Dendreon 2007 Annual Report and How Provenge Will Propel Company

I have finally gotten around to writing about some of the annual reports I have sifted through in the past month. The first one I am writing about today is Dendreon (DNDN), one of my Top Ten Stocks for 2009.

Dendreon had a nice 2007 as far as its pipeline was concerned. The company submitted Provenge to the FDA office of Cellular, Tissue and Gene Therapies Advisory Committee. That committee passed Provenge with a 17-0 annonymous vote and deemed Provenge "Reasonably safe". In March of 2007 Dendreon submitted Neuvenge, a drug that will be used in relations to breast cancer, into Phase I trials. This drug Neuvenge could also later be used for ovarion, colon, and bladder cancers based on its formation.

The company has CEA in preclinical trials. This targets lung cancer, colon cancer, and breast cancer. CA9, another preclinical drug, is aimed at a protein found in 75% of cervical cancer, and 95% of renal cancers.

TRP, an iron channel that regulates flow of iron in cells could be made into a pill by the company, and is likely to be sent as an IND in 2009.

The first phase III trial of Provenge demonstrated median survival benefit with Provenge of four and a half months and an amazing 41% reduction in death. In the same study it was found that 34% of patients were alive 36 months after the trial, compared with 11% of the placebo control groupl.

The lead doctor of the Impact study of Provenge has 21 years of practice and is a Harvard Professor of Medicine.

The company Dendreon has no revenue and as stated by the Risk Factors in the Annual Report, it is highly dependent on the FDA approval of Provenge.

The stock traded as high as $25.25 in 2007 and can now be bought for a fifth of that price per share. The company is now reporting that April will be the key month to watch for a report on Provenge.

I recommend the stock as a Speculative buy. I do not own shares of the company at the time of this writing but will be looking at adding some under the $5 range from now until March.

Provenge will pass trials, it will save lives. The company will have an amazing drug and will get bought out.

This article also appears on my blog here.

Disclosure: no positions

Comments

[sdbanks:]

When you mention "....committee passed Provenge with a 17-0 annonymous vote and deemed Provenge "Reasonably safe....".

You should balance it with that the drug was not approved at that time and has since dropped back from $25.00 - $3.50.

It's newest trial has just finished and results are expected within 90 days ( April??).

Jan 27 10:17 AM

[Frankie62:]

sdbanks left out that the primary opponent of Provenge wrote letters urging FDA NOT to approve Provenge for prostate cancer, in spite of the panel vote. There have been lawsuits filed. The same opponent has sources of revenue from the current "accepted" treatment - radiation and chemotherapy (which have devastating side effects), major conflicts of interest. The victims in final stages of PC have been begging for access to Provenge - it not only extends life, but there are virtually no side effects. DNDN's Provenge and Neuvenge are immunotherapies which are customized for each patient, using their individual blood.

Jan 27 02:49 PM

[Luis A. Tellez:]

April 30th is the day FDA will decide on the faith of this drug; the info in on EFTinnovators.com (Mike Harvillas) blog post.


On Jan 27 10:17 AM sdbanks wrote:

> When you mention "....committee passed Provenge with a 17-0 annonymous
> vote and deemed Provenge "Reasonably safe....".
>
> You should balance it with that the drug was not approved at that
> time and has since dropped back from $25.00 - $3.50.
>
> It's newest trial has just finished and results are expected within
> 90 days ( April??).

Jan 28 08:59 AM

[sieraromero:]

Are insiders buying or selling stock? This is a good indicater of whether its going to 25 or down to 2.50

Jan 28 12:34 PM

[amherst23:]

i have traded DNDN stock and own it now for the same reasons identified in the blog

in order to further understand prostate cancer i have done some research and set up a web site chronicling the relevant information about prostate cancer at this site:

prostatecancer.boomja..../

have a look




On Jan 27 02:49 PM Frankie62 wrote:

> sdbanks left out that the primary opponent of Provenge wrote letters
> urging FDA NOT to approve Provenge for prostate cancer, in spite
> of the panel vote. There have been lawsuits filed. The same opponent
> has sources of revenue from the current "accepted" treatment - radiation
> and chemotherapy (which have devastating side effects), major conflicts
> of interest. The victims in final stages of PC have been begging
> for access to Provenge - it not only extends life, but there are
> virtually no side effects. DNDN's Provenge and Neuvenge are immunotherapies
> which are customized for each patient, using their individual blood.

Jan 28 10:40 PM

[attenuation:]

Hate to say this, but vested interests in the approval "chain" are also working against the early approval of Provenge despite the positive results achieved in trials so far indicating that life expectancy would improve with its use at the cost of nearly zero side effects. The new administration would do well to keep an eye on the headwinds against approval of Provenge and safeguard the interest of the p.c. patients who are keen to use the drug to minimize their sufferings and improve the quality of their life.

"attenuation31"

Feb 03 10:11 AM

[Ardeis:]

It should be mentioned that the FDA has never explained why it delayed the approval of Provenge in 2007. Since that time, two close competitors of Dendreon had to terminate trials due to unexpected deaths leaving Provenge as the single, safest available alternative for this terminal disease versus the horrendous Taxotene. Likewise it is crucial investors and patients realize Provenge has already shown a 20% increased survival over chemo at interim results of the IMPACT trial, released by the company back in October and the final results are due sometime between now and the end of April. This is a very exciting time for immunotherapy.

Dr. Scott
Safety Harbor, FL

Feb 04 03:09 AM

[Whippet:]

Great company, great science, great products. The reason they got a raw deal the last time around was because the primary endpoint of their trial- time to disease progression- was not met. The survival benefit was clear, but the FDA held them to their failure to meet the "goal". Unfortunately, the way trials are carried out puts an intense pressure on this drug- because they need to conduct trials in patients who are on death's door, this sort of immunotherapy can be "too little, too late." (A trial with survival endpoints cannot be "closed" until a statistically significant number of patients are dead.) Its effects early in disease progression would theoretically be amazing- since Provenge is priming the patient's immune system to attack the tumor, there is a much higher probability of efficacy in early disease. But a trial like this would be onerous to carry out, and their cash would dry up before approval. Essentially, they had to take a novel therapy and place it in the most disadvantageous position to succeed, thus "rolling the dice". The safety profile is squeaky clean; if the FDA does not approve this drug they do a tremendous disservice to the one in six men who will develop prostate cancer. And to think they approve products like RU-486 ("Plan B") which cause extreme risk to healthy women for political expediency makes me want to vomit.
I think they have a pretty good shot at approval- it would be a "victory" for breakthrough medicines for the new administration's FDA... but I agree with the author that you should only gamble money you can afford to lose.

Feb 10 07:59 PM