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."
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.)
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. (;>)
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. (;>)
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.
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.
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:
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
(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:
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.
Lots of reasons for the seasonal dip...including the fact that some doctors offices close or run at reduced hours. This dip should not have been a surprise to anyone as it was observed in the gross revenues at the same time last year.
October: $26.8 million November: $26.6 million December: $28.2 million
This evidences an 'inflection' in the growth curve related to seasonal factors. For January, 2012, Guam2009lt projects gross revenues of $33.4 million, reaching the $40 million mark in the April-May time frame. Remember, $40 million/month, annualized, is roughly $500 million/year, the company goes cashflow positive.
I plotted Guam2009lt's data against the original gross revenue projections implied by management. Guam2009lt's data, if his assumptions obtain, suggest the gross revenues originally projected by management for November 2011 will be achieved in November 2012.
Finally, I would note that the 'hockey stick' ramp-up in gross revenues originally projected by management is aggressive on its face. Simply put, Gold & Company certainly should have done a better job of controlling the Street's expectations. That said, Provenge still is considered one of the more successful launches of a new oncology treatment in pharma history.
October: $26.8 million November: $26.6 million December: $28.2 million
This evidences an 'inflection' in the growth curve related to seasonal factors. For January, 2012, Guam2009lt projects gross revenues of $33.4 million, reaching the $40 million mark in the April-May time frame. Remember, $40 million/month, annualized, is roughly $500 million/year, the company goes cashflow positive.
I plotted Guam2009lt's data against the original gross revenue projections implied by management. Guam2009lt's data, if his assumptions obtain, suggest the gross revenues originally projected by management for November 2011 will be achieved in November 2012.
Finally, I would note that the 'hockey stick' ramp-up in gross revenues originally projected by management is aggressive on its face. Simply put, Gold & Company certainly should have done a better job of controlling the Street's expectations. That said, Provenge still is considered one of the more successful launches of a new oncology treatment in pharma history.
5 Drugs That Own The Prostate Pipeline [View article]
Take care.
Ted
Dendreon: Market Mania In Action [View article]
Ted
5 Drugs That Own The Prostate Pipeline [View article]
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
Dendreon: Market Mania In Action [View article]
http://bit.ly/rFbRLL
Ted
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
http://bit.ly/rFbRLL
Ted
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
http://bit.ly/uZAUtp
Now, are you happy?
Ted
Dendreon: Market Mania In Action [View article]
http://bit.ly/uZAUtp
Now, are you happy?
Ted
Dendreon: Market Mania In Action [View article]
Ted
http://1.usa.gov/oNQAli
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
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
Dendreon: Market Mania In Action [View article]
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
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
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
Dendreon's Capitulation [View article]
Ted
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
http://seekingalpha.co...
Take a look at these data. I have to believe that either or both the 'Icahn's' of the world and Big Pharma are sharpening their pencils.
Ted
Gross revenue estimates worked out by Guam2009lt on the Investor Village Message Board project the following for 4Q11:
http://bit.ly/sFu9qZ
October: $26.8 million
November: $26.6 million
December: $28.2 million
This evidences an 'inflection' in the growth curve related to seasonal factors. For January, 2012, Guam2009lt projects gross revenues of $33.4 million, reaching the $40 million mark in the April-May time frame. Remember, $40 million/month, annualized, is roughly $500 million/year, the company goes cashflow positive.
I plotted Guam2009lt's data against the original gross revenue projections implied by management. Guam2009lt's data, if his assumptions obtain, suggest the gross revenues originally projected by management for November 2011 will be achieved in November 2012.
http://bit.ly/v1zP6f
Finally, I would note that the 'hockey stick' ramp-up in gross revenues originally projected by management is aggressive on its face. Simply put, Gold & Company certainly should have done a better job of controlling the Street's expectations. That said, Provenge still is considered one of the more successful launches of a new oncology treatment in pharma history.
Dendreon's Capitulation [View article]
http://bit.ly/sFu9qZ
October: $26.8 million
November: $26.6 million
December: $28.2 million
This evidences an 'inflection' in the growth curve related to seasonal factors. For January, 2012, Guam2009lt projects gross revenues of $33.4 million, reaching the $40 million mark in the April-May time frame. Remember, $40 million/month, annualized, is roughly $500 million/year, the company goes cashflow positive.
I plotted Guam2009lt's data against the original gross revenue projections implied by management. Guam2009lt's data, if his assumptions obtain, suggest the gross revenues originally projected by management for November 2011 will be achieved in November 2012.
http://bit.ly/v1zP6f
Finally, I would note that the 'hockey stick' ramp-up in gross revenues originally projected by management is aggressive on its face. Simply put, Gold & Company certainly should have done a better job of controlling the Street's expectations. That said, Provenge still is considered one of the more successful launches of a new oncology treatment in pharma history.
Ted
Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging [View article]
Victrelis: predicted blockbuster sales of over $1 billion a year at its peak. With a royality rate of 5% or more for DNDN, that's not too bad!
http://bit.ly/rETt2m