Der erste Krebsimpfstoff
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| eröffnet am: | 17.02.05 15:17 von: | Nassie | Anzahl Beiträge: | 273 |
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interessant
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witzig
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gut analysiert
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informativ
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9
17.02.05 15:17
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 Kursverlust von 19 Prozent, den die Aktie von Dendreon (Nasdaq: DNDN; WKN: 615606) 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.
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15.12.11 13:37
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?
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05.01.12 16:01
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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.
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05.01.12 16:28
Das Gute ist die erste Immunkrebstherapie, Provenge von Dendreon gegen Prostatakrebs die von bad money und drecks shorties versucht wurde zu töten und sie töteten mit der FDA tausende Männer die schon seit 2007 Provenge hätte erhalten sollen! Pfui daifi, drecks Korruption und Chemokartelle!
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05.01.12 18:48
Go Debbie go........................................
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06.01.12 09:26
Die alten Kurse werden wir 2012 hinter uns lassen! ;)
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06.01.12 11:39
http://keyinvest-ch.ubs.com/seite?pageID=25&newsID=263410
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06.01.12 20:11
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08.01.12 10:50
Gründe: EU/ROW Partner , steigende Umsätze, weltweit alleinige Rechte und eine einmalige
Plattform um andere Krebsarten wie Brust, Blutkrebs.... zu behandeln und das
Alles ohne Chemo sondern mit dem eigenem Immunsystem!
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08.01.12 16:31
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08.01.12 16:54
Go Debie go......................................................
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08.01.12 22:16
hat so eben auch so ein mittel gegen krebs, und der kurs hat auch
schon reagiert.
bin derzeit weder dort, noch hier investiert
http://www.ariva.de/generex_biotechnology-aktie
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09.01.12 14:25
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09.01.12 18:36
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10.01.12 10:51
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10.01.12 18:58
http://video.cnbc.com/gallery/?video=3000066264
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11.01.12 20:31
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15.01.12 09:10
By: iStockAnalyst | Jan 06, 2012 | Stocks: DNDN,
inShare0
Deutsche Bank (DB : 36.31, -0.69) maintained its "Buy" rating and price target of $20 on biotechnology company Dendreon Corp. (NASDAQ:DNDN : 14.02, 0.23).
The company preannounced Q4:11 Provenge net sales of $77 million, which was well ahead of guidance of limited growth vs. Q3, DB said. Provenge is the company's prostate cancer therapy.
"We view this as a positive & the clarity investors on the sidelines have been waiting for as it indicates that Provenge is gaining traction w/ urologists," DB said. "We are increasing our Provenge ramp but maintaining peak sales."
The stock, which has been trading in the 52-week range between $6.46 and $43.96, rose 12.9 percent to $12.00.
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22.01.12 13:57
On 1/3/2012 (but news went out on 1/4/2012 after markets closed), Dendreon (NASDAQ: DNDN) granted a grand total of 1,387,000 shares to executives and directors. Quite a big number both in dollar terms ($10,000,000 give or take) and as a percentage of company capital: It’s somewhat less than 1% of total float.
All stock has been granted for free. Exercise price is $0.
Breakdown of stock grants is as follows:
This restricted stock award vest as follows: 25% on the first year anniversary and 6.25% quarterly thereafter:
John E. Osborn, EVP, General Counsel: 150,000
Gregory T. Schiffman, CFO, EVP of Finance & Treasure: 150,000
Mark W. Frohlich, EVP, Clinical Affairs & Chief Medical Officer, 150,000
Greg Cox, VP, Finance, 52,000
Richard J. Ranieri, EVP, Human Resources, 200,000.
All restricted stock shares vest (become sellable) on date of grant:
Richard B. Brewer, Director, 25,000
Susan Bayh, Director, 25,000
Pedro Granadillo, Director, 25,000
David C.Stump, Director, 25,000
John H. Johnson, Director, 25,000
Bogdan Dziurzynski, Director, 25,000
Gerardo Canet, Director, 25,000
Douglas G. Watson, Director, 25,000.
The award will vest ratably over 3 years based upon the achievement of Company performance goals:
Mitchell H. Gold, President & Chief Executive Officer, 460,000.
All restricted stock shares are fully vested (become sellable) on the first anniversary of the date of transaction:
Dennis M. Fenton, Director, 25,000
As if to mitigate shareholders’ anger, the following day Dendreon announced fourth quarter revenues and updated on commercialization. News was good and the stock price reacted accordingly. They almost doubled since.
I have two themes to develop today.
One is: why did management grant itself a so large amount of common shares?
The other is: how much is Dendreon worth?
Well, just start with a tentative answer of the second question.
I prepared a comparison table, as a valuation exercise.
We see that large, stable biotechnology companies have Price to Sales ratios ranging from 3.84 to 6.96; and Price to Earnings ratios from 16.86 to 30.79.
Company
P/S
P/E
Dendreon Valuation Table
Amgen Inc. (AMGN)
3.84
16.86
Gilead Sciences, Inc. (GILD)
4.12
13.32
Celgene Corporation (CELG)
6.96
30.79
Biogen Idec Inc (BIIB)
5.72
24.34
I also want to add some spice here.
On Saturday, January 7, 2012, Bristol-Myers Squibb Company (NYSE:BMY – News) and Inhibitex, Inc. (Nasdaq:INHX – News) announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire Inhibitex for $26.00 per share in cash pursuant to a cash tender offer and second step merger. The transaction values Inhibitex approximately $2.5 billion.
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. It does not have any single product on the market to date.
So, back to our question: How much is Dendreon worth?
Dendreon said:
■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.
Dendreon also said:
■EU application filed. Discussing partnering.
■“compelling” data to be presented at AUA and ASCO on both effect of Provenge at tissue level pre-surgery AND further analysis of Frovenge effect and “true” clinical benefit of Provenge.
■EU application filed. Discussing partnering.
■Sequencing study for Provenge and Zytiga.
■Discussing Japan with regulatory authorities.
■Projects underway to reduce COGS with automation.
■Special sales team for urology practices and with key aim of making large urology practices big prescribers.
I think we have enough data in place to try some “what if”.
What if Dendreon reaches $500 M within twelve months for now?
Valuation would range from $2B to $3.5B if it were a mature biotechnology. But, since DNDN is in “growth mode”, it think it might get an even higher price.
It all means a price per share (pps) in the $14-$28 range.
What if we add the $2.5B “acquisition premium” Bristol-Myers Squibb Company paid to gain control of Inhibitex? Then pps would be in the $30-$42.
Now, you see, I think I can give an answer to the first question: Why did management grant itself a so large amount of common shares?
In my opinion, management knows that current DNDN stock price is low and that a high enough offer (say, in the mid $30s) would be impossible to resist and would also still be a bargain for the acquirer.
I want to close this article with another “What If”, to see if, say, a hostile offer of $40 per share would be a bargain for the acquirer.
What if, in 2015, Dendreon reaches $1.5B in sales in the USA, $1B in Europe and $0.5B in Japan?
Dendreon would then have $3B in sales and we know from management that Dendreon would enjoy a 50% earnings margin. That would mean earnings of $1.5B. A reasonable Price-to-Earnings ratio might be 20. Just multiply $1.5B x 20 and we get $30B.
It would mean a pps of $210.
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25.01.12 12:00
buyout rumors:
Amgen to Acquire Dendreon
http://www.benzinga.com/trading-ideas/long-ideas/...nzinga+News+Feed)
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01.02.12 14:57
They will be replaced by John Johnson, known to biotech investors for taking control of ImClone Systems in 2007 and eventually selling the company to Eli Lilly for $6.5 billion. Johnson was already on the company’s board.
Johnson will take the CEO role immediately. Gold will serve as executive chairman until June 30, at which point Johnson will take that role, too. Brewer, the chairman, will remain a director.
(zitiert aus Forbes vom 1. Feber 2012, M. Herper)
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04.02.12 21:54
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06.02.12 22:08
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07.02.12 14:56
FREE Breaking News Alerts from StreetInsider.com!
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More News related to AMGN
Canaccord Genuity Raises Numbers on Dendreon (DNDN); Provenge Outlook Improved on Low Likelihood of New XGEVA Approval
Wedbush Starts NPS Pharmaceuticals Inc. (NPSP) at Outperform; GATTEX Up for Approval, NATPARA Next
Notable 52-Week Highs and Lows of the Day 02/06: (THLD) (GILD) (AAPL) High; (CYDE) Low
Dendreon (DNDN) Now a Double on the Year Amid M&A Speculation
Lazard Capital Downgrades Amgen (AMGN) to Sell
More News related to AMGN
More News related to DNDN
Canaccord Genuity Raises Numbers on Dendreon (DNDN); Provenge Outlook Improved on Low Likelihood of New XGEVA Approval
Stock with implied volatility movement; DNDN
Notable 52-Week Highs and Lows of the Day 02/06: (THLD) (GILD) (AAPL) High; (CYDE) Low
Dendreon (DNDN) Now a Double on the Year Amid M&A Speculation
Notable Analyst Rating Changes 02/03: (DNDN) (BBT) (NOV) Upgraded; (RIMM) (VRTX) (AET) Downgraded
More News related to DNDN
More News related to Analyst Comments
Canaccord Genuity on Life Sciences/Biomedical Devices and Services: Take on Q4 and Beyond
Goldman Sachs Raises Estimates On Wynn Resorts (WYNN), Maintains Neutral Rating
Canaccord Genuity Maintains a 'Hold' on Genomic Health (GHDX); Slightly Misses in Q4; Forms New Genetics Subsidiary
Canaccord Genuity Reiterates a 'Buy' on Orthofix (OFIX); Clearing Up Legal Overhangs
Canaccord Genuity Raises Numbers on Dendreon (DNDN); Provenge Outlook Improved on Low Likelihood of New XGEVA Approval
More News related to Analyst Comments
February 7, 2012 8:28 AM EST
Canaccord Genuity maintains a 'Buy' on Dendreon (NASDAQ: DNDN) price target raiesd from $16 to $18.
Analyst, George Farmer, said, "We maintain our rating and raise our target as a negative FDA stance on Amgen’s (Nasdaq: AMGN) XGEVA de-risks the outlook for DNDN’s prostate cancer vaccine, Provenge."
"Encouraging December sales in the face of holiday conflicts had justified our previously bumped-up 2012 $426M sales estimate. Our new 2012 $458M estimate assumes near-term acceleration of “same-store-sales” fueled by higher physician perception, although we caution that negative practitioner impressions of logistics and cost still lingers. Nevertheless, $500M in sales this year – a management-declared cash flow break-even point – is not far fetched, in our view."
For an analyst ratings summary and ratings history on Dendreon click here. For more ratings news on Dendreon click here.
Shares of Dendreon closed at $16.53 yesterday, with a 52 week range of $6.46-$43.96.
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07.02.12 15:30
MMhh, Freitag die 18$, dat wäre es doch! ;)
O.o
GLTA
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07.02.12 16:22
Dendreon wird "the standard of care" in der Prostatakrebsbehandlung werden da neueste Studien zeigen daß Provenge auch bei beginnenden Prostatakrebs sehr gut wirkt!
50 US Dollar Kursziel innerhalb eines Jahres bzw. Übernahme durch big pharma!
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