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Theodore Cohen

 
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  • Dendreon: Crushed By JNJ/Medivation Or By Own Management? [View article]
    Thanks for the vote of confidence. It's not an easy sell. But I believe the current sales team does know what they are doing...and they do know their targeted market. Pity the large urology centers were targeted 3 years ago.

    Ted
    Sep 10, 2013. 07:21 AM | Likes Like |Link to Comment
  • Dendreon: Crushed By JNJ/Medivation Or By Own Management? [View article]
    The fact is, JNJ well knew that that they probably would have the data to demonstrate stat sig OS within 60 days or so of the time they terminated the study. Still, they 'rushed to judgment' for reasons that were more related to competitive pressures than to ethical concerns. Several specialists stated unequivocally that they considered the trial to have 'failed' in that regard (see comments by Miller, at the time), and indeed, no stat sig OS was achieved. This is not to detract from the benefits Zytiga can provide patients, and I never said otherwise.

    Provenge HAS demonstrated a overall survival benefit...and it's the only treatment available in the pre-chemo space that provides such a benefit for the treatment for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

    Ted
    Sep 10, 2013. 07:18 AM | 5 Likes Like |Link to Comment
  • Provenge And The Immunodepletion Theory: The Facts [View article]
    I can't comment about that, sorry. You may want to discuss that with your doctor/oncologist or search the literature.

    Ted
    Sep 10, 2013. 07:09 AM | Likes Like |Link to Comment
  • Dendreon: Crushed By JNJ/Medivation Or By Own Management? [View article]
    Yes, I agree...there certainly were times where they could have raised money in the past. No question. It will be interesting to see how they address the near-term debt...Schiffman indicated this was one of his priorities. (At the same time, he suggested a path towards to addressing the larger debt problem.)

    A tragedy all the way around...beginning with the travesty of a corrupted advisory committee meeting (and the events that followed) in 2007. That cost the lives of tens of thousands of men with PCa who would otherwise have been candidates for Provenge to die early, painful deaths. Recall...even Dr. Howard I. Scher of Memorial Sloan Kettering--who, at the time, was working with Cougar Biotech on Zytiga and Medivation on Xtandi--stated he was frustrated by the fact he had no other options to offer these men (pp. 322, 323 of the advisory committee transcript)...yet he did everything within his power to ensure the treatment was not approved.

    http://bit.ly/pBsDWm

    Ted
    Sep 9, 2013. 08:16 PM | 6 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: 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
  • Yes, Gilead Did It Again [View article]
    Nice overview! Thanks.

    Ted
    Aug 30, 2013. 03:22 PM | Likes Like |Link to Comment
  • Dendreon: Too Little, Too Late? [View article]
    I'll comment if and when DNDN receives EU approval (which could come next month). Otherwise, we keep going over old ground.

    Ted
    Aug 28, 2013. 01:05 PM | 3 Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    Uros generally won't prescribe off-label, which is the reason Xtandi isn't being prescribed in the pre-chemo space. But again, that one West Coast case (which I described in an SA article) involving sequential use of Xtandi followed by Provenge certainly woke a lot of people up to the potential in using these two drugs together.

    http://bit.ly/14VTxpD

    Lots could change upon EU approval. Keep you fingers crossed!

    Ted
    Aug 26, 2013. 01:43 PM | Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    I hope you are correct. The lack of a biomarker and the narrow label are major impediments to uptake...and have been since inception.

    The fact is, however, no other treatment in the pre-chemo space offers an overall survival benefit. (BTW, I have a friend who has received Provenge (1.5 years ago), and when his PSA eventually started to rise again, his doctor put him on Zytiga. His quality of life now is sinking faster than whale poop with that drug (plus the prednisone). He can barely get out of bed and to work in the morning. He had no side effects whatsoever with Provenge.)

    But yes, from what I've seen, Xtandi + Provenge looks like it can deliver a one-two knockout punch. We need more data on this combination.

    Ted
    Aug 26, 2013. 11:17 AM | 2 Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    I won't be attending, but wish you well if you do. I think you may see something happen along the lines of a partnership with equity buy-in (?) upon EU approval, Tom.

    Ted
    Aug 26, 2013. 11:03 AM | 1 Like Like |Link to Comment
  • Dendreon, The Fabled "Next Amgen"  [View instapost]
    Regardless of what youthink about the corporation and the current state of affairs, oncodr was incorrect. Saul was right.

    Ted
    Aug 24, 2013. 06:19 PM | Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    Johnson has stated several times that they are going to partner in the EU. They already have a contract manufacture providing Provenge for the trial underway over there. I wouldn't be surprised if they announced a ROW upon EU approval (if and when that happens, which could be as early as next month). In the best of all worlds, it would be a significant 'positive' if the ROW partner took an equity position, with the proceeds helping to pay down the debt.

    Ted
    Aug 24, 2013. 06:15 PM | 2 Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    I don't know...didn't have any complaints when DNDN went from below $4 to $55. Where were you then?

    And yes, VICL was a disappointment, to be sure.

    Ted
    Aug 23, 2013. 10:48 AM | Likes Like |Link to Comment
  • European Committee Adopts Positive Opinion On Dendreon's Provenge [View article]
    There is some thinking along that line:

    "Because cancer cells don’t act normally our white blood cells often recognise them as different and attack them in the same way they would a bacteria or virus-infected cell. It is thought that the immune system can actually keep cancer cells in check for years, but eventually a cancer cell might gain a genetic mutation that allows it to evade the immune system. If this happens the cancer cell will thrive, multiply and produce many more cells that can avoid the immune response, meaning a tumour can grow more easily."

    http://bit.ly/16QKc4s
    Aug 16, 2013. 03:02 PM | Likes Like |Link to Comment
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