Dendreon Adds Heavyweights To Its Board
14 CommentsBy Ed Silverman // October 12th, 2009 // 6:10 pm
The little vaccine maker that could has added a couple of heavyweights to its board of directors.
Dendreon, which hopes to submit its application to the FDA next month for its Provenge prostate cancer vaccine, recruited Ian Clark, a Roche exec who was recently tapped to lead the big drug maker’s Genentech unit (see photo at left), and Pedro Granadillo, who once headed manufacturing at Eli Lilly. Here’s the press release.
The move prompted speculation that Roche, which has a large presence in oncology, could become a bidder for Dendreon. As Reuters notes, Dendreon stock has jumped 10-fold since last spring, when data was released showing Provenge prolonged life for patients by about four months. Meanwhile, Dendreon has been ramping up production and some investors are betting an acquisition may occur, since the vaccine maker projects annual sales of $1.2 billion to $2.5 billion.
Dendreon has generated enormous interest ever since Provenge became the center of controversy in 2007, when the FDA unexpectedly rejected the recommendation of its advisory committee. A group of investors and patients filed a lawsuit against the agency, alleging undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office.
Evelyn Pringle
I’m not too impressed by this news.
I was fully supportive of this small company a while back because I felt it really got a raw deal when the corrupt FDA and industry insiders ganged up to block the approval of its prostrate cancer vaccine.
I don’t know who else serves as directors but adding veteran employees from the drug companies listed in the press release adds zero credibility to the firm as far as I’m concerned.
So much for the old saying that “if you can’t beat em join em.”
All I can say is when it comes looking out for the public health, it’s a good that many of the rest of us refuse to adopt the same attitude.
Christian
Mrs. Pringle, like so many times, in the past has hit the nail w/the hammer. It is even now more obvious, than ever, that big pharma was scared by a new method in the treatment of any kinda cancer. I can only hold out hope, that the people, w/voices(journalist),will continue reporting as such.
cvsnumber1
As I always suspected Ms. Pringle was only interested in using Provenge’s rejection as a tool to bash the establishment with her dillusions of grandeur that the government is evil incarnate…She is a joke…I believe the appointments to the DNDN board will get Provenge to patients much quicker than without them. She will find another small little engine that could’t to hitch her “rage against the establishment” mantra.
Fordwill1953
Evelyn, you need to consider that back then Dendreon was a company of a half a billion or less in capitalization (total shares outstanding x share price). Now it is closer to $2.5 billion. The management needs to be much more cognizant of this responsibility and needs more experienced directors as this company continues to grow so rapidly.
Unfortunately, it is the way of the world. Highly successful companies will grow rapidly. With really great directors that have “been there, done that” before, they will be able to address concerns and obstacles and move past them. Keeping Dendreon in the small experimental research and development stage is no longer possible.
Evelyn, may I suggest that you don’t look at the “corporateness” of the decision. Instead look at the accomplishments of the individuals and see if they won’t speed up Provenge into the hands of the men that need the drug so badly.
I happen to interpret the hiring of these two gentlemen with this perspective and hope and pray for a quicker FDA decision as a result of this farsighted management decision.
Good luck.
kyoto27
If Roche, the FDA and The Cancer Letter naysayers had supported this ‘paradigm shift’ in cancer treatment when it was clear that Provenge extended life …late stage cancer patients may still be living today. The shame is on the politics, the money and the power that derailed Provenge and the drugs that Dendreon had/has in the pipeline. Maybe it is time for science and not politics to rule at the FDA, and at the cancer foundations that say they want change….
CMCguy
Once again kyoto27 you (and others) seem to exclaim a grandiose conspiracy theory that ignored “science” in the Provenge decision. You obviously fail to appreciate and understand the scientific process and in particular development of new drugs/treatments. Although there were issues that are disturbing and certainty frustrating those things are tangential to science.
From that rational view DNDN submission in 2007 was based on two Clinical studies that did not meet the designed endpoint(s) however they attempted to use the data to demonstrate that had achieved statistically success for a survival benefit that was not part of the design. The need for “more data” was a logical scientifically sound conclusion that was expected.
I could speculate that adding experience to their Board such as reported here years ago might have avoided events that occurred but not convinced would be so since have insufficient details of past actions and also know is much better to have actual staff with expertise rather than on the Board level.
The Dude Abides
It isn’t Roche’s style to acquire mid-stage biotech companies. It’s much more likely that a company such as Roche would be the lead Provenge distributor outside North America, while perhaps purchasing a small stake in Dendreon as part of a partnership deal.
Ms. Pringle, Dendreon does not have the resources in place to set up a worldwide distribution system for Provenge. Roche does. Are you advocating that the company should just withhold Provenge from the rest of the world?
David
CMCguy, every time I read something like your comment I wonder are you lying, or have you forgotten some of the pertinent facts, data, legal (the 1997 -?- law and Kesseler’s explanation for the purpose behind Fast Track etc.), precedents for approval of treatments for the terminally ill when the data is limited or not up to usual standards, or the vote of the A.C. committee (the 13 yes votes ignored the ‘bad’ science?), or the letters written to the FDA by M.D’s. supporting Provenge and criticizing the letters written by Scher et al and ‘leaked’ to the public and the problems therein, etc..
For example, Scher’s letter states Provenge had CVA problems that ‘concern’ even tho’ that was considered and deemed not a problem by the panel,unanimously. And, more to the point, the letter went on to state Taxotere, the only approved treatment for AIPC, has no CVA. The latter is false (look it up). So, did Dr. Scher lie, or did he make a mistake, or was that part of the letter written by someone else since there is public evidence for the fact the letter was probably written by two or more people. And no one knows for sure who.
Or have you just failed to do your homework. I trust the latter although that doesn’t speak very well of you either.
zino
I keep reading that the FDA is a science organization, and makes their decisions based on Science… What a crock!!… Do not confuse statistics with science… FDA uses statistics to justify decisions that sometime fly in the face of science… They are the furtherest thing from a scientific organization… They are substantialy a captured agency that uses statistics to cover their corruption.
FDAer
When drug studies don’t meet the pre-specified primary objectives FDA management essentially has no choice but to turn the drug down no matter how good the secondary objectives are.
This is because once you allow one drug to be approved based on secondary objectives then every company will demand an approval based on secondary endpoints or post-hoc analyses for every drug in the future that doesn’t meet the primary objectives. (They already come in and argue it every single time as it is.)
Having been around FDA for years I’ve found it’s an extremely corrupt organization. Safety issues are covered up, there is bending of criteria for approvals, and honest people are forced out. Even so there are certain precedents that even FDA management doesn’t want to establish.
The Dude Abides
FDAer: The pre-specified endpoint of the pivotal trial was time to disease progression. The Provenge arm was 11.7 weeks, the control arm was 10.0 weeks. The p value was 0.052. Statistical significance is p=0.050.
The survival p value for this trial was p=0.01. Are you saying that the FDA was correct in denying approval in May 2007 because statistical significance on a primary endpoint that was discredited by the FDA itself in 2005 was missed by an almost infinitesimal margin? And the survival endpoint (p=0.01), which the FDA itself had been saying for years was the gold standard for AIPC, should just be thrown out in the trash?
FDAer
Not saying I agree. Just saying there may be more issues than just this one drug.
David
FDAer, your first post is one grand circular argument.
You avoid dealing with the issues raised by ‘Dude’ by simply referring to the aforementioned ‘circle’ you drew in your prior post.
The supposed line the FDA has to draw, supposed precedents some in the FDA don’t want to establish just ‘begs the question.’
You never dealt with two key issues, three actually. It was voted safe. And the two others I mentioned above, Kessler and the originating law, and, the precedents ALREADY established.
And of course your last paragraph is a marvel of disingenuousness, and, a little fear mongering thrown in for good measure.
I don’t get it, really. Why did you post in the first place? Is this simply some gratuitous defense of the indefensible?
Evelyn Pringle
Call me a prude, but I refuse to jump in bed with the devil no matter how many justifications or rationalizations there may be.
As for responding to comments by “cvsnumber1,” I don’t get in debates with people who don’t have the guts to identify themselves with their real names.