Der erste Krebsimpfstoff
-- New Manufacturing Facility Under Development to Provide Additional Manufacturing Capacity to Support Commercialization of PROVENGE --
-- Ribbon-Cutting Ceremony Scheduled for September 30 --
SEATTLE and ATLANTA, Aug. 10, 2009 - Dendreon Corporation (Nasdaq: DNDN) today announced it has signed a lease agreement with Majestic Realty Co. to build a 160,000 square-foot manufacturing facility in Union City, Ga., where it expects to manufacture PROVENGE® (sipuleucel-T) for patients with advanced prostate cancer. The state of Georgia will be hosting a ribbon-cutting ceremony on September 30.
If approved by the U.S. Food and Drug Administration (FDA), Dendreon would launch PROVENGE from its existing facility in Morris Plains, N.J. and would then ramp up additional manufacturing capacity of PROVENGE at its other facilities under development in Union City and Seal Beach, Calif. once they are completed. The Company expects to disclose more details relating to its manufacturing facilities at an upcoming analyst day in New York City.
"We are pleased to announce that we are expanding our manufacturing capacity with the addition of two new facilities in Atlanta and Los Angeles," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We have particularly enjoyed partnering with the state of Georgia, Fulton County officials and the local community during this process and are grateful for their partnership and support as we prepare to commercialize PROVENGE to help the many patients with advanced prostate cancer who currently have few appealing treatment options."
"Hosting the 2009 BIO International Convention in May introduced biotechnology companies like Dendreon to Georgia's business assets," said Sonny Perdue, Governor of the State of Georgia. "Our state's world-class healthcare institutions and hospitals enable companies like Dendreon to conduct clinical research and engage in product development while benefiting from the vast scientific resources that Georgia has to offer."
About PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Dendreon recently announced that the pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study of PROVENGE in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The Company expects to complete its Biologics License Application (BLA) with the FDA in the fourth quarter of 2009.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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 www.dendreon.com.
Forward Looking Statements
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 and requisite receipt of FDA licensure for marketing and the risk that additional capital could be needed in the future for the potential commercialization of 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 presentation, except as required by law.
Contact Information:
Investor Relations:
Jennifer Cook Williams
Dendreon Corporation
(206) 829-1500
Media:
Katherine Stueland
WeissComm Partners
(415) 946-1082
Ich höre niemals auf mein Bauchgefühl und andere sollten es auch nicht tun.
Da! Da ist es schon wieder!
Ein split wäre jetzt völlig absurd. Jetzt geht es um Aufbau und Ausbau!
Da!...
Nicht Du Fredy, aber der Rest scheint zu pennen ;-)
http://www.investorvillage.com/smbd.asp?mb=971&mn=299056&pt=…
From IR about Analyst Day
-----Original Message-----
From: me
Sent: Wednesday, September 09, 2009 3:15 PM
To: Investor Relations
Subject: Analyst Day
Hello,
Something to pass on to management to keep in mind for Analyst Day ....
I'm pretty sure you guys know this, but it is SO SO important to say anyway. The
entire investment community is expecting something very big on Analyst Day. If you
do not deliver on these very high expectations, you can be assured that most will
bail out of the stock big time. It will not be pretty. I, however, will NOT be
selling on any news on the 24th so it will be extremely painful if there is nothing
new disclosed on this day. You guys cannot just repeat the same old presentation
like you did today and for the past several months. The 24th is considered special
whether you internally believe that or not. If you don't announce something
special, you should never have organized Analyst Day at all.
I hope and pray that you take serious advantage of Sept 24th to keep the investors
WELL satisfied.
I sincerely thank you for reading this.
Take care and good luck on the 24th!
IR Response:
--------------------------------------------------
Hi xxxx, and thank you for your input. Don't worry. We view the analyst day as
special as well and hope this will be a forum where we can roll out information
about our manufacturing and commercialization plans which we have never publicly
discussed before. I think it will be a highly informative day for people. Thanks
for your input.
Best regards,
-Jennifer
_____________________________
Jennifer Cook Williams
Investor Relations
Dendreon Corporation
(206) 829-1500
jwilliams@dendreon.com
Meiner Meinung nach völlig falsch, denn Dendreon wird mit Provenge die erste Prostatakrebsbekämpfung auf individuelle Casettentechnologie liefern.
Diese Casettentechnologie ist dann mit Neuvenge auf Brustkrebs....Darmkrebs etc. übertragbar!
Bayout für 50-60 US Dollar, mein KZ!
Beziehe unter dem Strich 60 % Risikoabschlag mit ein, nur zur Sicherheit (auch die Kommentare lesen, hier wird MM teilweise korrigiert).
Die Analyse hat er vor der Bekanntgabe der neuen FDA Richtilinen erstellt, diese könnte bei der
folgenden Pipeline starken Einfluß haben. Aber das ist wiederum Zukunftsmusik. :-)
FDA Richtlinie:
http://www.fda.gov/BiologicsBloodVaccines/...s/Vaccines/ucm182443.htm
Michael Murphy`s Analyse:
http://seekingalpha.com/article/...t-too-low?source=article_lb_author
Das ist keine Kaufempfehlungen, nur meine persönliche Meinung unter Zuhilfenahme der obigen LINKS. ;-)
http://www.investorvillage.com/...n=301127&pt=msg&mid=7939645
Foundations
The 20th century has seen 20 immunologist Nobel Laureates. People like Zinkernagel and Dougherty who discovered MHC restriction and Marrack, Kapler, Allison and Reinhertz who isolated T cell receptors for antigen. These scientists and others created the foundations for immune therapies but people like Reiner Laus (“Prostate” ’98) were able to fit the pieces or discoveries together and put them to use. The process that Laus and his associates came up with wasn’t ingenious for its complexity but rather for its simplicity and the recognition that the system, that is the immune system, doesn’t have to be reworked but just tweaked a little to recognize cancer as something to reject.
One of the most important discoveries of the 20th century was a simple, very short one page paper published in “Nature” in 1953 that described the DNA double helix. Watson and Crick’s paper started the revolution in biotechnology. The work of Laus et al will start a revolution in active specific immunotherapy for cancer that we are only beginning to discover the full impact of. Laus and his collaborators understood the implications of this statement, “New information indicates that DCs control responses by other classes of lymphocytes (B, NK, and NKT cells) and elicit T cell memory, a critical goal of vaccination.” The Dendreon scientists had the foresight to leave well enough alone when they decided to expose not only dendritic cells to the activation process but also T cells, B cells and NK cells (Table 2. Phenotype and Function of Provenge). With the recent discoveries of crosstalk between immune cells, the existence of NK cell memory, the synergy of adoptive T cell therapy and ASI and the feedback activation that helper T cells have upon DCs we are just beginning to see the wisdom in this approach.
The conference call that Dendreon hosts this week will be a pep rally for the future of cancer vaccines and give us some idea of what the future holds. Brewer, Gold, Urdal, Frohlich and the rest of the team at Dendreon had the persistence to take the science behind the cassette and guide it thru the regulatory gauntlet to approval and commercialization. They’ve been planning this conference call since ’06 when they first submitted the original Provenge BLA to the FDA. Since then they’ve expanded and refined their presentation. While the share price my not immediately reflect the potential that the company outlines in the call I’m confident that what we’re going to see is the beginning of a new era in cancer care. The next eighteen months are going to be mighty fine for Dendreon shareholders and lay a whole new foundation for cancer therapy.
By Zacks Equity Research
On Monday September 28, 2009, 2:21 pm EDT
Buzz up! 0 Print
Companies:Dendreon Corp.
Dendreon Corporation (NasdaqGM: DNDN - News) is likely to become the first company to receive approval from the US Food and Drug Administration (FDA) for an anti-cancer, immunotherapy based vaccine, as it released phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results for its key product candidate, Provenge, in April 2009. Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments.
Related Quotes
Symbol Price Change
DNDN 27.52 +0.90
{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of 2009. We believe that the FDA will approve Provenge in the first half of 2010 based on the positive late-stage study results. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S. We believe Provenge could have blockbuster potential if it is approved by the regulators.
Prostate cancer is the most common non-skin cancer in the U.S. and the third most common cancer worldwide. The American Cancer Society estimates that in this decade about 190,000 new cases have been diagnosed each year, and almost 30,000 men die every year from it.
We believe the approval of Provenge is critical for the financial performance of the company since the product has blockbuster potential and the successful commercialization of the drug can drive a company of Dendreon’s size to strong profitability.
The positive IMPACT results caused a significant rise in the company’s stock price. Taking advantage of its high stock price the company raised more than $200 million to support the manufacture and marketing of Provenge.
DENDREON CP (DNDN): Read the Full Research Report
Zacks Investment Research
Upgrade crossing
Dendreon initiated with a Buy at Canaccord Adams; tgt $43 (28.09)Canaccord Adams initiates DNDN with a Buy and price target of $43 saying with the randomized Phase III IMPACT trial reported out last April demonstrating a clear intent-to-treat overall survival benefit in men with asymptomatic hormone refractory prostate cancer they believe Dendreon is extremely well positioned to launch Provenge as the first blockbuster therapy for this indication. The firm says this data, along with a previously granted positive recommendation from an FDA advisory committee, an FDA approvable letter, and safe harbor via Special Protocol Assessment, supports the high likelihood of an amended BLA approval in Q2/10.
Dendreon Completes Submission of Biologics License Application for PROVENGE
Press Release
Source: Dendreon Corporation
On 8:30 am EST, Monday November 2, 2009
Buzz up! 0 Print
Companies:Dendreon Corp.
SEATTLE, Nov. 2 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.
Related Quotes
Symbol Price Change
DNDN 25.27 0.00
{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.
"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. "We look forward to working with the FDA to potentially make PROVENGE the first active cellular immunotherapy to be licensed in the United States."
PROVENGE is available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT (PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant Active Cellular immunotherapy). For more information regarding these studies, visit www.clinicaltrials.gov.
About PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer.
About Prostate Cancer
According to the American Cancer Society, prostate cancer is the most common 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. An estimated 192,280 new cases are expected to be diagnosed in 2009. Approximately 27,360 men are expected to die this year from the disease.
************************
The company said it will steadily ramp up production until full capacity is achieved by late 2011 at plants in New Jersey, Atlanta and Los Angeles, together able to support potential annual sales of $1.2 billion to $2.5 billion.
"The launch could be slow at first due to supply constraints, with demand outweighing supply in the first six months," said Deutsche Bank analyst Robyn Karnauskas. But peak annual U.S. sales of the drug may eventually top $1.8 billion, she added.
**************************
Let's call it 2 Billion in US sales to round it off...
Gold said Provenge manufacturing costs will run roughly 25%.
So... Of the 2B in revs from Provenge, 500M will go to its production. So we're left with 1.5B in profit.
Spread out over our roughly 115M shares comes out to about $13 eps. Now it's up to you to apply a multiple...
What kind of multiple should a cutting edge, potentially paradigm shifting, first-to-market, cancer immunotherapy biotech receive?
Assuming we reach the 2B mark in the US market by end of 2011, then our current PE would be roughly 2 (@ 26 pps) Yes 2.
What's the industry average? 8? 10? 12? 15?
And the best part is... THESE NUMBERS ARE FOR US SALES ALONE!!! This is not taking ROW sales into account which could be just as much as US...
And... P-I-P-E-L-I-N-E!!!!
http://messages.finance.yahoo.com/...2270&tof=49&frt=1#822270
Fri Nov 20, 2009 9:07am EST Email | Print | Share| Reprints | Single Page[-] Text [+]
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* Dendreon says FDA has accepted Provenge application
* Says will respond to the application by May 1, 2010
BOSTON, Nov 20 (Reuters) - Dendreon Corp (DNDN.O) said on Friday that the U.S. Food and Drug Administration has accepted its application to market its experimental prostate cancer vaccine and will rule on whether to approve it by May 1, 2010.
The drug, Provenge, is designed to treat men with advanced prostate cancer. If approved, it would be the first in a new class of treatment which use live human cells to activate a patient's own immune system.
The company has said it would be able to make enough Provenge to generate potential sales of $60 million to $125 million in the second half of next year. It expects to ramp up production to full capacity by late 2011 at plants in New Jersey, Atlanta and Los Angeles -- enough to support potential annual sales of $1.2 billion to $2.5 billion.
(Reporting by Toni Clarke, editing by Dave Zimmerman)
Wednesday, December 9, 2009, 10:12am EST | Modified: Wednesday, December 9, 2009, 10:13am
Dendreon to raise cash in advance of new cancer treatmentAtlanta Business Chronicle - by John Cook TechFlash
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Dendreon to submit Provenge for FDA OK in November
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Editorial
Dendreon Corp. is looking to turn on the marketing and production engines in advance of the launch of its prostate cancer treatment, Provenge.
The company said Wednesday it plans to sell 15 million shares of common stock, with proceeds from the stock sale being used to build-out new facilities in Atlanta and Orange County, Calif. as well its existing facility in Morris Plains, New Jersey.
Georgia offered Dendreon nearly $11 million in incentives to build the plant in Union City.
The Seattle biotech didn't disclose the price of the stock sale, which Dow Jones reports will increase outstanding shares by some 13 percent. But Luke Timmerman at Xconomy reports that the stock sale -- based on a five percent discount of today's closing stock price of $26.64 -- could easily raise $400 million.
Dendreon (NASDAQ: DNDN) is looking to begin selling its prostate drug, Provenge, after gaining FDA approval. And the company has talked before about its ambitious plans for manufacturing plants.
The stock has soared this year, up 481 percent to date as investors await the FDA approval.
TechFlash is a sister publication of Atlanta Business Chronicle.
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| Boardmail an "Heron" |
Wertpapier: Dendreon |
DGAP-News: CytoTools AG (deutsch)
CytoTools AG: Nach erfolgreichem Zwischenbericht der Phase IIa Studie für DermaProC in Deutschland werden die Planungen für eine deutsche Phase IIb Studie am diabetischen Fußulcer forciert
CytoTools AG / Sonstiges
10.12.2009
Veröffentlichung einer Corporate News, übermittelt durch die DGAP - ein Unternehmen der EquityStory AG. Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich.
--------------------------------------------------
Darmstadt, 10. Dezember 2009 - Der DermaTools Biotech GmbH, Tochter der CytoTools AG, liegen nun die Ergebnisse der Behandlung weiterer Patienten an den Zentren in Tübingen und Ludwigshafen vor.
Das dort verfolgte Studienprotokoll sieht vor, dass nur Patienten mit zwei chronischen Wunden an den Beinen, die eine vergleichbare Wund- und Durchblutungssituation aufweisen behandelt werden können. Diese Patienten sind nur sehr schwer zu finden, was zu den Verzögerungen geführt hat. Je eine Wunde des Patienten wird für 4 Wochen mit Wirkstoff- oder dem anerkannten Vergleichsverfahren 'feuchter Wundverband' behandelt. Nach 4 Wochen werden die Ergebnisse der Parameter Sicherheit, Verträglichkeit und Reduktion der Wundfläche protokolliert.
Alle behandelten Patienten haben die DermaProC Lösung außerordentlich gut vertragen und es traten keinerlei unerwünschte Nebenwirkungen oder allergische Reaktionen auf. Damit sind die wichtigsten Parameter Sicherheit und Verträglichkeit zu 100% erreicht. Weiterhin stellte sich bereits in den ersten 4 Wochen bei über 80% der mit DermaProC behandelten Patienten eine deutliche Reduktion der Wundfläche ein. Die durchschnittliche anfängliche Wundfläche in der DermaProC Gruppe betrug 15,7 cm², die in der Vergleichsgruppe 14,0 cm². Im Beobachtungszeitraum haben zwei Patienten die Behandlung auf eigenen Wunsch vorzeitig abgebrochen.
Aufgrund der bislang in allen Studien in Deutschland und Indien erhaltenen Ergebnisse über die ausgezeichnete Sicherheit und Verträglichkeit sind damit die Vorraussetzungen geschaffen, um eine indikations- und wirksamkeitsspezifische Phase IIb Studie am diabetischen Fußulcer nun auch für Deutschland zu beantragen. Aufgrund der bislang vorliegenden Ergebnisse sieht der Studienentwurf vor, 80 Patienten an drei unterschiedlichen Zentren (Schwerpunkt Diabetologie) zu behandeln. Es werden Patienten mit einer Wunde eingeschlossen und die Behandlung wird in zwei Gruppen (Wirkstoff- bzw. Kontrollgruppe) durchgeführt. Die Antragsstellung zur Genehmigung dieser Studie in Deutschland wird in Q1/2010 durchgeführt werden.
Chronische und schlecht heilende Wunden stellen ein ernstzunehmendes medizinisches Problem dar. Allein in Deutschland leiden rund vier Millionen Menschen unter schlecht beziehungsweise nicht heilenden Wunden, die durch Durchblutungsstörungen oder Verbrennungen hervorgerufen werden. DermaTools hat es sich zur Aufgabe gemacht, innovative Wirkstoffe zur Behandlung dieser schlecht heilenden Wunden zu entwickeln. Mit DermaProC befindet sich in Deutschland ein erster aussichtsreicher Wirkstoffkandidat in den entscheidenden klinischen Phasen.
Über die CytoTools AG Die CytoTools AG ist ein Technologieholding- und Beteiligungsunternehmen. Sie ist aus der CytoTools GmbH, einem erfolgreichen deutschen Technologieunternehmen aus dem Pharma- und Medizinproduktbereich hervorgegangen. Die grundlegenden neuen wissenschaftlichen Erkenntnisse der CytoTools AG, die das Resultat langjähriger intensiver Forschungsarbeiten darstellen, haben zur Gründung von drei Tochterfirmen geführt, mit denen die Produktentwicklung in den unterschiedlichen Indikationsgebieten durchgeführt wird. Die CytoTools AG hält jeweils Beteiligungen in Höhe von 49,9 % an der DermaTools Biotech GmbH (Therapiebereich Dermatologie), 24,7% an der TemplaTech GmbH (Therapiebereich Harnwegsinfektionen) und 46% an der CytoPharma GmbH (Therapiebereich Herz-Kreislauferkrankungen). Das gesamte Know-how ist durch entsprechende Basispatente geschützt.
CytoTools AG Dr. Mark Andre Freyberg Klappacher Str. 126 64285 Darmstadt
Tel.: +49-(0)6151-9515812 Fax: +49-(0)6151-9515813 E-Mail: kontakt@cytotools.de
10.12.2009 Finanznachrichten übermittelt durch die DGAP. Medienarchiv unter www.dgap-medientreff.de und www.dgap.de
Hier die Richtige:
Dendreon Appoints Hans Bishop as Chief Operating Officer
- Seasoned Global Oncology Executive Joining Team, Expanding Company's Commercial Expertise -
Press Release
Source: Dendreon Corporation
On 6:30 am EST, Thursday December 10, 2009
Buzz up! 0 Print
Companies:Dendreon Corp.
SEATTLE, Dec. 10 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that Hans Bishop has joined the Company as chief operating officer, effective January 4, 2010. Mr. Bishop most recently served as president of the specialty medicine business at Bayer, where he was responsible for a diverse portfolio of oncology, hematology, and neurology products. Mr. Bishop also served as an executive vice president of Bayer HealthCare LLC.
Related Quotes
Symbol Price Change
DNDN 26.11 0.00
{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} As a member of the Dendreon executive management team, Mr. Bishop will be responsible for preparing for and leading the commercial launch of PROVENGE® (sipuleucel-T), including sales and marketing, as well as manufacturing, supply chain, quality, and facilities engineering.
"Hans' extensive and successful global commercial experience will add tremendous value to Dendreon's already strong executive team as we prepare for the launch of PROVENGE in the coming year," said Mitchell H. Gold, M.D., president and chief executive officer. "Hans' deep knowledge of sales and marketing, manufacturing and operations will be integral to our success as we transform Dendreon into a commercial organization and work to fulfill our mission of transforming the lives of patients with cancer."
During his tenure leading specialty medicine at Bayer HealthCare, Mr. Bishop grew the specialty medicine business into a euro 3 billion global franchise, including overseeing the successful growth of Nexavar® and the significant expansion of the company's oncology pipeline. Prior to this position, Mr. Bishop served at Chiron Corporation as senior vice president of global commercial operations, as well as vice president and general manager of European biopharmaceuticals. In these roles, Mr. Bishop was responsible for commercial operations for the Global Biopharmaceuticals Division, leading country operations and programs such as new product development and pricing.
Earlier in his career, Mr. Bishop served in roles of increasing responsibility that included sales and marketing as well as business development at Glaxo Wellcome and SmithKline Beecham. He also spent four years as the executive vice president of operations with a global telecom service company, where he managed nine subsidiaries on three continents, before facilitating the sale of the company in 2004.
Mr. Bishop received a B.S. in chemistry from Brunel University in London.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce ACI product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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 www.dendreon.com.
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Both companies are working on drugs for prostate cancer. Everything with Dendreon (DNDN) hinges on its cancer drug, Provenge. The drug was approved in 2007 and then revoked pending new data from a continuing study. That data was released earlier this year and met all target points. On that alone, the drug stands a great chance, never mind the fact that the results exceeded expectations. Management and the FDA are working closely together to work through the issues. Sanofi (SNY) already has a prostate cancer drug, Taxotere, with $2 billion-plus in sales. Taxotere has enormous side effects, however, compelling many men to prefer cancer than use the drug. Provenge solves many of the issues and Sanofi would probably love to scoop it up before Dendreon becomes a $50 stock post-approval.
by: SA Editor Miriam Metzinger January 10, 2010 | about: FITB / DNDN / BA / CDY / SLX / WDC Miriam Metzinger 565
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an article to Font Size: PrintEmail TweetThis Stocks discussed on the lightning round session of Jim Cramer's Mad Money TV Program, Friday January 8.
Bullish Calls:
Fifth Third Bancorp (FITB): "Fifth Third Bank is a winner… I saw it tick off $11 today, and I remember when Goldman Sachs came out at $10 and said buy this one… Fifth Third, really good piece out the other day from one of the major firms, it was Morgan Stanley, talking about what banks could you do well… commercial real estate does well… this one, $15... I really like it here."
Dendreon (DNDN): "If they have the ultimate vaccine for cancer, you know this thing is going much higher… in the interim, I think that you stay with it, because this thing could go up 10 points on good news… so I think you are okay… I know that you battled back to even, let’s just stay long with it right now."
Boeing (BA): "I believe Boeing is an $80 stock… we are at the beginning of a major seven year move in Boeing… somebody downgraded it today on price… I say boo! This one is going higher."
Tue Jan 12, 2010 12:19am ESTStocks
Dendreon Corp
DNDN.O
$30.36
+0.06+0.20%
12:00am UTC+0100
SAN FRANCISCO, Jan 11 (Reuters) - Dendreon Corp (DNDN.O) expects to reach full manufacturing capacity for experimental prostate cancer drug Provenge by mid-2011, and will immediately launch sales of the drug when it is approved by U.S. regulators, the company's chief executive said on Monday.
Speaking at the JP Morgan healthcare conference here, CEO Mitchell Gold said an existing manufacturing plant in New Jersey is at 25 percent capacity, and will be up to full capacity -- supporting annual sales of $500 million to $1 billion -- by the first half of 2011.
Two other plants -- one in Southern California and another in Atlanta, each able to support sales of $375 million to $750 million -- are expected to be online by mid-2011.
The U.S. Food and Drug Administration is slated to decide whether to approve the drug by May 1.
Provenge, a therapeutic vaccine designed to activate a patient's own immune system, is produced by taking cells from a patient's tumor, incorporating them into a vaccine, then returning them to a physician to be injected back into the patient.
Gold said Provenge will be priced "in line with other biologics that prolong survival."
The company reported last April that Provenge extended survival in men with advanced prostate cancer. An outside advisory panel of doctors had recommended in March 2007 that the FDA approve Provenge, based on favorable efficacy and safety results from an earlier Phase III study, but the agency had declined to approve the medicine until data was shown to confirm earlier trends.
Gold said on Monday that the FDA has shown "no indication" that it would convene another advisory panel to review Provenge.
The CEO said Seattle-based Dendreon, which raised $410 million in a stock offering in December, has about $600 million in cash.
The company plans to commercialize Provenge on its own in the United States, but is looking for a partner to develop the drug in overseas markets.
Gold said Dendreon is in discussions with several potential overseas marketing partners, some of which had been seeking a share of the U.S. market for Provenge.
"We don't feel a lot of pressure to enter into a deal," he said.
The CEO also said Dendreon is "looking at" the use of Provenge in earlier-stage prostate cancer as well as other cancer types. (Reporting by Deena Beasley; Editing by Muralikumar Anantharaman)
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