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New Products and Line Extensions are the Contributing Factors to Growth in the Four Major Cancer Markets
Tuesday December 20, 12:00 pm ET
DUBLIN, Ireland--(BUSINESS WIRE)--Dec. 20, 2005--Research and Markets (http://www.researchandmarkets.com/reports/c29800) has announced the addition of Cancer Therapeutics 2006: to their offering.
Together, the four major cancer markets, which include colorectal, prostate, lung and breast cancer were valued at well over $16 billion in 2005, which was an increase of 14 percent in value since 2004. Driving this growth are innovative new products, line extensions for existing products, and the coming of age of the biotech industry.
Our new report entitled Cancer Therapeutics 2006: Market Dynamics and R&D Trends examines these four major cancer markets in light of newly emerging therapeutics, shifting market shares and line extensions for major products on the market.
Features of this Report
market analysis by class, cancer type, product, company, and geographic region sales data from 2000 through Sept 2005 as well as full-year 2005 estimates profiles of leading products in the four major cancer markets and analysis of their market impact presentation and analysis of clinical data underscoring success of key therapies market share data for leading companies and products in the field SWOT analysis for key products in each market profiles of key emerging therapies and clinical data supporting development financial forecasts for the four major cancer markets 133 tables/graphs/diagrams illustrating historical sales data, growth rates and market share by product, class, therapeutic category, and company, company portfolios, pipelines, clinical efficacy data, as well as epidemiologic
data
Additionally, Cancer Therapeutics 2006 offers readers a critical examination of emerging and pipeline products in colorectal, prostate, lung, and breast cancer. Pipeline products with the greatest potential are assessed for their clinical efficacy and possible market impact. Briefs are provided for companies that are either firmly entrenched in one of these four cancer markets or are developing groundbreaking new drugs that are being designed to treat not only one of the leading four cancers, but other cancers as well.
Key Findings
The market for colorectal cancer therapies has increased by over seven-fold since 2000. The increase in the value of this market can be explained by new and improved chemotherapeutic agents now on the market, the introduction of key biologic therapies, and improved chemotherapeutic regimens which take into account various new options.
The value of the prostate cancer therapy market is over $2.6 billion in 2005. Hormone therapies continue to dominate the market, as they have proven to be the most effective at treating later-stage prostate cancer and are usually second in line to radiation therapy for patients with locally-advanced disease. However, with the looming approval of vaccines, angiogenesis inhibitors, and increased use of chemotherapy in metastatic disease, future treatment will take into account the benefits and disadvantages associated with ALL of these therapies.
The market for the pharmaceutical treatment of lung cancer is still largely dominated by cytotoxics in 2005-2006, although targeted therapies are beginning to make an impact. Continued uptake of Tarceva and potential approvals for Avastin, Zactima, Erbitux and other new therapies will offset the decline in value that has come as a result of patent expirations in this market.
The breast cancer market is the most vibrant and dynamic of the four major cancer markets. Currently, the market is divided between chemotherapeutic agents, anti-hormonals, and Herceptin. The strongest growth in recent years has been in the anti-hormonal sector. The overall value of branded products should increase significantly during the next five years. Uptake of aromatase inhibitors, targeted therapies, and new cytotoxic combinations should increase patient options and result in increased competition and better clinical outcomes in this dynamic market.
Topics Covered
1 Methodology and Executive Summary
2 The Global Impact of Cancer
3 Product, Company and Geographic Market Analysis
4 The Colorectal Cancer Therapy Market
5 The Prostate Cancer Therapy Market
6 The Lung Cancer Therapy Market
7 The Breast Cancer Therapy Market
8 Company Briefs
Appendices
Tables
Graphs
Diagrams
Companies Mentioned
Abgenix, Aeterna Zentaris, Amgen, Antigenics, Antisoma, Aphton Corp., AstraZeneca, AVI Biopharma, Biogen Idec, Biomira, Bristol-Myers Squibb, Celgene, Cell Genesys, Chiron, Dendreon, Eli Lilly, Genentech, Genitope, Genmab, Genta, Genzyme (Oncology), GlaxoSmithKline, Hybridon, Igeneon, ImClone Systems, Intracel Holdings Corp, Lorus Therapeutics, Medarex, MedImmune, Novartis, Pfizer, Roche, Sanofi Aventis, Schering, Schering-Plough, Seattle Genetics, Therion Biologics
For more information visit http://www.researchandmarkets.com/reports/c29800
Contact:
Research and Markets
Laura Wood
Fax: +353 1 4100 980
press@researchandmarkets.com
http://biz.yahoo.com/bw/051220/20051220005040.html?.v=1
DNDN post by saft_stock_trader on yahoo.
Mentioned on CNBC. Up 6.5% on 300k vol the first 1/2 hour fwiw.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600905258&tid=dndn&sid=...
Guy named Michael Shulman, analyst with some firm which I did not catch, named DNDN as one of his biotech picks due for a 'breakout' (his words) in 2006.
Also said it is currently out of favor, but the fda seems to support them.
Also said the results of their trials were very positive (can't remember the precise words he used).
That was it. It was short and sweet.
Great article Dew, especially to support what I've been doing for the past 19 years as a Type 1 diabetic (trying to eat right, daily exercise, close monitoring of blood sugars, and good management of insulin shots).
I've been keeping my A1c in a range of 5.7-6.4, and have NO measurable adverse affects to my eyes, kidneys or feet.
It requires one to work diligently, and of course have a higher chance of hypoglycemia, but if you also test your blood sugar often enough (I do 8-10 x day) you can catch lows before they get too low.
Unfortunately, I believe even if doctor's were more aggressive in their push to have patients improve their control, the results come down to the patient's willingness to change their behavior. That is the single most important barrier.
Have a great holiday!
Dew, I experienced atrial fib a little over a year ago one morning. It was very strange. My chest felt tight and I couldn't get a measurable pulse as my HR was too erratic. I put my Polar heartrate monitor on and found out that my HR was in the 150's range (pretty hard running pace, 85% of max HR). Then I checked into the hospital ER to get diagnoised. In my case, the Afib was not brought on due to my age or poor health (hypertension, heart problems, etc) but possibly by the fact that I have a low resting heartrate (mid-40's at rest -- as I'm an athlete, and possibly because I'm a type-1 diabetic and prone to low blood sugar events which could trigger an A-fib response).
So now I'm taking a cardizin (calcium channel blocker) pill each day for the rest of my life. First shots, now pills! Guess I'll do what I have to do. I am appreciative of medical science, that's for sure!
That article is right on in terms of the hidden dangers to elderly women and even men. My father also experienced A-fib but his was due to his age (in 70's) and somewhat elevated blood pressure.
Terry, many thanks for your thoughts on AGEN!
I feel AGEN, CEGE and DNDN are reasonable stocks to have a small position in near the $5 price for their cancer vaccine potential.
Regards, Spartex
Anyone have thougths/opinions on AGEN?
Is there a reasonable risk/reward at around the current share price of $5.18 considering the recent news announcements on 30% cut in staff to control costs, while focusing on highest priority research (trials)?
http://biz.yahoo.com/bw/051206/20051206006004.html?.v=1
Many thanks!
<When the clinical data are not ready for prime time, it’s hard for management to look good.>
Quality of clinical data TBD by FDA but I do appreciate your's and others' opinions on trial results.
DNDN price asking 5.25 near the close (and at high for the day), off only 13 cents.
Heard from yahoo board that DNDN priced at $4.50 according to a one line Dow Jones wire release. Sounds outrageous since stock was just over $6 before the secondary share announcement.
If this is true, good grief, what have I invested in?!!
<<I think they may be holding their CC after the market close to give investors a chance to cool their heads.>>
Well, I think many intvestors are jumping ship today, while new ones are joining the party. You are right though, it is hard for investors to be cool headed an hour after lossing over 60% today. Ouch.
fwiw, DNDN showing strong action today to the upside.
Cell Genesys Announces Favorable 2-Year Survival Data From Phase 2 Clinical Trial of GVAX(R) Vaccine for Pancreatic Cancer
Tuesday November 15, 9:00 am ET
Vaccine Administered Following Pancreatic Cancer Surgery and Adjuvant Therapy
SOUTH SAN FRANCISCO, Calif., Nov. 15 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced interim findings from a Phase 2 clinical trial of GVAX® vaccine for pancreatic cancer in 60 patients with operable pancreatic cancer who received the vaccine after surgical resection of their tumor and adjuvant radiation and chemotherapy. The one-year survival was 88% and the two-year survival was 76%, with a mean follow-up of approximately 24 months. These results compare favorably with historical data from multiple studies in patients undergoing pancreatic cancer surgery and adjuvant therapy for whom the two-year survival has been reported to be in the range of 40 to 50%, as recently published in the July 2005 issue of the Journal of Clinical Oncology. Vaccine treatment was well tolerated. The details of the new findings will be presented by Daniel Laheru, M.D., assistant professor of medical oncology at Johns Hopkins Kimmel Cancer Center, and colleagues, on November 17 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held this week in Philadelphia, PA.
ADVERTISEMENT
The Phase 2 trial was conducted by the Johns Hopkins Kimmel Cancer Center and enrolled 60 patients with resectable pancreatic cancer. Of note, although all patients had resectable disease, 52 of the 60 patients were Stage IIb based on the unfavorable finding that their cancer had spread to regional lymph nodes. The study was designed to evaluate the safety and efficacy of GVAX® vaccine for pancreatic cancer which is a non patient-specific vaccine being developed as an "off-the-shelf" pharmaceutical product. All patients underwent extensive surgical resection of their tumors. The vaccine was administered as an intradermal (under the skin) injection before and after standard post-operative adjuvant radiation therapy and continuous infusion 5-flourouracil chemotherapy. Patients received up to five vaccine treatments -- the first prior to adjuvant therapy, the next three following adjuvant therapy at approximately one-month intervals and the fifth as a booster injection six-months later. Patients were monitored for evidence of relapse and survival, as well as the occurrence of adverse events.
"We are certainly encouraged by the initial results of this Phase 2 study with respect to the two-year survival data compared to previously reported results for surgery and adjuvant therapy of resectable pancreatic cancer," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Based on these findings, we plan to discuss with the Food and Drug Administration (FDA) a potential registration strategy for GVAX® vaccine for pancreatic cancer."
An earlier Phase 1 trial of GVAX® vaccine for pancreatic cancer was conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who received the vaccine following surgical resection of their tumor and standard adjuvant radiation and chemotherapy. As first reported in the Journal of Clinical Oncology in January 2001, three of eight patients who received the therapeutic dose levels of the vaccine had prolonged disease-free survival for a period of at least 7 years. This outcome is considered particularly significant since all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of residual pancreatic tumor following surgery and/or metastatic tumor in regional lymph nodes. In addition, the three patients with prolonged disease-free survival -- but not the five who progressed and died -- had biopsy-proven vaccine-induced antitumor immunity as well as functional evidence of vaccine-induced T cell immunity.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. According to the American Cancer Society, approximately 32,000 Americans will be diagnosed with pancreatic cancer in 2005, nearly all of whom will unfortunately die from their disease. Because symptoms are non-specific, cancer of the pancreas is rarely diagnosed at an early stage leaving surgical removal of the tumor as a treatment option for only approximately 20 to 30 percent of pancreatic cancer patients. The median survival of patients with operable cancer of the pancreas is approximately 12 to 18 months.
Clinical trials of GVAX® cancer vaccines are under way for multiple types of cancer in addition to pancreatic cancer, including prostate cancer and leukemia. GVAX® vaccines are whole-cell vaccines that are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been genetically modified to secrete GM-CSF, an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines and are being developed as non patient-specific "off-the-shelf" pharmaceutical products. GVAX® cancer vaccines have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX® cancer vaccines and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX® vaccine for prostate cancer, Phase 2 trials of GVAX® vaccines for leukemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer and potentially other types of cancer. Cell Genesys continues to hold equity interests in its two former subsidiaries -- Abgenix, Inc., an antibody products company and Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.
Clinical Trial Information
Patients seeking information about clinical trials of GVAX® cancer vaccines under development can obtain information by visiting the company's website at www.cellgenesys.com, or by calling 1-866-275-8578, and also by checking www.clinicaltrials.gov.
Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and pre-clinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2004 dated March 14, 2005 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
Contact: Ina Cu
Investor Relations
650-266-3200
--------------------------------------------------------------------------------
Source: Cell Genesys, Inc.
http://biz.yahoo.com/prnews/051115/sftu064.html?.v=31
<You believe this best positions remark? Seriously?>
At the moment, I do. I reserve the right to change my beliefs upon further news of course. The market action today is rather muted either way for DNDN.
<Events seem to be unfolding as predicted in #msg-8310781 (item #2).>
Dew, what about your #3 prediction. So you are saying that these plans for buildout are going to be moved to the backburner next?
3. DNDN will talk less often about its manufacturing buildout because these plans will be moved to the back burner.
The DNDN PR specifically says that "the realignment "best positions" the company as it prepares to commercialize Provegne, an advanced trial drug used to treat prostate cancer."
Time will tell which way #3 ends up going (unfolding) and whether Mitch is a straight shooter or not, eh?
Regards, Spartex
Cancer drug boom projected
Sector said to more than double by 2009, surpassing cholesterol-reducing drugs, says IMS.
September 19, 2005: 3:16 PM EDT
By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - Drug sales for cancer treatments are expected to more than double over the next five years, with cancer drugs replacing cholesterol-reducers as the number one pharmaceutical sector, according to a report from IMS Health.
"Right now it's probably the fastest growing drug sector," said Jason Kantor of RBC Capitals Markets.
Oncology drug sales are projected to reach $55 billion in 2009, compared to the $24 billion in 2004, according to data unveiled Monday by Graham Lewis, vice president of global pharma strategy for IMS.
Cancer is America's second-biggest killer behind heart disease, and analysts say that Genentech (down $1.99 to $88.01, Research), is one of the best-poised large bitoech drug makers to reap the benefits of growing sales in cancer treatment.
Analysts identified some of the fastest growing cancer drugs as Avastin and Herceptin, both from Genentech, as well as Gleevec, a $1.6 billion drug from Swiss drug maker Novartis (down $0.72 to $48.86, Research), and Sutent, which the drug giant Pfizer (down $0.33 to $25.57, Research) filed with the Food and Drug Administration this summer.
"The biggest oncology treatment would probably be Genentech's Avastin," said Howard Liang, analyst for A.G. Edwards & Sons. Liang said the biotech has completed late-stage data to expand Avastin into treatments for lung and breast cancer. The company is conducting tests for additional uses in treating prostate cancer.
Avastin, which combined with chemotherapy slows the spread of colorectal cancer, was introduced to the market in 2004 and totaled $447 million in the first half of 2005, on track to become a blockbuster this year at its current rate of growth.
Herceptin, a treatment for women with HER-2 positive breast cancer, which includes about one-fourth of women with breast cancer, totaled nearly $500 million in 2004 sales. Genentech has released data from a series of tests this year showing the increased benefit of combining Herceptin with chemotherapy, and prompting some analysts to project doubled sales.
Analysts also see Amgen (up $1.27 to $86.13, Research), the world's biggest biotech, well-poised to reap the profits of an expanding drug sector. Amgen has four oncology drugs on the market, including Aranesp, Neupogen, Neulasta and Kepivance, and nine in its pipeline.
So what's the downside in the cancer drug sector? The drug prices are unsustainably high, said Liang. "The drugs are so expensive, I think there will be some kind of pushback on the pricing," the analyst said.
Treatments for lowering statins, or blood fats, are currently the lead sector, totaling $27 billion in 2004 sales. This sector is lead by Pfizer's Lipitor, a statin and the top-selling drug of all time, with $10.8 billion in 2004 sales. The statin sector is projected to grow by more than half to $38 billion in 2009, but would slide to second place as oncology becomes the lead sector, according to IMS.
In addition, the IMS study, presented at a Generic Pharmaceutical Association conference in Washington, D.C., revealed that biotechs and generic drug makers have outpaced the overall drug industry in annual sales growth. Over the last 12 months ending in June, the total drug market grew 7 percent, compared to 17 percent for biotechs and 13 percent for generics.
-----------------------------------------------
http://money.cnn.com/2005/09/19/news/fortune500/cancerdrugs/index.htm
150,000 share block of DNDN bought at 2:07 PM at $6.13
Someone agrees it is a good value.
<The bar for Fast Track is very, very low.>
As is the price for DNDN imho. I expect the company's price to appreciate significantly over the next 3 mo. as I stated earlier. I believe there will be upgrades and supporting company news releases to follow.
Good luck.
Dew it may not be news in your mind, but it has caused a 10% move in the stock today, and ~2.5 mil shares of stock to trade in 2 hours time. Obviously a significant number of people believe today's news is of more substance compared to what Gold said on Friday.
You say Gold said "BLA would likely be submitted in pieces"
Seems the market wanted official confirmation on this news before believing it.
Cheers, Spartex
AP
Dendreon Gets Fast-Track for Provenge
Monday November 7, 10:37 am ET
Dendreon Gets Fast-Track Label From FDA for Its Provenge Prostate Cancer Treatment
SEATTLE (AP) -- Dendreon Corp. said Monday that the Food and Drug Administration granted "fast track" status to its experimental prostate cancer drug, a label that allows a company to submit data as it becomes available and includes scheduled meetings for FDA input.
The fast track designation -- for the treatment of metastatic, male hormone-independent prostate cancer in men who don't show symptoms -- is reserved for drugs that address an unmet medical need and can sometimes speed review.
Dendreon has said it will submit its application for the Provenge cancer drug using data from its two completed late-stage trials. The company's stock dipped in July over concerns that FDA might require a third study.
The company's shares rose 50 cents, or about 9 percent, to $6.08 in morning trading on the Nasdaq.
I got back on board DNDN last week during the sell off. $5.41 looked like too attractive of a price considering pending news from the company. Today news should move DNDN's story into the broader presses as well as allow analysts to start new coverage, or have current ones issue upgrades.
While I'm not sure which way the FDA review will go, I do believe that this stock will most likely start to ramp up in PPS over the next 3+ months. Could see 8-9 bucks by the New Year IMHO.
Best, Spartex
OT: Dew, fyi I'll be running in Boston marathon this April 17. Should be an exciting event, and something I've been looking forward to doing the past 4 years.
Thanks Dew. Actually my avg. price was only $5.7, as I put an equal share purchase on REGN and didn't want to go to far out on margin when DNDN dipped into upper $4.9 range. Sold 1/2 my REGN yesterday at $10 and change. Building up my cash position for other opportunities.
Best wishes on yours too!
Thanks Walldiver and Dew for your summmaries on PR and conf. call.
I sold 1/2 of my position (5000 shares) at 7, and am holding onto the other 1/2 until further developments.
Good luck longs and especially the patients that may someday have use of this treatment.
DNDN NEW IS OUT!
http://biz.yahoo.com/prnews/050721/sfth055.html?.v=17
>How is this relevant to 9902a? The 9902a interim survival data were not released when they were initially available nor were they released later at ASCO.<
Actually what Terry is saying could be relevant. If they didn't release 9902a before ASCO, then why didn't they release something during May 2005 ASCO? I believe this was one of your areas of possible concern to begin with. Seems that they put the focus at ASCO in May 2005 on 9901 details, but are holding 9902a information close to their chest. Does cause one to be somewhat suspicious. Anyone ask this question directly to DNDN investor relations?
Thanks again Terry and Dew for your thoughts!
Dew, how did DNDN deal with 9901 release of interim survival results? In other words, did they provide specific data like you were hoping to see out of 9902a at the interim stage?
I'm just trying to see if there is a pattern here: 9901 interim survival #'s provided, while 9902 interim survival #'s held back. That would make me more suspicious too.
Thanks
Hi Dew-- re: DNDN comments
>>However, events of the past six months are also consistent with the 9902a survival data being mediocre and DNDN’s scrambling to control the damage.<<
You have been valuable at finding links to news on biotechs as well as your Q's on conf. calls and inquiry with companies you invest in. Could you share what news you've discovered that would indicate that DNDN may have mediocre 9902a survival data as well as company scrambling to control the damage?
The yahoo board holligans aside, there were a few posters mentioning that DNDN is on a so-called "road show" with various analysts or investment banks.
Any news you could share would be most appreciated.
Thanks!
One of Nadine Wong's better picks last year (AMGN). :) Even her MEDI pick seems to be showing promise. Time will tell on DNDN, but it looks interesting still at these levels.
<You shouldn’t be. AMGN just reported a net profit for the second quarter of $1.1B. That’s the same size net profit that DNA reported for the full year in 2004.>
DNDN seems to have some resistance (sellers) at 6.18 today, so you picked a good spot to sell. If it can eat through this price it could run up to 6.3-6.4 or higher, especially with added Geron news and news clip below.
***Monane added that Monday's deal could also stoke interest cancer vaccine developers Cell Genesys (CEGE: news, chart, profile) , Dendreon (DNDN: news, chart, profile) and Favrille (FVRL: news, chart, profile) , all of which have products in Phase III testing.
http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yhoo&siteid=yhoo&dist=yhoo&gui...
My earlier link didn't work. Check out this 3 mo comparison in performance for SCLN, REGN, DSCO, CEGE and DNDN. Also go back 6 mo to see how their performance played out over that time frame. DNDN and CEGE are underperforming the others from their March-April lows. Seems to indicate that market doesn't have as much confidence in their trials and/or therapeutic and vaccine approach to cancers. Time will tell whether the market has misjudged DNDN. All I can say is that DNDN is building a very strong base in the $5-6 dollar range. My bets have been placed.
http://finance.yahoo.com/q/bc?t=3m&s=CEGE&l=on&z=m&q=l&c=dndn%2Cregn%2Cscln%2Cds....
Cheers, Spartex
Thanks Dew.
<Is that a fair statement? After all, it’s not that long ago that DNDN was in the mid 4’s and now it’s one-third higher at around 6.>
In light of DNDN's cash position and the fact that it is near another significant trial III announcement, I believe my statement is fair that DNDN is lagging the biotech sector, as well as other companies of similiar size and cash value. In fact, DNDN is much closer to a marketable drug/procedure than the others. Just take a look at the 1 year (or 6 mo) for SCLN, CEGE, REGN and DNDN as a few to compare.
The REGN news is for starting of a Trial I, while DNDN is awaiting a very important Trial III result. The market seems to be shying away from the one that is closest to reaching a marketable product. Now that is odd to me, but I realize Mr. Market can be a strange bird from time to time and misprice until there is enough evidence to "buy".
http://finance.yahoo.com/q/bcs=DNDN&t=1y&l=on&z=m&q=l&c=cege,regn,scln
Good luck and thanks for your thoughts, Spartex
Dew et al. DNDN is missing the biotech rally.
Any thoughts about what's going on other than funds don't want to put new money to work so close to 9902a pending announcement?
I'm puzzled, as REGN is up 50% from my purchase, while DNDN hasn't gone very far. SCLN continues to be hot, and even CEGE is moving higher this week with large block buys.
Thanks, Spartex
DNDN article
FEATURED EXPERT: Dr. Scott W. & Nadine Wong
02-JUN-05
Nadine Wong, editor of the BioTech Stock Report newsletter, discusses a recent announcement regarding Provenge. Learn about this novel dendritic cell-based treatment for prostate cancer and find out what its Phase III clinical results indicate. Then learn how the market reacted to all the news. Afterward, discover what this expert has to say about Dendreon’s share price.
Unappreciated -- Dendreon
At the first of the year, Dendreon (NASDAQ: DNDN ) took it in the chin over an announcement that Provenge, the company’s novel dendritic cell-based treatment for prostate cancer, did not inhibit time to disease progression compared to standard treatment alone. However, the company did note that patients receiving Provenge did have an increase in survival time.
At this year’s meeting, Dendreon and their clinical collaborators reported that the Phase III clinical results indicated that Provenge was associated with an increase in survival from 21.4 to 25.9 months. These results are nothing to sneeze at, as an increase in survival is an important and relevant marker for cancer treatment.
The Street’s reaction or lack of makes Nadine Wong and her team think that there are still lingering questions regarding the statistical analysis. That is, if the results were truly real, as the number of patients enrolled in the study was not large. There was also concern that the increase in survival might be due to other factors, such as age, weight and diet of the patient population, which would be unrelated to Provenge.
Armed with this clinical data, Dendreon intends to pool clinical data from two ongoing Phase III clinical trials with the existing data to ensure the reproducibility of the results. Although it is difficult to predict the outcome of the ongoing studies, Nadine Wong and her team think there is strong scientific and clinical evidence to support Provenge.
Despite this news, the market did not fully embrace Provenge’s clinical data and Dendreon’s share price did not show much change in valuation, positive or negative. Wong and her team think that the market is off base here, as Provenge was being evaluated in men with advanced prostate cancer. If the patient population were different, as is in the current Phase II clinical trial, which includes men with early- stage disease, Provenge would probably have been shown to be more efficacious. Advanced cancers of any kind are extremely difficult to treat.
Regardless, if all goes well with the Phase III clinical trials, which Wong and her team believe will happen, Dendreon should be able to submit a market application with the FDA in 2006. Wong and the team think Dendreon will prevail with Provenge along with Dendreon’s ability to identify a partner to help market Provenge. They predict an increase in share price for the company.
http://www.zacks.com/experts/featured/view_article.php?art_id=2018&newsletter_id=24&&PHP...
Some significant Pre-market action to the upside on DNDN. Rumors on yahoo board are that DNDN may have a partner or that there is an upgrade pending. fwiw-- Spartex
Last night there was also some after hours volume too, to the upside.
After Hours
Last: $5.66 After Hours
Best Bid: N/A After Hours
High: $5.67
After Hours
Volume: 23,799 After Hours
Best Ask: N/A After Hours
Low: $5.55
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
18.27 $ 5.66 3600
18.27 $ 5.66 400
18.27 $ 5.66 1000
17.14 $ 5.67 100
17.14 $ 5.67 500
17.14 $ 5.66 1000
17.14 $ 5.65 1000
17.14 $ 5.64 1000
16.01 $ 5.55 1000
16.00 $ 5.55 8000
16.00 $ 5.55 5000
16.00 $ 5.56 230
16.00 $ 5.56 969
This mornings trades..........
Pre-Market
Last: $5.83 Pre-Market
Best Bid: N/A Pre-Market
High: $5.85
Pre-Market
Volume: 51,596 Pre-Market
Best Ask: N/A Pre-Market
Low: $5.64
Pre-Market
Time (ET) Pre-Market
Price Pre-Market
Share Volume
09.04 $ 5.83 500
09.03 $ 5.83 500
09.01 $ 5.85 100
09.00 $ 5.85 100
09.00 $ 5.84 100
08.59 $ 5.80 1000
08.59 $ 5.78 882
08.59 $ 5.78 700
08.59 $ 5.78 400
08.57 $ 5.77 300
08.50 $ 5.77 500
08.49 $ 5.77 500
08.48 $ 5.78 100
08.48 $ 5.78 400
08.47 $ 5.76 1000
08.41 $ 5.78 400
08.40 $ 5.78 101
08.40 $ 5.77 399
08.35 $ 5.77 200
08.32 $ 5.73 500
08.28 $ 5.75 600
08.28 $ 5.75 399
08.28 $ 5.75 1600
08.28 $ 5.76 100
08.27 $ 5.78 817
08.27 $ 5.75 400
08.27 $ 5.78 100
08.27 $ 5.79 300
08.27 $ 5.79 200
08.27 $ 5.79 300
08.27 $ 5.79 200
08.26 $ 5.79 500
08.26 $ 5.79 500
08.26 $ 5.78 500
08.26 $ 5.77 100
08.26 $ 5.77 100
08.26 $ 5.77 100
08.26 $ 5.77 100
08.26 $ 5.77 100
08.26 $ 5.78 500
08.26 $ 5.76 1000
08.25 $ 5.78 800
08.25 $ 5.78 500
08.24 $ 5.80 100
08.24 $ 5.80 100
08.24 $ 5.80 1000
08.24 $ 5.80 4100
08.24 $ 5.80 900
08.24 $ 5.81 100
08.24 $ 5.85 100
Thanks Dew -- I don't think I'm going to push the a1c any lower than 5.6%, but you never know. Forgot to mention, though, that tight control comes with one adverse consequence, high incident of severe low blood sugars. However, one can offset that by testing frequently and having fast-sugar treats around to counter these episodes. I've had a few scarey lows for sure, but never had to go to emergency room.
I believe that the 6-6.5% range for a1c's is more realistic and better target for the general diabetic population.
Since I am more of a control person, I like to push the envelop a bit. Now if I can only qualify for the Boston Marathon this fall, I'll be a happy camper! Missed qualifying by 23 seconds this past March. ;)
Cheers, Spartex
Hi Dew-- I saw the link to that story this morning via yahoo too. fyi, on a personal note, I've been a type I diabetic since the age of 26. Now at age 44 I've been living with Type I (3-5 shots/day; testing blood sugars 6-9 x/day). The technology in types of insulin, syringes, test machines etc. have become very refined since I was diagnosed in 1986. What I find is most important with diabetes is education and action (discipline). Behavorial modification is the most important part of staying in control, and have some studies have show, reducing chances of retinophathy, kidney disease, and neuropathy. My recent tests have show after 19 years of diabetes that I am not leaking any protein in my urine, I just reach an all-time low A1C of 5.6% (usually around 6-6.3%), and my eyes have shown no affects on the retina.
I am very disciplined with my diet, exercise regularly (am fit, marathon train), but I do have to deal with occassional yo-yoing of my blood sugar numbers. I can routinely see blood sugars in the 200's, and as low as the 30's. Amazing that I can still function in the 40-50 range, whereas many people will already have shakes, etc.
Anyway, I can tell you that the primary reason we aren't doing better with Type II's in the last 10 years is most likely due to our life habits: sit all day at the computer, don't exercise, and eat processed foods rich in carbs. If I were to go into a new career field at this point in time, I'd love to be an educator, modivator and instructor on ways to improve behaviors for diabetics. However, as we all know, there are many non-diabetic people in the world that are overweight and don't exercise. We just don't emphasize this enough in our lifestyles anymore, and many love their damn cars!
Ok, that's my 2 cents on this subject.
Best, Spartex
Thanks for your reply Dew. Your judgement and knowledge on these and other biotechs appears very grounded.
It is interesting that DNDN seems to be drifting down from its momentary pop on the ASCO news to the $6.4 range. Many on the crazy yahoo DNDN message board point out that options expiration this coming Friday may be having some affect on the share price. There are a lot of open contracts from the 5.0 to 10.0 strikes, with heaviest open interest at $7.5 strike. Nonetheless, DNDN seems to be drifting very slowly down towards the mid-$5's range. Also of interest is that its been holding a very steady price during most of the day after noon. Some have even said it appears to be "collared", where market makers or traders are sort of controlling the action.
I would like to see some steady accumulation by fund managers and institutions over the next few months, at least to show confidence in what DNDN has accomplished to date with their trials of Provenge.
Thanks for any other thoughts or news you can dig up on DNDN.
Thanks also to walldiver regarding his thoughts on CELL GENESYS and other DNDN competitors.
Cheers, Spartex
Hi Dew,
I recently established a new position in DNDN at 6.03, and added more REGN at 6.6 (first position at 5.6). Do you believe these are fair values for buying these two biotechs?
I realize they have both run up from their lows in the $4's, however, I hadn't been monitoring either of them closely the past month.
Seems like DNDN may have the best chance of a significant positive move in the nearterm, assuming they have good results from their 9902A data, as well as Dr. Small's presentation on 9901 tomorrow.
Any addtional insights on REGN other than what is being presented by the company's PRs?
Many thanks, Spartex