Noch ist nämlich unklar ob, wann, und vor allem mit wem Dendreon Provenge in Europa auf den Markt bringen wird. Die Bekanntgabe einer Vermarktungskooperation läge durchaus im Bereich des Möglichen.

Provenge ist keine Impfung im herkömmlichen Sinne, sie kann einen Prostatakrebs nicht verhindern. Provenge fällt daher unter den Begriff der therapeutischen Vakzinen, diese gelangen zum Einsatz, wenn der Mensch bereits erkrankt ist. In Patienten mit Prostatakrebs macht Provenge das Immunsystem des Patienten auf die Krebszellen aufmerksam, woraufhin dieses die entarteten Zellen angreift und zerstört. Damit Provenge dies bewerkstelligen kann, werden dem Patienten bestimmte Immunzellen, sogenannte dendritische Zellen entnommen. Diese Zellen werden mit gentechnisch hergestelltem PSA in Kontakt gebracht, was zur Aktivierung der dendritischen Zellen führt, zurück im Körper des Patienten stimulieren diese dann das körpereigene Abwehrsystem. Die Tatsache, dass PSA in 95 Prozent aller Prostatakarzinome deutlich erhöht ist, macht das Enzym zu einem optimalen Tumormarker für diesen Krebs.

In den auf dem letzten ASCO Meeting präsentierten vorläufigen Phase III Daten konnte sich Provenge nicht nur als sicher und gut verträglich erweisen, sondern konnte darüber hinaus auch den Wirksamkeitsbeweis erbringen. In allen getesteten Patienten konnte die Vakzine eine zellvermittelte Immunität gegen das Prostata-Antigen PSA stimulieren. Dies geschieht durch eine Aktivierung von T-Zellen, die ihrerseits die antigentragenden Tumorzellen angreifen und zerstören. Nach Gabe der therapeutischen Vakzine wurde entweder ein Absinken der PSA-Konzentration oder aber die Verkleinerung des Tumors beobachtet. Der Überlebenszeitraum der mit Provenge behandelten Patienten konnte mehr als verdoppelt werden.

Doch nicht nur Provenge macht Dendreon als Investment interessant, die Bestätigung des Wirkprinzips von Provenge lässt darauf schließen, dass auch Mylovenge, das auf dem gleichen Prinzip beruht, die gewünschte Wirkung zeigen könnte. Die in Phase II befindliche Vakzine gegen bösartige Tumoren der B-Zellen beruht auf einem patienten-spezifischem Antigen mit der Bezeichnung M Protein, das sich ganz leicht aus dem Blut isolieren lässt. Wie bei Provenge, so wird auch bei Mylovenge dieses Antigen mit den patienteneigenen dendritischen Zellen zusammengebracht und diese nach ihrer Aktivierung in den Patienten zurück transferiert, wo sie eine Immunantwort gegen das Tumorantigen stimulieren sollen. Ergebnisse aus Phase I/II bestätigten bereits Sicherheit und Verträglichkeit des Produktes und wiesen auf einen Tumorrückgang hin.

Damit besitzt Dendreon also zwei potenzielle Produkte, denen schon in absehbarer Zeit der Sprung auf den Markt gelingen könnte. Bisher schreibt Dendreon noch rote Zahlen, zum Ende des Jahres 2003 wird ein Verlust von durchschnittlich $1,20 pro Aktie erwartet, bis 2004 soll sich dieser aber bereits auf $1,13 pro Aktie verringert haben. Mit $47,5 Millionen an Bargeldreserven und einer Burnrate von etwa $8 Millionen pro Quartal dürfte Dendreon allerdings keine Probleme haben, seine Forschungen bis zur Zulassung von Provenge weiter zuführen.

Wir vom Biotech-Experten besitzen die erforderliche wissenschaftliche Expertise, die für ein erfolgreiches Investment im LifeScience Sektor unabdingbar ist. Wenn auch Sie von unserem Wissen profitieren wollen, zögern Sie nicht und kontaktieren Sie uns noch heute. Unter www.Biotech-Experte.de erfahren Sie näheres zu unserem Service sowie unseren Expertisen

[meislo]

Dendreon To Present Promising Results From New Protease Activated Therapy (PACT) Program

- Preclinical results show improved efficacy and safety relative to chemotherapy -

Seattle, WA (Sept. 11, 2003) - Dendreon Corporation (Nasdaq: DNDN) today announced it will present data on a lead compound from its new Protease Activated Therapy (PACT) therapeutic platform. In preclinical testing to date, the compound, CVS 10290, has demonstrated a significant reduction in tumor volume compared to conventional chemotherapy. The results will be presented by Edwin L. Madison, Ph.D., vice president of biological research at Dendreon, during the Biochemical Society`s 57th Harden Conference: Proteinase Structure and Function taking place Sept. 9 to 13 in Oxford, UK.

Dendreon`s PACT program focuses on exploiting, rather than blocking, the activity of proteases on the surface of tumor cells. The goal of this prodrug approach is to deliver a potent cytotoxic, or cell-killing drug directly to the tumor cells, thereby sparing healthy tissue.

Data to be presented demonstrate in preclinical in vivo models of prostate cancer that CVS 10290 produced an approximately 85 percent reduction in tumor growth compared to conventional chemotherapy (p=0.0008). In addition, CVS 10290 was shown to have a considerably better safety profile than conventional chemotherapy, with no morbidity related to toxicity, as compared to 30 percent morbidity for conventional chemotherapy, and reduced chemotherapy-associated side effects. Additional studies with CVS 10290 demonstrated similar results in breast cancer models.

PACT involves the design of synthetic molecules composed of a sequence of amino acids that are selectively recognized by a targeted, cancer-associated serine protease. This peptide is chemically attached to a known cancer chemotherapeutic or cytotoxic drug, yielding a hybrid or conjugate molecule. This highly targeted approach is expected to reduce damage to normal, non-tumor cells because the sequence of attached amino acids delivers the cytotoxic agent directly to tumor cells.

"This study supports the role of this new and exciting class of drugs for cancer therapy that offers the potential for not only enhanced efficacy but reduced side effects as well," said Reiner Laus, M.D., vice president of research and development at Dendreon. "We look forward to advancing our first PACT compound into clinical development and expanding Dendreon`s platform technologies in oncology."

[meislo]

Dendreon gibt bekannt, in dieser Woche „viel versprechende“ Testergebnisse für den Krebswirkstoff CVS 10290 bekannt geben zu wollen.

Die Präsentation soll auf der 57th Harden Konferenz der Biochemical Society in Oxford, England, abgehalten werden. Der Wirkstoff zur Behandlung von Prostatakrebs habe sich überzeugend bei der Reduzierung der Größe von Prostatakrebsgeschwüren verhalten. Mit CVS 10290 habe sich das Tumorwachstum 85% besser eindämmen lassen, als mit der konventionellen Chemotherapie, so das Unternehmen.

In der letzten Woche meldete Dendreon, dass die US-Gesundheitsbehörde FDA das Prostatakrebsmedikament Provenge in einem beschleunigten Verfahren prüfen wird, was bedeutet, dass es bereits in den nächsten sechs Monaten zur Vermarktung freigegeben werden könnte. Die normale Zeitdauer für eine Zulassung beträgt normalerweise mindestens 12 Monate.

Die Dendreon (WKN: 615606, US: DNDN) Aktie schloss am Donnerstag 9.05% im Plus bei $8.90 und stieg in der Nachbörse um weitere 10 Cents auf $8.90 an.

Zahlreiche Unternehmen, zahlreiche Wirkstoffklassen, zahlreiche Chancen: Verschaffen Sie sich einen Überblick im Krebs-Forschungs-Sektor und finden Sie die Chancen, die es in diesem Wachstumssektor gibt.

[meislo]

8:08AM Dendreon upgraded to Strong Buy at Needham; tgt $15. (DNDN) 8.65: Firm believes there are many upcoming events to stimulate investor interest over the next 6-12 months, including 1) completion of enrollment of the D9902B ProvengePhase 3 trial; 2) marketing partnership for Provenge; 3) initiation of Phase 2 APC8024 trials in either breast, colorectal, ovarian cancer; 4) results from the Phase 2 rNAPc2 anticoagulation trial; and 5) advancement of the preclinical programs with prodrug CVS-10290 or monoclonal antibody DNDN1924

[meislo]

Nachdem die Analysten von Needham die Aktien des Biotechnologieunternehmens Dendreon (WKN: 615606, US: DNDN) „eine Weile beobachtet“ hatten, haben sie das Unternehmen nun auf „Strong Buy“ aufgestuft. Analyst Mark Monane sieht in den vier Produktkategorien des Unternehmens – therapeutische Impfstoffe, monoklonale Antikörper, kleine Moleküle und „Prodrugs“ eine positive Produktmischung, die durch eine hohe Diversifikation das Risiko streue. All diese Bereiche würden auf die Onkologie, also die Krebstherapie, abzielen. Die klinischen und finanziellen Ressourcen seien durch die Corvas Akquisition gebessert worden, hieß es weiter.

Die Aktie steigt um 13.29% auf $9.80.

[meislo]

Dendreon (WKN: 615606, US: DNDN) Aktien müssen in der Vorbörse Federn lassen, nachdem das Biotechunternehmen bekannt gab, dass das Prostatakrebs-Medikament Provenge in einem Punkt nicht die Erwartungen erfüllen konnte. Provenge habe die Verlaufsgeschwindigkeit des Krebswachstums nicht bremsen können. Das Medikament sei nun sieben Monate lang auf dieses Hauptkriterium hin überprüft worden, habe aber zwischen der Testgruppe und einer Gruppe, die Placebos erhielt, keine statistisch nachweisbaren Verbesserungen gebracht.

Die Aktie verliert um 8.90% auf $8.93.

[meislo]

Dendreon: Wachstum pur

--------------------------------------------------------------------------------
(©BörseGo - http://www.boerse-go.de)
Auch wenn Dendreon (NasdaqNDN) gestern mit einem negativen Vorzeichen aus dem Handel ging, so zählt das Unternehmen dennoch zu den 50 am schnellsten wachsenden Unternehmen im Staate Washington und das nun bereits das dritte Jahr in Folge. Die Auszeichnung wurde Dendreon von Deloitte & Touche im Rahmen seines „Technology Fast 50 Program“ überreicht. In diesem Jahr schaffte es Dendreon sogar bis auf Platz der Top 50 aufzusteigen. Mitchell H. Gold, M.D., CEO von Dendreon gab sich geehrt. In seiner Ansprache versprach Mitchell, Dendreon werden auch weiterhin mit vereinten Kräften forschen, um Krebspatienten endlich neue und vor allem effektive Behandlungsalternativen zur Verfügung stellen zu können.

Das Ranking für die 50 am schnellsten wachsenden Unternehmen im Staat Washington basiert auf einer Analyse der Jahresumsätze über einen Zeitraum von fünf Jahren, also für das Jahr 2003 von 1998 bis 2002. Die 50 Unternehmen, welche die Kriterien für eine Wahl erfüllen und zudem die größten prozentualen Umsatzsteigerungen aufweisen, werden in einer Liste der 50 Top Unternehmen aufgeführt. Als ein Empfänger des “Technology Fast 50 Award” wird Dendreon nun auch für die von Deloitte & Touche vergebene Auszeichnung der 500 am schnellsten wachsenden Unternehmen in Betracht gezogen. Dabei werden die 500 am schnellsten wachsenden Technologie Unternehmen in den USA ermittelt und erhalten eine Auszeichnung.

[05836]

An dieser Stelle auch mal ein Danke an Meislo für die
gründlichen und regelmäßigen Infos. Bin seit ca.
3 Monaten in DNDN investiert und habe es nicht bereut.
An schwachen Tagen zukaufen würde ich sagen!

[meislo]

Danke 05836

Ich bin aber nicht investiert da ich mich für geron entschieden habe

gruss meislo

[meislo]

Biotech Rebirth?
The maturing drug development pipeline at Geron promises much more than its much-hyped Fountain of Youth stem cell research of biotech boom days. Its cancer vaccine advances with positive data. It`s still a speculation, though, and there are other companies better positioned.

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Biotechnology


By David Nierengarten
September 30, 2003
When shares of biotech Geron (Nasdaq: GERN) spiked more than 50% to nearly $15 a share last week, investors took notice of the good news. Geron`s experimental cancer vaccine demonstrated effectiveness in a small phase 1-2 clinical trial with prostate cancer patients. Is it more false hope for investors interested in this speculative company, or a solid step toward a profitable future?

The company`s cancer and allegedly life-extending stem cell research brought enormous hype during the 1999-2000 biotech bubble, with headlines about the Fountain of Youth and New York Times pictures of the elderly on pogo sticks. But like many other cash-burning biotechs slapped down by the big, bad bear market of the past three years, Geron dropped into penny-stock territory by this March before rebounding with the first hints of positive clinical trial news in April.

Last week, CEO Thomas Okarma reported in the UBS Global Life Sciences Conference that the patients in this high-dose trial generated very good immune responses -- comparable to the immune response generated by traditional mumps or measles vaccines, and the best that has ever been seen in a cancer vaccine trial. These results show better and longer-lived responses than the low-dose experiment reported this April that sent shares shooting up from around $2 to over $5. In that small trial, the company reported that they had nearly eliminated all circulating prostate cancer cells.

The vaccine is still years from any application for FDA approval, but it`s welcome progress.


The telomerase connection
The vaccine showcases telomerase, a protein isolated by Geron`s scientists that allows all cancer cells, not just prostate cancer cells, to keep dividing and growing. Researchers at Geron use this protein -- not found in most normal cells -- to stimulate specialized immune system cells with the hope that they will then destroy any cancer cell that escaped the surgeons` scalpels.

Because the telomerase protein is present in all cancer cells, investors are hoping that there is a universal application for Geron`s cancer vaccine, increasing the market potential of it tremendously. While the prostate cancer market is not small, with nearly 200,000 men diagnosed with it annually and nearly 40,000 dying from it, a " universal" cancer vaccine has far more market potential.

Cancer vaccines: fact or fiction?
Cancer vaccines have been a Holy Grail quest for many biotechnology companies. The reasoning makes sense: The deadly aspect of most cancers is the propensity to metastasize to distant sites in the body. Because the cancer can spread to so many sites, surgery is impossible, and chemotherapy (the standard treatment to eliminate metastases) is toxic to the body`s normal, non-cancerous cells. So, if researchers could recruit the body`s own immune system to attack cancer cells, the colonizing cells would be destroyed, with no toxic side effects.

Of course, there are problems. Cancer cells resemble normal cells in many ways (after all, they are the body`s own cells that have gone outlaw -- growing without regard to the body`s regulations), and so the " trick" is to develop a vaccine that will stimulate a person`s immune system to attack only cancer cells, and avoid normal cells.

A new direction
Cancer vaccines are a relatively new direction for Geron, which was founded to find another Holy Grail, or to mix metaphors, to find the Fountain of Youth. The same protein, telomerase, that distinguishes cancer cells also allows normal cells to continue dividing past their usual limits. The theory is that by activating the protein in normal cells, the ravages of time would be reversed. The newly rejuvenated cells could divide again, replacing worn-out, old cells. In the same vein, the company has been conducting controversial research into using embryonic stem cells to repair damaged tissue and reverse the effects of aging.


However, Geron found its own time and cash running out as its anti-aging research foundered. So, at the beginning of the year, the company " refocused" (read: fired researchers) and concentrated at pushing their oncology products through clinical trials. Spending on oncology programs for the first half of the year totaled $8.5 million, while their regenerative medicine program received $6 million of the R&D pie at Geron. That latter figure is down from nearly $9 million in the year-ago period (oncology increased slightly from $8.3 million).

Competition
Naturally, Geron is not alone in trying to develop a cancer vaccine. Competitors abound, including some right in the prostate cancer arena, and many other drug candidates are farther along in the drug development pipeline than Geron`s hopeful in phase 1-2 trials.

One rival is Dendreon (Nasdaq: DNDN). Dendreon`s prostate cancer vaccine, Provenge, is on fast-track status with the FDA as the phase 3 trial gets wrapped up. Dendreon also has more money in the bank ($68 million), more products in the pipeline, and a lower market capitalization than Geron, along with ready collaborations to develop certain drugs with Genentech (NYSE: DNA). They`re even developing a competing telomerase vaccine, using technology licensed from Geron.

Cell Genesys (Nasdaq: CEGE) has been working on a series of cancer vaccines that also use a more traditional route of isolating special proteins that are found in each different tumor type to immunize patients against a particular cancer. The company`s product, GVAX, is progressing through phase 2 trials for prostate, lung, and pancreatic cancers, along with leukemia.

Genzyme (Nasdaq: GENZ) is also developing a vaccine that uses a patient`s own tumor cells to stimulate the immune system to reject tumors. The researcher creates a customized vaccine for each patient by isolating the tumor cells and fusing them to specialized immune cells. This approach is still in the early stages, like Geron`s, but Genzyme is one of the few biotechnology companies making money. Of course, you`ll pay a premium of nearly 45 times earnings to buy a share of this company, but at least there are earnings to buy.

Too risky?
Like many biotech companies, Geron is not profitable. Heck, it hardly has any revenues -- only $1.25 million over the past year, mainly from licensing technologies. It has reduced its annual cash burn from $45 million to just under $34 million last year, and it has $53 million left in the bank and under $7.5 million in debt. With these financials, Geron will have to find a partner to help shoulder the expense (and take a piece of any future profits) to bring this vaccine through further trials.

But if things go right, there will be plenty of profits to share. So, if you invest in a company like Geron, you`re essentially speculating that FDA approval will make the company and your investment profitable.

What could go wrong? First of all, this was a tiny trial -- only 12 patients, and it may be a statistical blip. Furthermore, there are normal cells that do use telomerase, including the tissues that make blood cells and those in the reproductive organs. Generating an immune response to a patient`s own reproductive organs or bone marrow seems to me to be a real possibility with this kind of therapy, despite the promising safety data. Additionally, cancers mutate all the time, and it`s possible that a strain of cancer cells could develop that evades the vaccination response.

I believe that Geron`s technology is promising, but it`s simply too risky to buy into a company valued at over $400 million for a single phase 1 product plus a handful of preclinical ones. For this kind of price, I would rather own a Dendreon with a phase 3 candidate, a different phase 2 hopeful, and several other earlier-stage drugs in development.

Like the quest for the Holy Grail that caused the demise of many a gallant knight, the quest for a cancer vaccine has littered the roadside with fallen biotechnology companies. Will Geron succeed? The complete results from this trial are scheduled to be released in December. I`ll be watching, but from the sidelines -- unlike some folks on the Geron discussion board


Trotzdem ich denke nach wie vor das geron das bessere investment ist

gruss meislo

[meislo]

Vaccine attacks breast cancer

Aaron Derfel
CanWest News Service


Saturday, October 25, 2003

Jane Sterett`s treatment for late-stage cancer has succeeded beyond her doctor`s expectations.


CREDIT: CanWest News Services

Cancer patient Jane Sterett meets with Jennafer Carlin, co-ordinator of clinical research at the UCSF Breast Care Centre.

ADVERTISEMENT


SAN FRANCISCO -- Jane Sterett took a deep breath as a nurse drew the last of a dozen vials of blood from her chest.

Two weeks earlier, Sterett had been infused with an experimental vaccine to treat her advanced breast cancer. The vaccine boosts her immune system to attack the cancer cells in her body -- especially the ones chewing away at her ribs, hips and spine.

The nurse gingerly packed the vials in a box. The blood samples would be analysed to measure the patient`s immune response.

Sterett smiled as she stood up from a chair in the UCSF Breast Care Centre on a sunny September morning. She was excited about going on vacation with her husband the next day to her hometown of Eugene, Ore. Her cheeks were rosy and her eyes twinkled blue, giving no hint that she has metastatic cancer.

Before she could leave the hospital, though, she had to wait a couple of hours for a checkup and a breast exam. She eased into a sofa -- careful to keep her posture straight to avoid back pain -- and chatted with Jennafer Carlin, co-ordinator of clinical research at the breast centre.

"Are you guys still following the people who have dropped out of the trial?" Sterett asked.

"I contact them," Carlin replied. "But the drug company doesn`t. They don`t know you or your name."

Sterett, a 55-year-old former kindergarten teacher, entered the clinical trial in June 2002 after suffering a relapse. Not everyone with breast cancer can qualify for the vaccine trial, which is sponsored by Dendreon Corp. And many who do enroll in such studies eventually have to drop out after failing the treatment, though their survival is still tracked for comparison.

Sterett, however, has responded beyond her doctor`s expectations. Her late-stage cancer appears to have stabilized after she was vaccinated last year. She did so well that her oncologist, Dr. John Park, let her take the vaccine again in early September.

"It was scary at first," Sterett told Carlin. "It`s experimental, after all. It`s not like there are thousands of people taking it."

The vaccine gears the immune system to hunt for cells that overproduce the HER-2/neu protein -- the cause of her cancer, invasive ductal carcinoma. What`s unique about the vaccine is that it`s customized for each patient.

Sterett first had to sit hooked up to a leukapheresis machine, her blood running through it. The machine skimmed the blood for dendritic cells. Those immune cells were then rushed to the lab at Dendreon, where they were force-fed fragments of the HER-2/neu target.

Two days later, the beefed-up dendritic cells were infused in the patient`s bloodstream, signalling the immune system to search and destroy the breast cancer cells. During infusion, the vaccine can cause the shakes and an overnight fever -- a sign of an immune reaction.

"The last time I got the shakes so bad, they had to give me a shot of Demerol," Sterett recalled.

Still, the vaccine`s side effects are considerably milder than chemotherapy and radiation. In October 1998, doctors diagnosed a pancake-sized tumour in her left breast after she noticed some swelling there. She underwent chemotherapy immediately in the hope of shrinking the tumour to avoid a mastectomy. The chemo, unfortunately, weakened her so much that she caught pneumonia and had to quit teaching.

Concerned that her tumour hadn`t been reduced enough, surgeons removed her breast. That was followed by more chemo and radiation.

"At that point, I thought: you go through these treatments and there`s an end and you get over it," Sterett said. "It`s a whole different thing when you get re-diagnosed and it`s spread. That came two years later."

In June 2000, she felt sore in the ribs and had trouble turning over in bed at night. A bone scan confirmed the worst: the cancer had metastasized to her ribs.

"It was very much of a surprise," said Barry Sterett, her husband, who got the news over the phone from a doctor.

"It was even more difficult because of the severity of stage four cancer. All of a sudden, the doctors can`t tell you what`s going to happen next because at that stage there are not a lot of treatments."

Sterett began a combination of two drugs, Herceptin and Taxotere, which stopped the cancer from spreading, but caused her intestinal pain. At the same time, she educated herself -- mostly through the Internet -- on new clinical trials. That`s how she came across the Dendreon trial at the UCSF Medical Centre, a top hospital in clinical cancer research.

She pursued the clinical trial not just for herself. Breast cancer runs in her family -- her mother and grandmother were afflicted by it -- and Sterett has two daughters in their 20s. In her own small way, Sterett said, she`s contributing to research that might help her daughters should they develop breast cancer.

"We`re very happy for her," said John Park, Sterett`s oncologist. "She`s had no progression of cancer-related problems for over a year."

When it was time for her checkup and breast exam. Karen Bayuk, a nurse practitioner, greeted her with a wide smile. They hadn`t seen each other in a year.

"You look fantastic!" Bayuk said, ushering her into her office. "How are you?"

"I feel fine. There`s some periodic back pain. I feel it at the end of the day."

Sterett was taking Zometa, which strengthens the bones, as well as Vioxx, which eases arthritic pain. The dosage hadn`t changed, she told Bayuk.

The nurse conducted the breast exam and searched the lymph nodes in her armpits for swelling -- a sign that cancer might have spread there. She found nothing. A bone scan was scheduled for the end of October. That would be more conclusive.

"I`m very pleased for you," Bayuk said, as Sterett got ready to leave for her vacation. "You`re doing great."

(Montreal Gazette)

[meislo]

Aktie schon über 10 Dollar



Dendreon`s Provenge Extends Survival in Advanced Prostate Cancer by Over Eight Months in Patients with Gleason Scores of Seven and Less
Monday January 12, 7:04 am ET
Results from ongoing monitoring of Company`s completed D9901 Phase 3 trial is longest survival benefit seen in late-stage prostate cancer


SEATTLE--(BUSINESS WIRE)--Jan. 12, 2004-- Dendreon Corporation (NasdaqNDN - News) today announced updated survival data from patients with advanced prostate cancer with Gleason Scores of seven and less who participated in its completed and previously reported Phase 3 trial (D9901) of Provenge®, the Company`s investigational immunotherapy for the treatment of prostate cancer.
ADVERTISEMENT


Patients with Gleason Scores of seven and less receiving Provenge had a significant survival advantage, having on average an 89 percent overall increase in their survival time as compared to placebo (log rank p = 0.047, hazard ratio = 1.89). This benefit is reflected by a prolongation in the median survival time in patients receiving Provenge by 8.4 months (30.7 months versus 22.3 months). At 30 months from randomization, the survival rate for Provenge-treated patients is 3.7 times higher than for patients receiving placebo (53 percent versus 14 percent, p = 0.001).

Consistent with previous reports, a majority of those patients in D9901 who are still alive have received treatment with Provenge and will continue to be followed according to the study protocol. The Company expects to present this as well as other updated data at major scientific meetings throughout the year.

Prostate cancer is the most common non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 cases diagnosed and 28,900 deaths in 2003.

"This is the longest survival benefit ever reported in a Phase 3 study in late stage prostate cancer," said Dr. John M. Corman Director of the Virginia Mason Comprehensive Prostate Cancer Clinic and Assistant Clinical Professor of Urology at the University of Washington in Seattle. "With the combination of this exciting new survival data and favorable side effect profile, Provenge has the potential to change the way we treat prostate cancer in the future."

These updated survival data are consistent with other previously reported data from the D9901 trial that showed significant clinical benefit from Provenge treatment for men with a Gleason Score of seven and less. For these men, the average time to disease progression is more than two-fold longer than that for patients treated with placebo (p = 0.001) and the average time to experiencing cancer-related pain is more than 2.5 times longer than that for patients treated with placebo (p = 0.016). Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events. As previously reported, no benefit has been seen in men with Gleason Scores of eight and higher.

Last year, Dendreon also released data confirming Provenge`s mechanism of action based on T-cell mediated immune response. These data showed that among men treated with Provenge, those with a Gleason Score of seven and less demonstrated a T-cell mediated immune response 7-fold greater than men with a Gleason Score of eight or more (p = 0.0065).

"Based on the strength of this survival data, which is consistent with all of the data gathered to date on our other endpoints in the trial for patients with Gleason Scores of seven and less, we are more enthusiastic than ever regarding the pivotal role that Provenge may play in providing a new and well tolerated targeted therapy for prostate cancer patients," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The results from this study represent an important milestone in the fight against prostate cancer and indicate that Provenge may provide for a well-tolerated treatment option that offers patients a potential survival advantage."

The ongoing, pivotal D9902B Phase 3 trial of Provenge is based on the knowledge gained from the results of D9901. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Provenge also has Fast Track designation. The pivotal double blind, placebo-controlled D9902B trial is now underway at leading cancer centers around the country. To be eligible for the study, patients must have metastatic prostate cancer that has progressed following hormone therapy and have a Gleason Score of seven and less. Patients must also be free of cancer-related pain. To learn more about the trial, go to www.dendreon.com or call 1-866-4-PROSTATE (1-866-477-6782).

Conference Call

Dendreon will host a conference call today, Monday, January 12, 2004, at 7:00 a.m. Pacific Time (10:00 a.m. Eastern Time). To access the call, please dial 888-323-9686 (domestic) or 210-234-0006 (international). The passcode for the call is "Dendreon." A replay of the call will be available by phone at 800-925-4850 (domestic) or 402-220-4323 (international).

About Provenge

Provenge is designed to stimulate a man`s immune system against prostate cancer. It is developed through Dendreon`s proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).

About Gleason Score

The Gleason Score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor. High Gleason Scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason Score of seven and less.

About Dendreon

[meislo]

Aktie steigt bis jetzt um 22%

Dendreon - Kurssprung nach Phase III Daten

--------------------------------------------------------------------------------
(©BörseGo - http://www.boerse-go.de)
Die Dendreon Aktie steigt vorbörslich um 16.01% auf $10.58, nachdem das Unternehmen aus einer Phase III Studie des Medikamentes Provenge melden konnte, dass die Überlebensrate bei Patienten mit fortgeschrittenem Prostatakrebs verlängert werden konnte. Die Lebenszeit der Patienten sei um durchschnittlich 8.4 Monate verlängert worden

[aquismat]

Dendreon,

einfach klasse; wegen neuer sehr teurer Produkte mittelfristig sehr interessant!

Kurszuwächse in den letzten 6 Monaten.

[ballard1]

die kennen echt kein halten mehr, strong buy!!!!!!

[meislo]

Schon gelesen?

http://www.forbes.com/sciencesandmedicine/2004/01/23/cx_mh_r…

[meislo]

Kommt gut an die katitalerhöhung Kurs bei 14,11 Dollar

Das Biotechnologie-Unternehmen Dendreon wird im Rahmen einer Kapitalerhöhung 10.25 Millionen Stammaktien zu $12.75 je Stück verkauft. Das Unternehmen rechnet mit einem Erlös von rund $130.7 Millionen aus der Aktienplatzierung. Bei Überzuteilung stehen weitere 1,514,705 Aktien zur Verfügung, hieß es. Die Aktie schloss am Montag 12% im Plus bei $13.23.


Das werden dann wohl eher 150 millionen dollar werden

[muycaro]

Ich habe mir auch mal ein paar DNDN ins Portfolio gelegt. Leider erst heute, obwohl die schon bei der Hälfte des heutigen Kurses auf meiner Watchlist standen.
Sind auf diesem Niveau nicht mehr ganz so günstig, ich sehe den Titel trotzdem als sehr aussichtsreich mit einem guten Chance/Risiko Verhältnis.

So, das war`s erstmal. Viele Grüsse an alle und Glück auf!

P.S.: Wenn ihr langfristig etwas noch spekulativeres sucht, guckt Euch mal Oncolytics Biotech (Nas: ONCY) an.

[muycaro]

Weiss jemand, ob das einen Grund hat, dass der Kurs in FRA zu Handelsbeginn knapp 10% nachgegeben hat (habe keine News gefunden)?

Wenn nicht wäre das m.E. eine 1A Kaufgelegenheit auch kurzfristig betrachtet.

[muycaro]

Das war anscheinend ein Headfake mit den -10%, bin froh dass ich noch ein paar "ermässigte" bekommen habe.

Es wird übrigens heute mit der erfolgreichen Zulassung von Imclone`s Erbitux durch die FDA gerechnet.
Sollte dies so sein, könnte es dem ganzen Sektor etwas Auftrieb verleihen.

Dagegen stehen die soeben veröffentlichten schlechten Arbeitsmarktdaten und schwachen Einzelhandelsumsätze aus den USA (Futures sind leicht ins Minus gedreht).

Diese Daten haben aber m.E. auch eine positive Seite: nämlich dass Greeny wohl die Zinsen doch noch nicht in allzu Zukunft anheben wird (gut für die Märkte).

[muycaro]

Hier nochmal die letzten drei Kommentare durch Marktbeobachter:



13.01.2004
Dendreon "strong buy"
Delafield Hambrecht

Rating-Update:

Die Analysten vom Investmenthaus Delafield Hambrecht stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) von "buy" auf "strong buy" hoch. Das Kursziel sei von 10 auf 16,50 USD erhöht worden.


http://www.aktiencheck.de/Analysen/default_an.asp?AnalysenID…


________________________________________________________________________________________________________


20.01.2004
Dendreon nicht aus der Hand geben
Global Biotech Investing

Die Experten vom Börsenbrief "Global Biotech Investing" empfehlen den Titel von Dendreon (ISIN US24823Q1076/ WKN 615606) zu halten.

Das US-Biotechunternehmen könne erneut glänzende klinische Phase III-Daten bezüglich des Präparats Provenge (gegen Prostatakrebs) vorlegen. Eine Zulassung könnte noch im laufenden Jahr erfolgen, was durch den Fast-Track-Status durch die US-Gesundheitsbehörde FDA noch beschleunigt werde. Der geplante Verkaufsstart sei dann das Jahr 2005.

Dendreon sei nun auf der Suche nach einen Partner, der sich um die abschließende Entwicklung und um die Vermarktung von Provenge kümmern solle. Favoriten seien dabei ganz klar die Branchenriesen im Pharma- oder Biotechbereich, um eine optimale Positionierung des Präparats im Markt zu erzielen. Gerüchten zufolge solle sich die Auswahl schon auf zwei Unternehmen reduziert haben. Hier würden die Wertpapierspezialisten in den kommenden Monaten also spannenden News erwarten.

Die Experten vom "Global Biotech Investing" raten den Anlegern kein Stück von Dendreon aus der Hand zu geben.


http://www.aktiencheck.de/Analysen/default_an.asp?AnalysenID…


________________________________________________________________________________________________________


26.01.2004
Dendreon festhalten
Hot Stocks Investor

Die Wertpapierexperten von "Hot Stocks Investor" raten an den Aktien von Dendreon (ISIN US24823Q1076/ WKN 615606) festzuhalten.

Das Unternehmen habe ausgezeichnete klinische Vorab-Testdaten mit dem Präparat Provenge gegen Prostatakrebs gemeldet. Provenge zähle zu der neuen Klasse von Präparaten, die eine Stimulierung des Immunsystems zur Bekämpfung der Krebstumore bewirke. Bis spätestens Ende des Jahres wolle der Konzern die Tests endgültig abschließen und einen potenten Vermarktungspartner ins Boot holen. Der Kurs habe daraufhin lediglich um 20% zulegen können. Anleger sollten sich jedoch davon nicht irritieren lassen.

Die Experten von "Hot Stocks Investor" raten an der Perle Dendreon festzuhalten und die Zeit für sich spielen zu lassen. Das Expertenteam sei sich sicher, dass in 12 Monaten ganz andere Kursgrößen zu sehen sein würden.


http://www.aktiencheck.de/Analysen/default_an.asp?AnalysenID…


_________________________________________________


Ganz ordentlich.

[Chris8888]

@muycaro,



woher hast du denn die information mit IMCLONE her?

Bitte Fakten und keine FAKES!!!


MfG

CHRIS

[muycaro]

Bleib mal locker Chris:

http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yh…" target="_blank" rel="nofollow ugc noopener">http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yh…


Zitat:

The Food and Drug Administration is scheduled to decide no later than Friday whether to approve Erbitux, an anti-cancer drug from biotech firm ImClone (IMCL: news, chart, profile) and its pharmaceutical partner, Bristol-Myers Squibb.


[...]

"We are expecting Erbitux to be approved," said John McCamant, editor of the Medical Technology Stock Letter. "I don`t think the FDA wants to deal with the pressure it would get if it were to issue a non-approval."


[...]

Fakten genug?
100%ige Sicherheit gibt es natürlich nie, ich schrieb ja auch "es wird erwartet". Ich denke die Chancen stehen allerdings sehr gut. Also, calm down, if you would.

[muycaro]

Bist Du sauer, weil Du keine Limitorder drinliegen hattest heute morgen?
Meine DNDN sind schon fast nen Dollar im Plus seitdem...

[muycaro]

Ooops, merke gerade dass der Link nicht funktioniert (kann nicht kopiert werden da redirected). Hier nochmal der richtige Weg zum Artikel:

http://finance.yahoo.com/q?s=imcl

Dort bei den News auf [external] ImClone rallies as FDA decision for Erbitux nearsWed 5:11pm - at CBS MarketWatch klicken.

Sorry nochmal!

[muycaro]

Ouch, IMCL ist gerade um ca. $10 auf $34 abgestürzt. Gerüchteweise(!) soll Erbitux wohl doch die Zulassung verweigert worden sein (hätte ich nicht mit gerechnet).
Jetzt ist die Aktie gerade angehalten (halted). DNDN jetzt auch etwas unter Druck.
Denke gleich wird es auch ein offizielles Statement geben.

[muycaro]

Erbitux doch zugelassen!

Reuters
FDA OKs ImClone`s Cancer Drug Erbitux
Thursday February 12, 2:08 pm ET

WASHINGTON (Reuters) - ImClone Systems Inc. (NasdaqNM:IMCL - News) on Thursday won U.S. approval to sell cancer treatment Erbitux, the drug at the center of an insider-trading scandal that landed the company`s founder in jail and put Martha Stewart (News) on trial.

The Food and Drug Administration announced its approval. It is the first commercial product for ImClone, a company whose image and share price were battered by a regulatory setback late in 2001 that led founder and former Chief Executive Sam Waksal to attempt to dump shares before the bad news was announced.

Bristol-Myers Squibb (NYSE:BMY - News) has rights to co-market the drug in the United States.


http://biz.yahoo.com/rb/040212/health_imclone_1.html

Bei Imclone sind wohl manche unter dem Druck zusammengebrochen (vielleicht ja weil morgen Freitag der 13. ist... )und haben panikartig vor der Entscheidung verkauft. Wow!

DNDN steigt jetzt.

IMCL immer noch angehalten.

[muycaro]

Ich denke heute geht es aufwärts, da Erbitux m.E. das schlechtere Medikament im Vergleich zu Provenge darstellt (obwohl keine unmittelbare Konkurrenz da die Zulassung ja für verschiedene Indikationen angestrebt wird).

Nach dem was ich gelesen habe, schrumpfte Erbitux die Tumore zwar, verlängerte jedoch nicht die Lebenserwartung.

Die Behandlung von Prostatakrebs mit Provenge dagegen hat eine deutliche Lebensverlängerung gezeigt.

Nachdem Erbitux jetzt zugelassen worden ist, werden wohl viele darauf spekulieren, dass Provenge dann erst recht zugelassen wird.

Die Marktkapitalisierung von Dendreon im Vergleich zu Imclone ist auch nur ca. 1/4, daher noch relativ günstig sollte es zur Zulassung kommen.

Viele Grüsse

[muycaro]

Yup, neues 52 Wochenhoch...

[muycaro]

FDA Sees Rebound in Approval of Innovative Drugs in 2003
New Innovation Initiative Anticipated to Speed Approvals in Years Ahead:

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html

Liest sich gut!

[muycaro]

Knacken wir heute die $15 - neues 52-Wochen Hoch?

[muycaro]

Das mit einem neuen Jahreshoch wird wohl heute nichts mehr.

Hier mal ein interessanter Artikel über die finanzielle Entwicklung von Übernahmeangeboten im Biotech Sektor in den letzten Jahren (wir wollen nicht hoffen, dass es dazu kommt, allerdings ist die/das Tendenz/Fazit doch erfreulich):

http://www.signalsmag.com/signalsmag.nsf/0/C0D67BEC3F48A27F8…

Viele Grüsse

[meislo]

Dendreon schlägt Analystenprognosen haushoch!
Dendreon gelingt erstmalig der Sprung in die Gewinnzone


Gestern wurde endlich klar weshalb die Aktie von Dendreon am vergangenen Mittwoch mit einem Minus von mehr als 6% in den Handel startete, dann jedoch mit einem Plus von fast 2% noch einen Turnaround hinlegen konnte. Die gestern nach Börsenschluss vorgelegten Geschäftszahlen für das vierte Quartal 2003 und das Update im Hinblick auf die Prostatakrebsvakzine Provenge lassen nämlich den Schluss zu, dass der temporäre Kursverlust nicht grundlos herbeigeführt worden sein könnte.


Die Zahlen und Daten von Dendreon sprechen ganz eindeutig für den künftigen Erfolg des Unternehmens, was nun scheinbar auch einigen größeren Investoren aufgefallen sein dürfte. Ein möglicherweise absichtlich herbeigeführter Kursverlust gab am Mittwoch dann auch den letzten Skeptikern noch eine Chance bei Dendreon einzusteigen und auf diese Weise doch noch vom künftigen Erfolg des Unternehmens zu profitieren.


Im letzten Quartal des Jahres 2003 gelang Dendreon immerhin der Sprung in die Gewinnzone. Anstelle des Verlustes von $5,8 Millionen oder 22 Cents pro Aktie im Vorjahr konnte Dendreon diesmal einen Gewinn von $1,3 Millionen, entsprechend 3 Cents je Aktie, ausweisen. Noch eindrucksvoller das Umsatzwachstum, das von $4,1 Millionen in Q4 2002 auf $21,7 Millionen zunahm.


Mit diesen Ergebnissen konnte Dendreon die Prognosen der Analysten haushoch schlagen. Gemäß einer Umfrage von Thomson First Call hatten die befragten Experten für das abgelaufene vierte Quartal mit einem ziemlich deutlichen Verlust von 32 Cents pro Aktie gerechnet. Entsprechend positiv fiel der Kursverlauf in der Nachbörse aus, wo Dendreon um 5,1% an Wert zulegen konnte.


Genaueres zur Analystenkonferenz, den Geschäftszahlen sowie Dendreon’s Erfolgen in Forschung und Entwicklung gibt es auf unserem Portal unter www.Biotech-Experte.de.



Dendreon Corporation Reports Fourth Quarter and Year End 2003 Financial Results & Corporate Highlights
Thursday February 26, 4:20 pm ET


SEATTLE--(BUSINESS WIRE)--Feb. 26, 2004--Dendreon Corporation (NasdaqNDN - News) today reported results for the year and quarter ended Dec. 31, 2003. Revenues for the year ended Dec. 31, 2003, were $27.0 million, compared to $15.3 million for the year ended Dec. 31, 2002. Revenues for the fourth quarter of 2003 were $21.7 million, compared to $4.1 million for the same period in 2002. Revenues for the fourth quarter of 2003 were primarily from Dendreon`s recent license agreement with Kirin Brewery Co., Ltd.
ADVERTISEMENT


The net loss for the year ended Dec. 31, 2003, was $28.4 million, or $0.82 per share, compared to $24.7 million, or $0.96 per share for the year ended Dec. 31, 2002. Net income for the fourth quarter of 2003 was $1.3 million, or $0.03 per diluted share, compared to a net loss of $5.8 million, or $0.22 per share, for the same period in 2002. Dendreon`s total operating expenses for the year ended Dec. 31, 2003, were $54.3 million compared to $41.2 million in 2002. Net cash used by operations in 2003 was $38.8 million compared to $26.5 million in 2002.

As of Dec. 31, 2003, Dendreon had approximately $113.2 million in cash, cash equivalents, short-term and long-term investments compared to $55.0 million as of Dec. 31, 2002. In January 2004, the company conducted a follow-on public offering of common stock resulting in gross proceeds of $150.0 million, or $140.5 million net of offering costs. Dendreon`s cash balance following the sale of the common stock was $250.2 million.

As Dendreon continues to advance its clinical programs and develop its commercialization infrastructure for Provenge, the Company estimates that cash used in operations in 2004 will be approximately $60 million to $65 million. This may be impacted by our ongoing collaboration discussions for Provenge as well as our investment in commercialization infrastructure for Provenge.

"Dendreon has established a strong financial foundation while continuing to advance its clinical programs during 2003," said Martin Simonetti, senior vice president of finance and chief financial officer. "We delivered on this commitment through our business development activities, access to the capital markets and by continuing the progress of our lead product candidate, Provenge®. Our balance sheet has never been stronger and data from our first Phase 3 clinical trial of Provenge, including the recent survival data, support continuing to advance this product candidate toward commercialization."

Dendreon`s 2003 highlights include:

Clinical & Regulatory

The company`s investigational immunotherapy product, Provenge, received Fast Track designation from the U.S. Food and Drug Administration.
Receipt of a binding agreement, known as a Special Protocol Assessment, from the U.S. Food and Drug Administration in June 2003 allowing for Dendreon`s pivotal Phase 3 clinical trial (D9902B) to serve as basis for a Biologics License Application for Provenge for the treatment of androgen independent prostate cancer, if it is successful in meeting its predetermined objectives.
The presentation of new data from the completed Phase 3 clinical trial (D9901) of Provenge at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2003 confirming that the underlying mechanism of action of Provenge, a T-cell immune response, is consistent with the clinical benefit seen in men with advanced, metastatic prostate cancer with Gleason scores of 7 and less.
The presentation of long-term results from Dendreon`s Phase 1 trial of its cancer immunotherapy APC8024 in patients with advanced, metastatic, Her-2/neu positive breast cancer at the ASCO annual meeting in June 2003. Data was presented on 16 patients whose disease had progressed after receiving chemotherapy. Fifteen of these patients had progressive disease following Herceptin therapy. Following treatment with APC8024, 25 percent of patients demonstrated clinical benefit defined as a partial response or prolonged stable disease.
The presentation of interim results at the ASCO meeting in June 2003 from a Phase 2 clinical trial sponsored by the National Cancer Institute, P-16, indicating that a combination therapy of Provenge and Genentech`s Bevacizumab (Avastin(TM)) may provide a significant improvement in the median PSA doubling time in men with androgen dependent prostate cancer.
Corporate

The acquisition of Corvas International, Inc. on July 30, 2003, through the issuance of Dendreon common stock.
The raising of $30.7 million through the sale of Dendreon common stock completed on June 17, 2003.
A licensing agreement with Kirin Brewery Co., Ltd. in November 2003 by which Dendreon licensed patent rights relating to the use of certain HLA-DR antibodies for which Kirin agreed to pay $20 million and returned the rights to Dendreon`s lead product candidate, Provenge, for countries in Asia that were previously licensed to Kirin.
The appointment of key management positions including Israel Rios, M.D., vice president of clinical affairs; and Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer.
Conference Call

Dendreon will host a conference call at 1:30 p.m. Pacific, 4:30 p.m. Eastern, today, Thursday, Feb. 26. To access the live call, dial 888-790-1712 (domestic) or 210-234-8001 (international), the passcode for the call is Dendreon. The call will also be webcast and will be available from the company`s website at www.dendreon.com under the "News & Events" section. A replay of the call will be available from the company`s website and by calling 800-871-1325 (domestic) or 402-280-9908 (international).

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit .

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license; the risk that the FDA will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied; the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial; risks that we may lack the financial resources and access to capital to fund required clinical trials for Provenge; the risk that we may not realize all of the anticipated benefits of the Corvas acquisition; the risks that the safety or efficacy results of preclinical studies will not support further development; risks associated with the development of early stage product candidates through preclinical and clinical research and development; the risks associated with a failure by Dendreon to secure and maintain relationships with collaborators, including a collaborator for the development and commercialization of Provenge; risks associated with completing Dendreon`s clinical trials; reliance on key employees, especially senior management; risks related to Dendreon`s limited operating history; dependence on the efforts of third parties; and dependence on intellectual property. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations, are contained in Dendreon`s public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available
www.dendreon.com

[quepos]

Folgende äußerst lesenswerte Beiträge fand ich im Yahoo-Board von DNDN (nicht von der Länge abschrecken lassen, ist interessant!):

Grüße

q.

What happened this week
by: tooskookum4u 02/28/04 03:05 am
Msg: 21786 of 21811

Didn`t post today because I was talking with my broker, their research analysts, a few fund traders, and my favorite analyst about the action in Dendreon over the last two weeks. A few people may have noticed the jump in put option buying recently. Most everyone noticed a large jump in the short interest.

Three to four weeks ago, short sellers discovered a Phase II trial lung cancer trial by CEGE stopped enrollment for a while because of patient deaths during the biopsy procedure required to harvest live tumor cells needed for that version of GVAX. The stop and the deaths were undisclosed by management. The trial enrollment procedures were changed.

This was uncovered by a medical consultant company. These companies put doctors on retainer (5 figures annually) to feed them information on clinical trials. Nobody knows for sure which consultant company it was that originally uncovered it, but one that was involved for sure was MCRI, Medical Consulting Referral, Inc. (medcri.com).

Funds pay companies like MCRI upwards of $50,000 per year for their research. This is the primary reason funds are almost always ahead of you and I when investing in biotech. MCRI distributed this research to their clients, who began initiating short positions in vaccine companies, assuming that when CEGE presented at the BIO/CEO conference, the company would disclose the stoppage and change in the Phase II trial causing a fall in the stock.

Dendreon was a special target among vaccine companies because of the large run in the shares recently. The short sellers knew the company was not sending Dr. Gold to BIO/CEO because of a Board of Directors meeting scheduled for this week, so they assumed no important new information would be released.

To cover their bases, the hedge funds who shorted did two things. First they secured a committment from MCRI to use their "research analyst" arm, Summer Street Research, to issue a sell recommendation on Dendreon the same day the CEGE story was supposed to break. Second, they leaked the CEGE story to news media outlets they know they can count on to run bad news quickly. This was a protection in case CEGE management decided to hide the news about the Phase II trial.

To start the ball rolling in DNDN, the hedge funds aggregated cash and placed high volume sell orders in DNDN the morning of the 25th, driving the price down. This was followed by large put buys. While someone here correctly pointed out the dollar investment in those put buys was inconsequential, the fact they were so far below the trading price and in the near-term contract generated a warning signal to other investors that something was up. It`s like a dog marking their territory. After the first big drop, they kept hitting the tape with small lots on every uptick to pressure the stocks lower.
Where Dendreon is concerned, the first thing MCRI`s clients didn`t count on was some fairly big money that had been sitting on the sidelines watching the stock. These players were well briefed in the company`s stock by reading the same research many here have read AND from participating in the road show for the UBS financing. As we know, there was pent-up demand from that offering. That money was largely responsible for the rebound beginning in the 12-o`clock hour that day.

The second thing MCRI didn`t count on was Biotech Monthly being so quick to respond. Because MORE THAN ENOUGH has been said about them in the last few days I won`t bother to say any more.

What happened after the bell yesterday and today was something different, though the activities by MCRI`s customers bled into today.

When Dendreon released their earnings, they showed a profit and beat analyst estimates. You and I know this make no difference to the value of Dendreon, but there are computerized trading systems that automatically buy any and all such earnings patterns the instant they appear on the news wires. This buying is what caused the after-hours run yesterday.

After the purchases are made by the computers, humans take over and figure out what to keep and not keep. Because the revenue was one time and since earnings make no difference to the Dendreon story, these computer traders were selling.

The stock opening strong this morning after a high volume bullish reversal two days ago created a really attractive technical chart pattern. Those traders piled in this morning about the time the computerized earnings traders were selling. Since the sideline bullish funds had already spent considerable money on the 25th, there wasn`t a great deal of cash to put into Dendreon so the rally flattened mid-day.

MCRI`s clients took advantage of this and tried a half-hearted run at the stock that pushed us towards negative/even. In addition, fast traders who saw the research out in the noon hour on the 25th took profits on some of their positions today.

I cannot guarantee this is a 100% accurate account, because it is really tough to get people to talk about bad trades. The sources I spoke with recognized some patterns and were familiar with some of the players from similar situations in the past. I probably have some of the smaller details wrong, but I`m confident the general themes and strategies described are correct.

As near as anyone can tell, the short positions initiated ahead of this failed strategy are still in place. Expect the ride in this stock to be considerably bumpier going forward according to my sources.

Have a great weekend.

[Guru-Schreck]

25.03. 16:42
Dendreon - wird Provenge doch noch ein Erfolg?

--------------------------------------------------------------------------------
(©BörseGo - http://www.boerse-go.de)
Piper Jaffray haben das Biotechnologie-Unternehmen Dendreon erstmals mit „Outperform“ und Kursziel $18 bewertet. Die Aktie notiert fast 3% im Plus bei $12.50. Der Verlauf des Aktienkurs hänge eng mit der Absatzlage des Medikamentes Provenge zusammen, hieß es. Dieses Medikament habe nach Beendigung einer Phase III Studie im August 2002 die primären Anforderungen nicht erfüllen können. Jedoch rechnen die Analysten damit, dass die neu gestartete und aktuell andauernde Phase III Erfolge zeigen wird. Die Wahrscheinlichkeit für einen Erfolg sei „hoch“, so die Analysten. Eine Zulassung des Medikamentes wird von den Analysten in der ersten Hälfte des Jahres 2006 erwartet. Die Bekanntgabe einer möglichen Vertriebs- oder Entwicklungspartnerschaft zur Jahresmitte könnte ein wichtiger Impuls für den Aktienkurs sein, so die Analysten ohne Nennung weiterer Details.

[meislo]

Dendreon Corporation to Present Data on Immunotherapy Programs at American Association for Cancer Research Annual Meeting
Friday March 26, 8:05 am ET


SEATTLE--(BUSINESS WIRE)--March 26, 2004--Dendreon Corporation (NasdaqNDN - News) today announced the scheduled presentation of two abstracts at the 95th Annual Meeting of the American Association for Cancer Research (AACR), March 27-31, 2004 in Orlando, Florida. Researchers will present data on Provenge®, currently in Phase 3 clinical trials for prostate cancer, and APC8024, currently in Phase 1 clinical trials for advanced, metastatic, Her-2/neu positive breast cancer.
Abstract Presentations:

Sunday, March 28, 2004; 2:45 p.m. - 3:45 p.m.; Room W315: Poster Discussion Session. (Abstract #1408). A placebo-controlled Phase 3 trial of immunotherapy (APC8015, Provenge®) for androgen independent prostate cancer (AIPC): Evidence that Gleason Score predicts immunologic as well as clinical responses to therapy.
Sunday, March 28, 2004; 1 p.m. - 5 p.m.; Hall B4-D: Poster Session. (Abstract #1229). (APC8024) Phase 1 study using autologous antigen presenting cells loaded with BA7072 to treat subjects with metastatic breast cancer that over expresses HER-2/neu.
Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com

[meislo]

Dendreon`s APC8024 Immunotherapy Shows Long-Term Disease Stabilization and Significant Immune Response in Advanced, Metastatic Breast Cancer Patients
Monday March 29, 8:01 am ET
Data presented at AACR annual meeting


ORLANDO, Fla.--(BUSINESS WIRE)--March 29, 2004-- Dendreon Corporation (NasdaqNDN - News) today announced that updated results from a Phase 1 clinical trial of APC8024, the company`s investigational immunotherapy for HER-2/neu-positive cancers, indicate that APC8024 continues to demonstrate clinical benefit and statistically significant T-cell immune responses in patients with advanced, metastatic, HER-2/neu positive breast cancer. The findings were presented Sunday, March 28 at the 95th Annual Meeting of the American Association for Cancer Research in Orlando, Florida.
ADVERTISEMENT


Results from 18 patients with advanced, metastatic, HER-2/neu-positive breast cancer (2+ or 3+ by immunohistochemistry or positive by FISH) were presented. All but one of the patients had failed Herceptin therapy and most patients had also failed chemotherapy treatment, including 32 percent of whom had received more than three chemotherapy regimens. Clinical benefit was demonstrated in 22 percent of patients treated with APC8024, including three patients with prolonged stabilization of disease. Further, long-term follow up on these patients indicates that they experienced stabilization of their disease for 15, 20 and 22 months following treatment with APC8024, respectively, without requiring additional chemotherapy. Treatment with APC8024 was well tolerated, with no significant side effects reported and no evidence of cardiotoxicity. Treatment with APC8024 also induced a robust cellular immune response specific to HER-2/neu antigens, and this immune response was statistically significant.

"It is encouraging that we are seeing both strong immunologic effects and prolonged stabilization of disease in selected patients, which now includes very extended durations post-treatment. Such results are notable among patients with advanced, metastatic disease who have failed other treatment modalities," said John W. Park, M.D., assistant professor of medicine and director of Novel Therapeutics in Breast Oncology at the University of California San Francisco Comprehensive Cancer Center, and principal investigator of the study. "Based on these results, we certainly believe that further studies are warranted."

"The clinical benefit and significant immune response demonstrated from APC8024 treatment among these patients with advanced, progressive breast cancer underscores the expandability of our therapeutic vaccine platform," said Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer, Dendreon Corporation. "Like Provenge®, APC8024 may provide patients with a new treatment alternative that is highly targeted and has a favorable safety profile. We look forward to advancing this program into Phase 2 trials."

The APC8024 vaccine targets tumors that express the HER-2/neu marker. In humans, HER-2/neu is overexpressed in a variety of solid tumors. APC8024 uses Dendreon`s proprietary Antigen Delivery Cassette(TM) technology to genetically engineer antigens such as HER-2/neu to bind to antigen presenting cells and stimulate T-cell immunity. Treatment consists of three vaccinations with APC8024 over the course of a one-month period. The APC8024 approach is similar to the approach used in the development of Provenge, Dendreon`s therapeutic prostate cancer vaccine, which has produced promising results in a Phase 3 clinical trial.

About Breast Cancer

Breast cancer is the most common cancer among women in the United States, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer, with approximately 216,000 new cases and 40,000 deaths estimated in the United States in 2004.

About Dendreon

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody, small molecule and prodrug product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.

[Oncolyt111]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[jethor tull]

17.05.2004
Dendreon "strong buy"
Global Biotech Investing

Die Experten des Börsenbriefs "Global Biotech Investing" bewerten die Dendreon-Aktie (ISIN US24823Q1076/ WKN 615606) mit "strong buy".

Vor wenigen Tagen habe die Gesellschaft ihre Quartalsergebnisse bekannt gegeben und dabei für die ersten drei Monate eine Umsatzsteigerung im Vergleich zum Vorjahreszeitraum von 1,8 auf 4,7 Mio. US-Dollar wegen einer Vorabzahlung des Lizenzpartners Nuvelo gemeldet. Der Nettoverlust habe sich aufgrund der deutlich gestiegenen Forschungskosten allerdings von 7,7 auf 13 Mio. US-Dollar erhöht.

Man halte die darauf gefolgten Kursverluste für eine perfekte Einstiegschance, denn als Early-Stage-Gesellschaft dürfte Dendreon wohl eher nach den laufenden Forschungsreihen als nach dem operativen Ergebnis zu bewerten sein.

Die Empfehlung der Experten von "Global Biotech Investing" für die Dendreon-Aktie lautet "strong buy".


Gruß
jethor

[jethor tull]

Vielleicht auch ein Grund für den Kursverfall?

. 09:17
Aventis: Taxotere-Zulassung erweitert

--------------------------------------------------------------------------------
(©BörseGo - http://www.boerse-go.de)
Der deutsch-französische Pharmakonzern Aventis hat von der amerikanischen FDA heute für sein Krebsmittel Taxotere erneut eine Freigabe erhalten. Wie der Konzern mitteilte, wurde die Zulassung auf die Behandlung bestimmter Arten von Prostatakrebs ausgeweitet.

Das Unternehmen geht davon aus, mit Taxotere weitere Krebsformen wie Magen- und Brustkrebs behandeln zu können. Hierfür seien bei der FDA ebenfalls entsprechende Anträge eingereicht worden. Im abgelaufenen Quartal wurde mit dem Präparat ein Umsatz von 334 Millionen Euro erzielt.


jethor

[jethor tull]

Schon wieder ich!

Denderon erste Wahl
Global Biotech Investing

Die Experten vom Börsenbrief "Global Biotech Investing" halten die Dendreon-Aktie (ISIN US24823Q1076/ WKN 615606) für die erste Wahl im Bereich der Krebsforschung.

Das Unternehmen habe für das experimentelle Präparat APC8024 positive Forschungsresultate vorlegen können. Bei der Behandlung von Brust-, Dickdarm- und Eierstockkrebs habe das Medikament den Krankheitsverlauf stabilisieren und ein Fortschreiten der Erkrankung über mehrere Monate hinweg eindämmen können. Des Weiteren habe man auch eine gute Verträglichkeit feststellen können. Nun sollten schnellstmöglich die Phase II-Studien ins Rollen kommen.

Nach Meinung der Wertpapierexperten werde Denderon damit auch für die Pharma-Branche immer interessanter, die derzeit aktiv auf der Suche nach neuen Blockbusterkandidaten seien. In den nächsten Monaten wolle Denderon einen Vertriebspartner verkünden.

Für die Experten vom "Global Biotech Investing" ist die Aktie von Denderon im Bereich der Krebsforschung die erste Wahl.



Weitere Analysen zu DENDREON CORP. alle
17.05.2004 Dendreon "strong buy" Global Biotech Investing
05.04.2004 Dendreon "buy" Brean Murray & Co
08.03.2004 Dendreon haltenswert Hot Stocks Investor

NEU: Analysen zu Dendreon in englischer Sprache [newratings_].


jethor

[LMeister7]

Guten Abend,
hoffentlich haben sich die Jungs mit ihrem Target nicht zu weit vorgewagt. Die Shorties habe DNDN immer noch auf der Agenda: http://www.newratings.com/analyst_news/article_434500.html Ist ziemlich frisch das Rating. Wär schön wenns der Markt auch so sieht, aber meistens macht er das Gegnteil von dem was erwartet wird.
Nacht allerseits,
LM7

[LMeister7]

Tach och,
Dendreon ist gestern AH um c.a. 5 % gestiegen. Vermutlich weil für heute ein CC zu D9901 angesetzt wurde. SR ist per 15.10. über 10. Schaun mer mal.
MfG,
LM7

[LMeister7]

Mahlzeit,
hier der passende Link: http://biz.yahoo.com/prnews/041028/sfth045_1.html
LM7

[quepos]

Moin,

wird wohl was werden mit "Provenge", es wird aber leider immer noch ein Weilchen dauern. Wollte die Shares schon fast vor ein paar Tagen aus dem Depot fegen, heute nun +35% im Moment !

Könnte natürlich auch ein günstiger Ausstiegszeitpunkt werden. Andererseits ist "Provenge" DNDN´s wixchtigster Kandidat, wenn das wirklich erfolgreich ist, kann ich mir gut eine Übernahme zu deutlich höheren Kursen vorstellen...
Nun gut, so weit sind wir noch nicht.

Grüße

q.

[LMeister7]

könnte natürlich auch sein, dass die Big-Pharmas jetzt doch auf den Provenge-Zug aufhoppen, wie z.B. JnJ bei MLNM oder Pfizer bei Medarex. Gibt viele Beispiele. Wenn man gute Nerven hat, konnte man Intraday aber auch ganz gut eintüten. Frage mich woher die Shorties die Nerven haben bei knapp 12 USD gleich wieder drauf zu dreschen. Respekt, obwohl ich die Aasgeyer nicht mag. Sie gehören nu mal dazu.
LM7

[therman]

News:

Dendreon Achieves Commercial Scale of Antigen for Provenge
11/3/2004 8:30:00 AM

SEATTLE, Nov 3, 2004 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (DNDN) today announced that it has succeeded in reproducing the antigen used in the preparation of Provenge(R), the Company`s investigational immunotherapy for the treatment of prostate cancer, at commercial manufacturing scale. The Company achieved this important milestone with its contract manufacturer, Diosynth Biotechnology, a unit of Akzo Nobel. Diosynth, a leader in process development and cGMP production of recombinant proteins/peptides for therapeutic and vaccine applications, has also made an investment in the Company by purchasing $3.5 million of Dendreon common stock in connection with the parties` antigen development agreement. This agreement has been expanded to complete the scope of work required for the chemistry, manufacturing and controls (CMC) section of a Biologics License Application for Provenge.

"This is a key step for Dendreon to ensure we have adequate capacity for the commercialization of Provenge," said Andrew Scherer, Dendreon`s vice president of manufacturing. "We are pleased to be working with a world-class contract manufacturer like Diosynth. Their investment aligns our two companies toward one common goal."

"We are proud to be associated with Dendreon, a leading company in cancer immunotherapy," said Jo Lennartz, Ph.D., president of Diosynth Biotechnology. "We believe that Provenge has the potential to significantly improve the prospects of the millions of men who suffer from prostate cancer across the globe."

Provenge is designed to stimulate a patient`s immune system against prostate cancer. It is developed through Dendreon`s proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in approximately 95 percent of prostate cancers, prostatic acid phosphatase (PAP).

[therman]

Hi,


Sehr gute Ergebnisse für Provenge gegen Prostatakrebs.

Allein in den USA leiden ca. 1.000.000 Männer an Prostatakrebs bei
ca. 200.000 Neuerkrankungen jährlich.

Provenge hat zweifellos das Zeug zum Blockbuster.
Bei einer Zulassung wird sich der Kurs von Dendreon
höchstwahrscheinlich vervielfachen oder auch schon vorher
in der Erwartung der Zulassung.

Das Heißt: Bei Kursschwäche einsteigen oder nachkaufen.

Dendreon`s Phase 3 D9901 Trial Shows Provenge Extends Survival in Patients With Advanced Prostate Cancer
Final Three-Year Survival Analysis Shows Statistical Significance in Favor of Provenge in Overall Intent-to-Treat Population
The pre-specified 36-month final survival analysis of the double-blind, placebo-controlled study of Provenge in 127 patients with asymptomatic, metastatic, androgen-independent prostate cancer showed a statistically significant survival benefit in the overall intent-to-treat patient population, defined as all patients randomized in the study regardless of their Gleason score. This survival benefit is greater than that observed with any type of treatment in any published Phase 3 study in late-stage prostate cancer. In addition, at the 36-month final follow up, the percentage of patients alive in the Provenge-treated group is substantially greater than the percentage of patients who received placebo.

The final survival data also showed a statistically significant survival benefit in the group of patients with Gleason scores of seven and less. The study`s principal investigators plan to submit the complete survival data from this trial for presentation at an upcoming scientific meeting and for publication in a peer reviewed medical journal.

In the D9901 study, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

Provenge is being further evaluated in an ongoing, pivotal Phase 3 trial (D9902B) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Provenge also has Fast Track designation. The double-blind, placebo-controlled trial is enrolling patients at leading cancer centers around the country. To learn more about the trial, go to

http://www.dendreon.com .

[puhvogel]

Ich finde die Meldung bemerkenswert, aber ob die Ergebnisse sehr gut oder nur mittelprächtig sind, kann ich wegen schlicht fehlender Daten nicht erkennen.
Mit Provenge werden auf jeden Fall nur diejenigen Patienten behandelt, bei denen herkömmliche Behandlung nicht anschlägt.

[quepos]

@puh...

Hallo,

das ist die normale Vorgehens- und Entscheidungsweise bei neuen Krebsmedikamenten. Schließlich will man ja a) nicht völlig neue Nebenwirkungen haben und b) nicht den Betroffenen ein möglicherweise viel wirksameres und schon vorhandenes Medikament vorenthalten.
Die Studien beginnen daher oft so wie in diesem Fall:
Wenn nichts anderes mehr hilft, versucht man´s halt mal.
Möglich wenn nicht wahrscheinlich (im Erfolgsfalle) ist aber eine Ausdehnung der Medikation.
Es könnte 1. Wahl werden bei der zu behandelnden Krebsart und (sehr oft) auch für andere Krebsarten zugelassen werden.

so long

q.

bushbushbush
...noch mehr Krieg und Verderben!...

[therman]

News:

Dendreon Names James Caggiano as Vice President, Sales and Marketing
11/9/2004 8:01:00 AM

SEATTLE, Nov 9, 2004 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (DNDN) has named James V. Caggiano to the position of vice president, sales and marketing. Caggiano will be responsible for Dendreon`s marketing, sales and other commercially-related activities, focusing initially on the Company`s investigational lead product, Provenge(R), a targeted immunotherapy that is currently in a pivotal Phase 3 clinical trial for the treatment of advanced prostate cancer.

Caggiano joins Dendreon from Abbott Laboratories where he served as vice president, U.S. Sales and Marketing of the Abbott Vascular Devices division and was responsible for all aspects of U.S. commercial operations. While at Abbott, he led a 170 person sales organization and coordinated all pre-launch and launch activities.

Previously, Caggiano spent 11 years at TAP Pharmaceutical Products Inc. in various sales and marketing positions where he most recently led marketing operations for Lupron(R), a prostate cancer treatment with annual U.S. sales approaching $1 billion.

"Jim has expertise in all stages of pharmaceutical sales and marketing," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The addition of Jim to our management team is an important component of our efforts to commercialize Provenge and build our oncology franchise."

"I am very enthusiastic to be part of the Dendreon team as we prepare for the commercialization of Provenge," said Caggiano. "This is a promising product candidate that has the potential to fill a large unmet need among prostate cancer patients who currently have few appealing treatment options."

[quepos]

Tja,
hallo erstmal,

wenn sich sonst keiner bereit erklärt dies zu posten,

hier sind die Zahlen, die einen kleinen Kurssturz verursachen. M.E. völlig überzogen, es sind wohl auch größtenteils Gewinnmitnahmen nach dem steilen Anstieg der letzten Tage.

Bei einem Unternehmen wie DNDN ist ein höher als erwartet ausgefallener Verlust vielleicht ärgerlich, aber irrelevant. War halt dies und das ein bißchen teurer.
So what?

Geht vielleicht noch runter auf 11, wenn´s ganz schlimm kommt auf 10 ($), danach hoffentlich weiter rauf.
Aufstocken will ich aber nicht, da mir die Firma zu klein ist, was sich natürlich auch rasch ändern könnte.



schönen Abend noch

Gruß q.



BOSTON (CBS.MW) -- Dendreon reported wider third-quarter losses on Tuesday, largely attributable to the company`s termination of a collaboration agreement with Japanese drugmaker Kirin Brewery.

For the quarter ended Sept. 30, Dendreon (DNDN: news, chart, profile) reported a net loss of $22.1 million, or 38 cents per share, compared with a net loss of $13.7 million or 35 cents a share for the same quarter a year ago.

The development-stage biotechnology firm said revenue for the quarter was $69,000, compared with $1.8 million last year.

Dendreon`s lead drug Provenge, a treatment for prostate cancer, is finishing up Phase III clinical trials.

A poll of analysts by Thomson First Call estimated the company would lose 33 cents for the quarter.

[wohinistmeinGeld]

In ihrer Analyse vom Freitag, 19. November 2004 stufen die Analysten von Brean Murray die Aktie des Unternehmens Dendreon (Nachrichten) von "Buy" auf "Sell" zurück. Das Kursziel für die Aktie liegt momentan bei 6 $.


Ohne Begründung

[metallix]

6 USD ist nicht wahr ?????
Die Bewertung ist ein bischen tief gegriffen....oder???

[quepos]

Moin,

leider fast 10% Minus
und eine Kehtwende von "buy" auf "sell", das Kursziel wurde gedrittelt.
Um es stark verkürzt zu sagen:
Es gibt Zweifel am Erfolg von "Provenge", kurzer Text siehe unten. Ich muß leider sagen, daß ich auch schon öfters erlebt habe, daß solche Analysten Recht behalten, selbst wenn man das natürlich nicht so gerne möchte. Ich erwäge daher, meine Stücke zu verkaufen (mit sattem Minus), zum Glück ist DNDN bei mir nur mit ca. 2% im Depot. Alternative wäre eine längere Wartezeit, bis Klarheit über den weiteren Verlauf bei Provenge herrscht. Sicher ist aber, daß bei einem Flop von Provenge mit Sicherheit erstmal nicht mehr als 6$ drin sind; die Aktie ist m.E. ohnehin recht gut bezahlt. Habe sie damals auch nur wegen des starken Aufwärtsmomentums gekauft (fast zum Höchstkurs) und den Ausstieg irgendwie verpaßt. Naja, sowas rächt sich dann halt mal.
Möglich wäre aber, daß die Firma so eine Art "Gegendarstellung" bringt, was dem Kurs natürlich kurzfristig helfen würde, man muß dann aber sehr genau hingucken!

Grüße

q.

und hier der Text:


Markets : Stocks In Motion
Health Stocks in Motion
By Mark Martinez
TheStreet.com Staff Reporter
11/19/2004 4:49 PM EST

Updated from 2:53 p.m.

Shares of Dendreon (DNDN:Nasdaq - commentary - research) were among the worst-performing health and pharmaceutical stocks Friday, falling 9.4% after an analyst slapped a sell rating on the stock.


In lowering his rating to sell from buy, Brean Murray analyst Jonathan Aschoff said "it is not worth waiting for another positive catalyst to provide a better price at which to issue a rating downgrade that we concede is already long overdue." The firm said that it no longer believes Dendreon can manage a partnership deal for the commercialization of Provenge. It also questioned how the Food and Drug Administration would view the company`s three-year survival data from trial 9901. Specifically, Aschoff said that if the data "are driven almost entirely by the healthier subgroup, then that would marginalize the relevance of Provenge to the sicker patients and undercut Dendreon`s conclusion that the three-year survival data is truly relevant to the entire intent-to-treat population." As a result of the firm`s concerns, Brean Murray put a $6 price target on Dendreon`s shares. Previously, the firm had a $21 price target. Shares of Dendreon traded down $1.05 to $10.18.

[wohinistmeinGeld]

Vor 3 Wochen hieß es noch die Phase 3 Ergebnisse seien beeindruckend, vielleicht meinten die beeindruckend schlecht, aber der Anstieg danach ließ doch eher positives vermuten.
Auf RB sind die meisten auch noch positiv gestimmt


Trotzdem noch das hier

Bei Dendreon läuft gar nichts

Brean Murray haben heute die Titel des Biotech-Unternehmens Dendreon (Nachrichten) von "buy" auf "sell" abgestuft. Das Kursziel wurde deutlich von 21 auf 6 Dollar herabgesetzt.

Wie der zuständige Analyst ausführte, sei es die Aktie wohl nicht mehr wert, auf kommende positive Impulse zu hoffen. Das Unternehmen glaube selbst nicht mehr, für sein Krebspräparat Provenge einen großen Partner zu finden, der weitere Testreihen und den Marktauftritt übernimmt. Auch die inzwischen seit drei Jahren laufende Studie zum Wirkstoff 9901 habe nicht die erhofften Resultate erbracht. Bei der viel größeren Zielgruppe mit den gesünderen Probanden habe man kaum Fortschritte gesehen; demgegenüber sei die lebensverlängernde Wirkung bei den schwerkranken Patienten wenig signifikant.

Dendreon sackten im Anschluss an diese harten Worte an der Nasdaq bislang um 9,44 Prozent auf 10,17 Dollar ab.

[Almeida]

Wer sich für Dendreon interessiert und Englisch versteht, dem kann man nur raten, die gehaltvollen Diskussionen am Yahoo Message Board zu Dendreon zu verfolgen.

Der Downgrade-Report von Freitag des "Analysten" Jonathan Aschoff von Brean Murray - ein Mann, der eine einschlägige kriminelle Vergangenheit hat - wurde dort eingehend diskutiert. Hier hat ein Market Maker von Dendreon sein eigenes Süppchen gekocht und / oder Kunden aus Positionen herausgeholfen, die gegen sie liefen.

Seriöse Analysten wie Mark Monane von Needham haben am gleichen Tag ihr "Strong Buy"-Rating bestätigt (Kursziel 22$, Zeithorizont 1 Jahr). Die Originalanalysen bekommt man übrigens, wenn man sich der Provenge-Group bei Yahoo anschließt.

Der deutsche Text von Börse Go ist dann nochmal eine Verballhornung des englischen Textes, wie bei der Geschichte, wo der General auf dem Kasernenhof eine Übung anordnet und nach Weitergabe des Befehls über einige Stationen angeblich in der Turnhalle ein Manöver stattfinden soll.

Gruß, Almeida

PS. Dendreon hat ein Verfahren entwickelt, mit dem das Immunsystem in die Lage versetzt wird, auf äußerst effiziente Weise Krebs zu bekämpfen. Dieses Verfahren hat seine hohe Wirksamkeit bereits in einer Phase III-Studie unter Beweis gestellt.

[puhvogel]

Wie ich schon in #57 angedeutet habe, sind einfach nicht genügend Daten vorhanden, um in irgendeiner Art und Weise den Erfolg oder Mißerfolg von Provenge abschätzen zu können.
"Dendreon did not disclose the clinical trial data, saying it would be presented at an upcoming scientific meeting and in a peer-reviewed medical journal."
Da ist eigentlich jede Abschätzung eines Analysten und wer sich sonst noch dafür hält im Grunde genommen unseriös.

Eins dürft ihr aber nicht vergessen: Die Vakzin-Technologie ist ziemlich teuer, und wird sicher nicht als Standardtherapie für den normalen Prostata-Krebs-Patienten verwendet werden, dafür sind gängige und bezahlbare Alternativen wie Hormontherapie zu erfolgreich. Die 5-Jahres-Überlebensrate bei Ca-Patienten, deren Krebs früh genug entdeckt wird,d.h. wenn der Krebs noch lokal geblieben ist, liegt bei 99 %!
Also geht zur Vorsorge, auch wenn nicht jeder gerne einen Finger im A.... haben möchte.

Mit 660 Millionen $ Marktkapitalisierung ist der Wert auch nicht gerade teuer.

[Almeida]

Tut mir leid, puhvogel, aber Du schreibst irreführenden Unsinn.

Man sollte unbedingt den Kommentar von Frau Hörrlein von heute zu Dendreon und dem Downgrade von Brean Murray lesen.

Gruß, Almeida

[wohinistmeinGeld]

wer ist Frau Hörrlein

[Almeida]

http://www.wallstreet-online.de/si/news/news/stocknews.inc?m…

[BrauchGeld]

das ist die von biotech expert findest die bei börse-go.de

[puhvogel]

So, so, es ist also irreführender Unsinn, was ich so schreibe.

Na wenn du das so mit knallharten Fakten wie in #67 widerlegst, dann muß ich mich ja geschlagen geben.

Und in #66 meinte ich natürlich zum Schluß, dass ein Wert mit 660 Millionen $ Marktkpaitalsierung nicht gerade billig ist.

[Almeida]

Hier ein seriöser Report eines im Gegensatz zu Aschoff respektierten Analysten, auch von Freitag.

Needham

November 19, 2004

Equity Research Morning Summary

HEADLINES:

DNDN Dendreon Corp. 3Q04 Review, Reiterating Strong Buy, 12-Month Target Price of $22

Mark Monane

Recommendation: Reiterate Strong Buy

Target Price: $22
Market Cap. (MM): $464.4
Price to LTM Sales: $26.7
Cash Per Share: $3.26

Investment Conclusion: At yesterday’s Analyst Day, Dendreon management team presented clinical, regulatory, manufacturing,and commercial progress on Provenge. The depth and breadth of the senior management showcased at the meeting continue to highlight that Dendreon is well on its way to bring Provenge to the market. Of note, the management reiterated that Dendreon is on track for a 2006 Provenge approval and launch, and remains committed to build the commercial infrastructure. The recently announced 3-year survival data continue to suggest the market potential of Provenge.

We reiterate our STRONG BUY rating, given the expected presentation/publication, completion of enrollment of D9902B, and potential partnering in the near term. To arrive at our target price of $22, we applied a 30x multiple to our 2008 EPS estimate as well as a 25% discount per year.

Summary:

• Dendreon recently announced top-line, 3-year survival data in the ITT group that reach statistical significance regardless of patient Gleason scores. While details of the data will not be available until at an upcoming medical conference (likely ASCO ’05), we continue believe that the therapeutic benefit of Provenge (based on the interim survival data, as well as previously positive signals regarding TTP and immune response) along with its excellent safety profile bodes well for the large potential of this product.

• Based on the D9901 survival data, Dendreon is currently in discussion with the FDA with regards to bringing Provenge to a broad prostate cancer patient population in a timely fashion. Of note, the D9902A study, which also included patients with all Gleason scores, will remain blinded until the regulatory weight of this trial has been discussed with the FDA.

While we believe that the D9902B data will be required for approval, and our model assumes a launch in 2006 in the Gleason score 7 or less population, an accelerated timeline or a broader label will represent upside to our model. Of note, several small trials testing Provenge in early stage prostate cancers including P11, P16 and D9905 are in progress as well.

• The depth and breadth of the senior management showcased at the meeting continue to highlight that Dendreon is well on its way to bring Provenge to the market. We believe the new hires in the manufacturing and commercialization areas are key to the Provenge commercialization. Dendreon is currently constructing two manufacturing facility in New Jersey and Texas, and will launch an aggressive medical education campaign on Provenge in 2005. Given Dendreon’s investment in those areas, we believe that the company will commercialize Provenge in the US and seek an ex-US partner.

• Newsworthy events expected within the next 3-6 months include plans:
o Seek ex-US corporate partnership for Provenge (ongoing);
o Present data of APC8024 in breast cancer at the San Antonio Breast Cancer Symposium (Dec. 8-11, 2004);
o Complete enrollment of D9902B Phase 3 trial for Provenge in androgen independent prostate cancer (1Q05);
o Complete enrollment of P11 Phase 3 trial for Provenge in androgen dependent prostate cancer (1Q05); and
o Initiate Phase 2 trial for APC8024 in HER2/ner positive breast cancer (1Q05).

• Investment risks include clinical and regulatory risk for the pipeline products that Dendreon is currently developing. In addition, the company also may not have sufficient fund to develop and commercialize all of its product candidates.

[Almeida]

Aktiencheck bringt eine Meldung zu einem Report von Piper Jaffrey vom vergangenen Freitag: "Outperform"

Aber abschreiben können die Jungs auch nicht: anstatt 2006 muß es 2005 heißen.

http://www.aktiencheck.de/Analysen/default_an.asp?sub=4&page…

[Almeida]

Im zweiten Absatz muß es 2005 heißen. Im dritten Absatz ist 2006 richtig.

[Almeida]

Diese Auflistung der zu erwartenden Ereignisse bei Dendreon könnte noch hilfreich sein (vom Yahoo Board):

12/8-12/11>>> San Antonio Breast Cancer Confab (Neuvenge Ph-I f/u analysis)

late `04-2005>>> Possible Provenge co-marketing collaboration annoucement

early `05>>> Initiate Ph-II trial APC8024 (Neuvenge), possibly in breast cancer

1H05>>> Present final survival data & analysis of D9901 (completed Ph-III study) - wahrscheinlich im Februar -

`05>>> New drug candidate moved into clinical trials (Trp-P8 small molecule)

`05>>> Present P16 (Provenge w/ Avastin) trial results

mid`05-mid`06>>> Possible Provenge BLA submission

`06>>> Possible D9902b trial results

late`05-late`06>>> Possible Provenge FDA approval

`06>>> Possible P-11 trial results (androgen sensitive prostate cancer)

[Almeida]

Das mit dem Manöver in der Turnhalle (# 65) wollten die Jungs von Börse Go doch nicht auf sich sitzen lassen und haben ihre Meldung noch mal neu geschrieben.

Jetzt findet es nur noch auf dem Kasernenhof statt: "9901" heißt nicht der Wirkstoff, sondern die Studie...

Der Gauner aber heißt Jonathan Aschoff.


19.11. 21:18
Analyst: Bei Dendreon läuft gar nichts (korr.)

--------------------------------------------------------------------------------
(©BörseGo - http://www.boerse-go.de)
Brean Murray haben heute die Titel des Biotech-Unternehmens Dendreon von "buy" auf "sell" abgestuft. Das Kursziel wurde deutlich von 21 auf 6 Dollar herabgesetzt.

Wie der zuständige Analyst Jonathan Aschoff ausführte, sei es bei der Aktie wohl nicht mehr angebracht, auf kommende positive Impulse zu hoffen und erst dann eine Abstufung durchzuführen, die nach Meinung von Aschoff bereits seit langem überfällig sei. Aschoff glaube nicht mehr, das Dendreon für das Krebspräparat Provenge einen großen Partner finden werde, der weitere Testreihen und den Marktauftritt übernimmt. Aschoff stellte auch in Frage, wie die US-Gesundheitsbehörde FDA auf die Daten zur Überlebensrate der Probanten in einer dreijährigen Studie des Wirkstoffes 9901 reagieren würde. Der Analyst kritisierte insbesondere die Möglichkeit, dass Dendreon die präsentierten Schlussfolgerungen aus der Studie mit den Ergebnissen einer Zielgruppe mit gesünderen Probanden beschönigt haben könnte und die Ergebnisse einer kränkeren Untergruppe im Gesamtergebnis weniger stark gewichtet habe. Damit werde die Aussage Drendreons untergraben, die Studienergebnisse seien relevant für die gesamte Patientenzielgruppe in der Bevölkerung.

Dendreon sackten im Anschluss an diese harten Worte an der Nasdaq bislang um 9,44 Prozent auf 10,17 Dollar ab.

[quepos]

Hallo,

bin noch dabei, der Kurs sitzt in Warteposition. Eine Kurslücke nach oben wie auch nach unten wartet auf Schließung.
Noch hoffe ich ja, daß die 25 Mio. Volumen mit 25% Kursanstieg Recht behalten und nicht der eine "Analyst" (d.h. Kurs schließt nach oben auf).

think positive

q.

[LMeister7]

Hallo,
habe heute folgende IR-Mail von Dendreon erhalten. Ist denke ich aber nicht unbedingt kursrelevant, weil es sich um Phase-1-Daten handelt:
_________________________________________________
Dendreon`s APC8024 Immunotherapy Shows Promise in Advanced Breast Cancer

-- Statistically Significant T-cell Immune Response Observed in Patients Treated --

SAN ANTONIO, TX, December 11, 2004 - Dendreon Corporation (Nasdaq: DNDN) today announced results from two Phase 1 studies demonstrating promising clinical activity of the company`s investigational immunotherapy, APC8024, in HER2/neu positive advanced breast cancer. Michelle Melisko M.D., Clinical Instructor, Carol Franc Buck Breast Care Center, University of California Comprehensive Cancer Center, San Francisco, presented the findings today at the 27th Annual San Antonio Breast Cancer Symposium.

The results focused on a combined analysis of 30 evaluable patients with advanced breast cancer from two previously released Phase 1 studies. A statistically significant (p-value < 0.0001) T-cell immune response was observed in patients with HER2/neu positive breast cancer treated with APC8024. Preliminary analysis indicates that APC8024 was well tolerated in all patients who participated in the study, with no reported treatment-related Grade 3 or 4 adverse events. The most commonly reported Grade 1 and 2 adverse events were infusion-related mild and transient fever, fatigue and rigors.

"The T-cell responses seen in these patients and the prolonged disease stabilization in the absence of other anti-cancer therapies in many patients are encouraging," said Dr. Melisko. "Further evaluation of APC8024 is clearly warranted."

In poster number 6079, entitled "Immunotherapy Targeting HER2/neu: Results from Phase 1 Studies of APC8024 in Women with Advanced Breast Cancer," Dr. Melisko and colleagues described results from a Phase 1 study (D2000-1) that enrolled 18 patients, 11 of whom had advanced HER2/neu positive breast cancer, and a second study (D2000-2) that enrolled 19 patients with advanced HER2/neu positive breast cancer. At least 90 percent of patients had failed prior chemotherapy and trastuzumab for metastatic disease. APC8024 induced a robust cellular immune response specific to the HER2/neu antigen, and there was a statistically significant difference between patients` baseline and Week 8 T-cell response to the target antigen. The median time to disease progression was 10 weeks (range 2-75 weeks), and 3 patients remain free of evidence of disease progression at 36 weeks (ongoing), 77 weeks and 94 weeks (both at time of study completion).

"APC8024 represents the expansion of our immunotherapy platform into other solid tumors," said Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer at Dendreon Corporation. "We believe APC8024 could provide physicians with a highly targeted and well-tolerated therapy for treating patients with breast cancer. Based on the encouraging data from these two Phase 1 studies, we are planning to initiate a Phase 2 trial with APC8024 in metastatic breast cancer in the coming year."

About APC8024

APC8024 is an immunotherapy that targets tumors that express the HER2/neu marker. In humans, HER2/neu is over-expressed in a variety of solid tumors, including breast, colorectal and ovarian cancer. APC8024 uses Dendreon`s proprietary Antigen Delivery Cassette(TM) technology to genetically engineer the HER2/neu antigen to bind to antigen-presenting cells and stimulate T-cell immunity. In these Phase 1 trials, treatment consisted of three infusions of APC8024 over the course of one month. The APC8024 approach is similar to the approach used in the development of APC8015 (Provenge(R)), another targeted immunotherapy that has produced promising results to date in clinical trials for the treatment of advanced prostate cancer. APC8015 is currently in a pivotal Phase 3 clinical trial in men with androgen-independent prostate cancer.

About Dendreon

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about Dendreon and its programs, visit www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include the risk that the safety and/or efficacy results of an early-stage clinical trial will not be confirmed in later clinical trials, the risk that a clinical trial may be suspended due to unacceptable health risks or for other reasons, the risk that a product candidate in clinical trials may not generate safety and/or efficacy results that support further clinical trials or an application for a biologics license, the risk that the FDA will not approve a product for which a biologics license
application has been submitted, the risk that competitors may develop products that are safer and/or more efficacious than a product candidate being studied in clinical trials, risks associated with dependence on the efforts of third parties and dependence on intellectual property, risks related to Dendreon`s limited operating history and risks related to the uncertainty of Dendreon`s future access to capital. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations are contained in Dendreon`s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

Monique M. Greer
Sr. Director, Corporate Communications
Dendreon Corporation
[phone]
-------------------------------------------------------------------------
Schönes Wochenende noch,
LM7

[wohinistmeinGeld]

Die letzten Zahlen unter Erwartungen, der angekündigte Partner kommt nicht und jetzt noch eine totale Nullnummer.
Haben die überhaupt noch genug Geld um lange weiter zu machen? Die anderen Dinge in der Pipline dauern ja wohl noch Jahre.



Dendreon: Aktie bricht nach schwacher Studie zu Krebspräparat ein

Das Biotech-Unternehmen Dendreon Corp. meldete am Dienstag, dass eine fortgeschrittene Studie zu seinem experimentellen Krebsmedikament keine Fortschritte bei der Verzögerung der Symptome der Krankheit gezeigt hat. Die Aktien verloren daraufhin deutlich an Wert.

Demnach hat die Phase III-Studie des Präparats Provenge nicht die erhofften Ergebnisse gebracht. Das Medikament war demnach nicht in der Lage, das Fortschreiten der Symptome der Krebserkrankung zu verlangsamen, was das primäre Ziel darstellte.

Das Arzneimittel Provenge soll wirken, indem es das Immunsystem des menschlichen Körpers stimuliert, um so Prostatakrebszellen zu bekämpfen. Die jüngste Studie zeigte jedoch gegenüber einer früheren Studie, deren endgültige Ergebnisse im Februar präsentiert werden, keine wesentlichen Fortschritte.

Die Aktie von Dendreon bricht an der NASDAQ derzeit um 23,87 Prozent auf 7,91 Dollar ein.

[Rainolaus]

13.01.2005 - 13:22
Aus für Provenge?

Provenge ist noch lange nicht aus dem Rennen!

Dreißig Prozent Kursverlust mussten die Aktionäre von Dendreon (Nasdaq: DNDN; WKN: 615606)in den vergangenen zwei Tagen verdauen. Studienergebnisse des therapeutischen Impfstoffes Provenge® hatten am Dienstag bereits in der Vorbörse zu einem Kursverlust von 20 Prozent geführt, welcher sich im Handelsverlauf dann bis auf 27 Prozent steigerte. Dem Kursverlust, der, wie wir glauben, deutlich übertrieben war, folgten die üblichen Abstufungen der bekannten Analystenhäuser. Wie immer folgte der Kurs auch in diesem Falle den Empfehlungen der Analysten, und fiel den Tag darauf erneut um acht Prozent. Damit schloss Dendreon das „gap“, welches die Aktie Ende Oktober/Anfang November 2004 aufgerissen hat.

Eines ist sicher, auf dem ersten Blick klingt die Aussage von Dendreon, Provenge® hätte in einer Phase III Studie den primären Endpunkt verfehlt, wirklich wie ein Desaster. Kein Wunder also, dass die Aktie des Unternehmens unter massiven Verkaufsdruck kam. Wer Dendreon auf der jährlichen JP Morgan Healthcare Konferenz aber etwas genauer zugehört hat und den entsprechenden Background besitzt, der wird Provenge® nicht gleich ad acta legen. Zum einen war der Patientenpool, nämlich Patienten mit einem Gleason Score von sieben und niedriger, zu klein und damit nicht repräsentativ. Zum anderen war der primäre Endpunkt während der Studie geändert worden.

Eigentlich hätte die Studie nur eine erneute Bestätigung einer größeren Phase III Studie werden sollen in der das immunstimulierende Provenge® eine überlebensverlängernde Wirkung gezeigt hatte. Bei der Auswertung der Daten fiel den Wissenschaftler aber auf, dass bei einer Subgruppe von weniger kranken Patienten zusätzlich eine Verlangsamung des Forschreiten der Erkrankung zu sehen war. Aus diesem Grunde wurden das Studienprotokoll, einschließlich des primären Endpunkts, kurzer Hand geändert. Anstelle einer Überlebensverlängerung war nun eine Verlangsamung des Forschreitens der Erkrankung das Hauptziel der Studie. Den sekundären Endpunkt, nämlich die lebensverlängernde Wirkung, konnte Provenge® erneut bestätigen.

Sollte die Auswertung sämtlicher Daten eine statistisch signifikante Verlängerung des Lebens von Prostatakrebs-Patienten erbringen, dann sollte Dendreon mit einer Zulassung kaum Probleme haben. Als Goldstandard für die Wirksamkeit eines Krebswirkstoffes gilt nämlich noch immer die Fähigkeit das Überleben eines Menschen zu verlängern. Eine Verzögerung des Fortschreitens der Erkrankung, was Provenge® der aktuellen Datenlage zufolge nicht kann, wird zwar von den Behörden anerkannt, ist aber weit weniger relevant als die Lebensverlängerung.

Provenge® ist also keinesfalls aus dem Rennen und wer den nötigen Mut aufbringt, der legt sich gerade jetzt ein paar Papiere ins Depot. Denn sollte Dendreon die Zulassung der FDA erhalten, dann gibt es mit Sicherheit eine ähnliche Kursveränderung, dann allerdings in die entgegengesetzte Richtung.

Simone A. Hörrlein, M.Sc.
Life Scientist (Univ.)
Medical & Scientific Writer

[wohinistmeinGeld]

Was ist denn das für ein Blödsinn?
Dazu muß aber mal erklärt werden warum eine Verlangsamung des Forschreitens der Erkrankung keine lebensverlängernde Wirkung hat. Das gehört doch zusammen das eine geht nicht ohne das andere.
Wenn das fortschreiten einer Krankheit verlangsamt wird lebt man automatisch länger. Das ist doch glattes verarschen.

Mir scheint, diese Hörrlein steht auf der Gehaltsliste bei Dendreon. Das erinnert irgendwie an Neue Markt zeiten als einem der größte Quatsch so aufgeschwätzt wurde, daß man dran glaubte. (ComRoad)

Ans einsteigen kann man jetzt nach diesem Fall denken und auf eine Gegenreaktion hoffen, aber fundamental ist es wohl vorerst vorbei und wer um die Jahreshochs 2004 gekauft hat bleibt auf seinen Verlusten sitzen. Ich hatte zum Glück früh gekauft und bin mit wenig Verlust rausgegangen.

[quepos]

@81

Hallo,

ganz so unsinnig ist das nicht, weil es umgekehrt im Artikel steht. Zwar würde eine Verlangsamung des Fortschreitens (vermutlich, auch nicht zwangsläufig) eine höhere Lebenszeit bedeuten, aber es kann auch ohne Verlangsamung des Fortschreitens eine längere Lebenszeit geben, so stellt sich das Resultat im Moment dar.
Und die Verlängerung der Lebenszeit könnte von Patienten wie Ärzten schon ein Grund sein, zu Provenge zu greifen, auch wenn die Krankheit trotzdem fortschreitet.

Dennoch gebe ich dir natürlich recht, daß diese Meldung ein großer Mist ist für DNDN. Wollte auch schon längst verkauft haben, jetzt aber ist das Kind in den Brunnen gefallen und ich sehe auch eher die Chance einer technischen Gegenreaktion gekommen. Hinzukaufen würde ich allerdings nicht.

Gruß q.

[quepos]

Moin,

DNDN wird ca. einen Monat nach dem Absturz das Kurs-Gap wohl wieder schließen können.
Ich denke, daß die 10$ wieder erreicht werden.
Aktie gestern vor der Meldung unter hohem Volumen +15%.

Gruß q.


Meldung dazu:

Prostate cancer vaccine helps patients live longer
Wed Feb 16, 2005 09:59 PM ET
WASHINGTON, Feb 16 (Reuters) - A prostate cancer "vaccine" made by Dendreon Corp. (DNDN.O: Quote, Profile, Research) can help patients with severe, advanced disease live a little bit longer, U.S. researchers reported on Wednesday.
The so-called therapeutic vaccine, designed to help a patient`s own immune system fight the cancer, added a few months to the lives of men with otherwise untreatable prostate cancer, the researchers said.

It is one of several experimental tailored approaches to cancer treatment.

"A therapy that prolongs life yet avoids the side-effects of other therapeutic approaches is clearly attractive to patients and physicians alike," said Dr. Eric Small, who led the study at the University of California San Francisco School of Medicine.

The vaccine, called Provenge, helped patients live an average of nearly four months, or 18 percent longer, the researchers told a joint meeting of the American Society of Clinical Oncology, the Prostate Cancer Foundation, the American Society for Therapeutic Radiology and Oncology, and the Society of Urologic Oncology.

Dendreon`s vaccine, made with South San Francisco-based Titan Corp., is designed to stimulate the immune system to attack the 95 percent of prostate cancer cells that generate prostatic acid phosphatase.

A patient`s own immune cells are collected and trained to attack the protein, then reinfused into the patient.

Small and colleagues tested this highly tailored therapy on 127 men with prostate cancer that had spread and that no longer responded to hormone therapy.

As part of a Phase III trial for Food and Drug Administration approval they gave the vaccine treatment to 82 men while 45 got a placebo treatment. On average the men who got the vaccine lived 26 months, while those who got a placebo lived 22 months.

Three years later, 34 percent of vaccine patients were still alive, compared 11 percent of unvaccinated patients.

Dendreon shares fell last month when the company said the trial failed to slow the progression of the prostate cancer in the patients but the researchers said extending life may be more important.


© Reuters 2005. All Rights Reserved.

[ballard1]

o, 17. Februar 2005 | 16:12 Uhr

Hörrlein
Autor: Hörrlein BioTech/NanoTech
16:12 | 17.02.05

Der erste Impfstoff gegen Krebs!
Leser des Artikels: 741
Dendreon - Plus 15% nach Provenge®-Daten

Nun scheint sich tatsächlich das zu bewahrheiten, was wir bereits am 12. Januar in Erwägung gezogen und hier veröffentlicht hatten. Die jüngsten Daten sprechen zumindest dafür, dass der Kurverlust von 19 Prozent, den die Aktie von Dendreon (Nasdaq: DNDN am 11. Januar bereits in der Vorbörse erlitten hatte, tatsächlich nicht gerechtfertigt war. Da die meisten Verkäufe, wie so oft bei solchen Szenarien, auch in diesem Falle vor Beginn des regulären Handels statt gefunden hatten, waren es wieder einmal die Kleinanleger, die die größten Verluste schlucken mussten.

Vor allem diejenigen, die sich aufgrund fehlender fachkundiger Informationen auf Spekulationen und Gerüchten aus Aktienboards und Chatrooms verlassen mussten, verkauften aus Angst nicht selten beim Tiefststand der Aktie, und nahmen damit einen dicken Verlust von bis zu 27 Prozent in Kauf. Wer allerdings mit den Geschehnissen bei Dendreon und seinem Krebsimpfstoff Provenge® vertraut war und dessen Entwicklung von Anfang an mit verfolgen konnte, wie dies beispielsweise die Abonnenten von www.Biotech-Experte.de konnten, der ließ sich weniger von der Panik der Masse anstecken.

Ganz im Gegenteil, ein wissender Anleger hätte den Kursabschlag eher als günstige Einstiegsgelegenheit gesehen. Wie wir bereits am 12. Januar mitgeteilt hatten, verfehlte Provenge® zwar den primären Endpunkt einer Phase III Studie, doch diese hätte Provenge® nur zusätzliche Patienten, nämlich die weniger Kranken mit Gleason Score <7, bringen sollen. Die primäre Zielgruppe für Provenge® sind aber schon von Anfang an Patienten mit einem bereits metastasierten, also fortgeschrittenen Prostatakarzinom. Bei diesen Patienten hätte Provenge® das Überleben, bei gleichzeitiger Verbesserung der Lebensqualität, verlängern sollen.

Diese überlebensverlängernde Wirkung konnte Provenge® auch in allen bisherigen Studien zeigen. Auch beim Corpus delicti, der Studie D9902B, konnte Provenge® das Überleben aller Patienten, auch der mit Gleason Score <7, verlängern. Die exakten Daten ließ Dendreon damals allerdings noch offen. Gestern am späten Abend wurde das Geheimnis endlich gelüftet, was den Aktienkurs diesmal in die Gegenrichtung, nämlich um mehr als 15 Prozent nach oben schießen ließ.

Das Immuntherapeutikum Provenge® scheint das Immunsystem eines Patienten tatsächlich auf die 95 Prozent Krebszellen aufmerksam zu machen, die das Enzym PSA (Prostatic Acid Phosphatase) synthetisieren. Provenge® fällt in die Klasse der individuellen Impfstoffe, da es körpereigne Immunzellen enthält, die außerhalb des Körpers trainiert und dann als Medikament verabreicht werden. Studienleiter Eric Small und seine Kollegen präsentierten die Daten gestern auf einem wichtigen Krebskongress in den USA.

Studienteilnehmer waren 127 Männer mit metastasierten Prostatakarzinom, welches bereits eine Hormonresistenz aufwies. Für diese Patienten gibt es bisher keine einzige Behandlungsalternative, umso ermutigender die Ergebnisse der Studie. Nach drei Jahren Provenge®-Therapie waren noch 34 Prozent der Patienten am Leben, während es in der Kontrollgruppe nur noch 11 Prozent waren. Im Hinblick auf die Tatsache, dass Provenge® das Überleben, ohne die schwerwiegenden Nebenwirkungen von Chemotherapeutika, verlängert, sollte es sowohl für Patienten als auch für Mediziner eine echte Alternative sein.

Auch Studienleiter Dr. Eric Small von der University of California, San Francisco School of Medicine, sieht in Provenge® eine echte Behandlungsalternative beim metastasierten Prostatakarzinom. Provenge® ist deshalb wohl noch lange nicht aus dem Rennen.

[dimonsire]

New Vaccine Boosts Prostate Cancer Survival

9 minutes ago Health - HealthDay


By E.J. Mundell
HealthDay Reporter

THURSDAY, Feb. 17 (HealthDay News) -- For the first time, a vaccine therapy that harnesses the power of the body`s own immune system is proving successful in the fight against metastatic prostate cancer.

Yahoo! Health
Have questions about your health?
Find answers here.






Researchers say the compound, called APC8015 (Provenge), primes patients` immune systems to recognize and kill prostate cancer cells that have spread throughout the body.


In a trial of 127 men with advanced disease, patients given the vaccine, called Provenge, experienced an average 18 percent increase in survival, compared to those on a placebo, the scientists report.


"For those of us doing research into metastatic prostate cancer, it looks pretty great," said study co-researcher Dr. Celestia Higano, an assistant professor of medicine and urology at the University of Washington in Seattle.


"We prolonged survival -- that`s great news. It`s the first time we`ve seen it with a vaccine in prostate cancer," she added.


She and her colleagues presented the findings Thursday at this year`s Multidisciplinary Prostate Cancer Symposium in Orlando, Fla.


Besides promising a potential boon to people struggling with prostate cancer, the therapy gives "proof of principle" to the idea that immune-based treatments can have a real impact on prostate cancer and other malignancies, experts said.


"There have been many failures with this kind of approach, and many have wondered if we shouldn`t set the bar lower, somehow lower our expectations, and not hope for extended survival," said Dr. Bruce Roth, a prostate cancer researcher at Vanderbilt University in Nashville, Tenn.


"But these findings are saying, `No, looking for a survival advantage is a valid endpoint to look at for these agents,`" he said.


When caught early, prostate cancer remains very curable. However, despite advances in early detection, the disease remains the second leading cancer killer of U.S. men, according to the American Cancer Society (news - web sites). Even among men who develop the disease while it is still confined to the prostate, between 30 percent to 40 percent will experience a recurrence in years to come, experts say.


Because prostate cells depend heavily on testosterone to grow, therapies that reduce levels of circulating testosterone are often the first course of action in men who experience a recurrence. However, prostate cancer cells gradually grow resistant to hormonal therapy, so relapse is almost inevitable. Until very recently, doctors could only offer patients palliative therapies once that relapse set in.


But just last year, one new chemotherapy agent -- docetaxel (Taxotere) -- was found to improve survival in patients with metastatic disease by an extra six months, on average.


Now, Higano and her colleagues say their vaccine may extend survival, too.


"The vaccine is composed of a person`s own immune cells that have been isolated from the blood and then sensitized to prostatic acid phosphotase, which is found on 95 percent of prostate cancer cells," Higano explained. These cells "are then infused back into the patient."


Once inside the patient, these sensitized cells prime the patient`s immune system to recognize and destroy prostate cancer cells roaming throughout the body, Higano said.


The Seattle study involved 127 men with cancer that had spread beyond the prostate and grown resistant to hormonal therapy. Eighty-two of the men received Provenge, while the other 45 received a placebo. The researchers tracked patient outcomes for three years.


The patients taking Provenge survived an average of 25.9 months, compared to 22 months for those not taking the vaccine. And by the three-year mark, 34 percent of those on Provenge remained alive, compared with just 11 percent in the placebo group.





"It`s the first immunological therapy to have some efficacy against metastic prostate cancer, after years of trying," Roth said.

The side effects were minimal -- "some fever and shaking for a few days at the beginning of therapy, but that was transient," Higano said.

Both Higano and Roth stressed that neither Taxotere nor Provenge represents a "cure" for metastatic cancer, but they agree that both bring a measure of hope.

"Along with Taxotere, this is the second trial [in a year] where something has impacted on survival -- that`s really exciting," Higano said.

She cautioned, however, that decisions by Provenge`s developer, the Seattle-based biotech company Dendreon, as well as the U.S. Food and Drug Administration (news - web sites), will largely dictate how long it might take before the vaccine is available to patients everywhere.

"Hopefully, we`re talking one to two years, though," she said.

In other news released Thursday at the symposium, a study by researchers at Brigham and Women`s Hospital and the Harvard School of Pubic Health suggests that increased levels of vitamin D may help protect against prostate cancer.

Comparing Vitamin D levels in blood samples from more than 2,400 men, the Boston team found that men with high levels of two vitamin D metabolites, in combination, were at a 45 percent lower risk of developing prostate cancer, compared with men who had lower levels of these two metabolites or those who had a high level of only one metabolite.

"Our finding suggests that vitamin D plays an important protective role against prostate cancer," said lead investigator Dr. Haojie Li in a prepared statement. Vitamin D is best sourced through exposure to sunlight, or certain foods.

In a third study, also from Brigham and Women`s Hospital, Dr. Jing Ma and colleagues report that obesity may increase risks for death from prostate cancer. They found that, even after adjusting for other risk factors, statistically obese men with a body mass index (BMI) of 30 or above were twice as likely to die of the disease than normal weight men.

According to the researchers, obesity also doubled the risk of being diagnosed with metastatic prostate cancer -- 19 percent among obese men vs. 8 percent among normal-weight men.

"There are two possible explanations for these findings," Ma said in a prepared statement. "First, that being obese may delay the diagnosis of prostate cancer, or second, that being overweight or obese is associated with a biologically more aggressive form of prostate cancer."

[Karl79]

..... habe diese Geschosse auch im Depot.. kann leider aber zu wenig englisch um die Kernaussage zu verstehen. sorry.. Wie sehen neben den erfreulichen Wirtschaftsnachrichten aber die ökonomischen Kennziffern aus? Ist der Impfstoff Provenge® das einzigste zur Zeit in klinischer Phase? Gibt es überhaupt weitere eigene Produkte?

[Guru-Schreck]

Das wichtigste steht zusammengefasst unter :

http://www.wallstreet-online.de/ws/news/news/main.php?action…" target="_blank" rel="nofollow ugc noopener">http://www.wallstreet-online.de/ws/news/news/main.php?action…

[wohinistmeinGeld]

war ja wieder eine kurze Freude.

[dimonsire]

ANALYST SET TARGET $15.
by: kill_shorters_tomorrow 02/18/05 01:16 pm
Msg: 77341 of 77341

NEW YORK, February 18 - Analyst Paul C Latta of McAdams Wright Ragen maintains his "buy" rating on Dendreon Corporation (DNR.FSE). The 12-month target price is set to $15.

In a research note published yesterday, the analyst mentions that the company has released some data, which indicate the success of the DD-9901 trial of Provenge for prostate cancer. The data exhibits a strong survival benefit and a high degree of statistical significance, the analyst says. McAdams Wright Ragen expects Dendreon to file for the approval of Provenge by the end of this year.

[dimonsire]

Thursday, February 17, 2005

Dendreon drug shows results
Provenge boosts survival rates in trial of prostate cancer patients

By BRAD WONG
SEATTLE POST-INTELLIGENCER REPORTER

Seattle-based Dendreon Corp. said yesterday that its lead experimental drug, Provenge, boosted the survival rates of men with hormone-failed advanced prostate cancer by more than three times, compared with those who were given placebos.

The news marks the first significant success of a cancer immunotherapy vaccine. The drug is not designed to prevent cancer but instead aims to stimulate the immune system to attack cells that express a certain type of protein found on about 95 percent of prostate-cancer cells. If it goes to market, Provenge will be the first cancer immunotherapy vaccine to ever work.

The results showed that 34 percent of men who received Provenge during a clinical trial were still alive at the end of the three-year study, compared with 11 percent who received placebos.

"This is the first time a non-chemotherapy agent has been shown to improve survival at this stage of the disease," said Tia Higano, a Provenge investigator and a University of Washington associate professor of medicine and urology.

Results of the study will be discussed Saturday at a meeting in Orlando, Fla., of the American Society of Clinical Oncology. The company will hold a briefing about the results today.

Those who received Provenge had a median survival rate of 25.9 months, compared with 21.4 months for those who took placebos.

Last year, Taxotere, a chemotherapy and competing drug that has an approximately 2.5-month median survival benefit, gained federal market approval for prostate cancer.

"We see it as a key step forward. It`s very encouraging data," said Mitchell Gold, Dendreon`s president and chief executive, referring to Provenge.

Unlike toxic cancer treatments, he said, the drug`s side effects were about two days of chills and fevers.



"The quality of life while on the drug is so much greater," he said, referring to patients. "They were able to live their standard lives."

Prostate cancer affects more than 1 million men in the United States. The California-based Prostate Cancer Foundation expects 232,000 men to be diagnosed with it this year.

More than 30,000 men die from the cancer each year.

Speculation about what the company will formally report this week contributed to a gain of more than 15 percent yesterday for Dendreon stock on the Nasdaq market, where it closed at $8.05.

While the company is pleased with this most recent data, it has not applied for Food and Drug Administration market approval. The company hopes to secure that approval as soon as possible.

Before it files its government application, it needs other data from different Provenge clinical trials. The company is expected to release more Provenge trial results later this year.

David Miller, president of Seattle-based BioTech Monthly, said the news should allay concerns of people who have questions about the drug`s effectiveness.

"I think that people who are going to be fair-minded about this have to acknowledge that this is a significant advance in the treatment of prostate cancer," said Miller, who owns Dendreon stock.

When questions about the drug`s effectiveness surfaced Jan. 11, shares dropped 27 percent to close at $7.62.

Wall Street analysts raised questions about an unclear company statement about the drug`s failure to meet a key goal -- to stop the progression of the disease.

After that announcement, some analysts rated Dendreon stock as neutral, hold or buy, according to information listed yesterday on Bloomberg News. At least three analysts have maintained a buy recommendation.

The company started Provenge research in the 1990s and has spent about $200 million on it.

P-I reporter Brad Wong can be reached at 206-448-8137 or [e-mail]

[dimonsire]

ich glaube das shorten hat ein ende. jetzt...

[dimonsire]

--------------------------------------------------------------------------------

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Adviser Soapbox
Prostate Drug Promise Vs. FDA Rigidity
Dr. Scott Gottlieb, Forbes/Gottlieb Medical Technology Investor, 02.18.05, 9:45 AM ET



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NEW YORK - Encouraging news that a new cancer vaccine may be saving the lives of patients with prostate cancer seems too hard to ignore, even for the U.S. Food and Drug Administration. The drug agency has kept the medical product off the market for more than two years, arguing that the proof of its value wasn`t convincing, even as evidence continued to accumulate that the new product was saving lives.

The treatment, developed by Seattle-based biotech company Dendreon (nasdaq: DNDN - news - people ), works by priming the body`s immune system to recognize special markers on the surface of prostate cancer cells and harnessing the body`s natural immune cells to seek out the cancer and destroy it.

When the company first submitted its evidence to the FDA almost three years ago, asking for permission to sell it, the FDA said no. When the agency looked at all of the patients enrolled in the company`s trial, the vaccine didn`t show an overwhelming benefit in the short-term study of more than 100 prostate cancer patients. But when Dendreon looked at a smaller subgroup of the patients in the trial, those with a certain less aggressive form of prostate cancer, the results looked great. The FDA, however, does not allow "retrospective" analysis, which is statistically impure and can lead to cooked results. So Dendreon was asked to do a new trial, studying the vaccine just in patients who had the less aggressive form of the cancer. There was evidence that the vaccine worked for certain patients, but the FDA wanted more convincing data.


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It turns out, however, that when Dendreon continued to follow the patients in the original study for another two-and-a-half years, the results continued to get better--for all the patients, not just those with the less aggressive cancer. Thursday evening, Dendreon announced that 34% of those who received Provenge in that original trial were still alive after three years, compared with 11% of those who took a placebo. The median survival, meaning the time by which half the patients had died, was 25.9 months for those who received Provenge, compared with 21.4 months for those who took the dummy vaccine.

That 4.5-month increase in survival is almost double the 2.5-month benefit shown in clinical trials of Taxotere, a drug that is the next best thing for patients like those in the Provenge trial whose cancer has spread beyond the prostate gland and is no longer being controlled by hormonal therapy.

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Dendreon`s vaccine product seems on track to win approval, the question now is whether the FDA will wait for the company to finish the trial it has underway or approve the product based on the mounting strength of the results of that original trial. If the FDA sticks to its rules, it will wait for the new study to finish, and patients will pay a significant price: denied access to a largely safe product that looks to be a real advance in cancer care. Dendreon has said it will wait for the results of its ongoing trial before filing for approval with the FDA.

The problem is that at the Food and Drug Administration, creativity is not a virtue. The Agency prides itself on developing fixed approaches to regulatory problems, striving to set clear requirements on how it reviews and approves new drugs and applying these criteria consistently across its different divisions and through the review of different products in different diseases. That really stings new medical technologies like cancer vaccines, which require a different regulatory approach. One of the big problems is that patients who get the vaccines in clinical trials are less likely to benefit from these products because regulatory rules compel companies to test them on the sickest patients.

The vaccines work by stimulating the immune system to begin fighting off the cancer on its own. Since most of the patients receiving these vaccines are already on death`s doorstep, their depleted immune systems are hard pressed to respond to the treatments. As a result, the trials are unlikely to yield the statistically favorable results preferred by the FDA. That was one issue in the case of Dendreon. Initially, in a shorter-term trial, the vaccine only seemed to work well in the patients with less aggressive cancer who weren`t as sick. It is for this group that Dendreon is now undertaking its new study.


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The larger problem is that inside the FDA the regulatory framework always lags the creation of new technology. FDA knows how to evaluate the safety of cholesterol lowering drugs and antihistamines. After seeing scores of these products, they have the regulatory routine down pat. When it comes to completely novel products like immune-boosting vaccines, the agency stumbles, forcing square pegs into round holes as it tries to adapt familiar regulatory models to technologies it doesn`t fully understand. In the case of cancer vaccines, that might mean more markers of vaccine response like scientific tools that can measure whether the vaccine is generating an immune response that can serve as a proxy for effectiveness.

It could also mean differently designed clinical trials. Instead of the traditional three phases of clinical trials, maybe cancer vaccines should be tested in clinical trials where the vaccine is given to small groups of people based on characteristics that help predict whether they will respond to the treatment. When one of these small groups does respond to the vaccine, it can be tested again in just that group, with the hope that researchers can glean even more characteristics that unearth what kinds of patients are most likely to respond. While promising, this kind of clinical trial design, called enriched trials, is still not well understood. A little scientific work can help hammer it out as a new model.

Finally, it could mean a greater reliance inside the FDA on mathematical tools for using data about new drugs that is not "randomized" or randomly compared to a placebo, but derived from large populations of patients all being given the same treatment. This kind of "dirty data" involves a mathematical science called Bayesian statistics that allows statisticians to glean strong conclusions off large, population data, just like economists do. This is another science that is poorly developed inside FDA.


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A way out of this box was a large part of the vision behind the "Critical Path" initiative announced by the FDA last year. That policy encompassed many things, but above all else it was about engaging the broader scientific community in an effort to develop better methods for evaluating the safety and effectiveness of new medical products. Right now, the medical products keep getting better and more advanced, and yet too often, the FDA`s processes and procedures for evaluating them are stuck in 1972.

This is a problem for Congress to ponder as well--especially the next time legislators have the itch to dump more money into that sinkhole off Maryland`s Rockville Pike, also known as the National Institute of Health. We can create all the nifty new technologies massive taxpayer spending can buy, from the best nanotechnology particles to innovative cancer vaccines. But all this effort to create wildly better products is for naught if they all eventually bump up against an FDA that`s ill prepared evaluate them.

Many other biotech companies are working on similar cancer immune therapies, including Medarex (nasdaq: MDRX - news - people ), Antigenics (nasdaq: AGEN - news - people ), Cell Genesys (nasdaq: CEGE - news - people ), Geron (nasdaq: GERN - news - people ), Corixa (nasdaq: CRXA - news - people ), Vical (nasdaq: VICL - news - people ), Progenics Pharmaceuticals ( PGNX) , AVI BioPharma (nasdaq: AVII - news - people ) and Biomira (nasdaq: BIOM - news - people ). So long as the FDA stands as an obstacle to bringing new medical products to the market, we ought to make sure the agency is infused with the thinking and the resources to advance alongside the science it`s charged with regulating.

Scott Gottlieb, a physician and fellow at the American Enterprise Institute, is editor of the Forbes/Gottlieb Medical Technology Investor. Dr. Gottlieb is a former senior official at the U.S. Food and Drug Administration and may own stock in some of the companies mentioned in this column or consult with firms that advise them. Click here for more analysis, or to subscribe to Forbes/Gottlieb Medical Technology Investor.

More Adviser Soapbox columns

Send comments and questions to [e-mail].

[dimonsire]

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…
morgen gehts um die weiter zukunft mit der aktie...

[quepos]

Hallo,

die Nachricht ist ja erstmal recht gut, immerhin der der Kurs in D ja auch +12%.
Wie gesagt rechne ich mit Anstieg auf ca. 10$ (7,7€, könnte meinen Verlust etwas mildern.
Hatte dummerweise ohne Recherche einfach mal auf die Empfehlung von Fräulein Herrlein (nein) Hörrlein gehörrt, war so ziemlich genau beim Höchstkurs seit Jahren. Und dabei bin ich selbst professionell genug...
Naja, passiert jedem mal .
Jedenfalls ist die Aktie m.M. auch jetzt noch sehr hoch bewertet (verglichen mit anderen aus der Branche) und bei einem evtl. Hype diese Woche werde ich wohl froh sein, mit ca 40-50% Verlust zu verkaufen!


Gruß q.

P.S.: Kann ich lieber noch mehr MEDX einsacken, aber mal seh´n.

[dimonsire]

ICH MÖCHTE MICH NICHT ZU SEHR AUS Dem FENSTER LEHNEN; ABER WICHTIG IST OB DENDREON NUN DIE FDA ZULASSUNG BEKOMMT UND MEHR ERFAHREN WIR MORGEN AB 10 am amerikanischer zeit. viell.handelt es sich bei der bevorstehenden konferenz sogar um die mitteilung einer partnerschaft.. sollten sie die zulassung vom fda bekommen so íst dieser kurs ein witz...denn dann gehts richtung 12-15 €. und das kann schnell gehen. man muss leider bedenken, dass hier einige hedgefonds grossen ja sehr grossen einfluss haben und es deshalb ein bis zwei wochen duern kann. dies ist eindeutig ein meilenstein in der geschichte der pharmazie und biotechnoligie der hiermit gelegt wurde. es geht schlicht und einfach darum ein lebensverlängerndes medikament für bedürftige von prostatakrebsbetroffenen auf den markt zuzulassen.lebensverläääängeruuung... strong buy

[wohinistmeinGeld]

sieht nicht nach einem positiven Entscheid aus.

[Karl79]

verdammt..... weiß irgendwie einer mal etwas genaueres? Jetzt wird mein Verlust ja noch größer. Dachte ich lass sie mal liegen und reifen. Stimmt wohl doch mit den Pferden.... die hätten nicht gekauft.

[Guru-Schreck]

Solange keine endgültige Klärung erreicht ist, ob man nun die Zulassung bekommt, werden die Schwankungen in beiden Richtungen hoch bleiben. Der Chart sieht ziemlich kaputt aus, eine Bodenbildung bei 6 Dollar ist noch möglich. Falls diese Marke signifikant unterschritten wird, sollte man erstmal die Reisleine ziehen. Wenn eine Aktie längere Zeit fällt, ohne dass entsprechend Meldungen kommen, kann dass heißen, einige wissen vielleicht mehr als allgemein bekannt ist und verkaufen.

[wohinistmeinGeld]

gestern gab es einen KonfernzCall.
Wer gut genug englisch kann, der kann ja mal hier rein hören was es gibt.
http://biz.yahoo.com/cc/3/52793.html

[wohinistmeinGeld]

ich habe jetzt lange erfolglos gesucht. Ich glaube nicht, daß das Minus heute viel zu sagen hat, die ganze Biotech läuft diese Woche ja schon äußerst mies.

[wohinistmeinGeld]

[ditzeroni]

Sieht so aus als am Ende doch noch ein Analyst den Wald vor lauter Bäumen gesehen hat.
Meiner MEinung nach war das jetzt der bottom, und Richtung May ASCO gehts bergauf, danach in Erwartung auf 9901/02a-pooled Data im August genauso.


"09:45 DNDN Dendreon: See shares as significantly undervalued - Soleil (5.61 -0.19)

Soleil out on Dendreon following Q4 results noting final survival analysis from the D9902A Phase III study of Provenge in prostate cancer is expected in 2H05. If data quality meets that shown in D9901, Dendreon is positioning to file a BLA in early `06 and launch later that year. Firm believes Provenge stands a strong chance of reaching such a commercialization timeline. Dendreon has lost significant stock value despite the release of what they believe to be very positive data regarding the survival benefits of Provenge therapy in androgen independent prostate cancer. Believes that this is because Wall Street is wary about Dendreon`s seemingly complex clinical trial story. Sees shares significantly undervalued at this time. Reits Buy and $19 tgt "

[ditzeroni]

Soso, endlich mal ein wenig Insider-Buying von Seiten der Top-Execs!
Sollte dem Kurs mal ein wenig helfen, auch wenn es nur zw. 4K und 4400 Aktien/Person waren.
Ist für mich ein Zeichen an den Markt, das sie selber an Provenge keinen Zweifel haben.
Also mehr ein Symbol, da ja 4K nicht gerade viel sind.

[Guru-Schreck]

Dendreon krebst am 52-Tief herum, ohne irgendwelche nennenswerte Erholungsversuche, dass sieht nicht wirklich gut aus. Wenn nicht bald etwas positives kommt, dann wird bald die 5-Dollar Marke getestet. Wenn die nicht hält, dann gute Nacht.

[ballard1]

Was meint Ihr wohin die Reise geht? Im Verlust sind wir ja alle. Halten und eventl. abschreiben, oder jetzt noch verkaufen?

[AragornMW]

Hallo zusammen!

Es wird Zeit!!!

Meanwhile, Dendreon (DNDN: news, chart, profile) got a lift after Paul Allen, the co-founder of Microsoft, became a passive investor in the company. According to an SEC filing, Allen now owns 2.9 million shares of the company, or 4.9 percent.

Dendreon was up 17 cents, or 2.9 percent, to $6.04

Gelegenheit! Beeilt Euch, kein Push über WO möglich.

Ciao, AMW

[wohinistmeinGeld]

wozu beeilen, das geht noch lange abwärts, bei 2 $ ungefähr kann man mal hoffen.

[ditzeroni]

Wer auch etwas englisch versteht, sollte sich diesen Link mal anschauen:
http://www.fool.com/news/commentary/2005/commentary05050304.…

Nette Story, und wie ich meine, eine Art "DNDN for dummies".

Ist gar nicht schlecht gemacht, aber trotzdem kommt der Autor wie bis jetzt so gut wie alle sogenannten Analysten vor ihm auch mal mit 9901/9902A/9902B durcheinander, aber das fällt hier nicht ins Gewicht.

Was mich angeht: I´m a believer!
Und entweder ich habe Recht und habe hier vor 3 Jahren das Investment meines Lebens machen, oder ich hab halt nicht Recht, und habe ein nicht geringes Vermögen verloren.
Ich gehe aber eher davon aus das ich aus einem nicht geringen Vermögen ein signifikantes machen werde.

Und falls einer hier der das liest noch nie gesehen hat, wie Level-II-mäßig per Computerprogramm die Bid´s/Ask´s mit 100-share-trades manipuliert wird, dann schaut euch das einfach mal bei DNDN an. Ist sehr traurig, das so etwas zwar illegal in den USA ist, aber trotzdem tagtäglich möglich.

[quepos]

Moin ditzeroni,

Die Analysen von Motley Fool sind eigentlich immer ganz gut. Und nun das:


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Press Release Source: Dendreon Corporation


Dendreon Announces D9901 Phase 3 Study Results for Provenge Immunotherapy to be Presented at ASCO

Thursday May 5, 8:30 am ET


SEATTLE, May 5 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that the D9901 Phase 3 clinical trial results of Provenge®, the Company`s investigational immunotherapy for the treatment of prostate cancer in men with asymptomatic, metastatic androgen-independent (hormone refractory) prostate cancer, will be presented during an oral presentation at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Orlando, Fla. May 13 - 17. Details are as follows:
ADVERTISEMENT


Results of a placebo-controlled phase III trial of immunotherapy with APC8015 for patients with hormone refractory prostate cancer (HRPC).

Oral presentation on Saturday, May 14, 11:15 a.m. - 12:30 p.m. (Abstract #4500) Targeted Therapies for Genitourinary Cancer Integrated Education Session, Level 2, Hall E2, Presenter: Eric J. Small, MD, University of California, San Francisco.

This abstract may be accessed online at www.asco.org at the conclusion of the meeting. The presentation will not be web cast.

About ASCO

The American Society of Clinical Oncology is the world`s leading professional organization representing physicians who treat people with cancer. ASCO`s members set the standard for patient care worldwide and lead the fight for more effective cancer treatments, increased funding for clinical and translational research, and, ultimately, cures for the many different cancers that strike millions of people around the world every year.

About Prostate Cancer

Prostate cancer is the number one non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About Provenge

Provenge is designed to stimulate a patient`s immune system against prostate cancer. It is developed through Dendreon`s proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP). Provenge is being further evaluated in an ongoing, pivotal Phase 3 trial (D9902B) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. The double-blind, placebo-controlled trial is enrolling patients at leading cancer centers around the country. To learn more about the trial, go to www.dendreon.com.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations are contained in Dendreon`s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.




--------------------------------------------------------------------------------
Source: Dendreon Corporation

[quepos]

Hui!

Ziemlich ordentlich, 17% Plus. Seit meinem letzten Posting immerhin 10%, das war vor ein paar Stunden.

Sind wohl auch Short-Eindeckungen dabei.

Gruß q.

[ditzeroni]

Hey quepos

Was du da gepostet hast ist dasselbe, was von Dr. Small schon bei der Prostate-Cancer ASCO mitte Februar veröffentlicht wurde.
Er wird das jetzt bei der Haupt-ASCO nochmal wiederholen, und damit dann nochmal ein viel größeres Publikum erreichen. Kann ja nicht schaden
Viel Neues wird es wohl nicht geben, dafür müssen wir auf ca August warten (9902A)!!
Wenn die Daten dann "similar significant" sind, wie ja im letzten 10K von DNDN veröffentlicht, dann heißt es: Hallo, BLA!! Falls nicht, haben Dr. Gold und Mr. Simonetti in einem SEC-Dokument, das sie selber unterschrieben haben, gelogen. Was in solchen Fällen passiert, hat man in letzter Zeit des öfteren gesehen (Knast!).
Ich kann mir nicht vorstellen, das die wirklich so blöd sind.
Noch was anderes: bin wirklich sehr froh, das DNDN sich (bis jetzt) noch nicht an einen Partner gebunden hat und zukünftige revenues teilen muss. Das ist wirklich schwierig für eine kleine BioTech-Co, unabhängig zu bleiben.
Für mich heißt das: DNDN ist sich entweder seiner Sache (mit den bisherigen Daten von P-11, 9905 (kommt noch in Mai), P-16 und vor allem interims-9902A) so was von sicher, dass sie meinen sie hätten es nicht nötig zu partnern.
ODER: sie sind zu blöd und überschätzen sich.

Nochmal: ich bin fest von ersterem überzeugt und hab gestern nochmal nachgekauft... ich denk jedesmal ich habe jetzt genug Aktien, aber dann überkommts mich doch wieder

Frohes Investieren weiterhin!

ps: DNDN´s chart zeigt eine typische "Three White Soldiers"-Konstellation der letzten 3 Tage.
Definition: "The bullish counterpart of three black crows is known as "three white soldiers" and is considered by some candle theorists as one of the most bullish candle patterns. The three white soldiers pattern is most potent when it occurs after an extended decline and a period of subsequent consolidation. When a particular stock posts a decline followed by a sideways movement, the appearance at that point of three white soldiers signals that higher prices are likely ahead.

This candle pattern is very potent when a stock is at or near its lows.

The "three white soldiers" pattern does not occur frequently, but as a swing trader you should definitely be on the lookout for it. These soldiers make great allies in your battle for swing trading profits."

[quepos]

@ditzeroni

Danke dir für das ausführliche statement zu DNDN, vielleicht sollte man wirklich erstmal abwarten, was passiert.Hatte auch schon mal damals Imclone günstig aufgeschnappt aber wieder ohne nennenswerten Gewinn abgestoßen. War ja eine irgendwie ähnliche Geschichte mit der erst nicht und dann doch erfolgten Zulassung, hatte mich natürlich schon geärgert, daß der Kurs sich anschließend vervielfacht hatte .

Es gibt auch noch ein kräftiges Gap zu schließen...

Naja, das kräftige Plus "on volume" ist ja auch ein Kaufsignal. Bleibe erstmal dabei.

Gruß q.

[ditzeroni]

DNDN weitet Verlust aus

Das Biotechnologie-Unternehmen Dendreon Corp. verbuchte im letzten Quartal infolge sinkender Umsätze einen höheren Verlust als im vergleichbaren Vorjahreszeitraum. Dies teilte das Unternehmen am Montag nachbörslich mit.
Unternehmensangaben zufolge sanken die Umsatzerlöse im ersten Quartal 2005 auf nur 57,000 Dollar, nach 4,7 Mio. Dollar im Vorjahr. Der Nettoverlust erhöhte sich von 14,9 Mio. Dollar oder 0,28 Dollar pro Aktie auf 19,5 Mio. Dollar bzw. 0,33 Dollar.

Analysten hatten im Vorfeld einen Verlust von 39 Cents je Aktie erwartet. Für das laufende Quartal rechnen sie bisher mit einem Verlust von 41 Cents je Aktie.

Die Aktie schloss in New York bei 5,57 Dollar (-3,63 Prozent).
-----------------------------------------
Haha, sag bloß! Ein Biotech-Unternehmen, das Verlust macht und dazu auch noch ausweitet?! Ja wo gibt´s denn so etwas... Wer auf Grund dieser Info verkauft, weil ja schon wieder ein größerer Verlust gemacht wurde, hat nicht verstanden, worum es hier geht. Schon mal dran gedacht, das 9902B immer noch Patienten aufnimmt und das so ein PIII-trial je mehr Geld kostet, je mehr Patienten involviert sind?! Außerdem gibt es keine direkten Einnahmen, und wenn man die Job-postings beobachtet und dazu wie viele davon schon geschlossen sind, also wie viele neue Mitarbeiter ständig zu DNDN stoßen, was erwartet man denn da?
Sehr schade, das solche Pressemitteilungen immer wieder kleine Anleger, die sich nicht wirklich mit der Materie beschäftigen, zum Verkaufen bewegt.
Wer sich den ConferenceCall gestern nicht angehört hat (kann man immer noch nachholen über die DNDN-HP), hier mal ein paar Highlights, die evtl dafür verantwortlich sind das der pps in AH auf $5.82 gestiegen ist:

1: Es wird WICHTIGE, NEUE Information geben bei ASCO, präsentiert von Dr. E. Small. Und nicht nur eine Wiederholung der PC-ASCO-daten. Das wird am nächsten Samstag passieren.
2: Data von 9902A wird im Sommer veröffentlicht
"Data will be out in summer. Not far away, it will be very shortly", hat Dr. Gold gestern gesagt. Aha, also nicht mehr wie bisher "2nd-half of 2005", sondern "unambigously summer". Das ist für mich juni/Juli, spätestens August.
Berücksichtigt man dabei, das in den letzten Tagen sehr viele August-Calls abgestoßen wurden, die meiner Meinung nach als Teil-Hedge für die >13Mio geshorteten Aktien dienten, sieht es so aus als ob da ein paar Shorts böse überrascht werden könnten.
3: Im offiziellen SEC-document 10Q stehts mal wieder drin:
9902A is similar to 9901.

Mehr brauch ich im Moment nicht zu wissen, um sehr relaxt auf nächsten Samstag zu warten. Ich rechne mit einer Presse-Mitteilung am Freitagabend oder Samstagmorgen, in der die "important NEW information" stehen wird.

Und noch so ein Gedanke: erinnert sich noch jemand an die letzten Insiderkäufe vom BoD (board of directors) vor kurzem: Nun, nach solchen Käufen gibt es ein Quiet-period, die 45 Tage dauert. In dieser Zeit darf kein Insider irgendwas internes öffentlich sagen, und kein Data veröffentlich werden. Diese 45 Tage sind mit Beginn der ASCO am 14. Mai vorbei; hmmm, sollte uns das was sagen?!
Keine Ahnung, aber ich find es gut. Und wenn es nur aus dem Grund ist, um ein paar Shorts bis dahin ins Schwitzen zu bringen.

Freu mich schon auf 15.30 Uhr nachher, wenn die US-Börsen aufmachen. Ich denke, was da gestern AH gelaufen ist wird sich noch fortsetzen. Jedenfalls wollte jemand nach Börsenschluss für DNDN über $6 bezahlen, die er 2h vorher noch für ca $.50 weniger bekommen konnte.
Naja, lassen wir uns mal überraschen.

Wünsch nen entspannten Tag,
ditzeroni

ps: auch wenn ich schon mal "meiner meinung nach" oben geschrieben hab, so bezieht sich der ganze text darauf, bis auf die als fakten und aussagen anderer klar gemachten dinge. Nicht, das mir hier hinterher einer blöd kommt, wenn was nicht stimmt. Man weiß ja nie, was an solchen MessageBoards so alles abgeht...

[ditzeroni]

Nachdem letztens bei Motley Fool ein Artikel rauskam, der darüber handelte, ob DNDN evtl ein "Rulebreaker" sein könnte, hier nun die Fortsetzung:

There is a heck of a lot of buzz around the small biotech Dendreon(Nasdaq: DNDN), and my colleague Karl Thiel has recently discussed whether or not it is a Rule Breaker. I personally think it is since it could be the first company to launch a vaccine for the treatment of cancer.

Dendreon`s lead drug, Provenge, is currently in phase 3 development for treating patients with prostate cancer. Provenge is not a traditional drug. It is a vaccine that stimulates the immune system to attack and wipe out cancer cells. That is a novel, and unproven, method of treating cancer. A cancer vaccine has yet to be approved by the FDA, though Provenge certainly could be the first.

There is reason to be optimistic. Back in February, Dendreon reported that Provenge increased patient survival by 4.5 months compared to a placebo. This Saturday at the ASCO meeting, additional data from this study will be presented, including results that have not previously been disclosed.

While the data at the ASCO meeting could be interesting, the big event in the near term will be the release of Provenge survival data from a second study this summer. Even though this is a small study, if this data is in line with what has been previously reported, Provenge will be looking good. It will be this event that gives some indication as to the timing of when Provenge could be approved. Or it may not. There are no certainties in drug development, so ultimately, we`ll just have to wait and see how it plays out.

-------------------------------

Freu mich schon auf den Rest der Woche und ASCO am Samstag!!

[ditzeroni]

Wie vorab bereits erwähnt, habe ich ja gesagt das ich mich auf Samstag freue. Hier ist der Grund:

"New data strengthens confidence in Dendreon drug
Sat May 14, 2005 02:07 PM ET
By Toni Clarke
ORLANDO, Fla., May 14 (Reuters), - A prostate cancer drug whose life-extending benefits had been questioned does seem to in fact to work, researchers said on Saturday.

New data shows that the longer survival seen in patients taking Dendreon Corp.`s (DNDN.O: Quote, Profile, Research) experimental prostate cancer drug Provenge was not due to a statistical fluke or to the supplementary benefits provided by chemotherapy.

Data presented in February showed that patients with prostate cancer that had spread, who did not respond to drugs that suppress the hormone testosterone and took Provenge lived an average of 25.9 months, compared to 21.4 months for those who took a placebo.

But investors and analysts had questioned the validity of the results, partly because the trial was small, just 127 men, and partly because it was unclear whether the results had been caused by factors other than Provenge.

Data presented at the annual meeting of the American Society of Clinical Oncology here showed that when potential alternative reasons for the longer survival were excluded, the probability that the positive effect was caused by Provenge was strengthened rather than diminished.

"These important additional analyses give us more confidence in the survival outcome we observed in this trial and further underscore the potential utility Provenge may have in this patient population for which few appealing treatment options exist," said researcher Eric Small, professor of medicine and urology at the University of California, who presented the data.

Dendreon is conducting two other trials of the drug and hopes to pool the results to make sure they are reproduced across a larger population.

The results of the first trial, of 98 men, are expected this year. If they are positive, the company said it could file a marketing application with the U.S. Food and Drug Administration in 2006.

In analyzing data from the Provenge trial in greater depth, Small said that several measures were used to rule out effects that could have independently contributed to the survival benefit, such as weight, age and where the cancer had spread.

The analysis also measured the potential impact of chemotherapy and found no difference in the amount taken by the treated group and the amount taken by the placebo group. In the trial, patients began taking chemotherapy once their disease began getting worse.

Provenge is designed to stimulate a patients` immune system against prostate cancer, which is the third most common cancer worldwide. More than one million men in the United States have the disease and it will kill 30,000 in 2005, according to the American Cancer Society.
-----------------------------------

Bin mal drauf gespannt, wie die Börse reagieren wird.
Wer sich mal kurz erinnert: UBS hat ein strong-sell mit Kursziel $6 rausgegeben, mit der Begründung, das die Trials "imbalanced" wären, usw. Sie haben in einer PR-release DNDN unterschwellig der Lüge bezüglich der im Februar veröffentlichten Daten bezichtigt. Daraufhin kam das "strong-sell", und er pps ging zügig von 10 auf 6 Dollar.
Jetzt stehen sie selber als Lügner da.
Ich muss sagen, das mir das sehr gefällt. Ich rechne nun bald mit den ersten Upgrades.

Meine Meinung: stetiger run-up gen 8 Dolllar, aber da am Freitag wieder mal Option-expiring ist, sehen wir dann wohl wieder die 7.50, damit die OS verfallen. Wem kommt das zu Gute?!
Richtig, den Investmenthäusern...

Gruß,
ditscheroni

[ditzeroni]

Und noch mehr press-coverage heute morgen von Businessweek-Online:

Several biotech companies are testing vaccines that would prevent the recurrence of prostate cancer after initial treatment. These trials take a long time to conduct, and results so far have been far from definitive.

However, Dendreon (DNDN ) reported promising data on Provenge, its prostate vaccine, which is one of the furthest along in this group. The late-stage trial found that patients on Provenge had a median survival of 25.9 months, compared with 21.4 months for the placebo group. Also, 34% of patients on Provenge were still alive at 36 months, compared with 11% on placebo.


Hier ist der Link:
http://yahoo.businessweek.com/technology/content/may2005/tc2…

[ditzeroni]

Mahlzeit!
Falls das hier überhaupt noch irgendjemand lesen sollte, ein kleines Update. Aber wer sich ein wenig mit DNDN beschäftigt, weiß das eigentlich schon:

Dr. Gold sagt des Öfteren, das die 9902A Daten "unambigously summer" bekannt gegeben werden. Kein Wort davon, das die Daten selber stat.sig. sind, aber sie sind "conformative" und "similar". Das steht sogar im aktuellen 10-K, also wird es wohl wahr sein.
Auf die FRage, wann der letzte Patient in 9902A aufgenommen wurde, meinte Dr. Gold: "Wir haben nie gesagt, das es August war!"
D.h. im Klartext, das es nun jeden Tag sein kann, das die Daten rauskommen. ICh für meinen Teil bin drauf vorbereitet und habe mich eingedeckt mit DNDN.

Und noch eine FRage: ist hier überhaupt noch jemand, der sich mit DNDN beschäftigt oder bin ich der Einzige bis auf ein paar Leute aus den USA?!
Würd mich mal interessieren...

[topware]

Bin auch noch dabei. Warum der Kursanstieg heute
Sind die Daten raus

[topware]

Ahhhh, gefunden

21.07.2005 15:36
Dendreon`s Second Randomized Phase 3 D9902A Trial Shows Provenge Extends Survival in Patients With Advanced Prostate Cancer

SEATTLE, July 21 /PRNewswire-FirstCall/ -- Dendreon (Nachrichten) today announced that the analysis of the final three-year survival data of its second Phase 3 study (D9902A) of Provenge(R), the Company`s investigational active immunotherapy for the treatment of prostate cancer, showed a survival benefit in men with advanced prostate cancer who were treated with Provenge. Prostate cancer is the most commonly diagnosed non-skin cancer in the United States and the third most common cancer worldwide. The Company will host a conference call today at 11:00 a.m. ET.

In the D9902A study, the three-year final survival analysis in the intent-to-treat population of the double-blind, placebo-controlled study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. As expected, the results from this study did not meet the criteria for statistical significance based on a log rank test. A secondary analysis using a Cox multivariate regression analysis of overall survival, which adjusts for prognostic factors known to influence survival, met the criteria for statistical significance. The hazard ratio observed in this analysis was similar to that seen in the Company`s first Phase 3 study (D9901).

As reported earlier this year, the final three-year follow up of the D9901 study of Provenge in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7). This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge.

A supplemental analysis that examined pooled survival data from the two companion Phase 3 clinical studies (D9901 and D9902A) showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, a 23 percent increase in median survival was seen in patients randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. In the combined D9901 and D9902A analysis, a Cox multivariate regression analysis of overall survival also met the criteria for statistical significance.

Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

As in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

"We believe the data from this second study support what we saw in the first Phase 3 trial -- that Provenge prolongs survival in men with advanced prostate cancer," said Mitchell H. Gold, M.D., Dendreon`s president and chief executive officer. "We plan to share all of the data collected to date from our clinical studies of Provenge with the FDA to determine the most efficient pathway for bringing Provenge to market."

"The results of this trial support our understanding of the potential utility of Provenge in the treatment of patients with advanced prostate cancer," said Celestia Higano, M.D., director and associate professor of the GU oncology clinical research group at the University of Washington, Seattle and a principal investigator in the D9902A study. "The survival benefit observed in these studies combined with a favorable safety profile holds promise for the many prostate cancer patients who have few appealing treatment options available to them."

More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease.

Study Details

The study, known as D9902A, is a double-blind, placebo-controlled Phase 3 trial designed to evaluate Provenge in men with asymptomatic, metastatic, androgen-independent prostate cancer. D9902A was originally designed to be the companion study to Dendreon`s completed first Phase 3 study D9901. The D9902A study was stopped in 2002 after 98 patients were enrolled when the analysis of D9901 showed that no statistically significant benefit in time to disease progression had been observed in the overall group, but that a benefit was seen in the subgroup of patients with Gleason scores of seven and less. In January 2005, the Company announced that the primary endpoint of time to disease progression in D9902A did not show a statistically significant delay in the overall group or in the Gleason score subgroups. Three-year follow up of patients for survival was the secondary endpoint of the D9902A study.

About Provenge

Provenge is designed to stimulate a patient`s immune system against prostate cancer. It is developed through Dendreon`s proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).

Provenge is being further evaluated in an ongoing Phase 3 study in asymptomatic, metastatic, androgen-independent prostate cancer (D9902B). It is also being evaluated in a Phase 3 trial, known as PROTECT or P-11, in men with early stage prostate cancer.

Conference Call LIVE Access on July 21, 2005, 8:00 a.m. PT; 11:00 p.m. ET: -- Phone [phone] (domestic) or [phone] (international) -- Webcast connection through the Dendreon website at http://www.dendreon.com/ in the Investors/Webcast section. REPLAY Access: -- Phone replay, available for 3 days by calling 888-203-1112 (domestic) or [phone] (international); Passcode: 5910894 -- Webcast replay is available for 90 days from the Dendreon website at http://www.dendreon.com/ in the Investors/Webcast section. About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit http://www.dendreon.com/.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of Provenge, our dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations is contained in Dendreon`s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov/.

[ditzeroni]

hey Topware

Wenn du demnächst die neuesten veröffentlichten Daten nicht verpassen und erst recht nicht suchen willst, trag deine eMail-add hier ein:
http://investor.dendreon.com/distlist.cfm?Header=IR

Sind im Normalfall schneller da als z.B. bei Yahoo-Finance oder auf der DNDN-HP.

Ich kann gar nicht sagen, wie sehr mich da Daten heute erfreuen. Gold sagte "im Sommer", und er hat Wort gehalten.
Credibility ist alles an der Wallstreet. Wird auch Zeit, das er welche zurückgewinnt.

Die nächsten wichtigen Ereignisse:
- Analyst-Updates
- Rest-Of-World Partner
(da DNDN ja in den USA laut eigenen Angaben in der Lage ist, den kompletten Markt selber abzudecken)
- 9902B-opening für alle GS
- BLA in Q1/2006

Alles meine eigene Meinung, natürlich.

Schönen Tag

[wohinistmeinGeld]

Zulassung verschoben????



UBS Cuts Dendreon Corp. To Reduce From Buy >DNDN

Friday, July 22, 2005 6:06:55 AM ET
Dow Jones Newswires



NEW YORK (Dow Jones)--UBS cut biotech company Dendreon Corp. (DNDN) to reduce from buy, saying it is likely that the U.S. Food and Drug Administration will require a confirmatory trial for Provenge and thus delay the product launch to the first quarter of 2008 from the first quarter of 2007.

[kep]

Die Rede im unten stehenden Newsletter ist vom Dendreon Corp. (DNDN)


Prostate Cancer Breakthrough
(A double short-term, ten-bagger in 3 years)


This has all the looks of a classic wealth-builder.


This little company is the leader of a new medical technology, which stimulates your own immune system in the fight against cancer.

You see, everyone’s body contains elements I like to call “warrior cells.”

These are the cells that lead the immune system into battle – enlisting all your other cells in the fight against disease. Without these warrior cells, you’re virtually defenseless. With them leading the charge, you stand a chance.

Every day of your life, these warrior cells fight off intruders – very successfully, in most cases.

But even the best defense fails on occasion. Maybe it’s just a bad flu – and the warriors bounce back on their own. But other times, it’s something like prostate cancer, where reinforcements would really help you in your battle.

Well, that’s where this company’s breakthrough therapy comes in.

It is targeted specifically for late-stage prostate cancer, and trial data shows that this treatment clearly extends life.

That’s why I believe this therapy could ultimately help hundreds of thousands of men throughout the world. And I also believe it could turn a $10,000 investment into $100,000 over the next three years.


The Gold Standard for FDA approval

Life extension is the Gold Standard for FDA-approval.

The agency typically bends over backwards to approve new therapies that extend life – even if for just a short time – in late-stage cancer patients.

And that’s why I believe this treatment will get approval – sooner rather than later. And that will take this $6 stock to $12-$14, within the next year.

Our ChangeWave Research Alliance agrees. Surveys on prostate cancer to qualified members highlight this treatment as:

*** the most likely new therapy to be approved; and

*** a likely big success in the marketplace.


What Wall Street doesn’t understand (yet)

This is a very different therapy – and the guys and gals on Wall Street can’t quite “get their arms around it.”

That’s great news for us, because it means they haven’t bid the stock price up – at least, not yet.

Briefly, here’s the process.

Cells are taken from a patient and loaded with something called antigens. Then these charged-cells are injected back into the patient to supercharge his own immune system.

It is quite a remarkable process – one of the first true versions of the personalized medicine, which will become the norm over the next decade.

And it only takes three days, thanks to this company’s technology and the quick delivery of Federal Express. Plus unlike most types of traditional chemotherapy, the treatment is quick and easy on the patient – it only requires about a half hour in an outpatient setting.

Best of all, it works. But you wouldn’t know it from Wall Street’s reaction.

In fact, the crowd basically yawned when the company first presented its data. But I’ve seen that same sort of skepticism before – just before American Pharmaceutical Partners’ Abraxane was approved – and just before that stock doubled.

You see, clinical data shows that our company’s therapy didn’t reduce tumor size. And the geniuses on the Street are so hung up on that sort of statistic, they totally missed the point!

*** The treatment is proven to extend life; and

*** The FDA is routinely granting approval for drugs that extend life.

And when that happens, we’re going to double our money fast.

FDA “Fast-Track” proves we’re on track

This treatment just received Fast-Track status from the FDA.

That means the FDA has committed to an expedited review of this drug – a very bullish sign that means we could have an agency bias for approval.

Under Fast Track designation, the company’s application is reviewed on a “rolling basis” – speeding up the process and enabling the company to submit more data to support its case.

In July, the company`s stock dipped over concerns by Wall Street analysts the FDA might require a third study. They were wrong – and yes, the stock got a quick pop last week on the news – so Wall Street is beginning to take notice.

That’s why you want to move in now.

Approval gets us a double from here. And if approved, it will come to market quickly -- only 5,000 physicians are actively engaged in the treatment of late-stage prostate cancer, and previous ChangeWave Alliance surveys show word about new treatments gets out very fast.

In fact, in our last survey, 17% of physicians were already familiar with the drug, even though it wasn’t on the market yet.

Let’s be frank: This is no sure thing. The company has other promising products in the pipeline, but if we don’t get approval for this prostate treatment, the stock will go down.

But for money targeted for high-growth, the potential rewards rarely get any better than this.

Approval of this treatment will be groundbreaking -- not just for the company but for the entire industry. And it would give this firm a huge first-to-market advantage with a unique technology, which could be successfully applied against many forms of cancer.

As I’ve said, we’re expecting to double our money short-term on approval. And as sales ramp up, we’re targeting a ten-bagger over the next three years.

[therman]

Habe bei DNDN bei 5$ nachgekauft.
DNDN wird m.E. bei Zulassung nächstes Jahr auf mindestens 20$ ansteigen.

News:
Dendreon Gets Fast-Track for Provenge
Monday November 7, 10:37 am ET
Dendreon Gets Fast-Track Label From FDA for Its Provenge Prostate Cancer Treatment


SEATTLE (AP) -- Dendreon Corp. said Monday that the Food and Drug Administration granted "fast track" status to its experimental prostate cancer drug, a label that allows a company to submit data as it becomes available and includes scheduled meetings for FDA input.
The fast track designation -- for the treatment of metastatic, male hormone-independent prostate cancer in men who don`t show symptoms -- is reserved for drugs that address an unmet medical need and can sometimes speed review.

Dendreon has said it will submit its application for the Provenge cancer drug using data from its two completed late-stage trials. The company`s stock dipped in July over concerns that FDA might require a third study.


Dendreon Late-Stage Study Approved
Tuesday November 29, 7:05 am ET
Dendreon, FDA Reach Agreement on Protocol of Late-Stage Study for Provenge


SEATTLE (AP) -- Biotechnology company Dendreon Corp. said Tuesday it has reached an agreement with the Food and Drug Administration under the Special Protocol Assessment, or SPA, procedure to amend the design of its ongoing late-stage clinical trial of prostrate-cancer treatment Provenge.
The SPA letter outlines the trial design and definitive clinical objectives and data analyses.

Dendreon may now expedite enrollment in the study and complete the marketing application for the drug, currently scheduled for 2006.

The company has already completed two late-stage studies of Provenge, which is in clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

The amended study will enroll about 500 men, and the primary endpoint of the study will be overall survival, with a secondary endpoint of time to objective disease progression.

Robert M. Hershberg, Dendreon`s chief medical officer, said, "In addition to providing additional information for our safety database to support our Biologic License Application submission, the trial could provide us with an opportunity for an expanded label in patients with minimally symptomatic disease in the future."

Dendreon Announces Public Offering of Common Stock
Monday November 28, 6:00 pm ET


SEATTLE, Nov. 28 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that it plans to publicly offer 10,000,000 shares of its common stock pursuant to an effective registration statement previously filed with the Securities and Exchange Commission. The Company also intends to grant the underwriters of the offering an option to purchase up to an additional 1,500,000 shares of common stock. All of the shares will be sold by Dendreon. Banc of America Securities LLC will be the book-running manager for the offering. JMP Securities and Lazard Capital Markets will be co-managers.
A preliminary prospectus supplement relating to the offering of the securities will be filed with the Securities and Exchange Commission but remains subject to completion. These securities may not be sold nor may offers to buy the securities be accepted prior to the time that the prospectus supplement and related prospectus are delivered in final form. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Copies of the preliminary prospectus supplement relating to the offering may be obtained from Banc of America Securities LLC (by email at [e-mail]) or from Dendreon Corporation (Attn: Investor Relations, 3005 First Avenue, Seattle, WA 98121).

[kep]

[posting]19.245.710 von therman am 11.12.05 19:02:59[/posting]@therman

Habe bei DNDN bei 5$ nachgekauft.

keine schlechte idee. wie war dein einstandskurs?

DNDN wird m.E. bei Zulassung nächstes Jahr auf mindestens 20$ ansteigen.

mit der betonung auf mindestens

Vielleicht interessiert dich folgender auszug aus einem newsletter. es hat mit DNDN zwar gar nichts zu tun, aber interessant hört es sich trotzdem an.
kaum hatte ich eine (kleine) position aufgebaut, schon liege ich 20% vorn.
VPHM und ELN entwickeln sich auch gut.

Es handelt sich um
um VirtualScopics VSCP .


This medical company has just come public.
For years it was the darling of
The FDA and Big Pharma...
But now that it’s public, its 4D imaging technology
will soon make its way into every hospital,
doctor’s office and MRI center across the globe.
...turning ordinary investors into millionaires
Its private investors include Pfizer,
GE and Loeb, to name a few...and
9 of today’s top 10 pharmaceutical companies
are vying to be their customers.
...Here’s what they know and what the rest
ofthe world is about to find out!

Dear Reader,

The last few decades have brought about quantum leaps in technology in just about every aspect of life… from the way we do business, to the video games our kids play.

In fact, just 10 years ago most people would tell you that e-mail and cell phones were Star Trek gadgets - as hard as that is to believe.

But what all these life altering technologies share in common is that each provided an invaluable service that was adopted by the masses almost immediately. Not regionally but globally.

The technology developed and patented by the company I’m about to share with you will soon be as common place in your local hospital or doctors office as cell phones are on Main Street USA.
Invest alongside Pfizer and GE and watch your investment “pop”
185% over the next 4 months!

There are a number of reasons I’m excited about this newly minted public company but the most important is the economic revolution that it will almost instantly create.

In fact, their market potential is so immense that they were courted by the biggest players in medicine before they ever considered going public!

The below reads like a who’s who of strategic investors – and each are heavily vested in the company I’d like to reveal to you in my new research report “Image based biomarkers: the biggest biotech breakthrough in 20 years ”

* The Loeb Group in 2001
* Pfizer in 2002
* GE in 2003
* Trillium Partners in 2003

This humble little company was getting so much private attention they had to cut off funding… They didn’t need any more money!. Their technology was already in place… patents already secured… and big ticket customers already lined up out of the door.

What these guys all know – but Wall Street doesn’t yet - is that this company’s product is already becoming the new standard of medical diagnostics… and will soon makes its way into every hospital, doctor’s office, and MRI center across the world.

(GE, who controls 60% of the medical diagnostic machine market, has said they want this company’s software installed in all of its machines by 2008 …more on that in a moment).

That’s the main reason I’m so excited about this company and that’s why I’m expecting its shares to climb from $3.50 to $10 in the next four months and reach $200 or more over the next few years.

My name is Luke Hodgens. I’m editor in chief of Powerhouse Profits, an independent research newsletter for conservative investors.
Look beyond the obvious… where real wealth is made

By the time hot investment ideas hit the main stream press they’ve already exhausted most of their profit potential. For example, it would seem obvious to most any investor today that the right oil and gas stock could return big profits.

And while it may be true that you can still bank a tidy sum off the right pick – the days of explosive triple digit gains in oil and gas are over. But… if you’d recognized the trend a few years ago, as I did within the pages of my monthly investment advisory, you could have turned $10,000 into $429,800!

That’s enough to pay off your first and second homes!

Here’s what I mean… in July of 2003 I wrote an issue called Making the Case for Cheniere. In it I told my subscribers that liquefied natural gas was the single most viable alternative energy on the market…

… that any company that could wrap its hands around the technology to liquefy, store, ship, and regassify it would have the market cornered. Well, Cheniere Energy (LNG), at the time a tiny $1.78 stock, turned out to be just that.

Today LNG is trading at $37 after a two-for-one stock split -- that’s a 4,298% gain.
My new investment research report “Image based biomarkers:
the biggest biotech breakthrough in 20 years”
reveals a stock that could make Cheniere’s gains pale by comparison

Of course a 185% return in four months is phenomenal… but once I explain what this technology does (notice I said does and not can do – there is nothing theoretical about this company – its technology is already working miracles)

…I think you’ll agree that the initial “pop” it will receive in share price is merely a drop in the bucket of what it will do within the next three to four years.
Big Pharma has a serious problem and only this company can fix it

Globally, pharmaceutical companies spend nearly $30 billion a year on research and development to bring new drugs to market. But they always run into the same problem, which dramatically increases the cost and time it takes to bring their products to market: clinical trials.

In a recent study, Lehman Brothers and McKinsey co., estimated that roughly 7 years (50% of the total time) and $690 million (80% of the total cost) is directly attributed to the clinical trial process. Now, consider these facts:

* On average it takes $1 billion to bring a new drug to market.
* It typically takes 10-14 years for a new drug to receive FDA approval.
* Pharmaceutical companies will spend between $5 and $995 million just to find out if their drug will meet FDA approval.
* MOST drugs will not meet approval!

But what if there was a way to determine early on if a drug will meet approval? That kind of information would be worth hundreds of millions of dollars to each of the major pharmaceutical companies, would it not?
Reducing the time from discovery to market – a $30 billion business

Let’s say you were conducting clinical research in arthritis and inflammation. Well, the success of your trial is going to rely almost exclusively on the quality and depth of your image analysis.

Chances are you’ll be studying a two dimensional, black and white, MRI pinned up to a light box. An MRI (magnetic resonance imaging) uses magnetic energy and radio waves to create cross-sectional images or " slices" of the human body.

The problem is that it does so in just three ways:

* Coronal orientation: in a cross section (plane), for example, across the shoulders, dividing the body into front and back halves.
* Sagittal orientation: in a cross section (plane), for example, down the middle, dividing the body into left and right halves.
* Axial orientation: in a cross section (plane), perpendicular to the long axis of the body, dividing the body into upper and lower halves

But these images cannot immediately tell you this critical information:

Is that cartilage I see or water? …If it is cartilage, how thick are the cartilage walls? …Are they deteriorating? …If so, at what rate? …Will my results comply with FDA regulations?

Because you can’t analyze this data in “real time” you’re forced to pay 1,000 or more subjects to participate in your study to eliminate “noise” (variations in testing)… you’re forced to make your test 24 months long or longer so that you can study the rate of deterioration… then you’re left hoping everything you’ve done is in compliance with the FDA.

This is a time consuming, expensive, and risky endeavor. Until now...
Real time 4D analysis instantly tells you what you need to know

Now, let’s say you plug your MRI into our company’s software. Instantly you can isolate the area of concern and analyze it in 4 dimensions (4D = 3D + time).

You’ll know immediately if the darkness around the joint in question is cartilage or water. At the click of your mouse, you can dissect the cartilage tissue to measure its thickness, integrity, and strength.

Because you can analyze this data real time and not have to wait on months of what could be faulty data, you can immediately stop, add, or subtract what you’re doing to get the results you want.

You’ll know instantly if your drug is working, which means you’ll know instantly if your drug is a “go or no go”.

In other words, you’ll get greater precision with smaller, faster trials… saving your company upwards of $995 million per project!

This is happening right now with the consent and approval of the FDA. In fact, Astra Zenica, Amgen, Johnson & Johnson, and Wyeth are all on a waiting list to use this company’s software!
But that’s just the tip of the iceberg…

There’s no doubt that diagnostics is the first market this company will conquer. GE has already committed to having its software installed in all of its diagnostic machines within the next 3 – 5 years (think Microsoft Windows).

Being that GE controls 60% of the medical diagnostics market, this little company can do nothing for three years and its stock price will still quadruple.

But where the impact of this technology will really be felt is in doctors offices across the globe.

Let’s use oncology for example.

Say a patient is diagnosed with brain cancer. Often times a doctor will administer a drug designed to shrink and ultimately kill the tumor. He’ll take a CAT Scan (CT) on day one and measure the size of the tumor from his readout using a ruler or pair of calipers.

He’ll then ask the patient to continue taking the drug for 8 weeks and come back to see if the tumor has shrunk. The problem is that many times a drug will be working – killing the tumor from the inside – but not show any change in size on the 2 dimensional CT readout.

The doctor will conclude that the drug isn’t working and change his treatment – often with dire consequences to the patient.

With this 4D software the same doctor will take a CT and administer the prescribed drug... but just two days later call the patient back for an evaluation. The doctor will instantly discern from his digital readout:

* If blood flow (what feeds a tumor’s growth) is effectively being cut off (an MRI or CT cannot show this).
* The exact size and thickness of the tumor as compared to before (again, an MRI or CT can’t do this).
* If the patient is positively responding to the drug.

The patient will not have to wait 8 weeks to find out something inconclusive (an eternity in the life of a cancer patient). The doctor will not have to rely on inaccurate, incomplete information to make life or death decisions.

The result is a real time diagnoses that can be tweaked and changed within days to find the optimum way to bring the patient back to health.

This software will forever change the way we fight cancer… there’s no telling just how high that will push the share price of this company.
Strong Intellectual Property = Barriers to Entry & HUGE Profits

“Biomarkers will fundamentally change the way drugs are developed. Using biomarkers should make drugs more effective and reduce side effects.”

This statement was recently released from drug maker Eli Lilly’s top brass – and they were referring to our company!

OK, but what is a biomarker? A biomarker is defined as an anatomic, physiologic, biochemical, or molecular parameter associated with the presence and severity of a specific disease.

For example, high cholesterol is a biomarker for heart disease… increased PSA levels are a biomarker for prostate cancer… and deteriorated cartilage is a biomarker for arthritis.

But here’s the best part: this company is the only company on earth to patent a biomarker. And not just 1 -- but 90!!

I know… it sounds too good to be true, but I assure you, there’s no catch. This company has exclusive rights to the means to dissect, measure, and analyze human tissue in real time - without ever breaking the skin!

That means as other companies try to analyze medical information the way ours does (as they invariably will), they’ll be directly infringing on our company’s patents!

It takes blue chip companies decades and billions of dollars to build an intellectual property portfolio like this!

But because this company pioneered the technology… and because they were the first to recognize the true value of biomarkers as a diagnostic tool, they were able “scoop” these patents up before anyone noticed.

In fact, because of the scope of this technology, the only company today with a comparable infringement/patent ratio is Microsoft! And I think you know what intellectual patents have enabled them to do!
The future of medical imaging is here, right now



http://www.virtualscopics.com/

[therman]

Hallo kep,

Meine ersten Käufe bei DNDN habe ich bei 5,94 und 6,15 dieses JAHR gemacht.

Die Geschichte von VSCP hört sich interessant an.

Gruß therman