Der erste Krebsimpfstoff

Tolles Interview:

Re: Hans Bishop Aims To Keep Provenge Trains Running On Time (whole article)
Excellent article Donlfought - Thank You - BTW CELG's current market cap is over $26 billion - here is the whole thing:

Dendreon’s New Operations Man, Hans Bishop, Aims to Keep Provenge Trains Running on Time

Luke Timmerman 1/19/10

Dendreon has a new man on the spot, and his name is Hans Bishop. The Seattle biotech company (NASDAQ: DNDN) settled the raging debate last year about whether its immune booster can help men with prostate cancer live longer without serious side effects. Now the company has graduated to a less glamorous, but equally important phase in which it must show that it can effectively manufacture and market its first-of-a-kind drug, sipuleucel-T (Provenge).

That responsibility falls to Bishop, its new chief operating officer. Bishop, 45, is a native of the U.K. who most recently worked as president of the specialty medicine business at Bayer Healthcare. He officially started at Dendreon on Jan. 4. He and his wife—who oversees communications at the Bill & Melinda Gates Foundation—have already moved into a new place in downtown Seattle which is about a 15 to 20-minute walk from Dendreon’s Belltown office.

I met Bishop and Dendreon’s vice president of communications, Katherine Stueland, while they were attending the JP Morgan Healthcare Conference last week at San Francisco’s Union Square. Before diving too deep, it’s worth noting that Bishop’s first name is correctly pronounced as “Hahnce,” not the Germanic-sounding “Hahnz.” He’s heard it both ways, and told me he doesn’t care when people get it wrong, but there you have it.

Like most of our interviews, I sought to get to know the person as well as the situation he is stepping into at an important local biotech company. Here are the highlights of the conversation.

Xconomy: Where are you from, and how did you get started in the pharmaceutical business?

Hans Bishop: I’m from New York, in the sense that’s where I was living last. My last job was as president of specialty medicine at Bayer. That was a 3 billion Euro business comprised of oncology, hemostasis, urology, and ophthalmology. It’s all of the specialty medicine parts of the Bayer business.

Hans Bishop
But I was born and raised in the U.K., trained as an organic chemist. I’ve spent pretty much all of my career, not all, but pretty much all, in healthcare and pharmaceuticals.

X: How did you find out about the Dendreon position?

HB: I met [CEO] Mitch [Gold] and the team during a business development discussion. I’m embarrassed to tell you that I wasn’t that aware of Dendreon in my prior job. I met them through business development talks, and I was really amazed. I learned about the product for the first time when I met with them, and the clinical data they had generated. I was really impressed with the product, all the technology they had built around the product, and the management team. So I came away really impressed. I was really delighted two weeks later when the phone rang and I was asked if I was interested in meeting with them about this position.

X: So Mitch Gold recruited you, after he met you when you were on the other side of the bargaining table?

HB: You should get the quote from Mitch, but Mitch clearly came away impressed with me. While it was unclear if he wanted Bayer as a partner, it was clear that he wanted me to join. That’s how it happened.

X: Why did this job appeal to you?

HB: I think Dendreon is unique at this point in time. There are several parts of that. Provenge addresses the needs of a group of patients who have got some very poor choices. The product is really launching into a market with a substantial unmet medical need. That’s important.

The product, of course, is unique. It’s not only unique in terms of the obvious clinical benefits—no one has shown a more than 4 month survival benefit in these patients—but it’s unique in terms of how well-tolerated it is. You put that together, and it’s going to be an important option for men with late-stage disease. That’s always my first test—how clear is the unmet need and how well does the new therapy address it?

The second thing is that it’s a company and a group of people that have already shown their ability to truly innovate. I’m proud to join a team that has that track record of innovation, and resilience.

X: What do you bring to the table that the company needs at this point?

HB: Commercialization experience, first and foremost. I’ve spent most of my career launching and growing major pharmaceutical products. Provenge is going to be a major therapeutic vaccine.

I’ve also had a good deal of experience with complex manufacturing environments. We (at Bayer) had an important manufacturing challenge to manage. And thirdly, managing growth. I’ve learned how to build organizations that are fast-growing.

X: Which product had the complicated manufacturing issues?

HB: Factor VIII (Kogenate). One of the businesses I ran before had a major product called Kogenate. It’s a recombinant protein for hemophilia. Actually, it’s the largest molecule administered in man. It’s a giant naturally occurring protein. It’s designed to fall apart in the body, naturally, with a limited half-life. So manufacturing is quite difficult. It isn’t inherently stable. It’s different than what we (Dendreon) do, and in some sense, what we do is a good bit simpler.

X: How is Provenge simpler?

HB: The intrinsic manufacturing steps are relatively straightforward. They are well-characterized. The company has shown in more than 1,000 patients already that it can do this in an incredibly reproducible way. The logistics around it [in which blood is shipped from the clinic to Dendreon and back] are different to other therapeutic proteins, but the inherent manufacturing isn’t particularly complex.

X: What are the top three priorities on your to-do list?

HB: To make sure we build a world-class team. The organization is going to grow substantially as we prepare for launch. Bringing in the best of the best is important to us. It’s going well so far, by the way. We just hired a number of district managers that I really believe fit that criteria.

We also need to make sure all the things you need in place for a good commercial launch are in place. We need to educate urologists and oncologists about the clinical data set we have, and the benefits of Provenge.

There are a couple things we clearly need to manage between now and the launch. In the first quarter of this year, we’ll have an inspection from the FDA of our manufacturing plant [in Morris Plains, NJ]. Those are the three major things on the list.

X: What do you want to accomplish in this first year on the job?

HB: The priority, without a doubt, is a successful launch of Provenge. All the other things we just talked about will support a successful launch of Provenge. That’s where I’ll spend all my time.

X: Will you be closely involved in figuring out what the price will be?

HB: Sure. What we’ve said is we’ll price Provenge similarly to other novel biologic drugs that extend lifespan.

X: I’ve heard that before. Can you be a little more specific? Will this be in the Erbitux range or the Avastin range? [Editor's note: Eli Lilly's cetuximab (Erbitux) antibody drug for lung cancer costs about $80,000 per patient, while Roche's bevacizumab (Avastin) antibody for lung cancer costs $8,800 per month, which can cost as much as $100,000.]

HB: I don’t think we’ll say more than that. It wouldn’t be appropriate. We haven’t made a final decision. But that’s the range in which we’re doing our analysis.

X: How has health care reform affected your ability to set the price?

HB: There’s been nothing directly in this round of healthcare reform that will change the process for us. There is no change. But we take the general debate very seriously. One of the things you find when you walk into the company is that this is a “patients-first” company. People come to work at Dendreon because they want to do something for patients with cancer, with our first product being for prostate cancer.

X: What worries you about this job, and keeps you up at night?

HB: It’s helpful to have a degree of paranoia when an organization is growing very fast. You need to pay attention to the details. You need to be involved in the key hiring decisions. You need to make sure that your first line of managers are really very able.

Katherine Stueland: We had 190 employees in March, and we started the year with 450. By the time we plan to launch Provenge, we should be at about 600 people.

HB: You’ve got to be intimately involved in many aspects of the business. You’ve really got to pay attention to where the team is just doing great and you can leave them alone, or where they need a little more support and coaching, or where they might need additional resources.

X: What other key slots need to be filled on the management team? Are there certain lieutenants you need to bring in to help you?

HB: There are two sets of positions that I am most focused on right now. We’re looking for a senior vice president of sales and marketing. In fact, the breakfast I just had was with [a job candidate]. And we’re also soon to hire two more vice presidents, who will be manufacturing heads in our second and third manufacturing plants. Those are very important hires. Those are big jobs inside Dendreon, and we are looking to bring in some new talent.

X: What kind of applicants are you getting? Because in talking to people around this meeting, I’m struck by how many Dendreon haters are still out there.

HB: They’re fading fast.

X: People are asking me if they think the drug is going to be approved. I don’t know if it’s jealousy, mistrust, something historical, or what it is, but this still seems like a company that some people love to hate.

HB: I’m new. I’ve been here one and a half weeks. I’ve had, I don’t know, 50-odd meetings this week. Overwhelmingly, the impression I get is that even former skeptics now get it. They now understand this is going to be an important therapeutic. There will always be skeptics out there. Apparently, you’ve met a few. But the impression I get is that the vast majority of people now get the importance of what we’re doing.

X: Are you becoming a talent magnet? Can you draw the kind of people you need to make this drug into a success?

HB: Yes, absolutely. Before I even joined the company, my hiring had been announced [December 10]. And you know how the e-mail addresses at Dendreon are pretty simple. And I picked up my new BlackBerry, about three weeks before my first day. I switched on my BlackBerry, and on my first day, I had e-mails from premier oncology company reps who were saying, “I’ve been following you closely. I want a job. Who do I speak to?” It’s been striking. There’s a huge amount of interest.

KS: The caliber of the people we are seeing are the best of the best from pharma. They are interested in coming on board with a company like Dendreon that has a rare opportunity to make the transition from an R&D company over the past decade to a company that’s on the cusp of commercializing a very high-profile product like Provenge.

X: A question on manufacturing. I know you just raised a lot of money [$630 million last year]. Do you have enough capacity as things stand now to meet demand during the early phases of the launch?

HB: We’ll be capacity constrained for about 12 months. At launch, there will be less capacity than there is demand. But with this raise, and the fact that we are bringing forward the construction of the Atlanta facility, and California, that period of time is only 12 months. We’ll have both of those plants online by the middle of 2011.

X: How much demand do you anticipate during those first 12 months? I’ve heard CEO Mitch Gold say that Provenge has 93 percent brand recognition already from the target population of urologists and oncologists who would prescribe Provenge, already, before you’ve ever run an ad.

KS: We expect demand is going to be high, but we’re also aggressively communicating that we’ll be launching it as we ramp up our manufacturing facility. Our goal is to make sure that physicians and patients understand that over time, more capacity will be built.

X: Is that a concern that patients who want the drug, and can’t get it, might be pretty unhappy about that? This is, as you say, a life-extending therapy.

HB: We would clearly like to be in a position where we could supply all the patients from Day 1. But as you think about the investment that Dendreon has made in manufacturing, prior to product approval, it’s truly extraordinary. I don’t know if we’ve disclosed the precise capital figure, but we are at risk in building three manufacturing plants before the FDA has approved the product. I don’t know of any other example of a company now that’s putting more capital at risk to get ready.

Every company needs to decide how much it’s going to invest before approval. What I’m saying to you is that we’re investing a very significant amount in capacity. But there will be a period, about 12 months, before we are up to full capacity and we can be assured we can meet full demand.

X: What is one thing you’d like to change now that you’re on board at Dendreon?

HB: I’d like to have a senior vice president of sales and marketing in the office on Monday [laughs].

X: You’re kidding, right?

HB: Well, we’ve had a good week this week. But yeah, it probably won’t happen on Monday.

But yes, I’m looking forward. I’m a great admirer of any organization that shows resilience, and the team at Dendreon has clearly shown resilience [with the FDA delay of Provenge in May 2007]. It’s a great test of any organization’s core strength.

I’m also hugely complimentary of the work that’s been done to manage the supply chain. You’ll hear people say—and you referred to skeptics earlier—who say, “Oh, Provenge, it’s complicated.” If you’re a physician, this is how complicated it is. You put in a call to our call center to schedule a patient. Two days later, the activated cells arrive at your office. That’s it. Everything else in the supply chain process, we take care of all those different steps. I’m very happy about it.

X: What’s the biggest misconception out there about the company? Is it the manufacturing logistics question?

HB: I think that’s one. People think the doctors need to get involved in scheduling the apheresis [a procedure in which blood is drawn and filtered]. They don’t. The product is going to be very simple to use.

KS: You asked before about things that Hans might want to change, but there are also things we want to maintain. And as we grow from 190 to 450 people to 600 people, one of the things we want to maintain is the culture.

HB: I’m sure about that. What are we at now, 450 people? Of that, I’m certain that 90 percent come to work because of patients. When you have a foundation where the culture is that strong, we need to continue to focus on that. We need to make sure that will grow with us.

X: Will you get involved with managing the pipeline as well, or are you exclusively going to be focused on Provenge?

HB: That’s not my day job, but clearly that’s something that Mitch has the management team discuss vigorously. Yes, for sure, I’ll work on the pipeline.

X: Will the manufacturing facilities that you are building now be ready and equipped to make other products for clinical trials?

HB: Yes. Our next most advanced clinical program is Neuvenge. It uses exactly the same technology platform as Provenge, but applies it to metastatic breast cancer. It uses clearly a different antigen, but a similar delivery cassette. And similar manufacturing processes. And if we’re successful with Neuvenge, it will absolutely utilize the structures we are putting in place now.

X: Is that moving ahead in clinical trials?

HB: We hope to start a Phase 2 program later this year, or early next year.

X: Five years out, what are your goals personally, and for Dendreon as a company?

HB: The first priority is to meet the needs of patients. That will continue to be our first aspiration. From a business perspective, the twinkle in our eye is to build a company that’s a bit like [Summit, NJ-based] Celgene (NASDAQ: CELG). That’s a company that many of us on the management team greatly admire.

X: What did they do right that you admire?

HB: They did many things right. They successfully commercialized their first product. They made smart choices developing their pipeline. They have a great team. And they managed their growth outside of North America very successfully. It’s important to remember for Provenge that the opportunity outside of North America is probably three times bigger than the opportunity in North America. The rest of the world opportunity is very important. It’s several years away. We are focused on the U.S. launch and getting that right. We have no manufacturing capacity outside of North America, so it is several years away. But don’t lose sight of the fact that it’s an important opportunity.

X: How can it be three times bigger?

HB: The numbers work roughly like this. If you look at the epidemiology of the disease in the big five countries of Europe, it’s about the same size as North America. The normal rule of thumb—and this can be a bit off—when you scale up for the whole of Europe with Scandinavia, Central Europe, it’s normally about 2x what you see in the big five countries, or 1.5x to 2x. Total Europe has about 150,000 to 200,000 [patients with prostate cancer that has spread, and no longer responds to hormone-deprivation therapy]. Then you add Asia, Japan, which has about 100,000. And North America has about 100,000. So that’s how we get that number.

X: One last thing. How old are you?

HB: I’m 45. But I look younger, don’t I?  

Der Gesamtmarkt bricht ein, Dendreon steigt, darum:

Microsoft Buys AOL and Four Other Deals James Altucher Says "Should" Happen
Posted Jan 22, 2010 01:25pm EST by Aaron Task in Investing
Related: AOL, MSFT, DNDN, GOOG, VRSN, ORCL, DELL
The market may be headed for its third-straight decline but that isn't stopping the optimists from speculating about that most bullish of events, M&A.
In the accompanying video, Formula Capital's James Altucher lays out the rationale for the five mergers he says "should" happen in 2010:

-- Microsoft-AOL: Altucher says AOL would give Microsoft a much larger online footprint and is much cheaper than buying Yahoo!, Tech Ticker's parent. AOL's cash generation means the deal effectively pays for itself in three years, he says.
-- Oracle-Verisign: With its Sun Microsystems acquisition, Oracle now has a great inroad into the start-up community via Sun's MySQL unit, he says. Given Verisign's dominance in domain names, buying them would give Oracle another opportunity to secure customers in their earliest stages.
-- Sanofi-Dendreon: Altucher believes Dendreon's controversial prostate cancer drug Provenge will soon by approved by the FDA. That makes Dendreon a natural fit for Sanofi-Aventis, whose own treatment, Taxotere, has problematic side effects.
-- Dell-Polycom: With cost-cutting and stricter security putting a crimp in business travel, video conferencing has a huge future, Altucher says. Polycom would given Dell the no. 2 spot in videoconferencing (behind Cisco) and help it get deeper into the enterprise space. Plus, Polycom's stock is cheap, he says.
-- Google-Blackboard: Blackboard can do for Google in online education what YouTube did for it in online video, Altucher says.
Disclosure: Altucher has long positions in AOL and Dendreon.  

A conversation with Mr. Schiffman this afternoon

Mr. Schiffman returned my call as I was posting the report from Jennifer. I told him that Jennifer and I had spoken earlier and gave him the benefit of her responses to same questions I would pose to him.

The conversation was longer than I had expected and covered a number of ancillary subjects in addition to the ones most on our minds today.

1. First, he laughed when I asked if the inspection in New Jersey was actually under way this week. As did Jennifer, he stopped short of a direct answer and merely reiterated that it was projected to be a 1st Quarter time frame. But, as with Jennifer, a reading between the lines seemed to be an answer in the affirmative. I did mention that before the company had taken the Q1 posture on that matter, Gold had indicated it likely would be in January. Greg said he believed that officially Gold had said "very early in the year" or something like that. We laughed and moved on.

2. When I broached the subject of a press release on the outcome of an Inspection, he was much more forthcoming. He said clearly, that if Management saw in the inspection anything at all that might prejudice the upcoming May 1, 2010 PDUFA date (an FDA Approval or non-Approval deadline), then the company would immediately issue a Press Release or otherwise make known such an adverse result publicly to shareholders.

3. Greg seemed to hold, and said, that small matters noted on a 483 that could be (and would be) easily corrected would not necessarily be made public—though he was quick to say such an intent to withhold was not present policy per se. He made the point clear by saying that in 2007, the bar code 483 issue was not a clock stopper in the sense that it could not have been fixed easily before the PDUFA deadline. (Actually, it seems the company's position that it could easily have been fixed if that had been all there was to fix.) He added that the existence of other more serious issues (that arose later—presumably in the Advisory Council meeting of March 28, 2007) such as the specious (my word) so-called Safety Question were the real show-stoppers in 2007 that put the PDUFA result awry.

4. (Let me insert a personal note here FWIW. That sounded to me like a reasonably good defense against the rancherho lawsuit that may now have crept into the company's official position on that and related such matters. We did not discuss any of that, but it does seem to minimize and render less necessary the 483 disclosure in 2007.)

5. To restate the above in Greg's way, he said specifically that if at any time the company sees something that potentially could cause the PDUFA date to slip or simply be missed, then shareholders will be notified promptly. On the other hand, the company is not required to report all their discussions with the FDA and the particulars of ongoing interaction with the Agency, and it likely would be inappropriate to do so. But he quickly added that anything material was going to be disclosed as soon as that material thing is known. He acknowledged that discussions on what they will do with regard to the current (or upcoming, whichever it is) Inspection were then in progress. (My earlier request for notification is at least being seriously considered.)

6a. He noted with some satisfaction, that their FDA questions such as the early administration of Provenge to Placebo patients in mid-2008 were run by both FDA Divisions (CDER and CBER)—within the Agency—so that nothing was being done unilaterally or in secret by the CBER Division without involving Pazdur's Division.

6b. Said another way, all feedback from the FDA has been Agency-wide feedback despite that all of our interaction with the Agency has been and continues to be solely with CBER. In other words, the Agency's two Divisions (an apt word IMO) are communicating on Provenge as we move along toward Approval. He saw that as being a major positive.

7.Mr. Schiffman readily agreed that we are "up in the air" until we no longer are "up in the air." But he said they had seen no evidence that a new Advisory Council is in the offing. He noted that the company knew in 2006 before the BLA was filed in November, that an AC would be part of the process. Yet, here we are 90 days from the PDUFA response deadline (self-imposed by the FDA's rules governing itself) and no mention has been made of a need for an Advisory Council.  That alone seems to me to be telling us that one is becoming highly unlikely. It is safe to say that so it also seems to seem to Greg.

8. On the December Financing, Greg noted that as a consequence of it we are much further along with our plant capacity schedules than originally anticipated before the Financing (on December 3, 2008 or soon after as I recall). He is pleased with that. Very pleased. I conveyed in person my congratulations on that monumental achievement that, as he said this afternoon, made us financially independent until we can live on revenue production—assuming the May 1 result is positive in an Approval for Provenge.

9. When invited to comment further for publication, he made special mention of Hans Bishop. He said Bishop rounds out the team with great expertise in effecting major commercializations of biotech products—an expertise not necessarily needed before now. But it is one absolutely necessary as we move to commercialization in just 90 more days—if it works out that way.

10. I asked him about the Windows for insider sales. He noted that the window was closed automatically when the December Financing took place. We both seemed to recall that the window in those cases (SEC imposed) is for 90 days from the date of the Finanacing—or until early March in this case. (For those unfamiliar with that set of rules, the insider sales we saw earlier this month to pay taxes on Option grants is exempted as being pre-stipulated in the law and could, therefore not be affected by—or be as a consequence of—insider information.) So, the window is closed for another five weeks or so. We do not know if the company will further close it at that time. He sounded as though it had not come up for discussion. With only two months left until the PDUFA date, I would not expect any such insider sales of shares. but If any there are, you can bet this Board will make immediate note of the fact. I suppose some over-cautious Directors or employees might hedge their bets with small partial sales, but nothing major in the face of a probable Approval, if that is what all are then seeing.

11. Greg's optimism and enthusiasm seemed at a high point, as well should be the case—considering all that this company has been through since he came aboard just over three short years ago, and, of course, those much leaner years that had preceded his fortuitous arrival in late 2006.

c

http://www.investorvillage.com/...n=322606&pt=msg&mid=8502934  

Der lange Weg Dendreons geht auf die Ziellinie, die bedeutet, daß trotz Korruption, Lobbyismus... das erste Immuntherapeutika, Provenge, gegen Prostatakrebs eingesetzt werden kann!
Wieviele Leben könnten seit 2007, dem Jahr der Verschwörung, lebenswerter sein!

Wenn es einen Gott gibt, werden die, die es verhindert haben die "Hölle" kennenlernen, hoffentlich!  

Auszug aus Cohen-Analyse:

Dendreon (DNDN) got an upgrade from Cowen, which included: “We believe DNDN’s New Jersey facility has been inspected with no major deficiencies noted.” They also said: “We believe robust operating margins combined with unmatched franchise longevity (no generic, biosimilar or other meaningful competition) could support 50%+ stock upside relative to the market.” And: “Sum-of-all-the-parts value (assuming approval)= $47-51; believe approval is 90%” DNDN remains a Top Buy up to $30 for a $40 target when they announce the partner and my $50 first target after Provenge is approved.  

Dendreon wird in einem Atemzug der größten Bioteches der Welt gennannt:

4 Winning Biotechs For Your Portfolio: Senior Analyst
Published: Monday, 8 Feb 2010 | 10:34 AM ET Text Size By: JeeYeon Park
CNBC News Associate

So far this year, the performance of the biotechnology index has been strong. So is there room for more growth in the sector? Mark Schoenebaum, managing director and senior research analyst at Deutsche Bank Securities, shared his stock picks and sector outlook.



In 2008, there were “massive outperformances in a horrible year” for the biotech sector, Schoenebaum told CNBC.

But in 2009, there was underperformance from the sector because President Obama took on health care reform, he continued:

“Biotechnology drugs are high-price drugs. As government got closer to health care, those price points looked less sustainable.”

This year, as the health care reform “doesn’t look real,” the price points look “more reasonable in long-term models,” said Schoenebaum.

Schoenebaum’s Recommendations:

Amgen [AMGN  57.56    -0.12  (-0.21%)   ]—“I like it on valuation—they have a big pipeline drug, which is a little bit risky, but even without that pipeline drug, the stock is not terribly expensive,” he said.

“The event that could be massive this year is that in the second half of the year, there’s a trial on their drug Denosumab…It’s not in Street numbers, but it’s a $1 to $2 billion opportunity and the stock will be up quite a bit if that works.”

Gilead Sciences [GILD  46.01    -0.37  (-0.8%)   ]

Dendreon [DNDN  29.36    0.60  (+2.09%)   ]—"There’s one catalyst left for Dendreon this year—that’s getting FDA approval…I believe that the probability for approval is about 90 percent,” he said. “That’s a reasonable catalyst for the stock this year to push up another 20 percent or so and that should come May 1.”

Acorda Therapeutics [ACOR  30.13    -0.49  (-1.6%)   ]—“The Street estimates are still a little bit low and I think they’re going to beat numbers over the next year or so.”

Schoenebaum recommended investors who are looking into the biotech sector to consider investing through ETFs or actively managed mutual funds.  

Dendreon Placing Its Final Bets on Provenge
By Lisa LaMotta Feb 10, 2010 1:55 pm
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    DNDN   29.52  +0.08 (+0.27%)   The next few months will be Dendreon's (DNDN) show as the company eagerly anticipates the potential approval of its prostate cancer drug Provenge by the FDA on May 1, marking its first product to make it to market.

The Seattle-based biotech has had a long, winding road trying to get Provenge approved, but the company is prepared to show investors that it has confidence in the cancer treatment that some interest groups have called a "miracle drug." Dendreon Chief Executive Mitchell Gold said Tuesday at the BIO CEO conference in New York that the company has prepared three plants to be in full manufacturing mode for Provenge by mid-2011 and that 125 sales people will be out in full force.

"Our plan is to commercialize this product ourselves in the United States," said Gold at the conference. "And we are currently evaluating potential structures for partnering outside the United States."

Provenge will target a patient population of about 103,000 men in the US. It has been shown in studies to prolong a patient's life by 4.5 months -- a huge period of time in the world of cancer treatments -- and to lower the risk of death by the cancer by 22.5%. Unlike chemotherapy, the drug works to boost a patient's own immune system, instead of introducing cell-killing toxins into the body. It is also more convenient than chemotherapy -- chemotherapy requires patients to get infusions every three weeks for several months, while Provenge only requires one infusion a month for three months.

"Within one year of potential approval, we will be in full capacity in terms of our manufacturing infrastructure that we will be able to supply to the marketplace," Gold added. "I do believe Dendreon offers a unique investment opportunity."

The company will begin manufacturing at its Morris Plains, New Jersey, plant, and then will expand production to plants in Atlanta, Georgia, and Orange County, California. At full capacity the New Jersey plant will be able to handle $500 million to $1 billion worth of sales. The other facilities will be able to handle $375 million to $750 million in sales.

Analysts believe that Provenge has the potential to break the $1 billion sales mark in its first year on the market and to surpass $5 billion in sales within a few years of that. The drug is also being tested for treatment of other types of cancer including bladder, colon, colorectal, and breast.

Yet, Provenge and Dendreon have had a rocky time over the last couple of years. Dendreon's stock has ranged between $2.55 and $30.90 over the last 52 weeks. The stock has been plagued by problems including a manipulated bear run on the stock last April, which caused the stock to lose 65% of its value in less than two minutes. The stock also took a hit in 2005 when CNBC's Jim Cramer told investors that Provenge had been rejected by the FDA when the company had yet to submit the drug for FDA approval. CNBC was forced to apologize for the mistake.

The SEC's Office of Inspector General is now investigating the bear run and other allegations that the stock has been subject to illegal naked short selling. "The OIG has opened an investigation into complaints from an investor alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug," said the report by the OIG.

This hasn't been the only scandal surrounding Provenge. The FDA has been accused of ignoring conflicts of interest for two of the doctors that were on the original advisory panel by a group called Care To Live after the FDA rejected the approval of Provenge and asked for further data. The FDA has responded by saying the accusations are "baseless speculation" and "conspiracy theory." Check out Pharmalot for further details on this scandal.

Investors and patients will be waiting with baited breath on May 1 for the FDA to finally bring the Dendreon saga to a close with the approval of Provenge.
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Neue all time high und daß bei dem nervösen Markt, Dendreon the game changer in treating cancer!  

Dendreon Corp. Shares Surge 7% On FDA approval rumor (DNDN)  
David Lipton
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Posted on 02/11/10 at 1:57pm by David Lipton Speculative biotech company, Dendreon Corp. (NASDAQ: DNDN) shares are surging nearly 7% in mid day trading on rumors of a potential FDA approval of its prostate cancer drug Provenge by May 1.

By mid day 4 million shares have already traded, average volume 2.2mil. The volume is being confirmed by options traders snapping calls, specifically the May 35's.

The past few months Dendreon's Corps.(DNDN) shares have seen wild gyrations in hopes of FDA approval. With the stock currently trading at 52 week highs, it appears there is great upside potential.

52 week range: 2.55-31.50  

Super Hisorie:

http://us.rd.yahoo.com/finance/external/...ium=portals&from=yahoo  

Muß natürlich Historie heißen!

Ein Auszug der Analyse für Dendreon:

Final Thoughts

Dendreon is one of the more fascinating companies I’ve covered in the 10 years our firm has been biotech specific. Provenge is an honest-to-goodness paradigm shift in the way we treat cancer. Good news from their IMPACT trial helped the entire biotech sector bottom early last year. Approval and strong sales should help the sector in 2010 and 2011.

Intellivenge is quite the accomplishment. It’s been personally fun watching the management team work out all the potential kinks and twists, attempting to account for every variable. While they're smart enough to know five nines perfection is impossible with this much human interaction, the combination of Intellivenge, the call center, and significantly motivated patients will minimize surprises considerably.

Our firm has projected Provenge will achieve over a billion in sales in the over the next few years. We’ve shared with our clients specific sales projections for 2010 and 2011. Managing demand will be Dendreon’s biggest challenge until full manufacturing capacity is online in mid-2011.

That’s a nice problem to have.  

JPMorgan starts coverage of Dendreon $DNDN at Overweight with a 2010 year-end target of $46.  

AstraZeneca Sees Bearish Move
By Jud Pyle CFA   02/23/10 - 04:01 PM EST   Loading Comments... Add Comment
Stock quotes in this article: AZN , DNDN  
NEW YORK (TheStreet) -- Shares of AstraZeneca(AZN Quote) have declined around nine cents to $43.46 so far on the day, and it appears as if at least one investor expects the stock could slide further between now and July.
More on AZN 10 Biotech Stocks Facing FDA ApprovalRigel May Get $1.245B in Drug License PactSmall-Caps Surge Up to 1,640% in a Year Market Activity Dendreon Corporation| DNDN DOWNAstraZeneca PLC| AZN DOWNAZN was the center of attention on Feb. 19, as the company reportedly still has plans to acquire Dendreon(DNDN Quote). Then today, the company raised its forecast for 2010 earnings after settling a tax dispute with the British government, according to published reports. Around 10:30 a.m. EST, an AZN investor sold off potential upside in the stock to decrease the cost of downside protection in a July-collar spread. The investor bought the July 40-50 risk reversal 5,000 times, buying the out-of-the-money July 40 puts for $1.35 per contract and selling the out-of-the-money July 50 calls for 60 cents per contract. The net cost of this risk reversal was 75 cents per spread.
The July 40 puts are home to current open interest of 1,000 contracts, while the July 50 calls are home to current open interest of 4,200 contracts, indicating the investor most likely initiated the trade to open.
AZN shares, which reached a high of $50.70 on Jan. 21, are currently trading roughly 14% off their highs. The stock has rallied nearly 45% since its March low of roughly $30 per share. While the options action we saw in AZN suggests bearishness, this could also be an investor who is long the shares and hedging that position after the run in stock. If that is the case, then this investor makes the most money if the stock rallies because they are long the shares against the collar.
-- Written by Jud Pyle in Chicago
 Loading Comments... Add Comment  

Dendreon "buy"
Rating-Update:

Vancouver (aktiencheck.de AG) - Die Analysten von Canaccord Adams stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) weiterhin mit "buy" ein. Das Kursziel werde von 43 USD auf 47 USD erhöht. (23.02.2010/ac/a/u)


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

Erneute Shortversuch durch Verbreitung von Lügen.... wurde abgewehrt, die Shorties werden gegrillt!
Neues All-Time-High! US Dollar 34,50 mein Tenbagger!  

Und hier das offizielle Dementi der FDA:

UPDATE 1-US FDA sees no public hearing for Dendreon vaccine
Tue Mar 2, 2010 11:53am ESTStocks  
Dendreon Corp
DNDN.O
$34.51
+2.00+6.15%
5:26pm UTC+0100
* No advisory meeting planned, FDA spokeswoman says

* Dendreon shares up 7 percent

By Susan Heavey

WASHINGTON, March 2 (Reuters) - The U.S. Food and Drug Administration is not planning to seek advice from its outside advisers over Dendreon Corp's (DNDN.O) experimental prostate cancer vaccine, fueling investor speculation about the product and sending company shares up.

"There is not going to be an advisory committee meeting," said FDA spokeswoman Shelly Burgess.

Dendreon's vaccine, Provenge, would be the first cancer vaccine aimed at treating a condition, rather than preventing a disease like traditional vaccines do.

The closely watched product could be a blockbuster for the biotech company, which has said it would ramp up production to handle an expected $1.2 billion to $2.5 billion in annual sales by late 2011.

The company's shares had fallen over speculation that Provenge might have to face public scrutiny at an FDA advisory panel, but later recovered to trade up as much as 8.5 percent.

The FDA often seeks advice on whether to approve products from its panels of outside experts and usually, but not always, follows their recommendations.

Its shares were up 7 percent at $34.85 in midday trading on the Nasdaq. (Additional reporting by Esha Dey in Bangalore) (Reporting by Susan Heavey. Editing by Robert MacMillan)  

Nach dem "wilden Tag" die sachliche Analyse:

UPDATE 3-US FDA sees no public hearing for Dendreon vaccine
Tue Mar 2, 2010 4:33pm ESTStocks  
Dendreon Corp
DNDN.O
$33.26
+0.75+2.31%
12:00am UTC+0100
* No advisory meeting planned, FDA spokeswoman says

* Dendreon shares close up 2.3 percent (Updates shares; adds background on previous panel meeting)

By Susan Heavey

WASHINGTON, March 2 (Reuters) - The U.S. Food and Drug Administration is not planning to seek advice from its outside advisers over Dendreon Corp's (DNDN.O) experimental prostate cancer vaccine, fueling investor speculation about the product and sending company shares higher.

"There is not going to be an advisory committee meeting," FDA spokeswoman Shelly Burgess said on Tuesday.

The vaccine, Provenge, would be the first cancer vaccine aimed at treating a condition, rather than preventing a disease as traditional vaccines do.

The closely watched product could be a blockbuster for the biotech company, which has said it would ramp up production to handle an expected $1.2 billion to $2.5 billion of annual sales by late 2011.

Prostate cancer is diagnosed in one of every six American men and is the second-leading cause of cancer death among men.

Dendreon's shares had fallen earlier on Tuesday over speculation that Provenge, also known chemically as sipuleucel-T, might have to face public scrutiny at an FDA advisory panel, but the shares later recovered to trade up as much as 8.5 percent.

The FDA often seeks advice on whether to approve products from its panels of outside experts and usually, but not always, follows their recommendations.

An FDA advisory panel previously met in May 2007 said Dendreon provided favorable efficacy and safety results from an earlier study of Provenge. The FDA declined to approve the product, however, until data from the Impact trial confirmed earlier trends.

Roth Capital Partners analyst Joseph Pantginis, in a note issued before the FDA said it would not convene a panel, said he expected Provenge to win the agency's clearance. He pointed to positive results released in April from a study called Impact.

"We believe Provenge will be approved on or about" May 1, the FDA's target date for a decision, Pantginis said. He reiterated his "buy" rating on Dendreon shares and a $50 price target.

Last April, data from the 512-patient Impact study showed the vaccine improved three-year survival of men with advanced prostate cancer by 38 percent compared with a placebo.

Dendreon shares gained 2.3 percent, or 75 cents, to close at $33.26 on Nasdaq. (Reporting by Susan Heavey and Lisa Richwine; Additional reporting by Esha Dey in Bangalore; Editing  

Wow, 40 % survival gegenüber Placebo nach 3 Jahren, sensationell:

IMPACT Results Confirming PROVENGE


Dendreon Presents Updated IMPACT Results Confirming PROVENGE Improves Overall Survival in Patients with Metastatic Castrate-Resistant Prostate Cancer



-- Data to be Presented at ASCO-GU Annual Symposium --



SEATTLE, March 3, 2010—Dendreon Corporation (Nasdaq: DNDN) today announced updated results from its pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrating that PROVENGE® (sipuleucel-T) extends overall survival in men with metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). The data will be presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco on Friday, March 5 at 1:45 pm PT.



A sensitivity analysis performed with longer-term follow-up (36.5 months) and additional events (349 deaths) collected at the time of study closure demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo (32.1 percent vs 23.0 percent), the median survival difference of PROVENGE compared to placebo was maintained at 4.1 months, with a 24.1 percent reduction in the risk of death [HR=0.759] and a p-value of 0.017.  



As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that PROVENGE increased three-year survival by 38 percent compared to placebo (31.7 percent vs 23.0 percent), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.  



In addition, new analyses demonstrated that the median predicted survival of the two treatment arms using the Halabi model were well balanced (20.3 months for PROVENGE vs 21.2 months for placebo).  Furthermore, in an analysis in which patients were censored at the time of docetaxel use, the PROVENGE treatment effect remained strong [HR=0.649].



As previously reported, the most common adverse reactions were chills, fever, headache, aches, influenza-like illness and sweating.

"The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer.  This is the first therapeutic vaccine to demonstrate a survival benefit in cancer," said Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at  Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study. "Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile."



Dendreon is seeking licensure for PROVENGE for men with metastatic CRPC and submitted an amended Biologics License Application for PROVENGE, for which the U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act date of May 1, 2010.





IMPACT Study Detail



IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) was a 512-patient, multi-center, randomized, double-blind, placebo-controlled study evaluating men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer, and the primary endpoint was overall survival.



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 Dendreon

Dendreon Corporation is a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that may significantly improve cancer treatment options for patients.  The Company applies its expertise in processing antigen-presenting cells and identifying and engineering antigens to produce active cellular immunotherapy (ACI) products, which are designed to stimulate a tumor-directed 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.  

UPDATE 3-Dendreon: Provenge boosts survival 40 pct
Wed Mar 3, 2010 7:46pm ESTStocks  
Dendreon Corp
DNDN.O
$33.62
+0.36+1.08%
12:00am UTC+0100
* Provenge extends 3-yr survival by 40 pct vs placebo

* Shares rise 2.9 percent after hours (Adds trial detail, sales projection, updates share price, paragraphs 2-4, 7)

By Deena Beasley

LOS ANGELES, March 3 (Reuters) - Updated trial results show that an experimental cancer vaccine developed by Dendreon Corp (DNDN.O) improved three-year survival of patients with advanced prostate cancer by 40 percent compared with a placebo.

Dendreon shares rose nearly 3 percent in after-hours trade.

The results, based on just over three years of follow-up, confirm earlier 34-month data presented last year, which showed that the drug improved survival by 38 percent in men whose prostate cancer had stopped responding to hormone blockers.

Patients in the 512-patient study who received Dendreon's Provenge, also known as sipuleucel-T, lived an average of 4.1 months longer than those who were given a placebo, according to the latest tally announced by the company on Wednesday.

Unlike traditional vaccines that prevent disease, Provenge treats it by stimulating the body's own immune system to attack cancer cells. It 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.

The U.S. Food and Drug Administration is slated to decide by May 1 whether to approve Provenge for treating advanced prostate cancer.

The closely watched product could be a blockbuster for the biotech company, which has said it would ramp up production capacity to handle an expected $1.2 billion to $2.5 billion of annual sales by late 2011.

Prostate cancer is the most common cancer in American men aside from skin cancers, according to the American Cancer Society. More than 1 million men have the disease in the United States and one in six men will be diagnosed with prostate cancer during their lifetime.

If approved, Provenge, which is administered in three doses at two-week intervals, would be the first cancer immunotherapy on the market.

Adverse events seen in patients taking Provenge were chills, fever and headache that lasted one to two days following infusion. This is seen as an enormous advantage over the debilitating side effects typical of chemotherapy.

Seattle-based Dendreon said the latest clinical trial data will be presented on Friday at a meeting of the American Society of Clinical Oncology in San Francisco.

Shares of Dendreon rose to $34.67 after closing at $33.62 on Nasdaq. (Reporting by Deena Beasley; Editing by Steve Orlofsky, Gary Hill and David Gregorio)

After reading this article, people also read:Sanofi drug boosts prostate cancer survival 30 pct
Mar 3, 2010
UPDATE 1-US FDA sees no public hearing for Dendreon vaccine
Mar 2, 2010
Dubai police chief says to seek Netanyahu arrest
Mar 2, 2010
Viacom to drop Jon Stewart, Colbert Report from Hulu
Mar 2, 2010
CORRECTED: Fish oil makers, drugstores, sued over supplements
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Dendreon shares climb on Provenge study results
Dendreon shares climb on positive update to potential blockbuster cancer drug Provenge

        Buzz up! 0 Print
Companies:Dendreon Corp.Banco Santander-Chile Related Quotes
Symbol Price Change
DNDN 35.16 +1.54

SAN 67.00 +1.26


{"s" : "dndn,san","k" : "c10,l10,p20,t10","o" : "","j" : ""} On Thursday March 4, 2010, 1:18 pm
NEW YORK (AP) -- Shares of Dendreon Corp. rose Thursday as updated study results suggested the drug developer's prostate cancer drug candidate Provenge will likely gain approval in spring and could become a blockbuster treatment.

The Food and Drug Administration is expected to make a regulatory decision on the drug on May 1.

Shares rose $1.54, or 4.6 percent, to $35.16 in midday trading. The stock earlier traded at $35.32, its highest price in a decade. The stock is up 13 percent so far this week.

The company on Thursday updated late-stage study results showing its lead drug candidate increased three-year survival rates by 40 percent. In April, it released results showing that the drug increased three-year survival by 38 percent. The latest analysis also reaffirmed that the drug added four months to the lives of men with advanced prostate cancer.

The updated results are further confirmation of the drug's likely approval by the FDA. On Wednesday, federal regulators said they haven't scheduled a public meeting on the drug. The FDA typically holds panel meetings when it needs guidance from outside experts about whether to approve a new treatment. A panel of experts usually votes for or against approval, though the vote is not binding.

Brean Murray Carret analyst Jonathan Aschoff reaffirmed a "Buy" rating and $40 price target on Dendreon stock in a note to investors. He expects approval in May and said the lack of a panel meeting on the drug is a positive sign that the approval process will move smoothly.

Provenge is designed to treat prostate cancer by stimulating the body's immune system and prompting it to fight the disease. It is technically a vaccine that treats the disease. There are few new treatments for advanced prostate cancer, with hormones and chemotherapy being the most widely used measures.

Dendreon has ramped up spending in preparation to sell Provenge. Rodman & Renshaw analyst Reni Benjamin said the company has hired regional and district managers and expects to have a sales infrastructure in place by May 1. In a note to investors Feb. 26, he said longer-term plans call for 100 representatives and 25 medical science liaisons.

In December, the company named former Bayer executive Hans Bishop chief operating officer, making him responsible for leading the commercial launch Provenge.

Meanwhile, the FDA has said it will give Sanofi-Aventis' advanced prostate cancer drug cabazitaxel, a chemotherapy treatment, a quick review. That drug extended the lives of patients an extra 10 weeks. No chemotherapy has yet been shown to boost survival in men with advanced prostate cancer.

       Buzz up! 0  

http://finance.yahoo.com/news/...-on-apf-2317203479.html?x=0&.v=1

"Brean Murray Carret analyst Jonathan Aschoff reaffirmed a "Buy" rating and $40 price target on Dendreon stock in a note to investors. He expects approval in May and said the lack of a panel meeting on the drug is a positive sign that the approval process will move smoothly.

Provenge is designed to treat prostate cancer by stimulating the body's immune system and prompting it to fight the disease. It is technically a vaccine that treats the disease. There are few new treatments for advanced prostate cancer, with hormones and chemotherapy being the most widely used measures.

Dendreon has ramped up spending in preparation to sell Provenge. Rodman & Renshaw analyst Reni Benjamin said the company has hired regional and district managers and expects to have a sales infrastructure in place by May 1. In a note to investors Feb. 26, he said longer-term plans call for 100 representatives and 25 medical science liaisons.

In December, the company named former Bayer executive Hans Bishop chief operating officer, making him responsible for leading the commercial launch Provenge."  

Hallo Magnetfeldfredy, ich könnte mir vorstellen das wir das Provenge Approval vor dem  01.05.2010 sehen? Die Daten der Studie fielen letztlich besser aus als bisher bekannt war. Diese Daten liegen natürlich auch der FDA vor. Es gibt keinen Grund weiter zu verzögern.

Nur meine Meinung.

http://www.minyanville.com/businessmarkets/...-drug/3/4/2010/id/27136

Now that Dendreon (DNDN) has overcome the confusion about whether or not it's going to require an advisory panel for its prostate cancer drug Provenge, the company is reinforcing shareholders’ hope that the drug will be a major blockbuster as it moves one step closer to May 1, when it will hear final word on the FDA’s approval.

(See Dendreon Drama Subsides; More Data to Come)

The drama-prone biotech released results Wednesday night providing more support for its late-stage Impact study showing that Provenge extends the overall survival of men with metastatic, castrate-resistant prostate cancer. The study showed that Provenge increased three-year survival by 40% compared to a placebo, extending median survival by 4.1 months and reducing risk of death by 24.1%. The full results of the study will be released on Friday at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium.

"This is the first therapeutic vaccine to demonstrate a survival benefit in cancer," said Philip Kantoff, M.D., director of the Lank Center for Genitourinary Oncology and principal investigator of the Impact study. "Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile."

The Seattle biotech's stock edged up almost 4% to linger near $35 per share on Thursday. "We continue to believe that the statistical results of Impact remain key to FDA approval and to this end we view the consistency from multiple analyses to be encouraging," wrote Leerink Swann analyst Howard Liang.

Liang believes that the new results quiet any fears that the positive data on survival rates from Provenge was impacted by use of the chemotherapy drug Taxotere.

Analysts believe that Provenge has the potential to break the $1 billion sales mark in its first year on the market and to surpass $5 billion in sales within a few years of that. The drug is also being tested for treatment of other types of cancer including bladder, colon, colorectal, and breast.

Hopefully for Dendreon, the second time is the charm. The company has been battling bears in the stock market and problems with FDA management over the past few years as the stock has gone from $30.90 to $2.55 and back again.

(See Dendreon Placing Its Final Bets on Provenge)

Meanwhile, Sanofi-Aventis (SNY) is making progress in the fight against prostate cancer as well. The French pharmaceutical company also announced results from a late-stage study on Wednesday night. The study showed that Sanofi's drug Jevtana reduced the risk of death by 30% in second-line prostate cancer patients, extending median overall survival to 15.1 months compared with 12.7 months on placebo.

"Jevtana delivered results in line with our predicted 30% reduction in the risk of death versus control, which supports the potential for significant pricing leverage versus our initial assumption that assumed pricing in line with Taxotere of $2,500 per dose," said Leerink Swann analyst Seamus Fernandez.

Prostate cancer is the second leading cause of cancer death in men in the US. In 2010, almost 200,000 new cases of the disease are expected to be diagnosed and 28,000 men will die from the disease. On Thursday the House Committee on Oversight and Government Reform will be holding a hearing to discuss prostate cancer screening and treatment.  

Hab ich in der Eile doch tatsächlich einen kleinen aber wichtigen Fakt vergessen. Neben der weit aus besseren Wirksamkeit sowie der sich abzeichnenden Schlußfolgerung ( meine), dass je früher man therapiert je höher die Wirksamkeit, das Zeug hat geringe bis keine ( verglichen zu Tax.) Nebenwirkungen.

Come on FDA, es wird Zeit für neue Wege!!!!  

Was für ein Vollpfosten, da hat Sanofi wiedermal ne Giftkur parat, weit weniger Vorteil bzgl. overall survival verglichen zu Provenge. Über die Nebenwirkungen wollen wir gar nicht erst sprechen. 2. Line Therapie, aber Sanofi is the winner, Lächerlich diese Clown`s and  Fool`s!

http://msn.fool.com/investing/dividends-income/...ublished=2010-03-04

Best in Class ... For Now
By Brian Orelli
March 4, 2010 | Comments (0)

With the prognosis for advanced prostate cancer patients so bleak, any treatment that yields even a minor increase in survival should result in decent sales. At least until the next drug comes along.

The winner, for now, appears to be sanofi-aventis (NYSE: SNY). Today the company released results for its tests of cabazitaxel in patients who had already failed the company's first-line treatment for advanced prostate cancer, Taxotere. Median patient survival was 15.1 months -- that is, half lived this long or longer -- a statistically significant 2.4 months longer than those given EMD Serono and OSI Pharmaceuticals' (Nasdaq: OSIP) Novantrone.

That's not a huge improvement. It's certainly no cure. But keep in mind that Novantrone isn't even approved to treat advanced prostate cancer, and the median patient survival in that group was slightly more than a year. There's clearly a need for something better, and cabazitaxel is an improvement on what's currently available.

As a second-line treatment, cabazitaxel will have to wait for patients to fail Taxotere -- and potentially Dendreon's (Nasdaq: DNDN) Provenge, if it's approved. But with these results, cabazitaxel should be able to capture most of the post-Taxotere/Provenge patients.

Sanofi plans to submit its marketing application to the Food and Drug Administration within the next few months. Given the unmet need, the FDA should certainly give cabazitaxel a six-month priority review, which should result in a decision by the end of the year. Assuming nothing pops up when the full data set is presented at a medical conference on Friday, the drug looks good enough for an approval.

In order to gain any marketing traction, new competitors will have to beat that 2.4-month survival gap. Johnson & Johnson (NYSE: JNJ), Medivation (Nasdaq: MDVN), and OncoGenex Pharmaceuticals (Nasdaq: OGXI) are all testing drugs as second-line prostate cancer treatments.

For now, though, Sanofi is in the driver's seat. Others will be gunning for it, but Sanofi should have a head start talking to doctors, and the results from any new compounds will be compared against cabazitaxel.

Given the choice, I'd rather be chased than be the chaser. But only by a little.  

Dendreon Corp.: Brean Murray analyst Jonathan Aschoff reiterated his buy rating on shares of Dendreon Corp. (DNDN) on Mar. 4.

The drug developer said on Mar. 4 that its Provenge compound increased three-year survival by 40% compared with placebo in patients with metastatic castrate-resistant prostate cancer.

Aschoff said in a note that the company updated results from a trial of Provenge in metastatic castration-resistant cancer, confirming extension of overall survival. He said he believes there will be no FDA panel for Provenge; he noted that the agency even made a comment on Mar. 2 strongly to that effect, indicating to him that no panel will occur. He said he believes subsequent "more cautious language" from the FDA was "nothing more than a strictly legally accurate response and in no way indicates any FDA caution on approval".

Aschoff expects FDA approval of Provenge for in metastatic castration-resistant cancer on May 1. He maintained his $40 price target.