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There's a lot of fast money trading in DNDN right now. Plus, many of the Dendreonites have held on through the FDA rollercoaster. However, IMO the biggest reason why DNDN has held up through the summer financial crisis is a macro one: a common paired trade of the quant hedge funds is to go long big biotechs and short development biotechs. This trade has been unwinding, because it takes more capital to short the same dollar amount of a stock than to go long that amount. So, the quant hedgies have been selling their big bios and covering their small bio shorts. DNDN seems to be the short of choice, as most specialized health care/bio hedge funds that have a position in DNDN are short.
Of course, if the short position for August has increased as a % of the float over July, then I wonder how accurate the quant theory is. It still could be true, but perhaps the specialized bio hedge funds will have increased their short position.
Avastin supposedly bombed a Phase 2 monotherapy trial in HRPC several years ago, but DNA is now testing it in Phase 3 combo with Taxotere, just as REGN-SNY are doing with VEGF-Trap plus Tax. It's hard to say how well these anti-angiogenesis drugs will do in HRPC.
DNDN tested Avastin in combo with Provenge in ADPC a few years ago, and had decent results. However, it's hard to say how much of that success was due to Provenge and how much to Avastin. If there is any added success for these two VEGF drugs in their Phase 3 combo trials, then there will definitely be some sales taken away from Provenge if it gets approved after Avastin. Avastin as you know enjoys almost mythical status among oncologists.
The 11% ORR for Taxol in the Abraxane trial was unusually low. I think the historical ORR for Taxol is double that or better.
Here is Provenge's newest prominent competitor:
http://biz.yahoo.com/bw/070823/20070823005167.html?.v=1
Press Release Source: Regeneron Pharmaceuticals, Inc.
Phase 3 Oncology Program for Aflibercept (VEGF Trap) Initiated by Regeneron and sanofi-aventis
Thursday August 23, 7:00 am ET
Studies in prostate and non-small cell lung cancer represent the first two Phase 3 combination trials
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) today announced the initiation of two Phase 3 trials evaluating the safety and efficacy of aflibercept (VEGF Trap) in combination with standard chemotherapy regimens in patients with prostate cancer and non-small cell lung cancer (NSCLC). Aflibercept is an anti-angiogenic agent targeting Vascular Endothelial Growth Factor (VEGF), currently being developed by Regeneron in collaboration with sanofi-aventis. These two trials will be double-blind and placebo-controlled.
Sanofi-aventis will provide an update of the broad-based clinical development program planned for aflibercept, and additional details on these two trials, at its R&D Day meeting scheduled to be held in Paris, France on September 17, 2007. That meeting will be webcast and will be accessible at their corporate website: www.sanofi-aventis.com.
Information on the two studies discussed will be posted on the Internet at www.clinicaltrials.gov.
About Aflibercept (VEGF Trap) in Oncology
Aflibercept is a fully human soluble VEGF receptor fusion protein with a unique mechanism of action. It is a potent, investigational angiogenesis inhibitor, which binds VEGF-A more tightly than monoclonal antibodies. It blocks all VEGF-A isoforms plus placental growth factor (PIGF), another angiogenic growth factor that appears to play a role in tumor angiogenesis. Aflibercept has a relatively long half-life of approximately two weeks. Other anti-VEGF agents have been approved for certain cancer indications and neovascular age-related macular degeneration.
About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's worldwide web site at www.regeneron.com.
[snip fwd looking statements]
The SPA for the current SNUS pivotal Phase III has both noninferiority and superiority pathways to approval...it's comparing TOCOSOL Paclitaxel vs Taxol. Topline response rate and side effect data is scheduled to be released by the end of Sept.
One of the reasons I don't believe the VITAL-1 SPA allows for noninferiority is that the company has never mentioned it in any PR, or even discussed it on the company website. If it did allow for noninferiority, it would be extremely stupid of the company never to mention an issue so vital to VITAL-1's success...or to bury said mention deep down in some SEC filing.
I'm definitely not 100% sure, and have asked that same question a number of times, and always gotten the "assumed superiority" answer. I was always focused more on DNDN back when I was long, and since VITAL-1 was way out in the future, I didn't bother finding out from CEGE itself. Now that I no longer have a position in DNDN, I'm probably even less interested in VITAL-1.
Who knows....maybe if the curves separate at about the one-year point, they're expecting them to come close to merging again around the 30-month point. Totally hypothetical.
It's not an 80% chance of success. The trial is 80% powered for a 33% increase in median survival, which was based on the TAX327 MS of 18.9 months for the intent to treat group.
The MS in TAX327 for asymptomatic pts was 23.0 months. Even if the MS for the GVAX arm is 30.7 months, there is still a 20% chance it won't be stat sig superior to Tax. VITAL-1 was powered and designed at a time when CEGE believed the MS target to beat was 18.9 months. In addition, all of the Phase 2 pts were at Johns Hopkins, and got excellent supportive care. I don't think the same will occur at the other trial centers. Lastly, I don't think allogenic cancer immunotherapeutics work. None have worked yet in any randomized trial. So we'll see.
I haven't heard anything in the past three years about GVAX only needing to be non-inferior, which is why I think VITAL-1 is going to fail.
Interesting...I was always under the impression that when you compare your product in a randomized Phase III to an already approved product, the FDA wouldn't want a crossover component. Should be wild 2008.
Perhaps Gold and Co. were waiting for "double-secret" notification from the JCO officially informing DNDN that the Neuvenge study would be in the next issue. If not, and they had already been officially informed in writing, then it's obvious that they deliberately waited until the market closed before issuing the PR.
The question is, would it have made it to $9 and stayed there? I don't think so. It almost certainly would have closed above 7.50, though.
I really don't think that DNDN would have jumped this much if the JCO announcement had occurred during regular trading hours. Sometimes it's easy for AH traders on Friday to bid the price up, as everyone else has gone home. It should be interesting to see what happens on Monday. I think it will be strong in premarket, but I don't know if it will pop much in regular trading, because the usual suspects (Brean, UBS, etc.) will dismiss Neuvenge as old news in an attempt to keep the price down. For once, they'll be right on the facts.
Neuvenge in Bloomberg from Luke Timmerman
This is a well-balanced article on Neuvenge. Herceptin was approved several years ago to treat those in the latter stages of HER2/Neu+ breast cancer, but it since has shown a two-year median survival advantage vs the control arm as adjuvant therapy in a long-running trial, basically killing off Neuvenge as a viable product in this indication. The previous post of mine wonders about the mystery of why DNDN hasn't gone after the same HER2/Neu mutation in ovarian cancer, because it would almost certainly be an orphan indication, which would mean the pathway to approval could be much, much faster and the company could charge more for treatment.
http://tinyurl.com/2bgtgc
Dendreon Breast Cancer Drug, Neuvenge, Shows Effect in Trial
By Luke Timmerman Aug. 17 (Bloomberg) -- Dendreon Corp., the developer of a treatment to stimulate the immune system against prostate cancer, said a small study suggests the same technique may help women with breast cancer.
A clinical trial of Neuvenge showed that four of 18 patients taking the treatment, or 22 percent, had their tumors shrink or stabilize, according to results published in the Aug. 20 issue of the Journal of Clinical Oncology.
The Seattle-based company, which has no marketed products, lost almost $1 billion of its market value May 9, when its leading drug candidate, Provenge, was delayed by a request from U.S. regulators for more proof that it works. Dendreon presented early results for Neuvenge, its only other drug in human testing, at a scientific meeting in March 2004. The company hasn't invested since in any large clinical trials needed for approval.
``The data are attractive, but there have been a lot of advances in breast cancer since patients enrolled in this trial,' said David Miller, president of Biotech Stock Research, an independent equity research firm in Seattle, in a telephone interview. ``It's a good example of a great drug that a company didn't invest in fast enough.'
Dendreon's shares rose 11 cents to $7.32 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares have gained 76 percent this year.
The study found Neuvenge was well-tolerated, with side effects including fever and chills after infusions that lasted one or two days, similar to those for Provenge, the experimental prostate cancer treatment.
Aggressive Tumors
Patients in the trial failed to respond to prior rounds of chemotherapy and Genentech Inc.'s Herceptin, for women with a mutation of a breast cancer gene called Her-2.
Once on Neuvenge, one patient had tumors shrink for six months. Three others had their disease stabilize from 75 to 94 weeks, with no other treatments, researchers said.
``I personally think it should have moved on in clinical trials, it merits that,' said John Park, an oncologist at the University of California, San Francisco, and the study's lead author, in a phone interview. ``The company was also trying to develop Provenge and that was further along.'
Dendreon had $143.7 million in cash and investments as of June 30. Based on its rate of spending, largely to support Provenge, it may have $50 million to $75 million in cash left by the second half of 2008, when it expects to have results from a study of 500 men with prostate cancer, the company has said.
Immunotherapy
Neuvenge, described as an immunotherapy, doesn't work like a traditional cancer treatment. Blood is drawn from a patient, and some white blood cells vital to the immune system are separated in a lab.
The white blood cells are shipped to the company and incubated with a genetically engineered protein found on some breast cancer cells, Her-2. The white blood cells are supposed to recognize the protein as an invader and attack the cells that contain it. The revved-up white blood cells are then shipped back and re-infused into the patient.
``These types of results clearly validate the approach we're using,' said David Urdal, Dendreon's chief scientific officer, in a telephone interview.
The trial also showed evidence that patients developed stronger immune systems within eight weeks against a cancer- related biomarker, Urdal said. Such measurements, which may explain why patients did better on Neuvenge, didn't exist when earlier Provenge trials were done, he said.
Dendreon is still working on plans to further develop Neuvenge, although the company's top priority is winning FDA approval of Provenge, Urdal said. If Neuvenge moves into advanced trials, it could be tested against types of breast, ovarian or colon cancer that have the Her-2 gene mutation, he said.
To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net
Last Updated: August 17, 2007 18:00 EDT
Very short thread on the BV board re Neuvenge:
#msg-22173320
#msg-22174495
re DNDN-nope, just the opposite, really. Neuvenge has been dead for a few years. IMO, the only logical way to resuscitate it would be to go after ovarian cancer patients. The company ran some earlier trials that included HER2/Neu+ ovarian patients in addition to the breast patients. I've never been able to get a satisfactory answer about why the company doesn't go after this ovarian indication. It would probably be an orphan indication, low-hanging fruit waiting to be picked.
Interesting post, but IMO the part about biotechs providing stability as a whole doesn't get into enough detail. The biotechs that have been falling during the subprime mess are the big and mid-size ones that generate revenue (i.e. AMGN & DNA, and OSIP & PDLI), and the development-stage bios that are not heavily shorted (i.e. SNUS, OPTR). The ones that have been holding up relatively well have been the heavily shorted small bios (i.e. DNDN, CEGE). This has been because the market-neutral quant funds have had to unwind their paired trade of going long big bio while shorting small bio.
All IMO
Wow you are really going to the trouble of splitting semantic hairs in order to make a point. It was fortuitous for AMGN because they saw an opportunity and took it. Enbrel is a multi-billion annual seller. That acquisition was several years ago. Even with the split going to WYE, I think it's seen as a moneymaker for AMGN. But if you want to devote some hours to the exercise of finding all the numbers and then calculating the NPV, go ahead.
re SNUS: Yes, the stock is acting like the trial is not going well...but I highly doubt that one can predict how well TOCOSOL paclitaxel is performing by knowing the pace of the events. The short position is only about 800,000 shares at last count, and we haven't had any very high volume days where the stock dropped. If SNUS were one of the stocks for which hedge funds pay the DSMB people to speak on conference calls, I think there would be a larger short position. So, I'm inclined to think that it's dropping on disinterest combined with seasonal biotech weakness. Also, notice that the November calls haven't dropped commensurately with the common.
My post implied that AMGN was fortuitous with its timing in picking up Immunex because of the latter's mfg problems. Despite the payments to Wyeth, Enbrel has been a big moneymaker for AMGN.
I think Provenge made a bigger relative difference in the two arms in the higher Gleason scores, or at least that was the case in 9901. Here are the three-year survivor numbers from 9901:
GS<=6 Provenge arm: 41% or 9/22
GS<=6 placebo arm: 28.6% or 2/7
-----------------------------------
GS = 7 Provenge arm: 32.1% or 9/28
GS = 7 placebo arm: 11.1% or 2/18
-----------------------------------
GS = 8 Provenge arm: 40% or 4/10
GS = 8 placebo arm: 12.5% or 1/8
-----------------------------------
GS>=9 Provenge arm: 27.3% or 6/22
GS>=9 placebo arm: 0% or 0/12
WSJ article on Barclays Global, IDCC's second largest institutional investor. Seems they will be giving an update tomorrow on the recent performance of one or more of their hedge funds. I'm not a WSJ subscriber, but here's the free preview:
http://online.wsj.com/article/SB118696001899395473.html?mod=hpp_us_whats_news
It's 'Challenging' for Barclays Fund
By Carrick Mollenkamp and Ian McDonald
Word Count: 880 | Companies Featured in This Article: Goldman Sachs Group, Bear Stearns, Barclays, ABN Amro Holding
Quantitative funds, which rely on computer models to make market bets, roiled the markets last week, with several such funds facing losses. Early this week, managers of several high-profile funds will start explaining themselves.
Barclays Global Investors, one of the world's biggest fund managers, with $2 trillion in assets under management, is expected by tomorrow to provide investors its weekly update for its 32 Capital Fund Ltd. The fund's performance has been "challenging," but it hasn't faced large-scale redemption requests from clients or liquidations of its holdings, a person familiar with the fund said.
And Goldman Sachs Group Inc., whose ...
Actually, AMGN scored big-time with one acquisition (Immunex), which probably wouldn't have been for sale if it hadn't miscalculated on its manufacturing capacity.
I'm guessing that Provost in her Feb 2006 presentation used a Feb 2005 enrollment number of 99...but it's only a guess, as I don't know exactly when enrollment reached 99.
The 179 and 294 figures were directly from the briefing documents. I don't remember exactly where I found them, but they're there.
OT-Looks like my geography lesson paid off...glad I could be of help
I think it's been more of a paired trade among some of the quant funds--go long big biotechs while shorting development-stage biotechs.
Then there are the health care only funds that have been shorting....these funds probably are not hurting from subprime exposure.
Well, this explains why DNDN stock price has been holding up...poached it off the IDCC board.
Short-Seller Crowd
Singing the Blues
After Taking a Hit
Bets on Share-Price Skids
Fail to Pay Off for the Bears;
Blame 'Quant' Fund Action
By KAREN RICHARDSON and JUSTIN LAHART
August 10, 2007; Page C3
On a day when stock prices tumble like they did yesterday, short-sellers -- investors who make big bets on declines -- should be grinning.
But in a twist, some of the day's best-performing shares were ones that these bearish investors love to hate. As a result, even short-sellers took it on the chin.
Shorting involves the sale of borrowed securities by an investor who hopes to make a profit by buying back an equal number of shares later, at a lower price, to replace the borrowed ones.
Yesterday, the Dow Jones Industrial Average fell 387 points, but beleaguered stocks popular among short-sellers -- for instance, those of home builders -- posted double-digit percentage gains. At the same time, long-suffering Vonage Holdings Corp., a telecom stock that has fallen 85% since it went public last year, jumped 10%.
Online retailer Overstock.com Inc., stun-gun maker Taser International Inc. and Krispy Kreme Doughnuts Inc., three popular issues among short-sellers, all closed higher.
The reason? Blame, or thank, so-called quant hedge funds, sophisticated investment vehicles that use complex computer calculations to pick their investments, then use loads of borrowed money to make their bets. Some of these funds have been forced in recent days to not only sell their regular stock holdings -- their "long" positions" -- but also their short positions to raise money as bankers knock on their doors with margin calls on their borrowed money.
When investors are forced to exit short sales, they must buy back shares, which can force prices higher.
"The liquidation of these quant funds is serving to produce not only downside pressure on longs but also upside pressure on shorts," says Douglas Kass, head of Seabreeze Partners Management Inc., a Florida hedge fund heavily involved in shorting.
The result is that some of the worst-performing or most heavily shorted stocks got a boost. Slammed all year by the roiling subprime-mortgage fears, the Dow Jones home builders index edged 0.8% higher. Home builders Beazer Homes USA Inc. and Hovnanian Enterprises Inc. rose more than 10% each.
Some more obscure companies that in previous months or years landed in the cross hairs of short-sellers beat yesterday's market rout. Knot Inc., a New York wedding-planning firm and publisher, vaulted 25% on Nasdaq. Isramco Inc., a Houston firm that explores and produces oil and gas in Israel and the U.S., climbed 21%. InterOil Corp., an oil and gas company that operates out of Papua New Guinea, ended up more than 10%. The company has yet to post an annual profit.
Write to Karen Richardson at karen.richardson@wsj.com and Justin Lahart at justin.lahart@wsj.com
Yes, but I think it's likelier that the SEC is investigating DNDN's disclosure of the CR letter, and not investigating the FDA's process in making that decision. I also think that this "disclosure" portion of the investigation won't amount to anything.
Blade re SNUS: I've been buying at these prices. I don't think a drop would be overly severe if it only comes back as noninferior (especially if side effects are reduced, which would probably result in a higher price), while a superior result would skyrocket the shares, IMO.
OT-Nmstav, sometimes I'm disappointed in my fellow progressives. The truth should take precedence over all issues. One shouldn't reflexively take a political position on an issue based solely on what one's ideological counterparts are saying, without looking objectively at the underlying facts. Right now, the FDA is under attack from some right-wing think tanks for not allowing limited approvals of some cancer treatments...so people on the left like Maggie automatically start out with the opposite view, use specious arguments that confuse "median" with "average," and then change the subject when you call them on it...and then say that an extremely close miss on an endpoint means that there was "no effect" on that endpoint.
<<...informal inquiry which appears to be related to disclosures regarding the approval process for Provenge and trading in the Company’s stock.>>
One other way this language could be interpreted: it's highly possible (at least a 50-50 chance) that in regards to the "disclosures regarding the approval process" phrase, the SEC is investigating the manner in which DNDN disclosed the CR letter from the FDA, and not investigating the FDA's decision process at all.
Actually, the negative FDA decision after the positive panel may be the first this this happened in a terminal indication. The agency just yesterday turned down an sNDA for Advair for a larger dosage in COPD, after the advisory panel voted thumbs up in a UNANIMOUS vote. But it wouldn't surprise me at all if the SEC is investigating both the insider sales and the FDA decision and how it played into the hedge fund trades.
I was glad to hear David Miller ask mgmt if they had closed some trial sites after the positive panel vote (and then reopened them after the CR letter). I'm going to take mgmt at its word that it did not close a bunch of sites after the panel meeting, as doing so would certainly have angered the FDA.
It would have been helpful if you had included the link and highlighted the section in question.
No idea. eom
Perhaps the old joint development agreement between IDCC and NOK for 3G played a role in IDCC only alleging infringement of two patents.
OT - David was answering me by saying that both he and Alan agree with my statement. I don't think he has any imperial aspirations.
TFA and Dew, I just posted this on the Biotech Values board:
I think a couple analysts are starting to agree with that view. I don't think there is any "competitive" reason to withold the IMPACT enrollment figures, or the p value interim look allocation, or the exact number of events for the interim look. All three should be disclosed, IMO.