San Francisco (aktiencheck.de AG) - Die Analysten von JMP Securities stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) von "market outperform" auf "market perform" zurück. (24.05.2007/ac/a/u)
: Michael Murphy Investment newsletter 31.5.07
Copy of Michael Murphy Investment letter and his take on FDA, SHorts and Politics concerning DNDN Kopiert aus MB Investor Village
Here is a copy of today's Michael Murphy Investment newsletter.
He is still strong on DNDN. He also pulls no punches in regards to the FDA, Politics, Shorts and FUD.......
Biotech MegaShift Dendreon (DNDN) jumped sharply today when the company announced exactly what I told you they would. With the huge short interest, though, I am not surprised that there is so much FUD (Fear, Uncertainty & Doubt) circulating about this company. I told you that the current clinical trial is under a Special Protocol Assessment with the FDA, and that Provenge will get approval if it shows a statistically significant survival benefit at either the interim peek at the data around April 2008 or the final data due in 2010. I also told you that the company has powered the interim peek for approval -- that means there will be enough patient data to meet the 95% statistical significance level if Provenge works as well in this trial as it did in the prior two.
Here's a typical negative response from Jonathan Aschoff, an analyst with Brean Murray & Co. He said that today's rally was unwarranted because the ongoing study will likely fail its primary goals, as did two earlier Phase III trials. "If this one fails, it will be the third time around" and likely doom the medicine, he said.
But what he neglected to say is the primary goal this time is survival, and the last two times it was tumor shrinkage. He also neglected to say that the two prior studies met the secondary goal of survival. I don't believe these are accidental omissions, because he went on to repeat the current FUD rumor on Dendreon: The prolonged-survival data was seen in a trial whose design may have favored Provenge, by including too many sicker patients in the placebo group and not enough such patients in the group taking the vaccine.
This is almost certainly completely false, because (1) this is an old trick that the FDA caught on to more than 20 years ago, and (2) Dendreon hired numerous ex-FDA examiners to hammer on the application during the rolling filing process, looking for any weakness, and stacking the deck with sick patients is elementary school stuff.
Pierre asked: "I have read with interest that any drug must meet the FDA's standard of 95% certainty that any positive results claimed for its use are not due to chance. What was Dendreon's score and can you comment on Richard Miller's (president and CEO of Pharmacyclics and adjunct professor of oncology at Stanford University Medical Center) piece that appeared in the Wall Street Journal of May 10?"
Dendreon hit 95% certainty on their secondary endpoint of survival. I talked about Richard Miller's similar turndown in the April 19 Radar Report, and I agree with him completely that the FDA must change its method of dealing with new biologics for terminal diseases. I go beyond his position, though -- I believe the FDA should put all its effort into insuring safety in Phase I and Phase II trials and leave efficacy decisions up to doctors and their patients. If any firm wanted FDA efficacy approval, they could voluntarily do a Phase III trial and then use FDA approval on their label.
Vic asked: "What about another company, a competitor -- could they get approval earlier? If so, the market will be occupied by them. The stock DNDN will not go up, right?"
No one else can get a prostate cancer personalized vaccine into the market before Dendreon. All of these diseases have multiple submarkets and often there is room for a cocktail of drugs to treat the problem. I am not worried about competitors, at this point. My main concern is just getting Provenge approved.
Roberto asked a series of questions: "I too smell a 'rat' with the massive shorting of DNDN and the volumes starting May 9, 2007. Please read this conspiracy- sensitive writer's article. I don't know if his figures are correct.
Yes, I saw this. There undoubtedly is naked short selling in DNDN. It is easy to hide with a complaisant market maker. In the last half of the 1980s, I had one of the largest short funds in the U.S. I know how it works, and what the shorts did was urge people like Dr. Fleming to write to the FDA. That's all it took for the bureaucrats to win over the Commissioner.
Have you or DNDN contacted Thomas Fleming PhD's about his thinking as to what constitute "more clinical data on efficacy?"
No need to, it is obvious. He wants to see the data from a trial with survival as the primary goal. That is precisely the trial that is now underway.
Hypothetically, when DNDN and FDA jointly unmask the test subjects, and Provenge-takers' incremental life span form a three-sigma normal-curve cluster that is at least four months longer than those in the normal curve fit for the longest living test subject on the placebo, will such constitute as the missing and now-FDA-required "more clinical data on efficacy?"
If so, when will such "unmasking" take place within the chronology of the FDA Phase tests?
Next April or May.
Another ISSUE is the absence to-date of a Partner whose expertise is in the appropriate process control, and manufacturing. Otherwise, test results may not materialize on the larger target population.
All of the Provenge used in the trials comes from a large contract manufacturer certified by the FDA
Do you see the likes of established names line Genentech or Amgen getting involved? Is DNDN the holder of the requisite patents such that they may enjoy leverage as a valuable partner for the Big Boys?
Yes and yes. The overseas partner certainly will be a big company. DNDN will try to stay independent in the U.S., which is practical because most advanced prostate cancer patients are treated in less than 500 clinics around the country, so a relatively small sales force can cover most of the market. But DNDN does have the patents if it comes to a buyout.
Please comment on the above many bases for Dendreon's value even before you do your pencil pushing. In short, don't you think there is a possibility that the FDA's COMPLETE RESPONSE LETTER of May 9, 2007 (aka Approvable Letter) is the sugar coating around a bitter hoax that Provenge could still potentially be?
How and what analyses have you done to rule this out?
Everything I have done on this stock and this drug has been aimed at whether it works and whether it can be approved. I was right on what the Advisory Committee would do because I was right on the science. I was wrong on what the FDA would do because I was wrong on the politics. The head of Chiron told me 25 years ago that developing drugs is not about curing patients, it is about getting FDA approval. Sadly, that hasn't changed.
In response to the delay of Provenge's approval, the company has cut 40 marketing people, or 18% of the work force, as they won't be needed for a year. DNDN remains a strong buy under $7, which I expect it to revisit as the shorts spread FUD. My target remains $40.
Isolagen (ILE) was the topic of a question from William: "I bought Isolagen's September 2007 call option (ILE IZ) on 4/10/07. At that time the stock was trading at $4.47. Now it is at $3.60 and I have lost a little over half of my investment. Do you expect some good news between now and the third Friday of September 2007 or should I cut my losses?"
They will restart the clinical trial in the next several weeks, but I'm not sure it will come in time to save your option position. In general, I don't buy options on stocks selling for less than $20 a share, and virtually never if they are under $10. ILE is still a good buy up to $4.50 for my $9 target next year
: heute interim analysis of IMPACT conference
SEATTLE, Oct. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) will host a conference call today, Monday, October 6, 2008 at 9:00 AM ET (6:00 AM PT) to review the outcome of the interim analysis of its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.
Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial Monday October 6, 8:30 am ET - Conference Call Scheduled for 9:00 AM ET Today -
SEATTLE, Oct. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) announced today that it has completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with metastatic androgen-independent prostate cancer. While Dendreon remains blinded to the data, the independent data monitoring committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC observed no safety concerns and recommended that the study continue to its final analysis.
ADVERTISEMENT "The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous Phase 3 trials in this patient population when analyzed at a similar 24-month follow-up time," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the PROVENGE arm at the time of the interim analysis, as well as a favorable safety profile."
At the final analysis, which is anticipated in the middle of 2009, if the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.
"We look forward to the final results next year and the opportunity to make PROVENGE available to the many men with advanced prostate cancer who currently have few appealing treatment options," said Dr. Gold.
The IMPACT trial is a randomized, double-blind, placebo-controlled Phase 3 study which enrolled 512 men with metastatic, androgen-independent prostate cancer with a primary endpoint of overall survival. Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA previously agreed that a positive final analysis for overall survival from the IMPACT trial would be sufficient to meet its request for additional clinical information to support the proposed efficacy claim for PROVENGE.
About Hazard Ratios
The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that a PROVENGE patient who at the time of the interim analysis has 0.80 times the chance of dying compared to someone in the placebo group. Its reciprocal, 1.25, means a placebo patient has 1.25 times the chance of dying compared to someone in the PROVENGE group (this is the method that hazard ratios were reported in our previous trials).
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
Conference Call Information
Dendreon will host a conference call today at 9:00 a.m. ET, 6:00 a.m. PT. To access the live call, dial 1-877-419-6598 (domestic) or +1-719-325-4935 (international). The call will also be audio webcast and will be available from the Company's website at http://www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 (domestic) or +1-719-457-0820 (international); the conference ID number is 5304314. The replay will be available from 2:00 p.m. ET on Monday, October 6 until midnight ET on Wednesday, October 8. In addition the webcast will be archived for on-demand listening for 30 days at http://www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of
operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov.
Bloomberg - Dendreon Rises After Prostate Drug Improves Survival (Update1) Dendreon Rises After Prostate Drug Improves Survival (Update1)
By Catherine Larkin
Oct. 6 (Bloomberg) -- Dendreon Corp., the company developing a treatment for prostate cancer, rose the most in more than a year in Nasdaq trading after its experimental drug reduced the risk of death 20 percent in an ongoing study.
The Seattle drugmaker gained $1.96, or 38 percent, to $7.16 at 11:10 a.m. New York time in Nasdaq Stock Market composite trading. The shares rose as much as 92 percent earlier, the biggest intraday jump since May 2007. Provenge is the most advanced candidate to become the company's first commercial product.
Dendreon expects the study in 512 men to meet its goal of improving survival 22 percent when it ends in mid-2009, Chief Executive Officer Mitchell Gold told investors today on a conference call. The U.S. Food and Drug Administration last year delayed Dendreon's application to sell the medicine, Provenge, and requested more evidence to support the survival claim.
``While we would like to receive a result that would have allowed us to amend'' our application, ``the final analysis by design has a higher probability for success,'' Gold said.
The company received the interim results from the study from an independent monitoring committee. Had the data showed the 22 percent survival benefit, Dendreon would have been able to submit the findings to the FDA, possibly expediting Provenge's approval. The study has shown no safety concerns, the company said.
Provenge, if approved, would be the first drug to train the body's immune system to attack cancer cells. Prostate cancer kills 27,000 men a year in the U.S., and analysts estimate that Provenge sales may reach $1 billion a year.
Dendreon asked for approval last year after a study of 127 men showed the drug prolonged lives with few side effects, while a second study didn't show a benefit. The FDA's decision not to approve Provenge in May 2007 sparked protests among advocates for prostate-cancer patients and almost led to a Congressional probe.