Provenge Rival Hits A Brick Wall And Stock Dives
8 CommentsBy Ed Silverman // November 5th, 2007 // 2:26 pm
A little company called Novacea is making big news today. A late-stage trial of its prostate-cancer medication was halted after one of arm of the study containing the drug showed a higher death rate compared with standard care. The disclosure, which you can see in the Novacea statement, sent Novacea stock tumbling so far by as much as 63 percent.
The main goal of the study was to compare the benefits of a weekly dose of Asentar in combination with Taxotere, the Sanofi-Aventis cancer drug, to the current standard of care in the treatment of androgen-independent prostate cancer (AIPC). But enrollment was suspended in other trials in other indications until data is reviewed. So far, more than 900 of the 1,200 needed patients were enrolled in the study.
The news, as always, reverberates in different directions. In this case, cancer patients and Novacea shareholders suffer a setback. So does Schering-Plough, which struck an alliance earlier this year with Novacea to market its Asentar drug. And so does Howard Scher, a Memorial Sloan-Kettering Cancer Center doc who is the lead investigator.
For those who don’t recall, Scher (see photo) is also one of two FDA panel members who last spring sat on an agency panel that recommended use of a rival prostate-cancer vaccine, Dendreon’s Provenge. But then Scher and the other doc wrote the FDA and urged a go-slow approach. The move set off a furor among cancer patients and investors, amid allegations of undisclosed financial conflicts of interest, and led to rallies and a lawsuit against the FDA. UPDATE: It was reported earlier this year that Scher and the other doc received threats, which we’ve mentioned before. We are attempting to verify the report.
Scher, by the way, is a scientific advisory board member for ProQuest, a venture capital firm, whose chairman, Jay Moorin, until recently was listed as a Novacea board member. As of this past summer, ProQuest held Novacea stock.
And so the Novacea news is prompting some to feel vindicated about their belief in Provenge. A quick visit to the Investor Village forum finds such remarks: The Novacea failure “just exemplies how outstanding Provenge results were,” writes one visitor. “With no real hope for prostate cancer patients, what the hell was the FDA thinking in delaying Provenge?” asks another. But no one expressed glee: “No hope for the victims. No alternatives. How many have died since the FDA decision? How many more will die before Provenge is allowed on the market? Saddest story…just heartbreaking.”
R Johnson
The appearance and possibly the reality of a major conflict of interest on Scher’s part is shocking - not as shocking as the FDA allowing him to serve on the panel - but shocking enough to make one wonder whether any claims from Novacea should be trusted. Memorial Sloan-Kettering should be ashamed to see its name associated with this sort of conduct.
No wonder the public has so little confidence in the industry or the FDA.
DNDN_watchdog
Thanks, Ed!!
Not one mention of the alledged “threats” to Scher.
I for one REALLY appreciate your effort to stop perpetuating an unproven accusation against DNDN supporters.
Provenge’s fantastic SAFETY profile should have been given greater weight by the FDA after the AC committee meeting.
The FDA action to block PV approval gets curiouser and curiouser ( or is that more nefarious?) as time goes by.
Appreciate your great blogs!!
Scott
When is Congress going to convene hearings about the Provenge debacle?
We know Scher had undisclosed conflicts of interest and was tied, professionally and financially, to a competing product (with an entirely different method of action) that has failed miserably.
What more is needed to convince Congress to intervene on behalf of the thousands of American men whose lives would be extended if only science, instead of turf wars, had prevailed at the FDA in May 2007?
Please, call your Congressmen and Senators today and demand hearings!
Barry Hornstein
We know(or strongly suspect) Scher had undisclosed conflicts of interest and was tied, professionally and financially, to a competing product. It’s very hard for me to believe that an independant investigating commission, after all this time, hasn’t found out the truth of this allegation. And if there hasn’t been an investigation so far then why not? I smell fish. I am so angry and frustrated over this. If Dr. Scher and his merry band of collaborating henchmen are guilty of this allegation then I think that they should be indicted for murder. How sad and sickening. Now with that “other companies” prostrate cancer drug in hot water perhaps now is the time to grant DNDN at least some form of conditional approval in hopes of saving or prolonging human life. Again, how sad can it get? God bless America or at least the FDA for their infinite wisdom.
Tom Smith
First, I just want to thank you Ed for your great work! Damn your right on top of it every time! As far as Scher goes what goes around comes back around! Lets hope now the FDA comes to their senses and gives Provenge at least a Condition Approval! ~14,500 dead from PC since 05/09/2007 aka Black Wednesday! I agree with Scott write a letter to your congressman and attach to it a copy of the FACTUAL SUMMARY (~25 pages long) CaretoLive lawsuit! Better yet drop it off at their local office it will get to the Rep. sooner! Back to Scher, IMHO if what the lawsuit alleges is true then he should be wearing a orange jump suit!
Tony F
Ed, you are correct in that there is no shouts of joy over Asentar’s ceasing its clinical trials over at iNvestor Village because, as noted, it’s the prostate cancer patients who are the true losers because it is their lives that are in jeopardy…. remember, 83 men die each and every day from PCa in the good old USA.
Also, it’s really heartening to see you take on the investigative journalistic task of checking out the alleged threats to Scher and Hussain as promised above. Many Thanks and, hopefully, you can eventually either confirm or deny such threats have been made AND (equally important) that they have been reported to the police which confirms that these are real, perceived adverse communications… as any normal citizen would do when so threatened.
Mike Huckman, CNBC, interviewed John Walker, Chairman/Interim CEO of Novacea(at that time, anyway, in early June of this year) about Asentar.
Walker made a point of stating Asentar P2, a large, random study, showed a 49% survival INCREASE when combined with Taxetore.
He continued that there was a 33% DECREASE in SASE (Serious Adverse Side Effects) in the study which also showed INCREASED “efficacy and an improved safety profile of Taxetore.
His HRPC trial was to be fully enrolled by end of ‘07 with 900 patients.
Additionally, Schering-Plough and NOVC were looking at other indications for the use of Asentar; for Pancreatic cancer in Q3-’07 and in earlier ADPC and Adjuvant Therapy (for earlier PCa patients) over the next 12-18 months.
Huckman then asked about Howard Scher, the Lead Clinical Investigator for Asentar and Conflict of Interests without naming Scher. Walker stepped right up and named Scher and is quoted speaking of Scher in the quote below.
Interview here:
http://www.cnbc.com/id/15840232?video=357427687
Huckman asked Walker about Scher, Scher’s over-the-top vehemence against Provenge and being the PI of Asentar… NOVC’s product … Walker replied:
“In my view, Dr. Scher is beyond reproach in turns of his scientific integrity. I know of no issue he has in regards to any bias towards our drug and our study other than the fact that he is someone who believes that advancing therapies for the treatment of prostate cancer is an important cause and he’s interesting in seeing our drug continue, in most part, because of the effect that he saw in our P2 study that I commented upon earlier.”
=========
Perhaps someone ought to send Walker a copy of the 17 Conflict of Interests for Scher that have been found on the internet so far and which are listed below:
Scher reported only 3 COI’s to the FDA per his filing in late February available at the FDA website which appears to be composed of ownership of 1 stock and 2 competing industry interest.
Internet research shows the following for Scher thus far and please particularly note #1 and #17:
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
Phil Vardena
Thank you Ed.
I especially like your update: “It was reported earlier this year that Scher and the other doc received threats, which we’ve mentioned before. We are attempting to verify the report.”
I’m very curoius about what you’ll find out!
That said, back to Novacea.
How much did $cher lose with the Asentar/Novacea debacle?
What does Schering-Plough think of their millions of dollars in cash given to NOVC and their millions of dollars stock purchase?
Asentar now has two things going against it. #1, it doesn’t work. And, #2, it kills you.
Dr. $cher doesn’t look like much of an expert now, does he?
Remind me again. How many patients died of drug-related reactions from taking provenge or provenge with taxotere?
Zero!
How many men died taking Asentar that could have been taking Provenge instead?
With kind regards,
phil
MyPharmalotID
From above…
“Mike Huckman, CNBC, interviewed John Walker, Chairman/Interim CEO of Novacea(at that time, anyway, in early June of this year) about Asentar.
“Walker made a point of stating Asentar P2, a large, random study, showed a 49% survival INCREASE when combined with Taxetore.
“He continued that there was a 33% DECREASE in SASE (Serious Adverse Side Effects) in the study which also showed INCREASED “efficacy and an improved safety profile of Taxetore.
“His HRPC trial was to be fully enrolled by end of ‘07 with 900 patients.”
Can you spell class action lawsuit?!