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Theodore Cohen

 
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  • 4 Biotech Stocks To Acquire Now For Gains In 2013 [View article]
    We need to correct some errors regarding JNJ's Zytiga.

    First, Zytiga is approved by the FDA for patients who have had chemotherapy. Some doctors are prescribing the treatment pre-chemo (i.e., in Provenge's space), but the number is estimated to be only around 20% of the patients eligible for Provenge. Such off-label prescribing of Zytiga is based on an NCCN Category 2B rating for Zytiga based on a small Phase 2 study. The median time of treatment is 8 months, and prednisone must be co-administered with the drug.

    Now, what many fail to mention is that when doctors prescribe Zytiga first, they put their patients at risk of having the disease progress during treatment to the point where upon exiting treatment, they are no longer qualified to receive Provenge. Part of the problem is that even after stopping Zytiga at 8 months, say (or whatever), the patient still needs 60 days to 'detox' because of the need to rid his body of prednisone. This is the reason that the Journal of Clinical Oncology made the following recommendation:

    "The practical dilemma of the appropriate sequence of use of the two new noncytotoxic agents (sipuleucel-T and abiraterone) is being addressed by trials that are under development. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with Abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed."

    http://bit.ly/oWIylJ

    The trials cited above now are underway and are being conducted by JNJ and Dendreon. Remember...JNJ and Provenge are not necessarily competitors in the PCa space...the treatment of cancer more often than not employs the 'layering on' of treatments, and there is every expectation that Provenge will be used not only with Zytiga, but also, with Medivation's MDV3100. If anything, it is JNJ and Medivation that will butt heads in the PCa marketplace.

    Finally, you are correct that the Phase 3 trial of Zytiga recently was stopped because the drug achieved stat sig on ONE of two endpoints: progression free survival, of PFS. It failed, however, to achieve stat sig on the second endpoint, overall survival, or OS. Now, with patients crossing over from the placebo cohort and being given Zytiga, the chances that the trial will show stat sig on OS is highly doubtful, throwing into question whether or not Zytiga will be approved by the FDA for pre-chemo applications (where it would compete directly with Provenge.)

    Please...do some research and get your facts straight. You are certaintly entitled to your own opinions, but you are NOT entitled to your own facts. You do yourself, your readers, and Seeking Alpha a distinct disservice when you publish articles containing unsubstantiated assertions and errors either by intent or omission.
    Apr 29, 2012. 09:13 AM | 15 Likes Like |Link to Comment
  • Dendreon: Fear is Our Friend [View instapost]
    Thank G_d...a voice of reason. Something realistic beyond the shills and amateur stock analysts that haunt the Internet these days. You know the ones . . . they'll put "Dendreon" in their article titles at the drop of a hat, and then, proceed to repeat incorrect data and rumors as if that would lend credibility to their already tarnished images and scribblings. And to think that journalism once was a lofty craft, its practitioners to be envied by all. I'd rather my daughters dated used car salesman than anyone resembling today's so-called "journalists" (not that there's anything wrong with that! (;>)) Most journalists today wouldn't be able to separate truth from fiction in any given story if you stuck their noses in the facts! Case in point: the difference between "average" and "median". I rest my case.
    Jul 7, 2010. 02:15 PM | 15 Likes Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    Brian,

    Regarding your comment on Dendreon's ability to manufacture Provenge in Europe, the company has been doing just that for over a year. Here are the details:

    http://1.usa.gov/Zj9gfO

    The data have been available on the FDA's Clinical Trials Web site since November 2011. The stated purpose of the trial is:

    To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

    The company would have no problem manufacturing Provenge upon approval, regardless of whether or not it partners or goes it alone in Europe.

    As to some of the other statements made in this article, I'm always surprised, when it comes to Provenge, that more care is not taken in presenting facts that are readily available in the literature...even the popular literature.

    For example, yes, JNJ's Zytiga does take about 20% of prescriptions in the pre-chemo space that might otherwise go to Provenge. But the FACT is (there's that word again), pre-chemo, Zytiga only carries an NCCN Cat. 2A rating in Provenge's space (Provenge carries an NCCN Cat. 1 rating...the highest). Why is this? Because, even though Zytiga is approved for pre-chemo use, it did NOT demonstrate a statistically significant overall survival benefit in the pivotal Phase 3 trial that was unblinded last year. Provenge is the ONLY FDA approved treatment for CRPC, pre-chemo, that has demonstrated a survival benefit. The ONLY one!

    And...this is important...while Medivation's Xtandi also carries an NCCN Cat. 2A rating in Provenge's space, it does NOT have FDA approval for use here. So, urologists, who tend to stick with labels, are not, in general, prescribing it pre-chemo. This may be moot, at this time, because I just learned on Tuesday of one case in which Express Scripts, Inc, which administers the Tricare for Life Pharmacy program (TPharm), apparently no longer is reimbursing a patient for Xtandi because he could not provide proof of having been treated with Taxotere (chemo). (He had not been treated with chemo, so now, no longer will receive Xtandi unless he pays for it himself.) Whether or not other insurers are denying patients reimbursement for pre-chemo use of Xtandi is not known.

    There are other issues with this article as well, but I only will touch on two:

    "On an average, each patient will have to shell out about $93,000 per therapy. This amount is quite expensive."

    First, there is nothing 'average' about it. the cost of the treatment, with the slight increase imposed in January, is a little over $94,000. If one checks with Dendreon Corporation (or the literature), one finds that more than 70% of all patients have no or little out-of-pocket expenses. Now, when you think about the fact that Zytiga is reimbursed as a pill (Medicare Part D), and costs $5,740 per month (not including prednisone plus monthly blood tests to monitor liver functions), a 14-month supply (that's the treatment regimen used in the Phase 3 study) costs over $80,000. Xtandi is even more expensive ($7,500 per month)...but again, it may be moot at this point. And with patients facing the Part D Donut Hole, the fact is, patients on Zytiga may end up paying more, out-of-pocket, than they would for Provenge.

    Regarding the number of doctors prescribing Provenge, even a cursory glance at the Seeking Alpha transcript for the last Dendreon conference call would have revealed significant growth in the number of community providers administering Provenge. The FACT is, there are more sites where Provenge is available than ever before, and the numbers have been growing steadily over time.

    As a scientist and Seeking Alpha writer, I pride myself on being able to substantiate my writings with references to the medical, scientific, and archival literature. I understand people are entitled to their own opinions, but I assert, a priori, they are not entitled to their own facts. We owe it to the readers of this and other fora to present responsible, objective analyses and, yes, opinions...but opinions substantiated with facts that support a well-developed thesis upon which the reader is provided the information he or she needs to inform their investment decisions.

    Ted
    Apr 11, 2013. 08:32 AM | 14 Likes Like |Link to Comment
  • 4 Biotechs Struggling Due To High Drug Costs [View article]
    Give me a break! You're not going to cite Marie Huber's paper as evidence that Provenge has no real effect on patients. I guess PT Barnum was right.

    Huber's theory was debunked at the CMS review of Provenge in November 2010 by none other than Dr. James Gulley, Director of Clinical Trials at the [US] National Cancer Institute, who said: "The number of white blood cells that were, the proportion of white blood cells that are removed in terms of the total body white blood cell count is around two percent, so it is not a clinically meaningful amount." In addition, a recent restrospective analysis of patients on the control arm of the IMPACT trial [ref 16] showed that those treated with salvaged Provenge many months after disease progression had median survival time 23.8 months which was far better than the 11.6 months seen with the pure placebo patients. The median difference between patients on the control arm treated and untreated with salvaged Provenge was a direct contradiction to the Immunodepletion theory.

    16 ^ a b "An analysis to quantify the overall survival benefit of Sipuleucel-t accounting for the cross-over in the control arm of the IMPACT study". http://bit.ly/Hl06IP.

    Dr. Carl A. Olsson, writing in AUA News for March 2012 (p. 42), had this to say about Huber's paper: "The authors missed the report by Hall et al that “there was no evidence that leukapheresis led to immunodepletion,” citing literature proving that each apheresis removed less than 1% of the total body pool of 1012 lymphocytes and reporting a normal measured cell count after the third
    apheresis in all men. (ref 3)

    3. Hall SJ, Klotz L, Pantuck AJ et al: Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol 2011; 186: 877.

    By the way, the reference to Ms. Huber as a scientist is specious, as well. She has a masters degree...specifically, an MPhil in BioScience. But her last postion was that of a managing partner in a private equity firm. Commenting on this, Dr. Olsson had the following to say about the Huber et al. paper published in the Journal of the National Cancer Institute:

    '"Finally, we are all used to the values of interdisciplinary conferences, which usually combine the experiential qualities of urology, clinical oncology, immunology and other disciplines. However, “healthcare analyst” and “investment management”
    are talents that appear unseemly in major publications.'

    Finally, the JNCI, which published Huber's paper, has no relationship whatsoever--NONE--with the US National Cancer Institute. You could have seen that on the JNCI's masthead, if you bothered to look. The JNCI is published by Oxford Press in Cambridge, England.

    Here's what Dendreon Corporation had to say about Provenge in the wake of the disinformation being spread by the media in general and people like you in particular:

    "The FDA approval [of Provenge] was based on a significant improvement in overall survival shown in three well-designed, randomized, double-blind, controlled clinical trials – including the pivotal IMPACT trial – with remarkably consistent results shown across the trials as well as in numerous patient subgroups.

    "The Provenge clinical data have undergone a rigorous scientific review process that included FDA review process, a Center for Medicare and Medicaid Services national coverage determination, a Technology Assessment and the peer review of multiple publications. As evidenced by the FDA approval, CMS national coverage decision, and NCCN treatment guidelines, the PROVENGE data clearly demonstrated a significant patient survival benefit and support its use as a clinically meaningful treatment option for certain types of advanced prostate cancer."

    You owe your readers an apology. The dissemination of such gross dis/misinformation on Seeking Alpha does no one a service...not your readers, not you, not Seeking Alpha. Please take the time to research your subjects in the future so that we may benefit from your work. What you presented above is sadly lacking in value.

    Ted
    Apr 5, 2012. 02:49 PM | 14 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    Confusion?

    With all due respect, sir, YOU are the one who is confused!

    If you want to have a debate, at least get your facts straight.

    The FDA's approval was based on a median (NOT average) life extension benefit of 4.1 months. (No, Provenge is not a cure...there is none at this time...but it does provide a life extension benefit.)

    That means that while half of all patients in the pivotal Phase 3 trials experienced a life-extending benefit of less than 4.1 months, half of the men had their lives extended by a longer period of time, some up to 7 to 8 years.

    Further, recent analyses indicate that because of crossovers in the placebo arms of the pivotal Phase 3 studies (that is, where patients in the placebo arms crossed over and were given a frozen form of Provenge (called 'Frovenge'), the final results were distorted in such as way that the TRUE median life extension benefit to Provenge probably lies somewhere between 7.8 and 12.1 months. This is considered absolutely astounding by the medical community for end stage prostate cancer victims.

    Specically, the median survival of patients in the Provenge Phase 3 pivotal trial were as follows: Those in the "placebo" cohort had a median survival of about 21 months, and those on Provenge had a median survival of a little over 25 months, yielding the approximate 4-month median survival benefit that was used for FDA approval. Some useful data points from the study:

    1) After 1 year, the survival rate was 80% for Provenge and 72% for placebo.
    2) After 2 years, the survival rate was 37.8% for Provenge and 32.2% for placebo.
    3) After 3 years, the survival rate was 14.5% for Provenge and 11.1% for placebo.
    4) After 4 years, the survival rate was 4.1% for Provenge and 2.3% for placebo.

    Instead of talking about a 4.1-month median survival benefit/advantage (which some people can’t understand), perhaps it would be better to talk about a 38% improvement in 3-year survival and/or a 22.5% improvement in risk of dying.

    Or put another way, the pivotal IMPACT trial of Sipuleucel-T (Provenge) showed an extension of 4.1 months median survival time in the treatment arm beyond the control arm.

    Further, the odds of a patient treated with Sipuleucel-T surviving at 3 years was about one in three comparing to the odds of about one in five for an untreated patient. This level of efficacy coupling with a mild side effect profile [mild flu-like symptoms] was remarkable when compared to the current standard of care, the chemotherapy Taxotere, which showed only a 2.5 months median improvement with possibly debilitating side effects.

    Finally, the full Provenge treatment (in its entirety (three infusions)) costs $93,000, but it is hardly the most expensive treatment on the market. Zytiga (which must be taken with prednisone and which has a median treatment length of 8 months) costs $72,000 per year (if annualized), so costs can rise significantly. Similarly, Revlimid costs $91,000 per year and may be taken as maintenance therapy for several years. Avastin can cost up to $100,000 per year. A bone marrow transplant can cost $250,000. So, stop the nonsense of using Provenge as the whipping boy for high-cost treatments.

    You call me a bull for Dendreon. Yes, I own the stock and I believe in the science. To that end, I have educated myself and strive to inform those to whom I address myself.

    I demand nothing less from others on Seeking Alpha.

    Ted
    Feb 6, 2012. 08:14 PM | 14 Likes Like |Link to Comment
  • Dendreon Is Way Undervalued [View article]
    I've said it before, and I will say it again: Dr. Mitch Gold will underpromise and overperform. Don't underestimate his company's ability to surprise on the upside--quarter after quarter--leaving the Street scrambling not only to update their earnings estimates, but also, to help their clients understand the unique franchise this company has carved out in the prostate cancer treatment field. Those who believe the company is a 'one-trick pony' have no concept whatsoever as to how earlier-stage PCa sufferers will eventually benefit from Provenge (and yes, Medicare will pay for it!), expanding DNDN revenues beyond anything analysts' forecasts currently take into account. As well, with Neuvenge for bladder cancer going into phase II trials and the company's small molecule for PCa program continuing apace, the greater risk is being out of this stock, not in it!
    Apr 21, 2011. 02:52 PM | 14 Likes Like |Link to Comment
  • Dendreon, The Fabled "Next Amgen"  [View instapost]
    Looking at the price of Dendreon today reminds me of this quote:

    “You Will Never Go Broke Underestimating the Intelligence of the American Public” – PT Barnum

    Mr. Market has put this stock on sale. Everybody was chasing it when it was in the 40s and 50s. They couldn't buy it fast enough.

    Now, everyone is running around with their hair on fire, mostly because of disinformation/misinfo... put out by 1. people who need to cover their short positions; 2. people who want to establish large positions on the cheap; 3. people who want to destroy Dendreon (yes, drive it out of business) before it destroys them (the chemo cartel); 4. people who are ignorant (and I'm being kind) and don't understand the difference between "average" and "median", among other things; 5. people who are paid shills for others with private agendas, whatever those agendas may be.

    So, what we have here, for those astute enough to recognize it, is a buying opportunity unlike anything we have seen since DNDN was selling for under $3 (yes, Virginia, there was a Santa Clause) in March, 2009.

    Here's the lowdown from DNDN that was published today by the recipient of an e-mail from Investor Relations:

    “Last week, the Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Analysis (NCA). A NCA is generally a review of evidence to determine if the use of a product is reasonable and necessary. In CMS’ announcement of the NCA, CMS stated it is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer. It is not a change in Medicare coverage policy.

    “What that means for physicians is that NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.

    From: Rightmire, Judy (jrightmire@Dendreon.com)
    Sent: Thu 7/08/10 3:22 PM
    Source:
    www.investorvillage.co...

    Don't take my word for it. E-mail DNDN IR. Ask!

    And be careful when your read what is written by some of the alleged biotech mavens these days ... you know the ones I mean ... some work for major newspapers and magazines, others for cable channels. What they are producing is loaded with the kind of stuff I see in the cow pasture about one-quarter mile down the road from my house, except the media products smell worse! It's all meant to generate controversy and "hits" for their sites, and gee, if it helps separate you from your money in the process, that's great, too.

    Saul's right. And I know for a fact he's put his money where is mouth is. Do your own research. Make up your own mind. But act with intelligence and foresight, not rumor and misinformation, as others would have you do.
    Jul 8, 2010. 08:34 PM | 14 Likes Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    "Given the context that surrounds Provenge – it is indicated for a disease with a poor prognosis, it has been demonstrated to extend life by about four months when compared to placebo, and it costs approximately $93,000 per treatment cycle..."

    Whoa...stop there, doc. There seems to be some misunderstanding, here. It's the MEDIAN life extension that the company is talking about, not the average. Please go back and read the results from the three Provenge trials. It think it would help you understand the significance of this immunotherapeutic treatment in PCa. Some men have lived more than 5 years (seekingalpha.com/symbo...) longer following treatment with Provenge. And after a few days of experiencing mild flu-like symptoms, they were back on the golf course. What were the chemo patients doing, other than the 2-3% that didn't die from their therapy? Probably requiring treatment for secondary indications resulting from their chemo! You really have built a house of cards, sir. And the foundation is as shaky as they come. Your entire argument is flawed.

    Dr. Cohen

    PS The cost of Provenge was based on the cost for the current standard of care. Dendreon's determination was not a casual exercise in cost analysis. Dr. C
    Jul 7, 2010. 09:17 AM | 14 Likes Like |Link to Comment
  • Dendreon: Crushed By JNJ/Medivation Or By Own Management? [View article]
    Interesting article, but you need to check your facts. Let's begin by correcting several misstatements/errors regarding treatment regimens, costs, and pre-chemo vs. post-chemo approvals (among other things).

    First, Dendreon costs $94,000 for three treatments given over a month's time (weeks 0, 2 and 4). That's it...done! There are no 'annual' treatment costs. Provenge is given as a one-time, three-infusion, 'treatment.' It provides, on-label, a median (NOT average) overall survival (mOS) benefit of 4.1 months. Post hoc analyses of the three Phase 3 studies performed for FDA approval showed that for patients with a PSA less than 22.1, the mOS was 13 months.

    In the pre-chemo Phase 3 trial that led to Zytiga's approval late last year in Provenge's space, the treatment period was 14 months. The cost of Zytiga used to be around $5,700 per month, but was raised earlier this year. A full 14-month treatment, plus co-administered prednisone, now costs around $84,000 (and this does NOT include the required monthly blood tests to monitor patient liver functions). Note that Zytiga does NOT provide any median survival benefit. It was approved mainly on the basis of having achieved a statistically significant progression free survival endpoint in its Phase 3 trial.

    Xtandi is NOT approved for pre-chemo use. It currently is being tested in a Phase 3 trial for such use, but any pre-chemo applications would be off-label at this time. The cost of Xtandi is around $7,500. So, a year on the drug would cost almost as much as Provenge. Importantly, Xtandi does not require co-administration with prednisone. (BTW, urologists normally do not prescribe off label, and so, I would not expect many are prescribing Xtandi for their pre-chemo patients' clinical pathways at this point. Thus, Provenge's main competition is Zytiga.)

    In sum, Provenge is the ONLY pre-chemo treatment for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer that provides a median overall survival benefit to patients.

    Regarding reimbursement, doctors are reimbursed directly by Medicare for Provenge, with more than 70% of patients having no or little co-payment charges (source: Dendreon IR). In the case of Zytiga and Xtandi, these are pills, and so, they are covered under Part D...which means, patients usually end up in the 'donut hole' at some point during their treatment. More often than not, users of Zytiga and Xtandi have to shell out more than do patients receiving Provenge.

    Europe does indeed present challenges, as you have noted. However, Dendreon has for some time been running a manufacturing trial in the EU using a contract provider. Their application to the EU licensing authorities has progressed into the final stages, as, I would surmise, have their negotiations with a partner. (The company has repeatedly stated they would partner in the EU.) Pricing, though challenging, should be manageable, given they will not have to build out their own marketing and manufacturing capabilities. Nevertheless, all of this remains to be seen. We should know shortly.

    I would not say management 'has lost hope.' There's a difference between stating the truth and giving up. I doubt seriously that John Johnson has 'lost hope' of maximizing shareholder value in his company.

    As regards the DTC advertising campaign, I think the jury is still out, given how patients respond to such advertising. The results for 3Q13 and 4Q14 will tell the tale.

    Finally, yes, the cost of goods sold and debt overhang have been and continue to be very troublesome. Unfortunately, the company has not been able to increase their revenues quarter over quarter on a consistent basis. Nor have they been able to drop their COGS to the 20-30% range (in line with their peers) quickly enough. This has been terrible frustrating for management and investors alike. But it's not been for trying. If I read the transcripts (available on Seeking Alpha) correctly, we should see a significant improvement in COGS by 1Q14.

    Articles such as this are always good for stoking up both the longs and the shorts. (Hey...you drew me out!). But frankly, I do wish that if you want to present data on a company--any company--you would invest a little more time in checking your facts and present the correct information on matters of importance. When one does discover errors and/or misstatements, it does throw into question a lot of what else is presented.

    Thanks.

    Ted
    Sep 9, 2013. 06:07 PM | 13 Likes Like |Link to Comment
  • Dendreon Could Dive If Sipuleucel-T Fails [View article]
    Yet another article that insults the intelligence of Seeking Alpha's readers and demeans Seeking Alpha's stature among online financial publications.

    The fact is, NCCN has given Provenge a Category 1 rating in its space. CMS has issued reimbursement guidelines (as of last August) that eliminated any barriers to payment across all payment centers. At least 75% of all patients receiving the treatment pay no or little out of pocket expenses. The last time I checked, there were 1,000 commercial and academic centers in the Lower 48 provided Provenge. Have you ever done any searches of the medical, archival, or popular literature?

    And who, by the way, are the patients treated with Provenge who have spoken out? Can you name names? Where can I find this information in the literature? Your article reminds me of that old joke about the fact that 95% of all statistics are made up on the fly. (Do you think I made that up...just like the stuff you dreamed up when you wrote this piece?)

    Frankly, this article is a disgrace. I think you would be doing you and your readers a service by pulling it now and reissuing it after you have brought it up to Seeking Alpha's standards.

    Ted
    Apr 19, 2012. 07:51 AM | 13 Likes Like |Link to Comment
  • Can Dendreon Become The 'Next Dendreon?' [View article]
    "Provenge is a revolutionary treatment for prostate cancer, and has allowed patients to live up to 4 months longer."

    Sigh...this statement is incorrect (I think this is the 3,254th time I have corrected it, but my count could be off by one or two (;>))

    Based on Dendreon's pivotal Phase 3 trial data, Provenge provides a median 4.1-month MEDIAN life extension benefit. Some analyses that removed the impact of crossovers (a process in which a frozen form of Provenge was administered to patients in the placebo cohort) estimated that the MEDIAN life extension benefit actually was between 7.8 and 12.1 months.

    Details can be found here:

    http://bit.ly/Al2XY9

    The Provenge administration process is NOT incredibility time and resource intensive. The patient has blood withdrawn three times and reinfused three times. It's all over in 6 weeks (Provenge is administered three times, two weeks apart). That's it...the patient is done. Now, his immune system goes to work. Side effects are minimal ... a day or two of flu-like symptoms and your back on the golf course. No daily pills, no steroids, or worse (if you're on tax).

    BTW, re Zytiga, the median treatment time is 8 months, it requires daily administration, costs $5,000 per month, has the second lowest NCCN rating in Provenge's space (Provenge has an NCCN rating of #1), must be administered with prednisone, and is intented for the post-chemo environment. If Zytiga is administered off-label pre-chemo prior to Provenge, the patient must wait 60 days to de-tox, and there always the possibility the patient then will have passed the point at which it's possible to administer Provenge. So, things aren't quite as simple as you would make them out to be.

    Finally, your article is woefully incorrect or out of date in several areas pertaining to Dendreon Corporation. For example, the number of provider sites currently listed at http://www.provenge.com is just under 1,000, and their cash is well over $600 million, as reported just this morning in a presentation to analysts.

    Ted
    Mar 7, 2012. 02:51 PM | 12 Likes Like |Link to Comment
  • Johnson & Johnson: Expect High Upside Movement [View article]
    Ah...what did you say?

    "The broadening use of Zytiga could potentially effect several of Johnson and Johnson's competitors in its attempts to corner the market for prostate cancer treatment. Denderon (http://bit.ly/ySVxZX), a company that developed Provenge, a treatment that has been proven to attack colon cancer prior to chemotherapy, could see their market share diminish due to Zytiga's ability to cater to patients both before and after chemotherapy. Also, due to Provenge's cost of $93,000 per treatment, the use of Zytiga could prove to be a more cost effective treatment approach. As a result of the news, Denderon experienced a 7% drop in share price the day that news was released of Zyitga's enhanced capabilities."

    Let's get our facts straight...please.

    Provenge is prescribed now for patients who have advanced to the late stage of the disease, metastatic, asymptomatic, hormone-refractory prostate cancer (HRPC). Zytiga, on-label, is prescribed post-chemo. Some doctors do prescribe Zytiga within Provenge's label, taking about 20% of Provenge's market. Zytiga costs about $5000 per month and the median treatment time is 8 months. The drug must be taken with prednisone, and there are strict requirements that pertain to patient use. There also can be some severe side effects.

    http://bit.ly/Hhau6a

    http://bit.ly/H0Fjqu

    If you look at the Journal of Clinical Oncology (see URL below), you will see, that because Zytiga carries the second lowest NCCN rating in Provenge's 'space,' it is recommended that Provenge be given first, followed by Zytiga.

    http://bit.ly/oWIylJ

    Finally, Dendreon and JNJ currently are running trials to determine whether or not Provenge and Zytiga can be given simultaneously, or whether patients on Zytiga must be given 60 days to detox before Provenge can be given. The danger to giving Zytiga off-label, pre-chemo--that is, prior to Provenge--is that if during their treatment with Zytiga progresses to far, the patient may no longer be a candidate for Provenge...and then, the window for immunotherapy as we know it today has closed forever.

    One last note regarding Zytiga's so-called 'extended' capabilities. The safety review board that recommended stopping the Zytiga trial did so because it had reached ONE of two trial end points. That is, the drug had reached stat sig on progression free survival, or PFS. It did not--and this is important--reach stat sig on the second primary end point, overall survival, or OS. Now, with patients from the placebo cohort crossing over and taking the drug, it will become increasingly difficult for JNJ to demonstate going forward that Zytiga can demonstrate OS stat sig. If this can't be done, it is questionable whether or not the FDA will approve Zytiga pre-chemo. It all will depend on how strong the PFS data are and how close the OS data come to stat sig. Put another way, the jury still is out as to whether or not Zytiga will be approved in the pre-chemo space.
    Mar 28, 2012. 03:13 PM | 11 Likes Like |Link to Comment
  • Dendreon: Fear is Our Friend [View instapost]
    I agree...to all those people who posted negative/incorrect information and articles today on SeekingAlpha, in Forbes, etc.: please retract your misinformation, apologize, or refrain from misleading your readers in the future. Thank you.
    Jul 7, 2010. 03:05 PM | 11 Likes Like |Link to Comment
  • Dendreon: Crushed By JNJ/Medivation Or By Own Management? [View article]
    I wouldn't use the term 'comical.' Actually, it's tragic, especially for patients.

    Let's cut to the chase. The problem, unfortunately, is with the label, which goes back to the protocols established years earlier for the three Phase 3 trials. Now, doctors must certify (and CMS/Medicare is very insistent that certification be provided and verified) that patients present with mets. This is highly restrictive and, unfortunately, requires a patient's disease load to progress to a point where such mets can be detected. True, there are techniques to push detection to earlier stages. I discussed this matter with Dr. Kapoor on several occasions. And while he and others are pushing detection to the earliest possible times, that does come with a cost.

    Zytiga (and Xtandi, if and when it is approved for pre-chemo applications) has no such label restriction. So, it's far easier for a doctor simply to write a prescription and send the patient off into the sunset...except for the fact that in the case of Zytiga (the jury is still out on Xtandi), pre-chemo, Zytiga provides no survival benefit. Zero. Zip. Nada!

    This is not to say that Zytiga is not without its benefits. Everything else being equal, one would intuitively want to upload Provenge at the earliest possible time--when the patient's immune system is the healthiest. Then, when and if his PSA begins to rise, sequence in, say, Zytiga. This is exactly what has happened with my friend Todd Seals. He received Provenge in May 2012. His PSA was held in check and he was doing fine until 2 months ago, when his PSA started to rise. His doctor put him on Zytiga (not without significant side effects that impacted on his quality of life (they seem to have abated some, as I heard today)), and now, his PSA is undetectable.

    But some patients progress rapidly, and so, doctors--and rightly so--put them on Zytiga prior to putting them on Provenge. Unfortunately, in some cases, where patients would be candidates for Provenge, doctors prescribe Zytiga first, and while on the drug, the patient passes through the Provenge (label) 'window.'

    I'm revisiting all this (which I'm sure you and probably others who have read your and my material know) to review the difficult 'marketing' landscape Provenge faces. There is no question the launch was flawed...out of the gate, they immediately should have focused on the urology community, and the larger providers, at that. This was a serious mistake. Nothing else comes close to capturing the essence of the mistakes made by the previous management team as does this error.

    There's no question that Johnson took on significant problems when he came aboard. I think he and Schiffman truly believed they could ramp up the marketing effort, improve the revenues, and, at the same time, drop the COGS by 2H13 at the latest. That hasn't happened for a lot of reasons, but as I said, not for trying. JNJ is a formidable opponent...with a inferior drug! And a pill at that. Provenge is a difficult sell, especially given that not only does it not affect a man's PSA, but also, the company has yet to provide a means by which to demonstrate efficacy to patients. But the stuff does work...three Phase 3 trials say it does. And some of the early results with sequencing suggest it, combined, say, with Xtandi, has the potential to deliver a knockout punch.

    So...comical...no. Tragic, very much so. I know of men who are being denied Provenge because it's not been possible (yet) for them to demonstrate the presence of mets. I know of another case where misinformation regarding Provenge almost caused an insurance company to deny a patient the treatment. (We got that reversed fast when the patient filed a complaint with his state's medical insurance board using factual information to counter this disinformation that was being put out by the insurance company.)

    The amount of dis/misinformation put out, intentionally or not, regarding Provenge is a disgrace...which is why, regardless of the company's financials (which, to be sure, make DNDN a risky investment), force me to comment on the facts in this matter.

    I'm sure you join me in that endeavor whenever possible.

    Ted
    Sep 9, 2013. 07:50 PM | 9 Likes Like |Link to Comment
  • Dendreon: The Median Is Not The Average [View article]
    Good overview. Some notes regarding the following statement, Jack:

    "The FDA in April 2010 approved Provenge with a 4.1 month median for survival benefit. Later the FDA approved Zytiga with a 4.5 month median and then recently approved Xtandi with a 4.8 month median. Both Zytiga and Xtandi have considerable side effects, while Provenge has only minimal side effects. It's noteworthy that the median differences are not great, less than a month in each case."

    The median 4.1 month life extension benefit for Provenge is in the pre-chemo space. The figures cited for Zytiga and Xtandi are for post-chemo (that is, post-Taxotere). The pivotal Phase 3 pre-chemo trial for Zytiga, which was unblinded earlier than expected last year, did NOT show a stat sig overall survival benefit (it did, however, show a stat sig progression free survival benefit). That's why in Provenge's space (pre-chemo), Zytiga today carries an NCCN Category 2A rating vs. Provenge's NCCN Category 1 rating. The pivotal Phase 3 pre-chemo trial for Xtandi has not yet been unblinded, though that drug also carries an NCCN Category 2A rating in Provenge's space.

    Regarding how fast these treatments work, if you look at the Kaplan-Meier curves for the Phase 3 trials, you'll see that the Provenge curves separated at around 6 months. Put another way, it took roughly 3-6 months for Provenge to 'ramp up.' In the case of the Zytiga trial, the curves did not separate until the 18th month...some 4 months AFTER patients came off the drug (and the point at which 20% of the patients in the treatment had died). This is not to say that Zytiga does not provide significant benefits to prostate cancer patients, especially those whose disease loads are increasing rapidly...only that it is not been possible to define a statistically significant overall survival benefit.

    Frovenge was not used as a placebo. The fact is, as an inducement to patients, the trial protocol included a provision for patients in the control arm to cross over and to be administered Frovenge under certain predetermined conditions. Many chose to do so. Unfortunately for the trial (but to the benefit of those patients who crossed over), Frovenge worked well and the trial almost failed the treatment. That is, because some patients in the control arm crossed over, the K-M curves did not separate as much as they otherwise would have (as we saw in several post hoc studies, one of which placed the 'true' estimate of the survival benefit at a median of 12.1 months).

    Dendreon will report on it work in sequencing Provenge and Zytiga later this month at the Genitourinary Cancers Symposium (February 14-16, 2013 in Orlando, Florida).

    Finally, it's interesting that Dr. Kapoor, who I interviewed a week ago, believes Provenge still is the foundation of care in the treatment of of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Further, when he uses Zytiga pre-chemo, he sequences it after Provenge.

    http://bit.ly/12igoyz

    Ted
    Feb 2, 2013. 11:05 AM | 9 Likes Like |Link to Comment
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