Brokerage Error Crushes Dendreon Stock: But Provenge Study a Success

There might have been a mishit of some keys at a brokerage firm that went on right before trading was halted.

In a statement, Nasdaq spokesman Wayne Lee said the exchange investigated trades between 1:25 and 1:27 p.m., the same time as the plunge. He said the trades will stand and that the decision cannot be appealed. Trading in Dendreon shares remained halted until market close.

Shares fell $9.74, or 45.2 percent, to $11.81 in afternoon trading before trading was halted. Shares were rising before the study was released at the American Urological Association's annual meeting in Chicago Tuesday.

Out of all the information, this is the part that should be looked at by the FDA.

Median survival was 26 months in men given Provenge and 22 months in the others. Three-year survival rates were 32 percent for the Provenge group and 23 percent for the others -- a 38 percent improvement.

It is either this or having to take Taxotere and face all of its painful side effects. Now the next study has to be if men take Provenge earlier in their prostate cancer cycle then what will happen to the disease. You figure that since your body itself is being helped to kill the cancer then it should work even better.

Also the FDA might be facing a lawsuit from patient groups because basically they kept this thing off the market for 2 years even though they said it was safe and their own advisory panel said it was effective. Imagine all of the lost months that end-stage prostate cancer patients would have gotten to live if the FDA listened to that advisory panel.

Dendreon Releases the Hard Data on PROVENGE

Here is a summary of the hard data on Provenge Phase 3 trial.

At the week zero dose of PROVENGE, the expression of CD54 on APCs was upregulated 5.8 fold. At the week two dose, it was 10.1 fold, significantly increased from week 0 (p <>

It seems to have convinced Joel Sendek at Lazard who is now upping Dendreon to Buy from a Hold. He thinks that the company could log $2 billion in sales of PROVENGE. Not bad considering that they booked only $111K in sales in 2008.

Lazard Capital Markets analyst Joel Sendek upgraded shares to "Buy" from "Hold" and boosted earnings estimates for the company because of Provenge, its lead candidate. He also set a $25 price target on the stock, which implies upside of 39 percent over its closing price Friday of $17.99.

Phase III IMPACT Study a Success: Dendreon Triples

At long last it seems that Dendreon and their Provenge drug are getting their just rewards.

An experimental medicine from Dendreon Corp improved survival in men with advanced forms of prostate cancer, the company said on Tuesday, bolstering chances of it becoming the first approved therapeutic vaccine for any type of cancer.

Shares of Dendreon (DNDN.O) more than tripled in heavy morning trading to as high as $22.10 as the study results suggested a revolutionary form of therapy is on the horizon for one of the most common cancers. Unlike traditional vaccines that prevent disease, the company's Provenge medicine treats it.

The FDA doesn't like to approve new forms of therapy so they had a right to be cautious. Now the hard data will come out April 28 at the American Urological Association's annual meeting in Chicago. I think the data will confirm the FDA Advisory panel's findings in 2007 that this drug is safe and it prolongs the life of the people who take it.

We also see a few mea culpas coming from the stock analyst community who either had the stock at a Hold or a Sell for the most part.

Merriman Curhan Ford analyst Joe Pantginis, one of two analysts who had a "sell" rating on Dendreon shares, admitted to getting it wrong.

"While we were wrong on our call for the outcome of the story, seeing the risk as too high, today's news is a great outcome for Dendreon," Pantginis said.

"We are especially excited that the cancer immunotherapy space has finally seen a win in a Phase III study. Importantly, we can now envision the first cancer immunotherapy on the market," he added.

The Long Dendreon Saga To be Settled Tomorrow

It seems that they will release information from their IMPACT study at 9:00 AM ET. It seems that the 16% move today was short covering ahead of the information.

The study includes more than 500 men with late-stage prostate cancer who have not benefited from drugs that sharply lower testosterone -- the male sex hormone which fuels progression of the cancer.

Seattle-based Dendreon has said it aims to seek U.S. approval of the medicine soon afterward if the trial shows at least a 22 percent reduced risk of death, versus a placebo.

I'm hoping for good information because those late-stage prostate cancer victims have only one other therapy to choose from and it is like living death from what I hear. Provenge is supposed to prolong their lives fairly comfortably for months and could lead to a whole new field of cancer-killing therapeutic vaccines.

These things actually allow the immune system itself to fight against the cancer. I'm always amazed how well the body heals itself and it seems that Provenge could be the first in a series of drugs that help the body do this. You figure a cancer patient would rather have their own body killing the cancer instead of being bombarded with radiation and getting sick because of it.

Dendreon Loss Greater and they Amended Provenge SPA

It seems they lost a little more then Wall Street Expected but beat on the revenue line.

The company reported a fourth-quarter loss of $27 million, or 32 cents a
share, swelled from $21.5 million, or 28 cents a share, in the comparable 2006
period. Quarterly revenue fell to $28,000 from $86,000 a year earlier.
Analysts surveyed by Thomson Financial had predicted a narrower loss of 25
cents a share, with revenue of $12,000.

They also made some changes to the IMPACT study:

Under the new conditions, the interim analysis is still scheduled for
the second half of 2008 but it will require a greater number of events (deaths)
and will have higher statistical powering.

I hate how the FDA terms deaths as "events." Just call them deaths and don't invent a neutral term for them like this. If the FDA appoved Provenge like their advisory committee recommended in March then more people will have had their "events" pushed back for a few months or even years.

Stong Words on Dendreon vs. FDA

I agree with his feelings on Dendreon 100%.

For the sake of prostate cancer patients, of whom we lose some 30,000
each year, here’s to hoping the decision to approve comes earlier rather
than later. Provenge is safe and effective even if the biostatistics are not
as perfect as some FDA bureaucrats and their enablers in the ivory towers of
academia would like. Last I checked, our society ranks saving lives well
ahead of bureaucratic perfection on our list of priorities. With some luck,
Congressional hearings might remind the FDA of this fact.

If it is safe and it is actually saving some lives then why hasn't it been approved? Late stage prostate cancer victims are dying while waiting for the FDA. Let's hope those Congressmen can get the FDA to budge on this thing.

Dendreon Supporters take out Washington Post Ad

Now this is an interesting development from the Dendreon support camp.

Usually activist shareholders target an actual company for change to
enhance share prices, but a group of shareholders, patients, advocates, and
activists have a made an unusual move. In Sunday's Washington Post, this
group took out an advertisement calling for citizens to contact their
Congressional representatives to urge the FDA to reverse their delay of
Provenge.

This drug is a big deal for these people because Provenge is one of the few drugs that will combat late stage Prostate Cancer. It is a drug that could potentially keep a guy alive for another few months so people are going to be passionate about it.

A few months doesn't seem like much to some people but it is enough to gather your family members together for a nice sendoff. And to these people the FDA is standing in the way waiting by waiting 2 or 3 years for more data. I think I'll e-mail my Congressman like the ad says to do.