Dendreon CEO Refrains From FDA Bashing

Provenge Now and their supporters march across the 'High Road’ to ‘Break down the Barriers’ blocking the bridge to meet with FDA commissioner Dr. Andrew von Eschenbach, the Congress and Senate leaders to demand the approval of Dendreon's (DNDN) Provenge now. I, along with tens if not hundreds of thousands of others ,will be cheering for their success. Godspeed!

I have been in London this past week and have not followed the Dendreon story as closely as I would have in the States. A few hours on the internet brought me up to date on the new dynamics at play. Last week Dendreon’s CEO, Dr. Mitchell Gold, was given a chance to bash the FDA and Provenge’s opponents. Dr. Gold was reported to have responded to questions with, “Human factor: I don’t want to say related to politics but human nature”.

Perhaps being in the land of Shakespeare, I am reminded of Captain Jean Luc Piccard, of the Starship Enterprise in, “Star Trek: The Next Generation” being held against his will by the omnipotent “Q” and being asked, “What it is to be human?" Captain Piccard quotes Shakespeare from Hamlet…

“What a piece of work is man! How noble in reason! how infinite in faculties! in form and moving, how express and admirable! in action how like an angel! in apprehension how like a God...”

Somehow I doubt that Dr. Gold had that quote in mind, but perhaps had a couplet often mistakenly attributed to Shakespeare…

“Oh, what a tangled web we weave,
When first we practice to deceive!
But when we’ve practiced for a while
How vastly we improve our style.”

Howard you must “Practice, Practice, Practice…”

According to MarketWatch:

Novacea Inc. (NOVC) shares skyrocketed Wednesday, rallying as the company signed a potentially lucrative deal with major drug maker Schering-Plough to commercialize Asentar, a drug candidate for treating prostate cancer.

Shares of the South San Francisco, Calif.-based biotech company advanced 78% to $14.36 in afternoon trading, after having reached an intraday high at $17.25…

…that would give Novacea $60 million upfront, along with laying out milestone payments of up to $380 million. Novacea would also stand to earn tiered royalties on any future sales of Asentar…

…If approved by regulators, Asentar would be Novacea's first product on the market.
"It's a nice amount of cash upfront, but what this deal really means is we've become more self-sufficient," Novacea chairman and interim chief executive officer John Walker told MarketWatch on Wednesday. "It also allows us to invest more aggressively in our pipeline.”

Based on the hormone calcitriol, Asentar is currently in Phase III clinical testing for the treatment of androgen-independent prostate cancer, an advanced stage of the disease. Novacea has been testing it in combination with the widely used chemotherapy drug Taxotere.

Let’s take a look at some of Novacea’s SEC filings…

SEC filing on March 26, 2007, Novacea states:

…Dr. Howard Scher, Chief, Genitourinary Oncology Service, and the D. Wayne Calloway Chair in Urologic Oncology of Memorial Sloan-Kettering Cancer Center, New York, USA, is serving as study chair…

In an SEC 10-K filing on April 2, 2007, on page 24 and 25, “RISK FACTORS”, Novacea concedes:

We are highly dependent on the success of our lead product candidate, Asentar ™ , and we cannot give any assurance that it will receive regulatory approval or be successfully commercialized…

On page 28:

There are currently clinical trials ongoing which seek to use other agents with Taxotere for the treatment of AIPC. If these clinical trials are completed prior to our current ASCENT-2 clinical trial, our ability to commercialize Asentar ™ may suffer…

On page 31:

If our competitors develop and market products that are more effective, safer or less expensive than our current and future product candidates, our commercial opportunities will be negatively impacted.

Our product candidates will compete with a number of drugs that are currently marketed or in development that also target proliferating cells. We expect that Asentar ™ will compete with products that have been marketed or are in advanced stages of development, including Emcyt ®, Novantrone ® , Paraplatin ® , Taxol ® , VEGF-Trap, and Thalomid ® , Avastin, Satraplatin, Provenge vaccine and the like.

Wow, what would have happened to the Novacea deal if Provenge were to be approved before Asentar?

In my article, “Dendreon: Are the Provenge Prayers Being Answered?". I referred to a WSJ Health Blog titled, “Dendreon’s Ups and Downs at FDA and on NASDAQ”, which received 109 comments ranging from outrage to a lengthy and detailed open letter to Dr. Andrew von Eschenbach, imploring the FDA to, “TEAR DOWN THIS WALL”.

In that article, Howard Scher is quoted in the Wall Street Journal as saying, “I take the high road…” in response to accusations of Conflict of Interest, and his ‘unusual’ steps in opposition to provenge approval. Well Howard, I think you have fallen off the high road into the sewer!

Howard seems to have forgotten a couple details of his various other involvements, which is understandable with his hectic schedule. I found myself wondering, “Where does Howard find the time to write to the caner (ous) letter?”

By the way, did anyone notice the similarities of all three letters [by Scher, Hussain and Fleming] as if they were a collaborative effort as well as the personal introductions to the readers? The one I like is, “I too was unable to sleep…” by Fleming, probably because he was on the phone with Howard all night.

Let/s review some of the facts…

1. High minded Howard serves on the scientific advisory board for the advancement of science at the ProQuest investments, a Venture Capital firm with over 40 portfolio companies.
2. Proquest holdings include Novacea.
3. At the advisory panel meeting on March 29th, Howard says, “investors seem to…” investors? Investors?? What do investors have to do with an advisory panel’s deliberation? Howard thinking about efficacy or investors?
4. Jay Mooring is the founding partner of ProQuest Investments.
5. Jay Mooring sits on the board of Novacea.
6. Novacea strikes an agreement with Schering Plough for Asentar, for which Howard Scher is serving as study chair. (oops, Maha Hussain is on the consultant advisory board of Novacea)
7. Maha was observed taking a nap during the panels meeting on March 29, 2007.
8. Pazdur from my last article Dendreon Disapproval: FDA Builds a Bridge to Afterlife was seen passing a note to Maha during lunch break.
9. If Provenge gets approved, Novacea suffers material damages per SEC filings.
10. And the largest Shareholder with Novacea, Perceptive Advisors, LLC managed by a Mr. Joseph Edelman.

All must be coincidences, and I haven’t even touched Taxotere. I am sure that Howard and Maha serve in the interest of science, humanity, and…yeah right!

Web site courtesy of Cliffhucker.

Last year, an advisory panel voted 9-2 against the approval of Gemzar, a drug sponsored by Eli Lilly. Yet, three months later Eli Lilly was able to satisfy the FDA against the panel’s recommendation and approve Gemzar. FDA approved Gemzar despite lack of efficacy.

This author believes Dendreon lacks the pocketbook, political clout, business experience, and lacks the relationships of a Pharmaceutical giant to get Provenge approved NOW without the efforts of its supporters even though the advisory panel voted in favor 30-4.

The decision to grant an, ‘approvable’ instead of ‘approval’ has caused much harm to patients and Dendreon. Harm from unnecessary deaths to loss of billions in shareholder value. Care to guess the damage to Hedge Funds that naked shorted the Dendreon shares?

I have refrained from referring to Maha Hussain and Howard Scher as Doctors in this article for they have violated the physician’s creed, “As to diseases, make a habit of two things—to help, or at least do no harm.”—Hippocrates, The Epidemics—

The approvable letter puts many promising therapies in Dendreon’s pipeline in jeopardy as well. Dendreon has toiled over a decade to develop exciting new therapies only to be jerked around by the FDA’s herky-jerky procedures.

FDA seems to keep its decision hidden with Johnny Carson’s ‘Carnac the Magnificent in a hermetically sealed Mayonnaise Jar’. Carnac the Magnificent with his borderline powers seemed to have been shared with hedged funds that took the opportunity to naked short and manipulate Dendreon’s share price like no other in recent memory.

Either the SEC is conducting the most clandestine investigation of all time or asleep at the wheel, looking for the next Martha Stewart.

I thought of contacting the Attorney General Alberto Gonzalez, but I hear he is pretty busy these days as well.

Leaders are measured by their Character and Competence. Last week Dr. Gold displayed his Character and now it is time to display his Competence as a CEO. With all the overwhelming goodwill and support Dendreon is enjoying, you owe it to your patients, supporters and shareholders to bring Provenge across the finish line NOW!

Last week, given a chance to bash the FDA, Dr. Gold and Dendreon took the high road.

That’s honorable, but not good enough. As Joseph Sperty of Boca Raton, FL has written to Dr. Andrew von Eschenbach and Congressional members’, “TEAR DOWN THIS WALL”.

Comments

[clutchrules:]

get these coi facts to the people who decide the fate of dendreon, this level of corruption is sickning. Sickning seems to come to mind when i picture maha taking a nap during a panel meeting on a therapy which could enhance prostate cancer patients lives!!!

2007 Jun 04 07:56 PM

[hpski:]

This is a reprise of a my comment, re Kelly Holloway's open letter to FDA, which provides more (outrageous) detail on Gemzar's approval. Clearly this recent FDA Provenge fiasco was about the money - hopefully a few MOC will hold hearings. "...Your merging of humanity with scientific principle is appreciated, and obviously in short supply amongst a significant majority of White House political appointees – why should FDA be any different? The link below is another slice of oncology product history, as it pertains to FDA's approval of Gemcitabine (Gemzar) for pancreatic, ovarian & lung cancer. The pivotal pancreatic study was very light on patients, but strong on p values. TTDP was increased by 1.2 months, median survival by 1.5 months, but the survival range in the control group, treated with standard 5-FU extended out to 12 months, vs. 9.4 months in Gemzar patients. No objective tumor responses were observed. In ovarian cancer, when combined with Carboplatin vs. Carbo alone, there was no survival advantage, yet progression free median survival was increased by 2.8 months. The overall and complete response rates had a p value of .11. In lung cancer, although median TTDP was increased by a month, there was no survival advantage. Are you sitting down? Survival was the endpoint. The secondary endpoint was quality of life – that wasn’t met either. Bottom line, Gemzar was initially and subsequently approved on threads of data because it offered some hope, and subsequently the $$ flowing to the sponsoring company, E. Lilly, helped fund additional studies, which expanded its use. Additionally, it helped & enabled a very, very smart oncologist, who pays serious attention to pharmacokinetics and drug sequencing, to develop a novel protocol for treating pancreatic cancer, called “GTX” (G is for Gemzar).

www.fda.gov/cder/foi/l...

So, there is precedent for granting highly toxic chemo drugs with questionable efficacy marketing clearance, and as physicians become familiar with them, there’s a good chance someone will find a way to harness the drug to a particular protocol to help the victims of these dreaded diseases even more. This is a dynamic business, subject to the winds of personnel change and philosophy. But looking back might be instructive – after all, isn’t that why we have historians?

2007 Jun 05 01:12 PM