Der erste Krebsimpfstoff

Dendreon Wins Final Medicare Coverage Decision on Prostate Cancer Drug

By Catherine Larkin - Jun 30, 2011 10:03 PM GMT+0200
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Dendreon Corp. (DNDN)?s prostate cancer medicine Provenge should be covered by the U.S. health plan for the elderly and disabled, regulators said, confirming a proposal from March.

The Centers for Medicare & Medicaid Services issued a final ruling today saying the $93,000 treatment is ?reasonable and necessary? for men with advanced, prostate tumors resistant to hormone therapy who have minimal or no symptoms. The decision is in line with prescribing information for the drug approved in April 2010.  

UPDATE 2-Medicare to cover Dendreon's prostate drug

http://www.reuters.com/article/2011/06/30/...ealEstateNews&rpc=43  

Umsätze nicht wie erwartet.

Wer hat auch Wunder erwartet bei Median 4 Monate  

 

Aber auf 12 $ runter, das ist schon heftig.  

http://www.businessweek.com/news/2011-08-04/...n-dendreon-plunge.html

 

ähnlich wie Sino-Forest!?

 

für diesen Kurssturz?

Leider ist mein Englisch nicht so gut.....ich habe mich trotzdem gut eingedeckt!

Gruß  

So viel zu weniger riskant. Dendreon (Nasdaq: DNDN) Lager ist der Handel um 65% heute auf den Fersen ein enttäuschendes Quartal. Vorbei  ist die ganzjährige Umsatzprognose von $ 350.000.000 auf 400.000.000 $,  wobei die Hälfte davon entfällt allein im vierten Quartal. Es  ist ein wenig schwer zu zu tun, 19.000.000 $ im Monat gehen die Umsätze  im Juli um durchschnittlich rund $ 60.000.000 pro Monat im vierten  Quartal.

Selbst  mit 50.000.000 $ Umsatz im letzten Quartal hat das Unternehmen noch  nicht einmal annähernd zu fließen positiven Cash, Ausgaben über $  100.000.000 in bar. Bei diesem Tempo würde das Unternehmen aus dem Cash in etwa sechs Quartale.

Natürlich  Einnahmen zu erhöhen; Dendreon neue Führung - wenn man es so nennen -  ist für "bescheiden" Quartal zu Quartal ein Umsatzwachstum. Das  Unternehmen plant zudem eine Skalierung zurück Aufwendungen sowie  einige der Start-up-Kosten weg, vorausgesetzt, die dritte  Produktionsstätte später in diesem Sommer verabschiedet.

Wann genau Dendreon wird in die schwarzen Zahlen zu bewegen, ist reine Vermutung, though. Ein  Analyst fragte, was Umsatzniveau des Unternehmens müssten getroffen, um  dorthin zu gelangen, aber das Management gesäumt und bevor er  schließlich zugab, dass es zu viele bewegliche Teile, um eine Antwort zu  geben hawed.

Das  Problem mit den passenden bezogen auf Umsatz wird durch die Tatsache,  dass Provenge ist speziell für den einzelnen Patienten hergestellt  intensiviert. Neben  der Verwaltung Außendienst Aufwendungen wie jeder Pharmakonzern würde  tun müssen, ist Dendreon abhängig passenden Herstellungskosten mit einem  Umsatz auf Kosten der Waren in Schach zu halten verkauft. Das  ist etwas, dass die jüngsten Markteinführungen von Medikamenten wie  Human Genome Sciences (Nasdaq: HGSI) BENLYSTA, Johnson & Johnson  (NYSE: JNJ) Zytiga oder Bristol-Myers Squibb (NYSE: BMY) Yervoy müssen  nicht zustande, weil sie sich Sorgen machen in großen Stückzahlen hergestellt werden.

Gleichzeitig muss Dendreon in der Lage sein, Rampe bis schnell. Die  Biotech beantragt die schleppende Einführung von Community-Ärzte nicht  zuversichtlich, dass sie schnell werde erstattet verursacht wird. Wenn  das Unternehmen richtig ist und Änderungen an Medicare Abrechnung sinkt  Erstattung Verzögerungen, können die Ärzte beginnen Verschreibung  Provenge mehr Patienten.

Bis wir einige Sichtbarkeit auf den Umsatz Rampe und Aufwendungen zu erhalten, ist Dendreon wird wirklich schwer zu schätzen. Glücklicherweise haben die Anleger viel Erfahrung mit der Volatilität von Dendreon ist pre-Provenge-Zulassung Tage.

Verfolgen Sie Dendreon, wie es seiner Markteinführung des Provenge weiter. Klicken  Sie hier, um es zu meinen Watchlist, die Ihnen helfen, den Überblick  über all unsere Foolish Analyse Dendreon hinzufügen.

http://www.fool.com/investing/high-growth/2011/08/...-whats-next.aspx

 

"Wer hat auch Wunder erwartet bei Median 4 Monate"

Auch hier die Frage was heißt bei Dir Median und wie sieht dieser bei dem einzig zugelsassenen Med.
(Wirkstoff Docetaxel, Produkt Taxotere) neben Provnege für diese Indikation aus?
Wie hoch ist dort der Median?
Wie sieht es mit den Nebenwirkungen aus?
Was kostet demnach die Behandlung mit Tax. wenn auch diese Punkte mit einbezogen werden?
Lebensqualität?

Kannst Du darauf antworten, bitte?  

 

http://seekingalpha.com/instablog/...ournalism-wherein-lies-the-truth

http://seekingalpha.com/article/...on-the-challenge-of-misinformation

http://seekingalpha.com/article/...age-is-still-on-track?source=kizur

Have Fun :-)  

Kommt doch alle ins Vical Forum!  

http://www.rush.edu/webapps/MEDREL/servlet/NewsRelease?id=1533  

Dendreon Begins Enrollment In Phase 2 Neu-ACT Trial For Second Active Cellular Immunotherapy Product Candidate, DN24-02

Dendreon Corporation (Nasdaq: DNDN) today announced that the company has begun enrolling patients into a Phase 2 trial for DN24-02, Dendreon’s investigational active cellular immunotherapy being evaluated for the treatment of HER2 positive cancer. The multicenter trial called Neu-ACT (NEU Active Cellular immunoTherapy) is expected to enroll approximately 180 patients to evaluate the safety and efficacy of DN24-02 as adjuvant therapy in patients with high risk HER2 positive invasive urothelial carcinoma, including bladder cancer, following surgical resection.

“We believe that our active cellular immunotherapy platform may have applications in the treatment of other cancers, and are pleased to offer patients and physicians access to DN24-02 through our Phase 2 Neu-ACT clinical trial,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer. “Initiating a Phase 2 clinical trial to evaluate immunotherapy outside of the treatment of prostate cancer is a significant milestone for Dendreon, and we look forward to the outcome of this important study.”

Neu-ACT is a multicenter, open-label, Phase 2 study. Patients will be randomized to receive either the investigational product, DN24-02, or standard of care. The primary endpoint of the trial will be to evaluate overall survival between these two groups of patients. Other objectives of the study are to evaluate safety, disease-free survival, and immune response to treatment with DN24-02. Additional information is available at http://clinicaltrials.gov.

http://www.thestreet.com/story/11278831/1/...t-candidate-dn24-02.html

 

http://www.foxbusiness.com/markets/2011/10/19/...n-aria-incy-ibb-xbi/

http://www.pharmabiz.com/NewsDetails.aspx?aid=65627&sid=2  

Dendreon Announces Webcast Presentations at Upcoming Conferences

http://www.marketwatch.com/story/...t-upcoming-conferences-2011-10-20  

Dendreon (-77.2%, in USD) hat im August ihre 2011-Jahresziele für die Provenge-Umsätze aufgehoben. Diese Enttäuschung betraf nicht nur Dendreon, sondern wirkte sich auch negativ auf viele Biotechnologie-Unternehmen aus, welche sich ebenso in der Produktlancierung befinden oder kurz davorstehen.

http://moneycab.com/mcc/?p=73622  

Was denkst Du wird DNDN am 02.11 vermelden?
July: 19M, August: 22M, Sep: ??

Analysten gehen von 22M für Sep. aus.
Die Anzahl der Insusion Centren ist steigen, dz. 716.
Kann es sein, dass die schwächer als geplanten Umsätze, mit der Unsicherheit bzgl. der Kostenerstattung zusammen hängen?

Wie wirkt sich die Klärung dsbzgl. auf den Umsatz aus?  

Immunotherapy with sipuleucel-T can be used relatively early in the course of metastatic CRPC.

http://jco.ascopubs.org/content/29/27/...ca1-8fd4-a16a19e7151f#sec-14

Sipuleucel-T is approved for use in patients with metastatic CRPC that are asymptomatic, or minimally symptomatic, and without evidence of visceral disease. Immunotherapy takes time to kick in, and although minor objective and prostate-specific antigen responses have been reported with sipuleucel-T, this should not be viewed as an agent that will provide rapid responses. Thus, sipuleucel-T may be considered almost an adjunctive therapy, given early, and followed by other therapies as needed. It is unknown whether therapies administered after immune therapy have an additive or synergistic effect, given that induced immune responses generally persist after the immune therapy has been discontinued. Retrospective data suggest that patients treated with docetaxel after sipuleucel-T had a longer survival than patients treated with docetaxel after placebo,26 which generates the hypothesis that treatment with immunotherapy before chemotherapy may represent appropriate sequencing. The optimal amount of time after (or before) the administration of sipuleucel-T before subsequently administering potentially immunosuppressive therapy (such as chemotherapy or steroids) is not known. However, because the trials of sipuleucel-T required that patients be off chemotherapy for at least 3 months before receiving the immune therapy, as a practical matter, that landmark can potentially be adopted.

The practical dilemma of the appropriate sequence of use of the two new noncytotoxic agents (sipuleucel-T and abiraterone) is being addressed by trials that are under development. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with Abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed  

 

die nächste rutsche...

langsam kommt DNDN zumindest wieder auf ein nicht mehr ganz so spekulatives Niveau runter  

 

Mein erster Tenbagger ist böse abgestürzt, aufgrund nicht erreichter Umsätze für Provenge, dem ersten Immunkrebstherapeutikum gegen Prostatakrebs.
Jedoch sind Umsätze in Höhe von US Dollar 64 Millionen! im letzten Quartal deutlich hinter den ursprünglichen Erwartungen geblieben, aber hochgerechnet kommt DNDN 2012 auf 300-400 Millionen US Dollar und kann den break-even erreichen.
Auch eine Zulassung für Europa ist in Q1 2012 vorgesehen mit Verpartnerungsmöglichkeiten!
Für mich eine zweite große Chance da Provenge erst am Anfang steht und Dendreon die weltweiten Rechte an Provenge hält und zudem trials für early Prostatakrebs im Köcher hat!

Sollte Dendreon die Labelerweiterung erhalten kann sich die Story wiederholen, Tenbagger?  

Mein Tenbagge is back, geiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiillllllllllll­lllllllllllllllllllllllllllllllllllllllll:

..

Dendreon Announces Fourth Quarter Revenues and Update on Commercialization


– Company Reports Gross PROVENGE Revenues of Approximately $82M in Q4, Gross PROVENGE Revenues of Approximately $228M in 2011 –
Press Release: Dendreon Corporation – 4 minutes 0 seconds ago.. .
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SEATTLE--(BUSINESS WIRE)-- Dendreon Corporation (Nasdaq: DNDN - News) today announced revenue for the fourth quarter ended December 31, 2011, reporting gross product revenue of approximately $82 million. This represents approximately 25% growth over the third quarter ended September 30, 2011, and approximately 230% growth compared to the fourth quarter ended December 31, 2010. In addition, Dendreon reported full-year gross revenues from PROVENGE® (sipuleucel-T) sales of approximately $228 million.

“We are pleased with the progress we have made in the launch of PROVENGE, which – based on its first full year of revenues – places it as one of the top 10 product launches in oncology,” said Mitchell H. Gold, MD, president and chief executive officer.

In addition, Dendreon provided the following updates:
• At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which: • More than 590 sites have infused PROVENGE, which represents the greatest growth in infusing sites quarter over quarter; and
• Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.

• Improved PROVENGE reimbursement landscape for customers and patients: • Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
• The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
• A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.


“Given our results for the past two quarters, physician and patient interest in PROVENGE clearly continues to grow. We believe that the improved reimbursement landscape, along with our improved sales execution and physician education initiatives, are contributing to the increased use of PROVENGE in the community urology and oncology settings,” said Mitchell H. Gold, MD, president and chief executive officer. “We had a strong fourth quarter that exceeded our expectations. As we look to 2012, we expect modest quarter-over-quarter growth while we focus on bringing additional clinics on board and converting them into steady prescribers.”

“Importantly, we have sufficient cash-on-hand to meet our needs, and our focus operationally for 2012 is to reduce COGS across our manufacturing facilities to more efficiently produce PROVENGE for as many patients as possible,” said Gregory T. Schiffman, executive vice president and chief financial officer.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE. 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. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.