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Theodore Cohen

 
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  • Dendreon May Have Another Run, But It's Risky [View article]
    JNJ, which owns Zytiga, has more to fear than does Dendreon from the first approval of Medivation's MDV3100. Further, given that MDV3100 does not require steroid co-medication (as does Zytiga (which requires co-medication with prednisone)), MDV3100 could be used syngeristically with Provenge, something that is being talked about more and more in the medical community.

    Ted
    Nov 14 12:47 PM | 3 Likes Like |Link to Comment
  • Dendreon's Best Days Could Still Be Ahead [View article]
    For the first PCa indication Medivation will seek approval for its MDV3100 drug, JNJ, which owns Zytiga, has more to fear than does Dendreon. Further, given that MDV3100 does not require steroid co-medication (as does Zytiga (which requires co-medication with prednisone)), MDV3100 could be used syngeristically with Provenge, something that is being talked about more and more in the medical community.

    Ted
    Nov 14 12:46 PM | 1 Like Like |Link to Comment
  • 5 Drugs That Own The Prostate Pipeline [View article]
    I think that could be said for more than a few parts of our bodies, Chuck. I'm truly sorry for your problems.

    Ted
    Nov 9 08:42 AM | Likes Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    For the results recently released by Medivation (in the post-chemo setting), it's JNJ that should be more concerned about Medivation right now. It also should be noted that Medivation, under a 2009 agreement, only receives a royalty for the sale of its PCa drug on ex-US sales, per its agreement with Astellas:

    "Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales."

    http://bit.ly/tWh527

    Dendreon, of course, owns 100% of the rights to Provenge...worldwide.

    Ted
    Nov 9 08:30 AM | Likes Like |Link to Comment
  • 5 Drugs That Own The Prostate Pipeline [View article]
    Nicely played, sir. (;>)

    Take care.

    Ted
    Nov 8 11:57 AM | 1 Like Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    What mistake was that, Justice? The approval to Taxotere?

    Ted
    Nov 8 09:25 AM | Likes Like |Link to Comment
  • 5 Drugs That Own The Prostate Pipeline [View article]
    Bryce, very nice review.

    I would note, however, that Dr. Gold, Dendreon’s President and CEO, pointed out on the November 2, 2011 conference call that “…a recent analysis suggest that up to 74% of patients had no out of pocket costs for Provenge and of the remainder of those patients we are supporting other assistance programs to ensure all patients have access to Provenge.” This puts to lie the criticism that Provenge is expensive to patients. So concerns about the cost of the treatment to individuals are a red herring.

    As you know, Zytiga (abiraterone acetate), according to JNJ, the manufacturer, in combination with prednisone, is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel. More specifically, although Zytiga has shown about a four-month median survival advantage in mCRPC, it is in a patient population that has FAILED docetaxel (Taxotere®; this is from the ‘COU-AA-301’ trial). Its survival benefit has not yet been proven (the ‘COU-AA-302’ trial is currently underway) in the asymptomatic/minimally symptomatic mCRPC setting for which Provenge is indicated. Indeed, in this specific space, the National Comprehensive Cancer Network, or NCCN, has given Provenge a category 1 rating, the highest evidence level recommendation based upon its three Phase III clinical trials.

    By contrast, and in Provenge’s ‘space’— asymptomatic/minimally symptomatic mCRPC setting— Zytiga has a category 2B rating, the second lowest rating, based upon small single arm Phase II trials. ("Abiraterone acetate can also be considered for men with metastatic CRPC who are not candidates for chemotherapy. Use of abiraterone acetate in patients who have not received prior docetaxel is based on single arm Phase II clinical trial data. A Phase III placebo-controlled trial in the pre-docetaxel setting has been completed; results are not yet available. Until those results are available, docetaxel remains the standard of care for CRPC for patients refractory to secondary hormone therapy who are candidates for chemotherapy."(NCCN; log-in required)

    The Journal of Clinical Oncology recently had the following to say regarding the sequencing of treatments:

    "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

    Zytiga currently is in a Phase III trial for pre-chemo use. As well, other treatments also may eventually pose threats to Dendreon's market, including Medivation's MDV3100. I would note, however, that the latter drug, initially, if approved, would NOT be for the same indication for which Provenge is approved. (Importantly, MDV3100 poses more of a threat to Zytiga than to Provenge.)

    Take care.

    Ted
    Nov 8 08:30 AM | Likes Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    Another insider also bought today:

    http://bit.ly/rFbRLL

    Ted
    Nov 7 06:12 PM | Likes Like |Link to Comment
  • Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
    Here's another insider buy today:

    http://bit.ly/rFbRLL

    Ted
    Nov 7 06:12 PM | Likes Like |Link to Comment
  • Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
    By the way, Bernie, I just noticed that Greg Shiffman, DNDN's CFO, heard what you have been saying about greedy corporate officers, and to hold the noise down from your end, he immediately called his broker and told him to purchase 30,000 shares as quickly as possible. Greg just couldn't take the constant chatter any longer. (;>)

    http://bit.ly/uZAUtp

    Now, are you happy?

    Ted
    Nov 7 06:09 PM | Likes Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    Bernie, I just noticed that Greg Shiffman, DNDN's CFO, heard what you said about the greedy corporate officers, and to hold the noise down from your end, he immediately called his broker and told him to purchase 30,000 shares as quickly as possible. Greg just couldn't take the constant chatter any longer. (;>)

    http://bit.ly/uZAUtp

    Now, are you happy?

    Ted
    Nov 7 06:07 PM | 1 Like Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    Here's the trial you're both addressing...'Sipuleuc... as Neoadjuvant Treatment in Prostate Cancer (NeoACT).' The FDA site (URL below) states the following: 'Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure).' Some think it will be 2012 before the results are available. And as Saul mentioned, what researchers will be looking for are signs of immune cell infiltration. This will be one way to demonstrate Provenge activity.

    Ted


    http://1.usa.gov/oNQAli
    Nov 7 03:22 PM | Likes Like |Link to Comment
  • Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
    Hi, Rain...

    It's a complicated market, to be sure. Look at this:

    http://bit.ly/vtKG9O

    Even Vertex' drug is going to meet significant headwinds. The stock has been downgraded recently by several houses, I believe, and currently, it is down almost $3. For example, here's one note I found today: Vertex Pharmaceutics (VRTX): The stock gets downgraded to Sector Perform from Outperform at RBC Capital.

    http://yhoo.it/t7jZYg

    Thanks for stopping by.

    Ted
    Nov 7 01:25 PM | Likes Like |Link to Comment
  • Dendreon: Market Mania In Action [View article]
    Saul,

    A well presented and thoroughly documented argument for the Street to take a second look! The panic has been unbelievable!

    I, for one, will be on the November Webcasts to see if any more tidbits can be gleaned from management.

    Nov 15, 2011 at 9:00 AM ET
    Lazard Healthcare Conference

    Nov 9, 2011 at 8:30 AM MT
    Credit Suisse Healthcare Conference

    http://bit.ly/vGZuSI/

    Well done.

    Ted
    Nov 7 12:54 PM | 2 Likes Like |Link to Comment
  • Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
    There is no question that the events surrounding the approval of Provenge beg for explanation and legal redress.

    Certainly, the tainted advisory committee meeting of March 29, 2007 and the events that followed, including the hastely called meeting at the FDA following the AC to discuss the preparation of Scher's letter; the letters written by Scher, Hussain, and Fleming to then-Commission von Eschenbach that were leaked to The Cancer Letter; Scher's position as co-lead on the pivotal Phase III trial of Novacea's Asentar drug for prostate cancer at the time he sat on the Provenge advisory committee panel; Scher's involvement with ProQuest Investments of Princeton, NJ, which owned 8+% of Novacea at the time of the advisory committee meeting (he was a Sr. Scientific Advisor, officer, and member of the BOD); the signing of a $440 million agreement between Novacea and Schering-Plough just three weeks after the FDA turned Dendreon's new drug application for Provenge down (BTW, Asentar failed, and both it and the agreement were dumped); and on, and on, and on! And let's not forget the Bear Raid of April 28, 2009, in which the stock dropped from $24.50 to $7.50 in 75 seconds. Now, that was a thrill and a half.

    Speaking of the Bear Raid, it is the subject of SEC Report OIG-521, which you can see below:

    http://bit.ly/vxFFqN

    I FOIAed and received this Report long before Pogo got its hands on it. Look closely at page 6. You don't see anything, do you? The explanation can be found in the cover letter I received from the SEC FOIA office. To paraphrase: 'Release of the material redacted would impact an ongoing investigation." Whether it is civil (SEC) or criminal (FBI) investigation is unknown, but it would appear that something is happening. As for the matter of the conflicts of interest that were referred to the HHS OIG, nothing has been done, an terrible indictment of the HHS IG.

    The entire Dendreon story, which had been 'up' on the DeepCapture Web site

    http://bit.ly/8JtvOv

    (now temporarily down) is told in Mark Mitchell's new book, 'The Dendreon Effect: How Felons, Con-men and Wall Street Insiders Manipulate High-tech Stocks,' which should be available shortly:

    http://amzn.to/spjKFF

    Say what people will about Gold & Company, they brought Provenge to market against an array of enemies both within the US government and on Wall Street. Pity they didn't have more market savvy. Had they, the stock would not be at the levels it is today.

    Take care.

    Ted
    Nov 7 11:42 AM | Likes Like |Link to Comment
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