Der erste Krebsimpfstoff

http://www.investorvillage.com/...n=369040&pt=msg&mid=9471473

Medicare's Provenge review comes into clearer focus

By John Carroll

Created Sep 2 2010 - 7:43am

With billions in revenue at stake, every new twist and turn in the saga revolving around the rollout of Provenge gets put under the microscope. Any possibility of market restrictions, a fear raised by CMS's decision earlier in the summer to review Provenge's use in the elderly, is enough to panic investors. To some, it looked as if the agency was considering that it might not pay for Provenge at all.

So when Medicare announced earlier this week that it's scheduled a Nov. 17 advisory panel meeting to discuss the "labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer," investors generally decided that Dendreon had dodged a bullet. TheStreet's influential Adam Feuerstein set the tone with a piece outlining the likelihood that Medicare is preparing to make sure that the patients OK'd for the $93,000 therapy look a lot like the patients picked for the late-stage registration trial. That still leaves Provenge poised to develop into a blockbuster, and Dendreon's shares jumped 6 percent.

Dendreon already has most of the carriers who manage each of Medicare's 15 regions on board to pay for the therapeutic vaccine. And there was never really any serious question that CMS would deny coverage altogether. They have never denied coverage of an approved therapy and only rarely go out of their way to draw a line around a drug's label, specifically excluding non-labeled use.

Just in case Medicare was considering stepping over the line, Sens. John Kerry and Arlen Specter waved them off in a recent letter expressing their concern. Patients and physicians have already made their feelings known to CMS. The events leave Provenge not just on track to blockbuster status, but politically connected as well. It doesn't get much better than that.  

Heute das CMS Panel, eigentlich eine Frechheit:

Doctors, users back Dendreon vaccine for Medicare

ShareretweetEmailPrintCompanies:Aetna Inc.Dendreon Corp.Humana Inc. Related Quotes
Symbol Price Change
AET 30.37 0.00

DNDN 35.87 0.00

HUM 58.26 +0.69

TRI 36.46 -0.33

TRI.TO 37.29 -0.41


{"s" : "aet,dndn,hum,tri,tri.to","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} On Wednesday November 17, 2010, 1:19 pm

* Vaccine approved to treat prostate cancer



* Nationwide coverage for $93,000 therapy at issue



* Medicare panel to offer agency advice



* Sales seen reaching nearly $2 billion by 2014



* CMS to make initial decision by end of March 2011



By Susan Heavey



WASHINGTON, Nov 17 (Reuters) - Patients, doctors and the company that makes a prostate cancer vaccine all urged U.S. Medicare advisers on Wednesday to support their pleas to have federal insurance pay for Dendreon Corp's (DNDN.O: Quote, Profile, Research, Stock Buzz) therapy regardless of its hefty price tag.



The Medicare advisory panel is weighing the evidence for the expensive therapeutic vaccine, called Provenge, and whether the government should pay for it under the nation's health insurance program for the elderly or disabled.



Centers for Medicare and Medicaid Services (CMS) officials will take the panel's advice into account in making a final ruling, expected next year.



The decision is not only critical for patients but also Provenge sales, which could reach $1.9 billion by 2014, according to data from Thomson Reuters (TRI.N: Quote, Profile, Research, Stock Buzz) (TRI.TO: Quote, Profile, Research, Stock Buzz).



"This is a new agent that is clearly beneficial for patients," said Dr. Mark Scholz, a California-based prostate oncologist and one of nearly two dozen speakers urging Medicare's support.



Most analysts expect Medicare to pay for Provenge even if additional data were sought, a move that could also encourage private insurers to follow suit.



Aetna Inc (AET.N: Quote, Profile, Research, Stock Buzz), Humana Inc (HUM.N: Quote, Profile, Research, Stock Buzz) and several other health insurers have already agreed to pay for the vaccine, which does not prevent cancer but fights the tumors, according to a company spokesman.



Provenge was approved for the U.S. market in April to treat men with advanced prostate cancer after company data showed it help men live another 4.1 months on average.



It costs $93,000 for three infusions given over the course of one month. While many cancer therapies are also expensive, their costs are spread out over more time or are stopped when they do not seem to be helping.



Dendreon says the high price reflects a unique manufacturing process that takes cells from a patient's tumor, mixes them with some of the patient's own immune cells and then infuses the immune cells back into the patient.



Unlike traditional vaccines that prevent disease, Provenge stimulates the body's immune system to attack malignant cells.



REASONABLE AND APPROPRIATE



Dendreon Chief Medical Officer Mark Frohlich told the panel the therapy, also known as sipuleucel-T, is one of few available options that actually helps patients live longer with fewer side effects, providing "an important new treatment."



While the Food and Drug Administration approved Provenge as safe and effective, CMS is deciding whether its use is "reasonable and appropriate." By law, it cannot consider the vaccine's cost in making its decision.



Still, there are larger financial concerns for Medicare, and patients have worried that the therapy's price was an unspoken stumbling block, especially since most men with prostate cancer are older and are covered by the program.



Medicare covers roughly 45 million Americans -- 40 percent of whom are men -- but faces possible insolvency and was recently targeted for major cuts by a U.S. deficit panel [ID:nN10200961].



"One has to wonder if today's meeting is indeed about something other than the science, namely the cost," said Brad Loncar of Kansas, whose grandfather had the disease. "It's very concerning."



Laurel Todd, the head of reimbursement and health policy for the Biotechnology Industry Organization industry group whose father had prostate cancer, said: "There should be no question that an FDA-approved therapy should be covered by Medicare for patients and conditions indicated on its label."



Nearly 218,000 U.S. men will be diagnosed with prostate cancer this year, according to he government's National Cancer Institute, although not all those men will either qualify for Provenge or be enrolled in Medicare.



CMS has said it is only looking at clinical data in weighing Provenge. The panel's chairman, Lewin Group Senior Vice President Clifford Goodman, noted the agency in the past has declined to pay for FDA-cleared drugs and devices but has also covered other, experimental ones not yet approved.



Shares of Seattle-based Dendreon have fallen nearly 38 percent from a year high in the wake of FDA's Provenge approval, in part over concerns about the product's launch.



Its shares were halted on Wednesday ahead of the Medicare advisers' votes.



The agency will factor in the panel's recommendations in making its proposed payment decision, expected by March 30. A final decision is due by the end of June. (Reporting by Susan Heavey. Editing by Gerald E. McCormick)


Follow Yahoo! Finance on Twitter; become a fan on Facebook.  

Dendreon?s Provenge Survival Data is Adequate, U.S. Panel Says
By Catherine Larkin - Nov 17, 2010 8:27 PM GMT+0100 Tweet LinkedIn Share
Business Exchange Buzz up! Digg Print Email Dendreon Corp. has shown adequate evidence to determine whether its prostate cancer drug Provenge improves survival, according to a U.S. panel helping the government decide whether to pay for the $93,000 treatment.

Outside advisers to Medicare, the health insurance program for the elderly and disabled, expressed confidence in the quality of the Provenge data at a meeting today in Baltimore. The panel will vote next whether they think the drug does help men with advanced prostate cancer live longer.

To contact the reporter on this story: Catherine Larkin in Baltimore at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.  

Dendreon Wins Medicare Panel's Backing That Provenge Helps Cancer Patients
By Catherine Larkin - Nov 17, 2010 8:49 PM GMT+0100 Tweet  (1)LinkedIn Share
Business Exchange Buzz up! Digg Print Email Dendreon Corp. won the backing of an advisory panel helping the U.S. government decide whether to pay for its $93,000 prostate cancer treatment.

Outside advisers to the Medicare health plan said today they were confident that Dendreon?s Provenge ?clinically significantly? improves survival in men with advanced prostate cancer. Medicare, the U.S. insurance program for the elderly and disabled, will take the recommendations into account in a coverage proposal due by March 30 and a final decision in June.

Seattle-based Dendreon won Provenge approval in April based on a study showing a four-month survival benefit. Three-quarters of patients approved for the drug also qualify for Medicare, making next year?s reimbursement decision critical for sales. Provenge may bring in $1.75 billion in 2014 with Medicare coverage, according to the average estimate of four analysts surveyed by Bloomberg.

?It improves survival without the additional adverse reactions that are known with some of the other cancer therapies,? panel member Karl Matuszewski, a pharmacology expert and editor for Reed Elsevier NV health publications, said today at the meeting in Baltimore. ?This is really another option.?

Dendreon shares are up 36 percent this year even after having fallen 28 percent since Provenge?s approval on April 29 because of reimbursement and supply concerns. Trading on the stock was halted today on the Nasdaq Stock Market.

To contact the reporter on this story: Catherine Larkin in Baltimore at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.  

Dendreon's Provenge Extends Survival, U.S. Panel Says
By Catherine Larkin - Nov 17, 2010 9:45 PM GMT+0100 Tweet  (2)LinkedIn Share
Business Exchange Buzz up! Digg Print Email  
Cell separation during the manufacturing process of Dendreon Corp.'s Provence vaccine for prostate cancer. Source: Dendreon Corp. via Bloomberg
Dendreon Corp. won the backing of an advisory panel helping the U.S. government decide whether to pay for its $93,000 prostate cancer treatment.

Outside advisers to the Medicare health plan said today they were confident that Dendreon?s Provenge ?significantly? improves survival in men with advanced prostate cancer. Medicare, the U.S. insurance program for the elderly and disabled, will take the recommendations into account in a coverage proposal due by March 30 and a final decision in June.

Dendreon won Provenge approval in April after studies showed a four-month survival benefit. Three-quarters of patients approved for the drug also qualify for Medicare, making next year?s reimbursement decision critical for sales. Provenge may generate $1.75 billion in 2014 with Medicare coverage, according to the average estimate of four analysts surveyed by Bloomberg.

?It improves survival without the additional adverse reactions that are known with some of the other cancer therapies,? panel member Karl Matuszewski, a pharmacology expert and editor for Reed Elsevier NV health publications, said today at the meeting in Baltimore. ?This is really another option.?

Panel members rated Provenge?s survival benefits on a scale of one to five with five being the most confident that the drug helps patients. The 10 voting members supported Provenge?s survival benefits with an average score of 3.6. Analysts had said that a vote of three or greater would be a win for Dendreon.

?Positive? Result

The recommendation is ?very positive? and ?will provide a relief to investors,? said Robyn Karnauskas, an analyst at Deutsche Bank Securities in New York, in an e-mail. ?We think stock could trade up with the removal of this overhang.?

Shares of Seattle-based Dendreon increased 36 percent this year even after having fallen 29 percent since Provenge?s approval April 29 because of reimbursement and supply concerns. Trading on the stock was halted today on the Nasdaq Stock Market.

Provenge is the first medicine that trains the body?s immune system to attack cancer cells as it would a virus. The therapy involves extracting white blood cells from a patient, mixing with vaccine components and delivering the combination as an infusion. Treatment lasts one month with three doses each given two weeks apart.

Prostate cancer will be diagnosed this year in 217,730 U.S. men and lead to 32,050 deaths, according to the American Cancer Society. Symptoms typically start when patients have less than a year to live. Of more than 1 million men with the disease, about 70,000 qualify for Provenge, according to Karnauskas.

No Cure

No cure exists for advanced prostate cancer that has spread outside the prostate gland. Patients often are given hormone therapy or chemotherapy drugs such as Paris-based Sanofi-Aventis SA?s Taxotere or Jevtana. Those drugs improved survival by 2.4 months in studies and are linked to higher rates of side effects and longer treatment regimens than with Provenge.

While 14 of 15 regional Medicare contractors are paying for Provenge in the interim until the coverage determination is made, most patients face waiting lists. Dendreon has said it will meet demand for the drug when new plants open next year.

To contact the reporter on this story: Catherine Larkin in Baltimore at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5  

'The Fly': Leerink - OUTPERFORM
 
News Breaks  
07:07 EDT  DNDN theflyonthewall.com:  Dendreon panel favorable for Provenge reimbursement, says Leerink
Leerink views yesterday's MEDCAC panel as supportive of Dendreon's Provenge's use in the currently approved FDA labeled patients. The firm continues to expect reimbursement of Provenge for the current FDA approved use and maintains an Outperform rating on the stock with a $55 price target. :theflyonthewall  

Dendreon Provenge wird erstattet

Kulmbach (aktiencheck.de AG) - Die Experten vom Anlegermagazin "Der Aktionär" empfehlen, die Dendreon-Aktie (ISIN US24823Q1076/ WKN 615606) bei Schwäche zu kaufen.

Wie erwartet habe sich die amerikanische Krankenkasse Medicare für eine Kostenerstattung von Provenge ausgesprochen. Provenge sei eine von Dendreon entwickelte Anwendung zur Therapie von fortgeschrittenem Prostatakrebs. Auch wenn die endgültige Entscheidung erst im Sommer gefällt werde, seien die Experten diesbezüglich zuversichtlich.


Die Experten von "Der Aktionär" raten, die Dendreon-Aktie bei Schwäche zu kaufen. Das Kursziel sehe man bei 35 Euro und ein Stopp sollte bei 20 Euro platziert werden. (Ausgabe 48) (25.11.2010/ac/a/a)


Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen  

Heute großes Update, Kurs ist auf Niveau vor der Zuslassung:

Dendreon to Host Conference Call to Provide Updates on U.S. Commercialization Progress, European Strategy for PROVENGE, and Pipeline Progress
Conference Call to be Hosted Friday, January 7, 2011 at 9:00 a.m. ET


ShareretweetEmailPrintCompanies:Dendreon Corporation Related Quotes
Symbol Price Change
DNDN 35.42 0.00


{"s" : "dndn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Thursday January 6, 2011, 4:00 pm EST
SEATTLE, Jan. 6, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq:DNDN - News) management will host a conference call on Friday, January 7, 2011 at 9:00 a.m. ET to provide updates on U.S. commercialization progress, European strategy for PROVENGE, and pipeline progress.


Date:
Friday, January 7, 2011
 
Time:
9:00 a.m. ET / 6:00 a.m. PT
 
Dial-in:
1-877-548-9590 (domestic) or +1-720-545-0037 (international);
 

conference pass code 35063654
 
Webcast:
www.dendreon.com (homepage and investor relations section)
 
 




A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-800-642-1687 or +1-706-645-9291 for international callers; the conference ID number is 35063654. The replay will be available from 12:00 p.m. ET on Friday, January 7 until 11:59 p.m. ET on Monday, January 10.  In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.

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 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/.


Follow Yahoo! Finance on Twitter; become a fan on Facebook.

Related Headlines
Top 8 Financial Blogs - at The Wall Street Journal
[video] Liz Clairborne Shares Plummet - at Forbes.com
Dendreon to Host Conference Call to Provide Updates on U.S. Commercialization Progress, European Strategy for PROVENGE, and Pipeline Progress - PR Newswire
Complete Genomics (GNOM) Target Price For Human Genomes In The $10,000 Range; Figure Is An All-in Cost And Seen To Be Incredibly Competitive By Senior Analyst - Wall Street Transcript
December's Healthcare Winners and Losers - at Investopedia
Related Blog Headlines
Good News for Celldex Therapeutics - Zacks
Loss at DNDN Up on Higher Costs - Zacks
Why Do Bears Seem Smarter Than Bulls? - at CNBC
10 Most Expensive Stocks: Danger Ahead? - at CNBC
Lightning Round: Alcoa, Dendreon, AMD and More - at CNBC
Related Message Boards
Dendreon Corporation

1 commentShow:  Newest FirstOldest FirstHighest RatedMost Replied    Post a comment  0 users liked this comment Please sign in to rate this comment up. Please sign in to rate this comment down. 0 users disliked this commentKarenA 10 hours ago Report Abuse Great news hopefullyReply
Post a comment
Sign in to post a comment, or Sign up for a free account. Top Stories
December jobs report seen showing greater hiring - AP
Samsung sees record 2010 sales, operating profit - AP
Asian shares higher after weak Wall Street finish - AP
Fed boss likely to sound more hopeful on economy - AP
Tech Ticker Recent Posts
"It's a Terrible Recovery": Dan Greenhaus Explains Why The Economy Feels So Bad - Aaron Task
Risky Business: Gridlock in Congress Will Do More Harm Than You Think, Says Global Risk Expert - Stacy Curtin
There's Only One Way To Pick A Good Mutual Fund--And It's Not What You Think - Henry Blodget
View More
Subscribe to Topics
Top Stories
  Add Alert
dndn Headlines
  Add Alert
See all RSS links  

Dendreon Announces Plans to Seek Marketing Authorization for PROVENGE in Europe
- Company to Provide Updates on U.S. Commercialization Progress, European Strategy for PROVENGE, and IND Filing for DN24-02 -
Conference Call to be Hosted Friday, January 7, 2011 at 9:00 a.m. ET


ShareretweetEmailPrintCompanies:Dendreon Corporation Related Quotes
Symbol Price Change
DNDN 35.42 0.00


{"s" : "dndn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Friday January 7, 2011, 8:30 am
SEATTLE, Jan. 7, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq:DNDN - News) today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline. The Company will host a conference call at 9:00 a.m. ET to review additional details.  

"Last year was foundational for Dendreon with the successful introduction of PROVENGE as the world's first autologous cellular immunotherapy," said Mitchell H. Gold, MD, president and chief executive officer.  "As we look to 2011 and beyond, we are positioned for significant growth with our increased capacity in the U.S., our European strategy for filing now set, and our progress in advancing our ACI pipeline in bladder cancer.  Most importantly, we are proud to deliver on our commitment to transform the lives of patients with cancer by making PROVENGE more broadly available in the U.S. and abroad."  

U.S. Commercialization


In 2010, Dendreon achieved revenues from PROVENGE of approximately $48 million.  
In anticipation of a ten-fold increase in capacity from its facilities in New Jersey, Los Angeles, and Atlanta coming on line this year, Dendreon has increased its sales force to approximately 100 reps to service approximately 450 centers by the end of 2011.
In 2011, Dendreon plans to increase marketing and awareness efforts to educate physicians and patients and to maximize the additional capacity.




European Plans


Following a number of pre-submission meetings with European Union (E.U.) National Agencies, the company expects that data from the IMPACT study, supported by data from D9901 and D9902A, will be sufficient to seek regulatory approval in the E.U.
Dendreon plans to use the clinical data described in its U.S. Biologics License to file its marketing authorization application (MAA) to the European Medicines Agency (EMA) in late 2011/early 2012.
To accelerate the regulatory timeline, initially PROVENGE will be manufactured through a Contract Manufacturing Organization (CMO) while Dendreon concurrently builds an immunotherapy manufacturing facility in Europe.
The company anticipates a regulatory decision in the first half of 2013.




DN24-02 IND Filing


Dendreon filed an Investigational New Drug (IND) application in December 2010 with the U.S. Food and Drug Administration (FDA) for DN24-02 for the treatment of invasive bladder cancer.
The randomized Phase 2 study will evaluate the safety and efficacy of DN24-02 in patients with HER2+ invasive transitional cell carcinoma (TCC) of the bladder following cystectomy.
The primary endpoint is to evaluate overall survival. Approximately 180 patients will be enrolled at clinical sites throughout the U.S.  




Conference Call Information

Dendreon will host a conference call today at 6:00 a.m. PT, 9:00 a.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international). The call will also be audio webcast and will be available from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section. A phone replay of the call will be available for 3 days by calling 1-800-642-1687 (domestic) or +1-706-645-9291 (international); Passcode: 35063654.

PROVENGE Indication and Safety

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 1-877-336-3736

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 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. 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.


Follow Yahoo! Finance on Twitter; become a fan on Facebook.  

Hoffnung für alternative Behandlungsform für Prostatakrebs in Europa:

UPDATE 1-Dendreon to seek European approval for Provenge
Tweet This Share on LinkedIn  Share on Facebook 0diggsdiggRelated NewsUPDATE 2-Bayer, J&J ask for approval for main use of Xarelto
Wed, Jan 5 2011
UPDATE 1-Celgene submits new applications for cancer drugs
Tue, Jan 4 2011
UPDATE 1-Vivus files to market weight-loss drug in EU
Mon, Dec 20 2010
Greengate, Capital Power plan Alberta wind farm
Fri, Dec 17 2010
Amgen shares rise on denosumab data
Mon, Dec 13 2010Related TopicsStocks »
Global Markets »
Healthcare »
Stocks    Fri Jan 7, 2011 9:02am EST

* Plans to file European approval late 2011, early 2012

* Increases U.S. sales force as capacity increases

BOSTON Jan 7 (Reuters) - Dendreon Corp (DNDN.O) said on Friday it plans to apply for marketing approval of its prostate cancer vaccine in Europe.

The product, which is already approved in the United States, generated sales of about $48 million in 2010.

In anticipation of a ten-fold increase in capacity from new facilities coming on line this year, the company has increased its sales force to about 100 representatives.

The company said it expects to file a marketing application with European regulators in late 2011 or early 2012. It expects a decision on its filing in the first half of 2013.

(Reporting by Toni Clarke, editing by Dave Zimmerman)

StocksGlobal MarketsHealthcare  

UPDATE 1-US Medicare plans to cover Dendreon's Provenge
Share this
inShare00diggsdiggEmail
Print
Related NewsAttention to detail drives Top 100 Hospitals
Mon, Mar 28 2011
What's next for the healthcare law?
Wed, Mar 23 2011
UPDATE 2-US Medicare proposes no changes for anemia drugs
Wed, Mar 16 2011
Special report: On borrowed time: budget delays start to hurt
Wed, Mar 16 2011
Special report: Big California quake likely to devastate state
Tue, Mar 15 2011Analysis & OpinionRussia?s babushka time-bomb
Rand Paul and the 2012 Republican presidential nomination
Related TopicsStocks »
Regulatory News »
Global Markets »
Financials »
Healthcare »
Stocks  
Dendreon Corp
DNDN.O
$35.54
-0.34-0.95%
10:00pm UTC+0200
Wed Mar 30, 2011 4:28pm EDT

* Medicare: adequate evidence for prostate cancer vaccine

* Final decision due June 30

LOS ANGELES, March 30 (Reuters) - Men in the U.S. Medicare health insurance program will get full coverage of Dendreon Corp's (DNDN.O) prostate cancer therapy under a proposed payment decision by U.S. regulators announced on Wednesday.

In its proposal, the U.S. Centers for Medicare and Medicaid Services said there is adequate evidence to pay for Provenge's approved use in men with advanced prostate cancer.

The agency also said there is "insufficient evidence" for use of the vaccine treatment in other settings.

Medicare coverage of Provenge, which costs $93,000, is key since the disease strikes mostly older men. The program covers those aged 65 and older along with the disabled, and about 40 percent of its 46 million enrollees are men.

A final decision is expected by June 30.

Analysts have said they expect Medicare's decision to help streamline the reimbursement process for the vaccine that right now varies region to region.

The U.S. Food and Drug Administration approved Provenge, also known as sipuleucel-T, last year for certain men with advanced prostate cancer.

Unlike traditional vaccines, Provenge does not prevent disease. Instead, it treats prostate cancer by stimulating the body's own immune system to attack malignant cells.

Provenge could see more than $2 billion in global sales by 2015, according to consensus analyst forecast data from Thomson Reuters. (Reporting by Susan Heavey and Deena Beasley; Editing by Tim Dobb  

The next Dendreon will be: Dendreon!  

Bin mal wieder hier, Dendreon liegt on Track, alles was bisher prognostiziert wurde ist entsprechend umgesetzt worden.
Ausbau von New Jersy, Umsatz in Q1 2011 und Anzahl der Infusion Centers.
Was bleibt:
- Letztlich CMS Entscheidung
- Zulassung der bieden weiteren Produktionstätten
- Bestätigen der Vorhergesagten Nachfrage.
 Dazu nur eines, Q1 ca. 28 Millionen, nur für April sind es 15 Millionen.

Ich bleibe weiterhin Long!  

Ich denke nach einer Konsolidierung wird dendreon Richtung AH maschieren!  

Ja mittelfristig ist das auch mein KZ. Langfristig (2-3 Jahre) sollten auch neue Höhen erklimmbar sein.  

wenn Dendreon bis dahin nicht längst übernommen wird!  

Ich denke das wird dann aber richtig teuer. Wenn man Dr. Gold folgt, hört es sich nicht danach an das Dendreon so einfach zu haben ist.

Anbei ein link der Seatle Times, die gehen auf die unterschiedlichen Betrachtungweisen der Analysten ein. Wirklich aufschlussreich sind für mich die Statements des Managements.

http://seattletimes.nwsource.com/html/...014984737_sundaybuzza08.html  

------Dendreon Sees Robust Demand for Provenge

Dendreon Corporation, a biotechnology company focused on cancer treatment therapeutics, could see near-term upside after as demand for its Provenge treatment continues to rise. Earlier this month, the company reported that the number of accounts infusing the treatment rose to 135, while noting that it is on-track to meet its goal of 225 sites by the end of the second quarter.

Analysts ranging from Leerink to ThinkEquity have raised their price targets on the stock in recent weeks, suggesting that the company is making solid progress towards implementing its 2011 launch of Provenge. Meanwhile, other analysts like Collins Stewart studied physician surveys that suggested that demand is tracking above consensus analyst estimates. -------

http://seekingalpha.com/article/...talysts-and-potential?source=yahoo  

http://www.youtube.com/user/JohnsHopkinsKimmel#p/u/7/5T1VaR2w9SI  

Deutsche Bank Dendreon Alert

Dendreon Alert

Our take on Provenge ASCO abstracts

There are 2 abstracts of importance for Dendreon.

*1st abstract showed that Provenge delayed pain. At 12 months, 39.3%
of Provenge vs. 18.9% of control subjects were pain free.

*2nd abstract looked at "Frovenge" and notes that cross-over likely
reduced OS benefit with Provenge.  

*2nd abstract looked at "Frovenge" and notes that cross-over likely
reduced OS benefit with Provenge.

meint nichts weiter als:
Das der Überlebensvorteil von Provenge  (4,1 Monate) höher ist, da der Placebo Arm mit einer gefrohrene Variante von Provenge (F = Frozen) behandelt wurde. Der letzlich erzielte Endpoint könnte verwischt (zum Nachteil von Provenge) sein.

Einfach zusammengefasst, Meinungen dazu ?  

Zur Ergänzung:

"Das der Überlebensvorteil von Provenge  (4,1 Monate)"

Die 4,1 Monate sind natürlich der Median, nicht der Durchschnitt!!!!
Ein gewaltiger Unterschied!

Stark vereinfachtes Beispiel Durchschnitt vs. Median:

1-1-2-3-3-6-9-12-24-25      Monate

= Durchschnitt = 8,6  Monate für das willkürliche Bsp.
= Median =   4,5 Monate für das willkürliche Bsp.!!!!! !!!!!!  

das Dendreon den 8. Tag in Folge im Plus schließt?
Egal, das wird ein spannender Monat.
Wie geht die CMS Entscheidung aus?
Was wird auf ASCO an Daten präsentiert?
Eine weitere Produktionsstätte steht zur FDA Zulassung an!

http://www.healthcanal.com/cancers/...nts-with-Recurrent-Disease.html

Immune System Therapy Shows Promise in Slowing the Progression of Prostate Cancer in Patients with Recurrent Disease

OHSU Knight Cancer Institute study results suggest that Provenge® could potentially prove effective in slowing down the progression of prostate cancer in its early stages

An immunotherapy for prostate cancer, which is currently used to treat men whose disease has spread to bones and is considered life threatening, shows early promise in slowing cancer progression in men whose disease has recurred following surgery, an Oregon Health & Science University Knight Cancer Institute study found.

The study results also suggest that more research is warranted to determine if the therapy, Provenge® or sipuleucel-T, could be effective in slowing the progression of the disease in its early stages.

The results of the randomized study, which were recently published in the online edition of Clinical Cancer Research, indicate that rate of rise of PSA measured in the blood was 50 percent slower in men who received the immunotherapy sipuleucel-T than those who did not. Other studies have shown that when prostate cancer returns after surgery or radiation, how rapidly PSA, a blood marker of prostate cancer, goes up correlates with the risk that the cancer will spread. It also correlates with length of life.

?One of the questions on everyone?s mind is whether sipuleucel-T could have more of an impact if it were used before the disease became life threatening. This is the first study to ask that question,? said Tomasz M. Beer, M.D., deputy director of the OHSU Knight Cancer Institute, professor of medicine in the Division of Hematology & Medical Oncology and lead author of the study. ?It?s an important question for our patients because this is a drug that?s approved and available.?

Sipuleucel-T is made from a patient?s own immune cells. It is designed to stimulate a patient?s immune system to attack prostate cancer. The drug, which is manufactured by Dendreon Corp., is currently approved by the FDA to treat men with metastatic prostate cancer that is resistant to standard hormone treatment and who have minimal or no symptoms of the disease. Studies found these men live a median of four months longer when treated with the drug than those who don?t receive therapy.

But, exactly who can be helped most by the immune system boost is a subject for additional study.

?Men can live a long time with prostate cancer. If there?s a way to slow the cancer down even more at the earlier stages, the appeal is that you can change the trajectory of the disease,? Beer added. ?There?s a chance of making a bigger impact.?

The study was too small to determine if the slowing in the rise of PSA will lead to delays in more serious manifestations of disease, such as spread of the cancer to bones or if it will result in longer survival. Additional larger studies are needed to answer these questions. This study, however, provides the first signal that immunotherapy may be impactful when used early after cancer recurs rather than only after the cancer is widely disseminated.

The study, titled ?Randomized Trial of Autologous Cellular Immunotherapy With Sipuleucel-T in Androgen Dependent Prostate Cancer,? was funded by Dendreon. Along with Beer, the other authors are Guy T. Bernstein of the Center for Urologic Care, John M. Corman of Virginia Mason Medical Center, L. Michael Glode of the University of Colorado Health Science Center, Simon J. Hall of Mount Sinai School of Medicine, Wayne L. Poll of AKSM Clinical Research Corp., Paul F. Schellhammer of Urology of Virginia, PC/Eastern Virginia Medical School, Lori A. Jones and Yi Xu of Dendreon, Jelle W. Kylstra of Spectrum Pharmaceuticals and Mark W. Frohlich of Dendreon and PROTECT Investigators (PROvenge Treatment and Early Cancer Treatment).  

nicht schlecht, werden wir jetzt eine Korrektur sehen?
wer weiss, darauf wetten könnte gefährlich werden denn es steht einiges an.  

FDA Approves Dendreon's Los Angeles Cancer Immunotherapy Manufacturing Facility

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