Der erste Krebsimpfstoff
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Dendreon Announces Webcast Presentation at Eleventh Annual BIO CEO & Investor Conference
Last update: 7:30 a.m. EST Feb. 3, 2009
SEATTLE, Feb 03, 2009 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (DNDN:dendreon corp com
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DNDN 3.41, +0.04, +1.2%) today announced that management will present a company update at the Eleventh Annual BIO CEO & Investor Conference in New York City, on Tuesday, February 10, 2009 at 1:45 p.m. ET.
A live audio webcast of the presentation will be accessible through the Investor Relations section of the Dendreon website, http://www.dendreon.com. If you are unable to listen to the live webcast, it will be archived on the site following the presentation. To access the replay, go to the Investor Relations section of the website.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets Trp-p8 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 http://www.dendreon.com.
SOURCE Dendreon Corporation
http://www.dendreon.com/
Copyright (C) 2009 PR Newswire. All rights reserved
The conversation was sparked by some personal (and board) misunderstandings about the history of the Azimuth deal. It branched a bit from there, but I will begin with Azimuth.
I cannot take notes and think at the same time, so I elected to focus on the conversation itself and must now report from fresh memory inasmuch as we spoke within the past hour or so by the time this is printed.
_________
1. Dendreon did not recently draw down money on the Azimuth Agreement. Instead, the Agreement was renegotiated solely to extend it for one year past April when it was set to expire. Greg noted that after Final Look results are known sometime in April, if that materializes as expected, then we might want to increase expenditures in a ramp-up. He noted, in what seemed an under-statement, that having an instant place to turn for money seemed worthwhile to keep in place.
2. The Susquehanna deal from a year or more ago (a different deal altogether), brought in 50 million for the purchase of stock and provided, at nominal cost, a like number of warrants exercisable for shares at $20. (I did not ask if a market is being made in the warrants, but assume that it is a private market if one exists at all.).
3. He said something about a more recent raising of $20 million (many months ago) but I failed to grasp who it was that did that deal—except to note that it was not Azimuth, if I heard him right. In other words, we had the Azimuth deal in place for a year, did not exercise any of it, and needed to extend it or lose it. It was the same with Azimuth, i.e. to extend or lose. Both companies deemed a 130 million extension to be in their best interests, so it was extended and an SEC Form to that effect was filed.
4. Azimuth, which gets a small discount when it buys, is basically an arbitrager. They immediately sell at a profit the shares just bought. Ergo, Azimuth fears only a non-liquidity situation (as with penny stocks, for example). The advantage to DNDN is that they can “put” a sale to Azimuth at any time (without negotiation) so long as the trading price of the shares is above $4 (which at this present moment is not the case, though we are trading at $3.85 as this is being written—after a 2/2/09 52-week low of $3.26 at the Open that day).
5. Of course, DNDN obviously is disadvantaged if the stock price is too low, and Azimuth might also be disadvantaged. Therefore, the new agreement provides, as did the old one, for Azimuth to pass a purchase offer made when the share price is below $4. This they presumably would do only if they could not see an immediate gain certain.
The assumption by both parties is that if DNDN wants to sell shares below $4, then Azimuth will go forward with the deal so long as there is good general market liquidity. As an aside, share volumes on rising prices this week (which were running millions above the normal 1 million per day) argue that liquidity is doing just fine. Further, Greg clearly expects higher share prices for exercise purposes if the Final is Statistically Significant (and so also do I).
6. Bottom Line on Azimuth: Greg acted to preserve an expiring financing advantage that he had first negotiated in 2007 or 2008 and which had been set to expire two months from now. It is now being extended for one additional year (and likely will be renewed beyond that date as well). There are no warrants attached to the Azimuth Deal.
(Continued to Part 2)
_____________________
(Continued from Part 1)
The rest of our talk ranged over a number of FDA-related topics. Little that was new came out, but certain prior expectations were renewed. He had some positive things to say about CareToLive and Abigail Alliance initiatives as possible factors—along with the disappearance of competitive reasons for opposition—in how things go this time around.
7. Scary for the Shorts is the possibility that the FDA under some new management might choose, as is their option, to be more expeditious in bringing Provenge to market this time around, though he had no basis for expecting such a changed approach. In other words, having noted that we don’t even know who is going to be running the FDA, and acknowledging no new insight as to Pazdur’s degree of opposition, he did say that he thought CTL and Abigail Alliance people had met with (Janet?) Woodcock seeking to gain assurances that the FDA would handle upcoming re-applications differently.
8. He did say that he expected Provenge to continue to be Fast-Tracked for an early PDUFA date (6 or 8 months) after the BLA is filed. He mentioned two or three times that the FDA has the power to change almost anything it does, but that the company had to expect matters to proceed in a routine manner—meaning 6 to 8 moths to a PDUFA date once the “Amended” BLA is filed.
9. As to the “Amended” new BLA, he said as we let our imaginations have free rein, that the Amendment process could be greatly simplified and expedited, if the FDA’s expectations for satisfactory further evidence of Efficacy were to be not so stringently applied due to ample evidence already on file in the first BLA. But for that to happen, the FDA would need to make clear that they intend to Approve Provenge, in the absence of serious immunotherapy and new PC chemotherapy competition that would suffer huge financial losses, be disrupted to the point of shutting down product lines and otherwise be inconvenienced in conducting placebo Trials (as was the case in early 2007).
10. We discussed briefly the matter of CMC issues and the possibility of re-inspections at the New Jersey plant. On this, he said that they believed all CMC issues of record before have been entirely handled. But that did not preclude the FDA wanting to have a full-blown new inspection. Accordingly, he had to concede that we still could be at the mercy of the Philadelphia Inspectors and their too heavy workload that makes scheduling inspections somewhat problematic—even in a rush to save lives. Indeed, if there is a bottleneck in this aside from Pazdur and his people, that would be a genuinely unavoidable one IMO.
11. He said this is an exciting and busy time. Employees who have been around much longer than Greg, are “getting excited” as the moments of truth approach once again. All in all it was an upbeat report and a good talk. I thanked him for keeping us at ease on the matter of Financing, saying that we didn’t have to worry about that aspect of things any more—adding that, of course, we didn’t have to worry because he was worrying about it. He laughed.
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I'm not really enjoying my "day off" so far here in rather gloomy, cool L.A. as I've been kept pretty busy trying to chase down the Dendreon [DNDN 5.98 1.64 (+37.79%) ] story.
The shares are hitting a new intra-day high on heavy volume on word that the American Urological Association is saving a seat at the table for DNDN at its annual meeting the end of this month.
The stock started moving this morning when that information was posted on the AUA's website. I started getting tweets on Twitter and emails from Dendreonians calling the news, volume and movement to my attention.
I ran it down with calls to Dendreon, the AUA and Dendreon's outside PR. Got quick calls back from all of them, but DNDN CFO Greg Shiffman was the first to get back to me.
He said he didn't see why this was creating so much buzz.
Yes, he confirmed, AUA has given the company a "placeholder" to present the highly anticipated Provenge data in a prestigious "late breaker" session if they're ready in time for the event. But that will only happen in the event the clinical trial results are available by then. Shiffman pointed out that the company has been saying the data were expected sometime in April.
Shiffman also told me Dendreon does not have a similar placeholder at the American Society of Clinical Oncology meeting which takes place about a month later.
Interestingly, the placeholder info seems to have been taken off the AUA website. I have a call into the organization about that and I will update the blog if/when I hear back. I suspect it was at the company's request given the frenzy it triggered.
Never a dull moment.
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Apr
15Flash Alert - 4.15.09 - Dendreon Wins!
Michael Murphy Flash Alerts 2009-04-15
Don’t Sell Dendreon Yet!
Dendreon (DNDN) yesterday held a conference call to report that Provenge met the goal of reducing mortality in men with advanced prostate cancer by 22%. This was a big win for the company, and I am going to quote several statement that show how wrong the bears were on this drug. But the company did not report the actual top-line data for Provenge, and here is why you should NOT sell Dendreon yet:
I suspect the survival benefit was stunning!
Beyond that, later this year Dendreon will be announcing a major partner for European sales that is bound to include a huge cash infusion, at no dilution to the shareholders. And I have not even seen anybody comment on the fact that this first anticancer vaccine technology that works will be in trials for breast and head & neck cancer in 2010 – two more billion-dollar markets.
Here’s what happened. In the press release, management simply said: “The IMPACT study met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study’s design. The safety profile of Provenge appeared to be consistent with prior trials.”
Several media stories said that Provenge reduced mortality by 22% , but that was the “pre-specified level of statistical significance,” not the actual results. The results will be released on April 28 at 2:20 PM Central time, at the American Urological Association annual meeting. Remember that in the trials presented to the FDA in 2007, 34% of the men who received Provenge were still alive after three years. That compared with 11% of those in the placebo arm – the highest survival benefit ever seen in a trial for hormone-refractory prostate cancer patients. Provenge also showed very few side effects, just the fever and chills that happen when your immune system is effectively fighting an invader, like the flu. Because the FDA turned the drug down, many men died needlessly in the last two years. Someone will write a book someday about this shameful blot on the FDA’s already-tattered reputation.
On the conference call, management said: “The results are unambiguous in nature. It was a clear hit on a pre-specified primary endpoint of overall survival.”
A number of analysts said the interim peek last October that showed a 20% survival rate at that point was a stupid mistake, because those cases would have to be removed from the final calculation of statistical significance. Management commented: “The overall Alpha for the study was 0.05 as defined in the SPA [Special Protocol Assessment]. The company spent a very small amount of Alpha on the interim analysis, so the majority of the Alpha was reserved for the final analysis of overall survival…we’re not going to get into details of that, but it was an unambiguous hit on the primary endpoint of overall survival in terms of statistical significance…the results that we’re seeing here are very consistent with what we’ve seen in our other Phase 3 trials of Provenge in other studies, so we’re seeing a consistent result in IMPACT as we saw in our other Phase 3 clinical trials.”
And on safety: “We’re not seeing anything in the preliminary analysis that looks different from our previous studies.”
Provenge will be a $1+ billion drug just based on the price ($50,000 for the three infusions, one every two weeks) and number of men in the target group. But it will be a $2+ billion drug with off-label usage for earlier-stage prostate cancer, because this is the right way to treat cancer. Cancer is an indication of a weak immune system – even the American Cancer Society has said that if one’s immune system is strong, one will not get cancer. Chemotherapy and radiation weaken the immune system even as they treat the tumor. Provenge treats the underlying cause of tumors, boosting the immune system. That is the main reason I have continued to recommend the stock.
On the conference call, management said: “As you know, Provenge employs our novel proprietary Antigen Delivery Cassette technology that may be leveraged to develop similar products to treat breast, colon, bladder, kidney, and multiple other types of cancer. The IMPACT results renew and validate our confidence in this platform technology and our ability to extend its benefits across other cancer types. We will be evaluating a more comprehensive development plan to expand our cancer immunotherapy product pipeline. We anticipate that many of you will have more in-depth questions about our future commercialization and clinical development plans, and therefore we plan to host an Analyst Day this summer to review our plans in greater detail.”
Each of those cancers is a multibillion dollar market for Dendreon’s technology, in the U.S. alone. Using my earnings and valuation model, each $1 billion of ultimate sales is worth $40 a share to Dendreon today. So Provenge for its indicated patent population should make DNDN a $40 stock. Adding Provenge used off-label makes Dendreon an $80 stock. Adding breast, head & neck, colon, bladder and kidney cancers…well, the numbers just get ridiculous, even before adding in Europe and Asia.
I expect analysts to dramatically increase their estimates after the April 28 meeting, because the sales prospects for Provenge depend in part on the extent of patient benefit and the severity of any side effects, which will be detailed when the IMPACT study is presented at the American Urological Association meeting in two weeks. About half of the 512 trial patients were treated by urologists, and about half by oncologists. Dendreon believes they can serve these very targeted groups with a 100-person sales force.
The company will analyze the remaining data and file a Type 2 resubmission with the FDA in the fourth quarter. I expect that to happen by October 15, and the FDA has six months to April 15 to respond. So a year from today, Provenge should finally be approved. Sometime between now and then, I fully expect DNDN to hit $40 a share. I am doubling my buy limit to $16 and maintaining my $40 target.
22 April 2009 Filed under Biotech companies, Cancer Treatments, Dendreon, Immunotherapy, Prostate Cancer, Provenge, Vaccines, trial results Posted by jacquie strax »
Hyam Levitsky
Hyam Levitsky
A four part interview with Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website.
Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009.
By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other speakers at Cancer Immunology & Immunotherapy 2008: From Discovery to Development to Drug.
EXCERPTS FROM INTERVIEW
Conversation with Dr. Levitsky Part 1
“. . . . how this impacts on the field of tumor immunology, I feel it will very much depend on the nature of the data they present, assuming for the sake of discussion, that this is an unequivocal and unambiguous win, then I think it will have a very significant impact. Number one, I think that unless there are aspects to this that have not been made public, I think the FDA would in this instance need to move it forward in the approval process and I think that how it ultimately gets integrated into clinical practice will be a fascinating thing to watch.
“. . . . It is important to acknowledge that tumor response is a surrogate endpoint. It is a surrogate endpoint for perhaps 2 other endpoints that might be more meaningful. One is overall survival which is the gold standard and the other perhaps is the quality of life. No one can argue that those two things have sort of the paramount importance where as to an objective 50% or greater reduction in the mean diameter of all measurable tumor masses is an interesting yard stick, but it is only a yard stick.”
“. . . . issues of the drug approval process and how the rules are set is an extraordinary challenge, and I have strong opinions about this as a scientist and as a physician that cares for patients. I will comment on my own beliefs in just a moment. It is important to recognize that whoever sets this policy has to do so with the recognition that is really the interface between science, medicine and the business world. And that wherever the bar is set it cannot be arbitrary.
“It can’t be, ‘we will do it one way because that is how we feel today and we will do it another way because that is how we feel tomorrow.’ It has to be reasonably unambiguous so that the investment community and other people that choose to place their bets, in the business sense of the word, know exactly what they can anticipate. I’m conceding that there are challenges to doing it.
“Having made that concession, I feel the way it has been done is not in the best interest of patients. I also think that just as science and our knowledge of biology evolves, we should also take fresh looks at the way we test and ultimately approve drugs for cancer. I am saying two contradictory things, you have to have consistency and you also have to evolve.”
EXCERPTS from
Conversation With Dr. Levitsky Part 2
“. . . . it was quite clear at the time of the FDA hearing (Advisory Panel), that there were 2 kinds of mistakes that could have been made and the FDA had to choose which one they were willing to make. Right?
“They could make the mistake of approving a drug or therapy on insufficient data, only to be shown 2 years later that it was really nonefficacious. Right? And the risks of doing that would have been, I guess the cost of the health care system in that two years and I guess the embarrassment and I don’t think it should be viewed as an embarrassment, but I guess they would view it as an embarrassment of having to pull a previously approved drug off of the market.
“My own sense of that is, we are learning all the time and if something tomorrow looks bad that today looks good, you pull it off the market. There is no shame in that.
“The other kind of mistake that they could have chosen to risk is to say, ‘nope the data isn’t good enough, we are not going to approve it, so keep studying it and bring it back when you have better data.’ Of course that risk there is to the patient, because individuals that would have benefited from that therapy aren’t going to be able to get it.
“And if you want to be harsh about it, that given the number of men that have had prostate cancer– and I have never run the numbers, but you could– and given the number of those that have Hormone Refractory Metastatic Disease which is also a big number .. . and of those, based on the Dendreon results if you apply the stats to that denominator, there are people out there, not a small number, that are dead now that might not be otherwise.”
“. . . . There are counter arguments that can be made too, that the companies can do compassionate use if somebody really wants the compound etc. etc. but I think that becomes untenable on the scale of what is the problem of prostate cancer.”
EXCERPTS from
Conversation With Dr. Levitsky Part 3
“The whole focus of the company had been on turning the cells and the apheresis product into dendritic cells. Which of course it does to some extent, but a lot of what is in there are not only dendritic cells but a lot of other cells like T cells for example the product, O.K.
“So, if you remember, they did 3 infusions based 2 weeks apart. First when they take the blood out, they throw in the protein fused to GM-CSF and then they take a small sample of the material before they add it and another aloquot of the material after it has been incubated with the antigen and they do flow cytomotry and measure the level of CD54. If it goes up, they call that the delta or difference or the up regulation of the CD54. So they measure the numbers from the 1st cycle, 2nd cycle and the 3rd cycle.
“What they noticed was it went up very little, if at all with the 1st cycle. But, in some patients in the 2nd cycle and particularly with the 3rd cycle, it went up a lot. And in other patients it didn’t. They found that if they made a mathematical index for summing up or making the average of the increase in CD54 measurement across the 3 infusions, that they could separate, there was a good correlation between those subjects that had a high up-regulation and those that didn’t and that correlated very well with a beneficial survival.
“At face value, it didn’t make sense because CD54 is found on the antigen presenting cells, like the dendritic cells and they are not long living cells. They live normally only a few days and then they die. So it didn’t make sense in the 2nd and 3rd infusions that they were pulling out the cells that they had put in 2 weeks earlier. It just didn’t make any sense. So something else had to be responsible for the increasing CD54 in these cells.
“So looking at the data and thinking about it, we knew there were a couple different things that cause CD54 to go up. One of the things is when the antigen presenting cell is activated by a T cell. So if an antigen presenting cell has captured the antigen and is presenting it to a T-cell that is specific for that antigen, the T-cell among other things will send a signal back to the antigen presenting cell helping to activate it. As a result, CD54 goes up.
“So in a long winded way of saying it, what I proposed to them, was that by measuring CD54 up-regulation in the product after peptide incubation, what they were really indirectly measuring was the frequency of antigen specific T-helper cell. They are long living unlike the dendritic cells. And you would expect them to not be very abundant in the 1st product. But, if you had successfully primed the patient there would be more abundant in the 2nd product and even more in the 3rd product.
“. . . . Furthermore you would predict that a patient with a higher number of helper cells would do better. And that is exactly what they showed. That the patient that had the CD54 up-regulation , which I am just making the case reflects the frequency of Antigen specific helper cells. They did better. So there are many interesting implications to this, one of which is that their product is not strictly a vaccine, it is also a form of adoptive T-cell therapy.
“. . . . I think the relationship between tumor burden and the nature and magnitude of the immune response is a fascinating topic. I don’t know, it is my belief, based on a lot of animal work and reading clinical literature that the likelihood of success is going to be great in the setting of minimal residual disease or microscopic disease. But, I don’t know that the reciprocal is also true. I don’t know that a vaccine couldn’t work in the setting of a more extensive tumor and in the melanoma literature, there are these anecdotes , or renal cell for that matter where people have had a chest x-ray full of cannonballs and have them go away. So, I don’t know if it is an absolute but I think that if you took across the spectrum of lots and lots of cancer, the likelihood is greater that it would work in microscopic disease.”
EXCERPT from Conversation With Dr. Levitsky Part 4
“Most lymphocytes traveling throughout the body never make it to the tumor site. But they do make it to the lymph nodes. In the lymph nodes with the exception of tumor metastases in the lymph nodes, which clearly does happen and is an interesting event in it’s own right, with the exception of that, the vast majority of cells that will present tumor antigen to the tumor specific T-cell are in the lymph node, not in the tumor, and they are antigen presenting cells. So, the models that I have looked at have suggested that they are much more the determiner of the outcome rather than if the tumor cell does express or doesn’t express those tumor antigen molecules.”
http://www.psa-rising.com/blog/2009/04/...interview-with-hy-levitsky/
Ok, Handel wurde ausgesetzt und nach der PK scheint sich ja alles zum Guten zu wenden ;)
Hoffen wir das für die Investierten und für Erkrankte, die vielleicht tatsächlich eine höhere Überlebenschance erhalten
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Puget Sound Business Journal (Seattle)
* Investoren jubeln Dendreon's Provenge Ergebnisse
* Dendreon Kürzungen Q1 Verlust
* Dendreon zu verkaufen 12M Aktien an Unterstützung Provenge
Dendreon Corp sagte er, die $ 221 Millionen in einem öffentlichen Angebot von fast 12 Mio. Aktien der Lager.
Die Seattle Biotech, in dem angekündigt wurde das Angebot der letzten Woche, sagte sie Pläne zur Verwendung der Netto-Erlöse zur Unterstützung der Herstellung und Entwicklung seiner Arzneimittel Provenge Prostatakrebs.
In einer Erklärung, Dendreon (NASDAQ: DNDN) Beamte sagte das Geld wird für die "Entwicklung von Produktionsanlagen, ein Vertriebsnetz, eine IT-Plattform und andere Infrastruktur, zur Miete Vertrieb und Marketing, Produktion, Qualität und anderes Personal in Vorbereitung auf die die Zulassung durch die FDA und der Kommerzialisierung von Provenge, und für allgemeine Zwecke Unternehmen, einschließlich des Working Capital. "
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Deutsche Bank - Equity Research
Dedreon Corporation {Ticker: DNDN, Closing Price: USD 25.46, Target Price: USD 36, Recommendation: BUY}.
** Top 7 questions & controversies
(1) Is the pivotal data sound?
(2) Is there risk to manufacturing?
(3) Can management deliver?
(4) Will there ever be a generic Provenge?
(5) How big is the Provenge market?
(6) What will thesales ramp look like?
(7) What is the stock worth? We rate the stock Buy, based on our assumptions that Provenge will be approved
by 1H10 and that it will be a blockbuster therapy for prostate
cancer.
** Initiating at Buy - we assume Provenge will be approved in early 2010
Provenge is a personalized immunotherapy for metastatic prostate
cancer. Recently phase 3 data from IMPACT was released, confirming
two previous trials showing Provenge increases survival by ~4
months. The trial was conducted under a special protocol agreement
with the FDA. Dendreon expects to file in 4Q09, with approval early 2010.
** We believe the FDA is unlikely to find fault with the IMPACT study
Provenge was rejected in 2007 by the FDA following a positive Adcom panel on the basis that the two trials submitted did not define survival as a primary endpoint and statistical analyses were not predefined. We believe the data is strong enough for approval, given the survival benefit was significant across multiple subpopulations, even when adjusting for later lines of therapy. The fact that the data are consistent with previous trials and our view that the FDA will likely face public scrutiny, as it did following its last decision, support our thesis.
**We did a manufacturing deep-dive & believe CMC issues have been
resolved
The primary issues raised by the FDA in its 2007 inspection were bar coding and lack of data supporting handling multiple samples at a time. We believe DNDN has resolved all issues. The real risk in our view is that scale up will not be fast enough to meet demand. We address key manufacturing hurdles for DNDN in our report.
**We see at least 35% upside upon approval
We believe Provenge has the ability at peak to be a ~$1.8B+ product in the US alone, with limited generic risk following patent expiration in 2020. Our NPV analysis suggests 35%+ upside upon approval in 1H10. Nevertheless, a lack of apparent near-term
catalysts could keep the stock range-bound near term.
**Valuation/Risks
Our one-year $36 target priced is based on a discounted cash flow analysis. Downside risks include FDA rejection of Provenge, delay of approval, poorer-than-expected sales, and a lower price point.
(Please see pages 5, 9, and 34 for details)