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>>Even with Provenge, the later Taxotere patients are merely a self-selected subgroup.<<
Yeah. The way I put it on another board was ...
Dead men don't take chemo.
Nor do nearly dead men, in most cases.
micro
>>What would you guys think a company like pfizer would end up doing with its research group. Here's a company that's spending 15% of sales ($7.5b / $45.0b) so if its sales drop by $15b that means a $2.5b hit to research. That's a big number to a group thats having trouble producing products right now.
Would this start pfizer down a slipperly slope? <<
Oh. I've been scooped.
micro
>>PFE should forget about trying to replace the sales that will be lost to patent expirations because this can’t be done without incurring even greater problems.
Instead, PFE should continue to downsize and should aggressively leverage the balance sheet to the point where ROE becomes impressive. Doing this would leave a very different company, but it’s the best chance to increase shareholder value, IMO.<<
As we've discussed previously, this seems to be trend we're seeing from Big Pharma. Yes, they are buying drugs to replace ones lost due to patent expiration, but more obviously they are losing weight and hunkering down.
So where does this lead? It would seem to lead to drug companies spending less money - including less money on discovering new drugs. Alarm bells have already rung about the slowing rate of drug discovery and commercialization - particularly per dollar. Well guess what? The rate at which new drugs are discovered and commercialized may decrease further as Big Pharma downsizes.
Furthermore, small biotechs are unlikely to make up the deficit unless Big Pharma opens the pocketbook up wide to fund them.
And why have less drugs been commercialized lately? Is it only due to a cautious FDA? Or is biology a finite science and the new continents are becoming fewer and fewer ...
I'm not sure if I'm reading the trends right, but if I am I'll be adding more companies to my portfolio in areas like robotics and nanotechnology and less in drug discovery and commercialization!
micro
P.S. I fully expect some hand grenades tossed my way tomorrow, and will be disappointed if otherwise.
>>The following excerpt from a GVAX + Docetaxel animal study provided some evidence of docetaxel actually slightly increased circulating antigen-specific T cells. Sorry to clutter the board. But again, it might not help to promote a competitor..<<
Competitor?? This isn't the Dendreon board, is it?
I find it interesting that Cell Genesys is carrying out a large Phase 3 pivotal trial of GVAX + taxotere, when (to my knowledge) there has never been any *clinical* trial testing the combination, even in healthy volunteers. Mouse studies are one thing, but why would the FDA sign on with an SPA for a combination untested in people?
micro
ACTC
>>Something must be going right with the ~40 or so patients in the Phase I trial for the FDA to approve proceeding to Phase II, after reviewing the data from Phase I.<<
That speaks to safety, not efficacy.
The FDA doesn't care if a company throws its money away ...
micro
cardiomyocytes, pgs
Thanks much for your insightful comments.
>>Consider that they are grafting human cells to a rat. The rat heart beats about 300-400 times a minute whereas the human heart beats about 70. The limiting factor for large mammals is the kinetics of the proteins underlying the contractile activity. So how is it that a graft of human tissue keeps up with an underlying heart beating at 300 times a minute? I think this is a very large question. Is the graft actually contractile, or is it largely noncontractile but providing an elastic rebound to reduce load?<<
I've thought a bit about that. Of course an optimistic view would be that even better results might be obtained in a large animal model (work in progress) where the cardiomyocytes don't have difficulty keeping up.
micro
cardiomyocytes, cardiac repair
>>1) It is clear that these stem cells are not efficiently mobilized (or are too few in number) during heart attacks, otherwise we wouldn't see patients getting scar tissue in their heart.<<
If the problem is that they are too few in number, then one must increase that number.
>> 2) If a heart attack isn't enough to mobilize them and cause them to differentiate and repair the area, then what would simple injection hope to achieve?<<
If the problem is that adults have lost the power to make new cardiomyocytes, then more must be made in vitro. Perhaps one must add a 'special sauce' as well ...
>> 3) *If* they are cardiomyocyte stem cells at the point of harvest, then it must be because they haven't received the differentiation / integration signal in the heart. Without knowing what that signal is, it would be wishful thinking to assume that simply culturing more of them in the petri dish and reinjecting into the heart would do any good. Still need to know the signal to drive the differentiation.<<
Back to the special sauce ... I'm going to email you a preclinical paper pgs. I think it is possible that some - though probably not all - of your concerns have been addressed. Would appreciate your comments, either privately or publicly.
Thanks,
micro
>>While nexavar's initial data was excellent in my view it was rapidly overshadowed by sutent so I think a lot of people put Nexavar on the back burner.<<
At ASCO Sutent presented liver cancer results in a small trial. There were some responses, but AE's were a serious problem.
Here's a more recent presentation:
>>After an average follow-up of 15 months from enrollment, the average progression-free survival was four months. This is "in the same neighborhood" as the 4.5-month median progression-free survival seen in the trial of sorafenib for hepatocellular carcinoma, Dr. Zhu said.<<
>>The treatment was generally well tolerated, he added, with less than 20% of patients experiencing grade 3 toxicity in any category. These included 16% leukopenia, 16% lymphopenia, 10% fatigue, 19% elevated aspartate transaminase (AST), 6% elevated alanine transaminase (ALT), 6% skin rash, 6% hand-foot syndrome, and 6% thrombocytopenia.
The only grade 4 toxicity was thrombocytopenia in 6% of patients.
http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/7099
But this was a single arm study. Sutent has a long way to go before it can get approval in liver cancer, let alone overturn Nexavar as the standard of care there.
>>Pfizer itself is working harder on it's new TKI axitinib, which actually is being tested against sutent, which we assumed is the top drug in rcc right now.<<
AG-013736, yeah. It had a very impressive response rate in RCC. At first Pfizer said they weren't going to develop it further in RCC, presumably because they already had the #1 RCC drug and didn't want to compete with themselves. But then patients screamed and I believe they may have relented.
I have not heard of any results from AG-013736 in liver cancer.
>>Isn't there a Hcc trial with stutent ongoing?<<
Yeah, more than one. But to my knowledge Pfizer is still doing only Phase 2 trials, so they are probably several years away from having a shot at approval.
In summary, I certainly don't expect Nexavar will be the only drug approved for HCC ever. I do think they have a several years head start. Keep in mind that there have been >100 Phase 3 failures in HCC prior to Nexavar's success. The odds are still against the challengers - including Sutent and also axitinib.
Any drug trying to get approval in HCC is going to either have to go head to head against Nexavar and win, or be tried in Nexavar refractory patients for a 2nd line approval, or be tried in combination with Nexavar vs Nexavar alone. The only way Nexavar gets toppled from its 'king of the hill' position in HCC is if a new drug goes head to head *and* it wins.
Nexavar's results are so impressive in HCC and HCC has historically been such a tough cancer to treat, that my guess is that it is unlikely Nexavar will lose the #1 spot for a decade or more. But sure - it could happen earlier. In which case Nexavar could drop to #2 in HCC and still generate enough revenues to support the present market cap.
;o)
And then there's the lung and breast shots on goal coming up ...
In Phase 3 trials Nexavar is 2 for 3, with the only failure being melanoma. But even in melanoma, a randomized Phase 2 trial using different chemos than the Phase 3 trial demonstrated efficacy. (I think the results were statistically significant in PFS but showed only a positive trend in overall survival. There were only 100 patients.)
So certainly there is a chance for additional indications.
Again, Nexavar reminds me of Avastin, but it hits more targets and is oral.
micro
>>Yes, the right cell type. However, in the heart it is all about integration. When you mature cells in the petri dish, and then hope to inject those mature cells into the myocardium and hope they integrate, it is a big leap of faith that is not being appreciated.
For example, myocardial cells nearer to the epicardium are of slightly different characteristic than those nearer to the endocardium. So if you mature cells extracellularly, are you maturing them towards an endocardium phenotype or an epicardium phenotype?<<
O.K. So you need cells which have more flexibility - both in terms of multipotency and in terms of 'knowing how' to integrate properly into existing heart tissue.
So start with something more primitive than cardiomyocytes. Cardiomyocyte stem cells.
Does your answer change at all?
micro
>>I should note that the next 2-3 years are going to have plenty of these stem cell and stem cell like therapies for heart failure. Epithelial stem cells, mesenchymal stem cells, stem cells from adipose tissue, etc... <<
What about cardiomyocytes - derived from ESCs? Do you think they have a chance, pgs?
At least they are the right cell type ...
micro
>>Onyx only gets single digit royalties in Japan<<
Sorry - high single digit royalties.
micro
>>ACTC trial data at AHA<<
They say that efficacy has been demonstrated, but then gave no numbers to back that up. Not a single number. And clearly no difference with the control group was statistically significant or else they would have said so.
I assumed that when West jumped ship, ACT was probably toast.
micro
ONXX
>>Though someone will challenge the patent sooner or later.<<
Bayer must have composition of matter patents issued or in the hopper, and I think those are usually pretty easy to defend with small molecules. I expect other companies will eventually come up with other angiogenesis and/or RAS/RAF inhibitors - and in fact several are in development. But nobody is going to market Sorafenib before 2020.
micro
ONXX
Bayer's peak sales numbers are no where near yours
This is the html version of the file http://www.investor.bayer.com/user_upload/2702/.
that doesn't mean you are wrong they may just want to be conservative.<<
That presentation is from June. Just a few days ago Bayer in their Q3 cc gave guidance of 500M Euros (close to $750M) from RCC and HCC alone - not counting Asia at all. Again, Asia could be huge, even if only ~10% of the patients find the money to pay for it.
>>The problem my be that although your European patient numbers may be correct the pricing there may not be anywhere near the pricing they get in the US.
Au contraire. Bayer and Onyx have reported that on average the price for Nexavar in Europe is approximately the same as the price in the U.S.
>>Is the pricing they are getting in Europe for the Kidney indication the numbers that you are using in your analysis.
Yeah. But I think that may well be an underestimate. I expect that once they get approvals for HCC everywhere they will raise prices more than a few percent a year. That might mean they will lose some RCC business (since there are better drugs than Nexavar in RCC), but RCC is a pittance compared to HCC, and in HCC there is no competition. Even NICE (the U.K.) will have a hard time saying "no".
But again, I have not assumed any increase in pricing. Not even the ~10% a year which is standard.
>>when do they expect approval in Japan and what is the royalty rate that Onxx will get there?
I don't think anybody really knows. I am guessing that for RCC it will come in 2008 because I think the application went in during 2006. But for HCC it might take longer because Japan asked for a study involving Japanese HCC patients which is still enrolling. (Another HCC study involving Chinese and Korean patients was stopped early because of positive results. That was the third of three HCC Nexavar studies stopped early because of positive results! The Japanese study might be the 4th.)
Onyx only gets single digit royalties in Japan, but with 40,000 HCC patients dying each year in Japan - more than double the number in the U.S. - you can see that this could be quite substantial. Also I think pricing in Japan is typically a lot higher than in the U.S. and Europe, but I'm not 100% sure of that. I am assuming slightly under $1 pre-tax peak EPS from Japan, which may be conservative.
>>thanks <<
Sure.
micro
ONXX: >>Microcapfun, interesting projection, can you elaborate on the calculations? You also indicate "Pretax", is this because of the nol carryforward of ~461 million? This would be used up in a little over one year if your projections are correct. Thanks.<<
Yeah, for 2008, pre-tax will probably be the same as post-tax, at least from a cash flow perspective. By 2009 that probably won't be the case.
As for my calculations, I've looked at this from many angles. Here's one version (ask me if you want more details):
I'll estimate HCC sales by comparing to RCC sales which are pretty much known and are also holding quite steady.
Nexavar sales for RCC are at a annual run rate of ~$116M in the U.S. and ~$181M ex-U.S. Sales above that run rate in Q3 were off-label, mainly HCC.
Let's compare the potential HCC market to the RCC market:
Estimates for RCC deaths:
12,890 in the U.S., 18,400 in the EU, 44,000 in ROW
Estimates for HCC deaths:
16,780 in the U.S., 60,000 in the EU, 528,000 in ROW (mainly China, Korea and Japan)
For the U.S. I'll assume the total HCC market is 16,780/12,890 = 1.3 times bigger than the total RCC market. Outside the U.S. and EU I'll assume only ~10% of patients will be able to pay. So I'll assume that ex-U.S. the HCC market is bigger by the factor of (60K + 52.8K)/(18.4K + 4.4K) = 4.95.
Now this is important! In RCC, there are multiple approved therapies. Sutent is #1. Probably Torisel will take the #2 spot, though for now I think it is #3 with Nexavar #2. Avastin is probably #4. So RCC is a crowded field, and Nexavar probably only has somewhere between 1/4 and 1/3 of the market. (I believe Sutent has close to 2/3.)
In HCC the situation is dramatically different. Nexavar is approved in the EU and will be approved in the U.S. any day now. Nobody else is close. Also Nexavar has some really stunning efficacy results in HCC that I won't review here. I think they will be the only approved drug in HCC for several years, and then the #1 approved drug in HCC for several more.
So Nexavar has ~1/4 - 1/3 market share in RCC and should have ~1/2 - 2/3 market share in HCC. In comparing Nexavar sales in HCC to RCC we therefore need to multiply by ~ another factor of 2.
Now putting everything together for the final result for estimated peak HCC Nexavar sales:
U.S.: 2 x (1.3 x $116M) for the U.S. + 2 x (4.95 x $181M) for ex-U.S. = $2.09B!
The analysts are having a hard time getting their brains around such a large number, because there has never been a significant liver cancer market before. Given that there have been no approved systemic therapies - i.e. no systemic therapies that worked - that is not so surprising. The analysts also focus a lot on the U.S. where the HCC market is modest. Bayer has a very strong marketing team worldwide, including China. The analysts started assuming Nexavar would generate ~$250M/year in liver cancer, then $500M/year and now a few are tentatively suggesting ~$750M. But I think it will be more like $2B, as indicated above.
[If ~$2B HCC revenues + $300M RCC revenues + ??? (other possible approvals include lung and breast) seems on the ridiculously large side, consider the following. Avastin U.S. [JUST U.S.!!] sales were at a $2.4B run rate 2Q07, up 37% year-over-year. Avastin and Nexavar both target VEGF, BUT Nexavar also targets PDGF, RAF, RAS, ... AND Nexavar is oral whereas Avastin is IV! So there is every possibility that Nexavar sales could eclipse Avastin sales ($2.4B in the U.S. alone and increasing at 37% year over year!) in a few years.]
Coming back to the $2.09B HCC estimate, the only remaining question as regards 2008 revenues is how fast it ramps. Onyx's CEO - who tends to be quite conservative when it comes to guidance - suggested that reimbursement from 4 of the 5 big EU countries will be obtained by sometime in 1Q08 (2 of the 4 in 4Q07). Reimbursement in the U.S. should come this quarter. Asia, where a huge number of liver cancer cases occur, is more problematic, but Bayer and Onyx have already reported some off-label cash sales from China.
With most approvals obtained by 1Q08 in the U.S. and EU, and no other systemic therapies in HCC, even w/o any Asia sales I estimate something close to $1B in Nexavar HCC sales in 2008. I.e. the ramp will be very fast. Add in the stable ~$300M in Nexavar RCC sales and you come up with >$1.2B in worldwide Nexavar sales in 2008.
So that is one way of coming up with the revenue estimate I gave in post #54631.
The $6.65/share EPS comes from subtracting Onyx's estimated share of expenses from half that revenue. (Onyx gets half the profits worldwide except for Japan where they get a royalty.)
The stock price is only $56.50 now (up from the 11's in February). Unless I am drastically overestimating the 2008 EPS - which is certainly possible - we should easily see a stock price over $100 sometime next year.
micro
>>Onxx or bayer have not had a patent for nexavar approved in the u.s. yet <<
Don't think that's true. See my previous post.
micro
ONXX: >>When does the nexavar patent expire? Nexavar was in development for a long time. That would be my one concern.
From the Onyx Q3 10-Q: "In the case of Nexavar, the global patent applications related to this product candidate are held by Bayer, but licensed to us in conjunction with our collaboration agreement with Bayer. Bayer has a United States Patent that covers pharmaceutical compositions of Nexavar which will expire in 2022. Bayer also has a European Patent that covers Nexavar, which will expire in 2020. Bayer has other patent applications that are pending worldwide that cover Nexavar alone or in combination with other drugs for treating cancer. Certain of these patents may be subject to possible patent-term extension, the entitlement to which and the term of which cannot presently be calculated."
micro
>>
>Dew - I wonder if you can dig up my post from earlier this year where I "pounded the table" (the only time I've pounded the table on this board) for INCY and ONXX<
See #msg-21247942. Nice call, old pal!
<<
Thanks. I'm usually fairly conservative with my modeling, but I am coming up with >$1.2B in worldwide Nexavar sales in 2008, with a $6.65 EPS for ONXX (before taxes kick in).
That compares to my estimate of $0.06 EPS for 2007 ...
I know the 2008 numbers sound pretty outlandish, but I may ask you to dig up this post in about a year when ONXX hits $150/share ...
micro
ONXX
Dew - I wonder if you can dig up my post from earlier this year where I "pounded the table" (the only time I've pounded the table on this board) for INCY and ONXX (loaded up the truck with ONXX in the 11's in February, now near 60). I remember discussing the liver cancer opportunity in that post which was underappreciated by the Street - and IMO still is.
As I've been saying for a while, Sorafenib looks to be the next Avastin, but better because it is oral. I believe ONXX has quite a ways to go and will likely exceed $5 EPS next year (!).
INCY has done well too since my post, but is at a much earlier stage and the stock is very volatile.
micro
OctoPlus, Biolex Report More Color on Phase-2a Locteron Data
I guess the main advantages that HGS has at this point are a ~3 year head start (assuming OctoPlus+Biolex carry out a P2b trial after their P2a trial) and Novartis as a marketing partner.
micro
>>HGSI: Albuferon results: same efficacy as pegasys, but with fewer shots. An also ran.<<
ThomasS: You seem to be underestimating the importance of the dosing frequency. Remember that Pegasys and PegIntron took ~95% of the IFN market solely because of the advantages of once per week dosing.
It isn't just the convenience of less often dosing that's important. The discomfort associated with IFN treatment occurs in the ~2-3 days after receiving the injection. Albuferon patients report QOL improvements and less days of work missed.
That said, it is still somewhat mysterious to me why more of the patients in the Albuferon arms of the Phase 2b trial suffered a higher rate of adverse events and dropped out more often than those in the Pegasys arm. The company has suggested that these problems will disappear in the Phase 3 trials due to more careful titration (dose reductions as needed), but one must remain skeptical.
http://www.hgsi.com/events/AASLD%202007/Zeuzem%20AASLD%202007.pdf
micro
Verenium
>>There are options, which even have a bit of OI and some volume, but my, those spreads . . . huge!
Exactly. I refuse to buy options with a 10% spread between bid and ask because in such cases the 'effective commission' is typically ~5% buying the option and ~5% selling it.
micro
Manipulation ... O.K. I'll follow pgs and waste 2 minutes of my life.
>>1) Why do large wall-street houses pay exhorbitant amounts of money to analysts so that they give their opinion for free to the public? Are they a charity or is it manipulation?<<
Wall street houses pay exhorbitant amounts of money to analysts and fund managers in order to make money. Sure free analyst reports are sometimes made available and fund managers go on T.V. in part to support their positions. Is that any different than when some retail investor posts on a message board why he likes a stock he is holding?
It's called 'free speech'. Not manipulation.
>>2) Why does wall-street allow shorting (legal or naked does not matter). Is it really for "liquidity and efficiency" or is it for manipulation?<<
It is not Wall Street that allows shorting but the SEC. Though you may not like shorting, it is legal and part of the rules investors have always played by.
Not manipulation.
>>3) Why does the financial media (including CNBC, Forbes, Wall street joornal, reuters, and all the rest...) put such a concerted spin in reporting about stocks and companies, and why is the spin always identical for all the media? Is it to inform the public or is it because they get dictated to them by the crooked hedgies?<<
I don't know what spin you are talking about. You think hedge funds collectively control all the newspapers and all the financial news on T.V. and the web??? What happens when one hedge fund is long a stock and another is short? Do they flip a coin?
***
Of course whenever money is at stake there are some who will do whatever they can to make a buck, no matter if it is immoral and/or illegal. But 90% of stock movement is "manipulation"??? Again - only if you consider buying and selling to be manipulation.
micro
MAXY - Have you heard anything from MAXY regarding their infringement suit against Verenium?
Verenium, the merger of two failed companies, would probably be a good short candidate, by the way. However no shares are available to borrow.
micro
>>Perhaps not every drop in price is due to manipulation but at least 90% of them actually are in today's markets.
And your evidence is ...?
Perhaps you consider the buying and selling shares to be "manipulation" ...
micro
>>Did you attend the event in Philadelphia?<<
No.
micro
Uh, oh Monogram.
I've heard complaints that Trofile is too slow and misses some low level CXCR4 tropism. As a result HIV patients take too long to go on maraviroc, and some fail treatment due to missed CXCR4 tropism. Now the largest diagnostics company in the world will be marketing a faster and apparently more sensitive assay. Comments?
>>MADISON, N.J., Oct. 26 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX - News), the nation's leading provider of diagnostic testing, information and services, announced today that it has entered into a non- exclusive license agreement for the heteroduplex tracking technology underlying Pathway Diagnostics' SensiTrop(TM) HIV co-receptor tropism test. Tropism refers to the way a virus targets host cells. A molecular-based assay for HIV co-receptor tropism will help physicians personalize therapy for HIV patients. Quest Diagnostics is the first full-service national clinical laboratory in the U.S. to license the technology. Terms of the agreement were not disclosed.
"Pathway Diagnostics' heteroduplex tracking technology is an important new advance that highlights the growing importance of diagnostics to personalized medicine," said Joyce G. Schwartz, M.D., vice president and chief laboratory officer. "HIV co-receptor tropism tests can help physicians identify which patients, of the estimated 500,000 people in the U.S. being treated for HIV infection, will benefit from entry inhibitor drugs, the latest development in life-enhancing anti-retroviral therapies."
Pathway Diagnostics' SensiTrop technology is designed to enable physicians to identify the HIV co-receptor tropism status of a patient infected with HIV, the virus that causes AIDS. HIV co-receptor tropism refers to the preference of strains of HIV to bind, activate and infect cells, promoting disease progression, according to the type of co-receptor, specifically CXCR4 (X4) and CCR5 (R5), on the surface of the cell. Entry inhibitor anti-retroviral drugs, such as Pfizer's Selzentry(TM) therapy, which is the first in its class to be FDA approved, block the CCR5 co-receptor to inhibit disease progression.
Selzentry clinical trials showed that patients infected with CXCR4 or X4/R5 viral mixtures were at an increased risk for treatment failure taking Selzentry, and therefore should not receive the drug. Pathway Diagnostics' technology detects the CXCR4 HIV co-receptor in patient samples that have as little as one percent CXCR4-tropic virus, enabling physicians to identify with a high degree of accuracy those patients with X4-tropic virus who are unlikely to benefit from, and should not receive, treatment with entry inhibitor therapies. The heteroduplex tracking technology, which is molecular based, also can yield test results within seven days of receiving a specimen, compared to up to four weeks to receive results with cellular-based methods. During the first quarter 2008, Quest Diagnostics expects to develop an in- house laboratory validated assay based on the licensed technology. Until then and beginning November 1, 2007, physicians may order SensiTrop through Quest Diagnostics, which will refer the test to Pathway Diagnostics.<<
http://biz.yahoo.com/prnews/071026/nyf042.html?.v=101
micro
Projects for partnering ...
http://www.windhover.com/ezine/html/TA07prjcts.htm?&utm_source=TA07agenda
micro
>> I’m surprised no one commented on the irony in #msg-23786276.<<
Are you referring to the fact that #1 ("More aggressive Gx players") and #3 ("Ongoing price erosion") are related?
micro
>>ASTM results - still feel stemcells might go nice in the US as well when the democrats step in<<
Why would the Democrats support ADULT stem cell applications more than the Republicans??
>>BRCs are derived from a small sample of the patient’s bone marrow that is processed using Aastrom’s Tissue Repair Cell (TRC) Technology<<
micro
>>Sermo (and I am a member) is anonymous as a forum, but you cannot post or become a member without having your medical license and credentials substantiated.<<
A doctor friend joined upon my request and gave me his username and password so I could take a look.
It was a little interesting, but I've only gone back once since (in the past few months). There's probably not much more 'inside' information for investors there as on a typical patient discussion group website IMO.
micro
>>Does anybone know why BSRDavid diss'd INGN's last PR?
<<
>> few weeks agoe INGN released a PR that seamed positive.<<
Didn't read what BSRDavid wrote, but I don't see why Introgen's (n+1)st retrospective, Phase 2, data mining PR should be called "positive".
Introgen finished its Advexin head and neck cancer trials ~6 years ago. Doesn't it seem suspicious to you that they are still putting out PRs on the results??? They also started their *unblinded* Phase 3 trials more than 6 years ago but never came close to finishing them - in fact all indications are that they intentionally slowed them down to a near stop a few years ago. Doesn't that make you suspicious? Those Phase 3 trials had clear endpoints that the company had discussed with the FDA. Doesn't it make you suspicious that the company has been trying like crazy to change the rules and move the goalposts for the past 2+ years - especially given that the trials are unblinded and so the company probably knows the results despite claiming otherwise??
I would guess that BSRDavid would answer "yes" to all the above ...
micro
Oncologist ask a lot from combination therapies.
>>WALTHAM, Mass., Oct. 9 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that oncologists want to see significant improvement in overall survival before adopting targeted polypharmacy in first-line settings. According to the new Physician & Payer Forum report entitled Premium-Priced Targeted Agents in Oncology: Clinician and Payer Attitudes to Polypharmacy, surveyed oncologists were asked what the minimum benefit is that would persuade them to add ImClone/Bristol-Myers Squibb/Merck KGaA's Erbitux to Genentech/Roche's Avastin and chemotherapy for first-line treatment of advanced non-small-cell lung cancer (NSCLC).
In this first-line treatment scenario, the largest group of oncologists (41 percent) would require a significant improvement in overall survival in order to add Erbitux to Avastin and chemotherapy. On average, oncologists require 24 percent improvement in median survival, which would represent close to three months' additional survival, a very difficult requirement to meet in advanced NSCLC. Only 37 percent of oncologists expect Erbitux/Avastin to increase median survival of NSCLC patients.
The report also finds that up to one quarter of managed care organizations (MCOs) fail to cover both agents where two similar targeted agents are available. Marketers of Tykerb, Nexavar, Sutent, and Sprycel need to address the fact that some MCOs appear to perceive Herceptin/Tykerb, Nexavar/Sutent, and Gleevec/Sprycel as interchangeable, "me too" agents.<<
http://www.pharmaceuticalmarketnews.com/2007/10/oncologists-wan.html
micro
>>Microcapfun--Thank you for your response. In your opinion, could the responses in the non targeted tumors be attributed to Reolysin?
John<<
It seems from what you posted, with one possible modest exception, the non-targeted tumors exhibited stable disease at best. Stable disease simply means that those tumors did not grow more than ~50% in a certain amount of time. So a slowly growing tumor can be classified as exhibiting "stable disease".
I remember a case in which a cancer drug showed something like 50% stable disease in a single arm study. Then it was compared against placebo in a randomized trial with a very similar result in the active arm ... but the placebo arm had something like a 70% stable disease rate ...
I can't remember the specifics, but I bet somebody here can come up with that or another example showing how uninformative 'stable disease' can be in a single arm trial.
micro
O/T >>Who would pay big money for a marketing report
that doesn’t know which vendors sell which drugs?<<
Reminds me of a Frost & Sullivan conference call that I took part in a few years ago. The idea was that an analyst would give a brief overview of the report, people could ask questions, and then hopefully some would buy the report for $3000.
The analyst mentioned a 'key' Phase 3 trial being conducted that I knew for a fact had been discontinued some three years previous. When I pointed that out he told me I was wrong - even though I had a link as well as an email from the company ...
micro
>>AMLN – A tidbit from NVO’s UBS webcast that may interest you: the presenter said that inhaled insulin is all but doomed to be a non-factor in the market due to the advent of GLP-1 drugs. The premise is that GLP-1 drugs will routinely be added to a regimen that includes long-acting, basal insulin.<<
Has anyone seen a recent article comparing the long-lasting GLP-1 drugs? A table comparing halflife and phase of study would be nice.
I know GSK has one in a 300 patient P2b study that Human Genome Sciences has some rights to. (Used to be called Albugon.) But Novo Nordisk is way ahead of GSK:
>>Novo Nordisk today announced clinical results from the second and third of five phase 3 studies with liraglutide - the once-daily human GLP-1 analogue. The two 26-week studies are part of the LEAD® (Liraglutide Effect and Action in Diabetes) programme and comprised 2,132 patients in total.<<
http://www.glucagon.com/liraglutide_phase_3_lead_data.htm
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>>Their margin rates seem to be very competitive, and more so once you get beyond $1 million dollars of borrowing (goes from 8% to 6.5% margin rate).<<
Fidelity charges 5.5% above $500,000.
8.575% for $100K-$500K.
Personally I'm not ready to go above $500K margin debt, but I guess it's something to shoot for ...
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>>Encouraging results in ONCY trial.
To summarize, in a small single arm trial of REOLYSIN + radiation, some tumor shrinkage was seen.
Apparently no correlation with REOLYSIN dose was observed (or otherwise it would have been pointed out in the PR).
So there is no evidence that REOLYSIN is having any effect.
I remember looking into that company *many* years ago and rejected it on the grounds that optimized (i.e. engineered) viruses were more likely to be efficacious against human cancers than naturally occuring viruses. (What in evolution would cause naturally occuring viruses to preferentially attack tumor cells?) Also management sounded like a bunch of hucksters on the only cc I listened to.
After something like a decade in the clinic, has ONCY achieved proof-of-principle in man yet??
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>>It seems that the reason no one on the board is too impressed by Feursetein's analysis is because the contributors on this board probably are more qualified to write about biotech than he is.<<
You do know that in addition to writing about biotech companies for several years for TheStreet.com, he also worked at a hedge fund as a biotech analyst for a couple years ... right?
I agree with Dew that Feuerstein's main bragging rights come from his Rolodex. I would also put his writings into context. 99% of what is 'professionally' written about the biotech biz is totally worthless, consisting mainly of regurgitated PRs, hype, bash and demonstrations of fundamental ignorance about the companies being written about. Though far from immune to criticism, he is probably in the top 1% by default.
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>>Funny you should mention that. The only "adverse effect" I've suffered from Chantix is vivid dreams. Deliberate use of quotes: I actually think the dreams are pretty cool.
The question is whether Chantix is eliciting the dreams, or if it is just helping me remember them. I suspect the latter given nicotine's effects on short-term memory.
And I have a hot neighbor, so if I bang on her door late at night no harm done.
Preparing an alibi via a 'Biotech Values' post.
Nice strategy!
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