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SGMO >>I think you are reading way too much into the "supression of viral load" headline!<<
Agreed. There may be 10% suppression. The suppression may or may not be statistically significant. Certainly no evidence of "a cure" at this point.
And let's not forget that CXCR4 is also a receptor for (some strains of) HIV. Even if SGMO was able to obtain *complete* suppression of CCR5, most HIV patients would still not be "cured".
micro
newbie-investor misconceptions
>>Maybe I should keep an updated list in the Biotech Values iBox so we can refer to it easily when the inevitable pumping posts arrive. Comments?<<
Sure - I'm flattered. Feel free to edit my original list as you see fit.
micro
Cardio vs cancer drugs
>>Tufts researchers have tracked the actual and probable "success" rates for newly developed drugs and found that of all new drugs first tested in humans between 1993 and 2004, the rate of "successful" approvals for new antineoplastic and immunologic drugs was more than double that of new cardiovascular drugs, at 7% vs 3% [2].<<
>>In an interview with heartwire, senior author on that paper, economist Dr Massimo Riccaboni (Institutions, Markets, and Technologies Institute for Advanced Studies, Lucca, Italy), explains that drawing on past drug approvals, they were able to estimate annual sales per expected new drug approval and came up with average US sales for cancer drugs that reached almost $200 million per product per year. By contrast, sales of drugs targeting the cardiovascular system would garner, on average, $45.6 million per product per year.<<
>>Milne cites a survey by consulting company Decision Resources, which asked a panel of experts across science and business to pick the 12 most promising therapeutic areas for drug development: eight out of 12 were cancer subtypes; none were forms of cardiovascular disease.<<
http://www.theheart.org/article/1261569.do?utm_campaign=newsletter&utm_medium=email&utm_source=20110811_EN_Heartwire
Full article:
Drugs, money, and glory: Is cancer beating cardiovascular disease?
August 11, 2011 | Shelley Wood
©Ragsac19/Dreamstime.com
New York, NY - If a story could be told in numbers alone, there'd be some twists and turns found in the figures underpinning the quest for new therapies to treat the world's two most lethal diseases. Heart disease is the number-one cause of death in the US and in most high-income countries, followed by cancer, and for years deaths from both diseases have been on the decline. That slope is substantially steeper for cardiovascular diseases than for cancers: according to the Centers for Disease Control and Prevention (CDC), age-adjusted deaths from heart disease dropped by almost 31% between 1999 and 2009; by contrast, cancer deaths dropped by just 11.9%.
But if medications alone could cure all that ails, those mortality trends could be on the brink of change. A quick look at new drug approvals over 2010 and the first half of 2011 shows that the cardiovascular sphere got just three new medications: dabigatran etexilate (Pradaxa, Boehringer Ingelheim), azilsartan medoxomil (Edarbi, Takeda Pharmaceutical), and ticagrelor (Brilinta, AstraZeneca). By contrast, 13 new drugs have been approved since January 2010 for different cancers.
Drugs still in development paint an even starker picture: while cancer has over 700 drugs in development, the number of cardiovascular drugs in the pipeline is just 147 [1].
Cardiovascular is definitely losing ground in terms of the number of approved new drugs.
According to Dr Christopher Milne, associate director of Tuft University's Center for the Study of Drug Development, the rise of cancer treatments can be traced back several decades. He points to studies conducted at the Tuft's center showing that back in the 1980s, five times more cardiovascular drugs were approved than oncology drugs: 52 vs 11.
"By the 1990s it was only twice as many [38 vs 74]. And now, in the 2000s, it's equal [47 vs 49]," says Milne. "So cardiovascular is definitely losing ground in terms of the number of approved new drugs."
Milne also looked at the top 100 investigational (unapproved) drugs, also compiled by R&D Directions: almost 30% were in cancer, while just 6% were in cardiovascular disease.
Dollars driving development decisions
While the "market" of people with cardiovascular disease may still be greater than the number of people with cancer, for the companies making the products, potential revenues are the bigger driver. Making drugs is an expensive undertaking: ergo, resources are devoted to projects most likely to come to fruition.
Tufts researchers have tracked the actual and probable "success" rates for newly developed drugs and found that of all new drugs first tested in humans between 1993 and 2004, the rate of "successful" approvals for new antineoplastic and immunologic drugs was more than double that of new cardiovascular drugs, at 7% vs 3% [2].
Others have noticed similar trends. In a paper published earlier this summer in Nature Reviews: Drug Discovery, Pammolli et al report that, over time, cancer-medication projects have taken over the lion's share (30%) of total R&D projects—that's up roughly 8% from the 1990s [3]. By contrast, cardiovascular-drug projects have declined by almost 5%, now comprising only 6% of total projects.
It's tough to see this, because it's not like cardiovascular morbidity and mortality have been resolved, by any means.
In an interview with heartwire, senior author on that paper, economist Dr Massimo Riccaboni (Institutions, Markets, and Technologies Institute for Advanced Studies, Lucca, Italy), explains that drawing on past drug approvals, they were able to estimate annual sales per expected new drug approval and came up with average US sales for cancer drugs that reached almost $200 million per product per year. By contrast, sales of drugs targeting the cardiovascular system would garner, on average, $45.6 million per product per year.
Of note, cancer-drug projects, if looked at as far back as the preclinical work, also had much lower probability of success (POS), according to the Italians, something Riccaboni called highly desirable, if counterintuitive. Low probability of success, he points out, leads to drugs that fill new niches, rather than being me-too drugs: they will fetch a higher price and have little or no competition. For cancer drugs, the average POS ranged from 1.29% to 1.8%; for cardiovascular drugs, the POS was 4.86%.
Regulatory issues
Key to a drug's progression along the drug-development pathway is the regulatory rubber stamp required from the FDA that tells companies what kind of data will be considered sufficient for approval. And here, too, are profound differences between the cancer- and cardiovascular-disease spheres.
Dr Eric Topol (Scripps Clinic, La Jolla, CA) points to a fundamental difference in the way cancer drugs are now being studied, with cancer researchers turning to pharmacogenetics to develop targeted medications that can be tested in relatively small studies. In the cardiovascular arena, by contrast, companies have persisted in seeking broadly effective agents that yield benefits in almost everyone who takes them.
"Basically the CVD field got into this 'megatrial' world, enrolling tens of thousands patients testing a drug that would be good for all people—things like statins—and it kind of got stuck in this approach," says Topol. "We see this now with the anticoagulants—apixaban and dabigatran—and all the -prils and -sartans. That mentality, that strategy, just isn't sustainable, because the drug companies don't want to go there anymore."
Facing the prospect of multibillion-dollar drug-development costs, companies are getting out of the business of cardiovascular medicine and are turning to therapeutic areas where smaller, more focused research can bring a drug to market, he says.
"There's just not the drive in cardiology to identify root-cause variations in the genome or to use other means, like wireless sensors, to individualize treatment and prevention and better strategies," says Topol. "There's not a lot of that going on right now. . . . It's tough to see this, because it's not like cardiovascular morbidity and mortality have been resolved, by any means."
A double standard?
Dr Clyde Yancy (Northwestern University, Chicago, IL), who serves on the FDA's Circulatory System Devices Committee, points to another difference in how drug efficacy is viewed by the FDA.
In cardiovascular medicine, he says, "we insist on meaningful mortality benefits and minimal side effects/morbidity, while cancer is comfortable with much more modest gains and a higher tolerance for drug toxicity/side effects/etc."
For example, he continues, "We willingly accept and prescribe without hesitation chemotherapy agents that we recognize will put a patient at risk of developing heart failure, and I wouldn't advocate against that because those drugs, those Adriamycin-type compounds, are critical in the fight against certain types of cancers. . . . But if there is any cardiovascular drug for which there is even a hint that a contribution to malignancies might occur, it would be totally unacceptable to allow a drug on the market, even if it had a clinical experience of being beneficial."
If there is any cardiovascular drug for which there is even a hint that a contribution to malignancies might occur, it would be totally unacceptable to allow a drug on the market.
And whereas an approach that Yancy calls "poison, cut, or burn" has long dominated—and been deemed acceptable—in cancer therapy, the approach to heart-disease treatments has "always been more measured and conservative," he says, in part because of the huge number of patients who may end up getting the kind of cardiovascular drugs approved in recent years. "Even an infinitesimally small side-effect profile in clinical trials will be realized in clinical practice."
Dr Thomas Bersot (University of California, San Francisco) has also served as an FDA advisor—on the agency's Endocrinologic and Metabolic Drugs advisory committee—and he points to the fact that most people diagnosed with heart disease have many more years of life ahead of them, something that can't be said for many cancers. And the "acceptable" level of risk for a cardiovascular drug expected to extend life by at least a decade will be lower than that of a drug for a cancer that kills within months.
The gap widens even further for metabolic conditions like obesity and diabetes, Bersot adds. "You have to decide whether or not the issue of safety is a critical one," especially if it's a disease that's not lethal in the short term.
"When you have a drug that is basically going to be taken indefinitely, the FDA's position is that you need to know over a long period of time what the adverse effects might be, because if you're obese, you're not going to die in five years, whereas if you have lung cancer, you're probably going to be dead in five years."
But Dr Donna Arnett (University of Alabama at Birmingham), a scientist and epidemiologist, points out that while the lethality of certain cancers is widely feared, it's not the case that there are no parallels in heart disease.
"Heart failure has a shorter life expectancy than almost every cancer, with the exception of maybe pancreatic," she says. "Heart failure is one of those conditions that's really lethal," and it's by no means rare.
Hot or not
But medical need doesn't drive up stock prices; successful drugs do. And all signs suggest: cancer is hot; heart disease is not. Milne cites a survey by consulting company Decision Resources, which asked a panel of experts across science and business to pick the 12 most promising therapeutic areas for drug development: eight out of 12 were cancer subtypes; none were forms of cardiovascular disease.
There are some encouraging signs. Arnett and Topol are quick to agree that the cardiovascular-drug research lags far behind cancer in terms of pharmacogenomics and individualized therapy, but at the same time, this also represents a huge area for growth. Many of the most basic discoveries in cancer research, including the strides made in immunomodulating therapies, microRNAs, and epigenetics, may one day prove transferable to the cardiovascular arena, they say—presuming, of course that there is funding, passion, public support, and political will for this kind of knowledge transfer to occur.
Just how those different factors stack up in both the cancer and cardiovascular fields, however, is a different numbers game altogether.
ISRG Mea Culpa
Before disappearing again, I must make amends for not replying to a post of Dew’s several months ago. He asked for an update of my thoughts on Intuitive Surgical and its growth performance.
Intuitive’s year-over-year procedure growth rate has plummeted from 50% in 1Q09 to 30% in 1Q11. For a while I thought the rapidly decreasing procedure growth rate (in %) could be explained as the temporary impact of a bad economy (which caused people to postpone elective procedures), because there seemed to me to be a lot ‘more juice in the tank’ - enough procedures in the queue to keep the rate of adoption of the technology near 50% for a few more years.
I no longer think that.
The numbers suggest Intuitive may have reached a linear growth phase, with procedures growing ~75-80K/yr and revenues growing ~$225m/yr. If so, over the next 5 years, the revenue CAGR would be a modest ~12.4%. Margins are pretty well saturated, so EPS would probably grow at about that rate as well.
If this is the case, the stock may be fully valued or worse.
I don't see any huge procedures in the early stages ready to provide the fuel for more-than-linear growth, with the possible exception of single-site cholecystectomy (gall bladder removal). Each year there are between one and two million cholecystectomies (depending on what you read) carried out in the U.S. alone. They are very easy to do minimally invasively, but Intuitive hopes patients would prefer if they are done even more minimally invasively – with the instruments all going through the umbilicus (belly button). And who cares about a scar there?
But getting another shot of exponential growth out of single-site cholecystectomies within the next few years is kind of a long shot, given that the company hasn't even gotten FDA approval for its single site surgical instruments yet. They'll be starting from scratch and competing with a very routine, cheap and well-established laparoscopic procedure.
So maybe the linear growth will continue.
micro
>>I am curious, but did the Baker Brothers buy YMI in the open market or did they buy them in some sort of private placement or financing YMI had in the low single digits?<<
Not sure. All I know is that they broke the 5% barrier in August of 2010 and by January they owned ~9% of the company. They haven't filed a 13G since, so they must still own over 5%.
http://www.sec.gov/Archives/edgar/data/1087940/000114420410045951/v194863_sc13g.htm
http://www.sec.gov/Archives/edgar/data/1087940/000114420411008609/v211344_sc13ga.htm
>>I vaguely remember the Baker Brothers as being large holders of ARIA after Berger over at Ariad did many famous PIPES in the low single digits, only to see their holdings go to zero in short order...as if they were just in there to flip the stock.<<
Don't know about that, but I've 'bumped into' the Bakers in following various biotech stocks, and had the impression they were quite savvy and successful overall. I bet some others on this board have amusing stories about them.
The intriguing point, however, is not that somebody bought a lot of shares of YMI, but that they were purchased by a group of Incyte backers with inside information about Incyte's competitor research into CYT387.
micro
YMI
>>But this time there is another more real concern, namely the hyping of 2 drugs that they picked up for a combined $15M by buying Cytopia. Both drugs were already in the clinic, yet Cytopia sold for pocket change.<<
I know I am going to get crucified for what sounds a whole lot like newbie biotech mistake #4, but are you guys aware that the Baker Brothers bought over 9 million shares of YMI in the open market?
http://www.j3sg.com/Reports/Stock-Insider/Generate-Institution-Portfolio.php?institutionid=4698&DV=yes
The Baker Brothers are long-time supporters and backers of Inycte, having financially bailed out the company more than once. They presently own ~15% of Incyte and have had board representation for many years - so they would have access to Incyte's competitive analysis of CYT387.
I know Incyte is very thorough in carrying out such competitive analysis.
I found it quite surprising and unusual that the Bakers would buy such a large stake in a competitor and it suggests that they - and Incyte - take YMI's anemia improvement claims seriously.
Should we???
micro
>>AF is right. Orphan protects INCY against generic competition.<<
Thanks. Apologies for my confusion on this issue.
micro
Carfilzomib
"Obviously the near term price drivers will be whether Carfilzomib will be granted accelerated approval and how the lawsuit with Bayer plays out."
I think accelerated approval is unlikely, but Carfilzomib will get approved eventually.
micro
YMI/Feuerstein today
"I decided to place YM Biosciences at the top because CYT387's mechanism of action is well understood and the drug could be a viable treatment for myelofibrosis even if the controversial anemia benefit turns out to be a zero. (Just not as commercially successfully.)"
http://www.thestreet.com/_yahoo/story/11171001/1/biotech-stock-mailbag-ranking-cheap-biotechs.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Is he correct? Incyte has orphan drug status for its JAK1/JAK2 inhibitor which is almost sure to be approved within a few months. How could YMI sell their drug within 7 years if it inhibited the same targets and had the same effects (reduced spleen size, reduced night sweats, weight gain, etc.) for the same indication (MF)?
My understanding is that the only way to get around orphan drug status for the same indication is if the 2nd drug is superior or if it hits different targets. They both hit JAK1 and JAK2. If YMI's JAK inhibitor somehow improves anemia, unlike Incyte's, I can see how it would get to market within 7 years - but not if it doesn't.
Who is wrong - AF or me?
micro
re: micro - onxx
You're right - I was way too bullish about Nexavar expansion into Asia on the basis of high HCV/HCB/liver cancer rates. I agree Nexavar sales have been relatively disappointing. I guess the drug is too expensive and offers too little benefit in the areas where liver cancer is most prevalent. Also in patients with severe liver damage, the drug is too toxic. That might be the majority of patients with liver cancer.
Carfilzomib looks good - agreed. Too bad there won't be much sales and marketing overlap between a blood cancer drug and a solid tumor drug. Also the company has to start from scratch in Europe.
I think the Proteolix acquisition was smart. There's a guy named Lasowski that CEO Coles hired early on who is apparently very good at corporate development (M&A). When he was hired he was told: "You are the pipeline." At that point the company had no early R&D/preclinical group at all, no drugs in development, nothing except Nexavar.
So the company and the CEO has done some good things. But I'm still not that impressed. I met the CEO once and he rubbed me the wrong way. Strikes me as a pompous, greedy, control freak, though I could be wrong. He has fired a number of good execs, which disturbed me. And I think expenses haven't been managed that well.
I guess the main reason I have soured on the company is that they don't have any edge, any platform technology. Coles made one good acquisition - though it wasn't cheap. That's about it.
I still own shares, but will sell the rest of them eventually.
micro
DFRAI,
I did not provide any quotes or suggest that I did. I do think I fairly accurately paraphrased/summarized some of the arguments in your posts from May (which I just read), however.
If you are going to post hundreds of comments on a topic, it would seem reasonable that you are looking for some sort of response. But I can see why you would find my responses annoying; feel free to call me whatever you like.
micro
ONCY
>>standard of care for specific type of cancers is pretty much a known result - easily quantifiable based on the last 1-20 yrs research which has not changed much.
example - pancreatic cancer patient - on standard soc lives 6 months
what is the value of subjecting those patients to another round of SOC when you know the outcome - 6 months
hence my reservation about randomized trials.<< (DFRAI)
I do not mean this to sound like a personal attack, but it is rather amazing that you make just about every biotech newbie mistake in the book. (These are all from your posts on ONCY - with only a small amount of exaggeration.)
1. Randomized trials are not necessary because we can just compare to historical data - which doesn't change much over the years.
2. Success in animals implies success in humans. [Virtually no drug makes it to Phase I w/o success in animals!]
3. Success of a somewhat related drug implies success of my company's drug. [But OncoVex, a Herpes simplex type 1 virus *engineered* to not replicate in normal cells and *engineered* to express GM-CSF, is EXTREMELY different than the naturally occuring reovirus!]
4. If a fund buys a lot of my company, they must know what they are doing; that is evidence my company will succeed. [If you think a fund does better DD than you ... BUY THE FUND!]
5. There is no need for a pivotal Phase 3 trial to be built upon a similar randomized Phase 2.
6. If the CEO says it - it's true.
7. My company would not have moved into Phase 3 and started preparing for launch if they were not fairly sure of success - and since they're fairly sure, I can be as well.
8. If my company pays a well-known company to manufacture the drug, it is a very good sign. A well-known company wouldn't waste its time with losers. [The key word here is "pays".]
9. If my drug + a standard drug improves the condition of cancer patients, then it is clear that my drug works.
10. There is nothing suspicious about my company carrying out a string of small, single-arm studies over ~ a decade that prove nothing regarding efficacy.
11. If the stock goes up, that's a good sign. If it shows weakness, it should probably be sold. [See post #120060!]
I'm sure I missed a few.
All I can say is ... good luck!
micro
>>They sure dont look like dragging things out to me.<<
Really? Didn't clinical trials on the reovirus start 11 years ago? Don't you think that if it worked and management had a clue, it would have been proved in a randomized trial by now??
I studied that company a decade ago and decided it was probably a scam.
The odds of finding a virus in nature that can outperform several well-engineered viruses against human cancer, when there has been absolutely no evolutionary pressure guiding it to do so - is close to nil.
I look forward to the P3 results.
micro
ONCY
>>I suspect that in the next 1-4 months, we will get the results from the first part of phase III (aprox 80-100 patients) and it will be hugely successful.<<
Considering all the oncolytic viruses which were cleverly engineered to be extremely selective to cancer cells, some of which also were given an additional killing or immune-activating gene - all of which failed or were given up on ... the chance that a non-engineered, naturally occuring virus will succeed is next to nil (IMO).
The real question is how many more years ONCY can drag things out before being forced to admit failure. Doubt they can beat Introgen's record.
micro
Feuerstein
>>The crappier a biotech company is, the more vociferously its investors complain about Feuerstein’s articles.<<
Partly this is because the crappier the biotech company, the more negatives Feuerstein tends to write about it, and partly it is a reflection of the type of people who invest in crappy biotech companies.
micro
David Nance of Introgen 'fame'
Don't know if this has been discussed here, but Nance is not exactly retired ...
>>Convergen sues to prevent release of documents tied to $4.5 million grant<<
>>An Austin company at the center of a controversy over a $4.5 million state grant is asking a court to block the release of information that Attorney General Greg Abbott has deemed to be public.
The Austin American-Statesman sought the grant application and other documents from Convergen LifeSciences Inc. following news reports that the company, led by David Nance, had won the money after sidestepping or ignoring the usual channels of review.
An Austin-area screening board rejected Convergen's initial application for money to develop a cancer treatment, and Nance sidestepped screening by another board that focuses on life sciences applications.
Instead, Nance went to a 17-member state advisory board, made up mostly of appointees of Gov. Rick Perry, and asked Alan Kirchhoff, Perry's director of economic development at the time, to intervene.<<
>>The attorney general said that the law did not apply because Convergen already had been awarded the money and is no longer "being considered for an award."<<
http://www.statesman.com/news/texas-politics/convergen-sues-to-prevent-release-of-documents-tied-1212299.html
micro
Elective Procedures
>>I can confirm from the reports by such companies as AGN, SYK, and ZMH that elective procedures have been relatively weak during the past year or so, although they have been improving lately.<< (Dew)
Indeed.
>>Americans are more optimistic about their ability to pay for healthcare services in the coming months, particularly for elective surgeries, according to a survey issued on Thursday.<<
>>"Throughout 2010, elective surgery was the thing they were most likely to say they would delay or cancel," Shook said. "That apparently has turned around."<<
http://www.reuters.com/article/2011/02/17/us-usa-healthcare-confidence-idUSTRE71G36120110217?feedType=RSS&feedName=smallBusinessNews&rpc=43
micro
O/T The Decline Effect and The Scientific method
That was a very scary article! All scientists should read it.
Thanks!
micro
O/T #'s of operations
>>Very occasionally the answer is basically, "Who do you think you are to question me?" at which point I find someone else.<<
Reminds me of a colonoscopy I had a few years ago when I was with Kaiser. As way of background, Kaiser treats such common procedures like an assembly line, with patients essentially lined up in gowns waiting for their turn tummy down.
When it was my turn I asked the impatient doc how many colonoscopies he had done previously. He scowled at me and w/o a moment's hesitation said, "dozen a day, 6 days a week for 25 years - YOU do the math!"
That's a lot of colonoscopies. I wonder if he dreams about them.
micro
>>Once GIVN’s colon capsule is FDA-approved, I would expect it to be a no-brainer for insurance companies to cover it insofar as it’s more convenient and less costly than the alternatives.<< (Dew)
But does it work as well? I remember looking into this a while ago (maybe the situation has changed since then), and claims were made that GIVN's capsule might miss a lot of polyps compared to a colonoscopy because - it might be pointing in the wrong direction as it passed by, or the camera might be obscured, etc. And whereas a doctor performing a conventional colonoscopy can spend more time looking at a suspicious area from every angle, the capsule just keeps on moving down, never to return ...
Have more recent studies put these concerns to rest?
A separate issue, that someone here already pointed out, is that if one has to perform a biopsy or remove a polyp - this can be incorporated into the colonoscopy - but the pill is just a voyeur ...
micro
>>Doctors Need 1,600 Robot-Aided Prostate Surgeries for Skills, Study Finds<<
Yeah I saw that, jbog. It has been pointed out previously that surgeons who have done >100 of some new type of surgery tend to claim that at least 100 is needed for proficiency. Surgeons who have done >200 say that 200 is needed for proficiency, and so on. Surgery is a competitive business and surgeons look for ways to differentiate themselves from their competition. Having more experience is one such way.
I wonder if thinking along these lines motivated this study.
That said, surgical learning curves do seem to go on almost forever - though they get flatter and flatter over time. Depending on the 3 surgeons you pick (that's all they followed in this study!) and where you draw a horizontal line defined as 'proficient', you can make the number of surgeries needed for proficiency as large as you like.
There have been many similar ('learning curve') da Vinci surgery studies over the past decade or so. I've seen learning curves that get fairly flat after 50 surgeries.
All I know is that I wouldn't want to be the patient of a surgeon doing his first of anything - not counting maybe a cadaver or a pig.
Interestingly, Intuitive recently started selling a da Vinci simulator - so that surgeons can practice da Vinci surgery as many times as they feel necessary before carrying it out for real. This might give a learning curve 'head start' to the next generation of surgeons.
micro
>>ISRG is down about 30% from its price in early 2010 during a period when stocks have rallied. Do you have anything to add to what you previously posted on this board? T.i.a.<< (Dew)
Dew,
I apologize for the rather tardy reply to your query ... and by the way, Happy New Year.
ISRG is now up slightly from its price 1 year ago - but in any case - wasn't it you that said, "The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated
in any area of human knowledge!”?
Anyway, da Vinci procedures increased by ~35% in 2010. I thought they would grow a bit faster, but it seems a lot of people delayed elective surgeries due to the economy. In any case I continue to feel Intuitive will have many more years of rapid growth ahead of it and is significantly undervalued on a cash flow basis.
micro
>>You have been mostly negative regarding Onxx, which is fine, but you have been most negative at the wrong times.<<
You have been unable to show that any of my statements involving Onyx were incorrect, so you attempt to negate them by labeling them "negative"? Dear me.
This discussion started simply because I said "One thing to keep in mind is that Carfilzomib has to be marketed to a quite different set of doctors compared to Nexavar - hematologists instead of oncologists, hepatologists, etc. Also Onyx plans to do its own marketing for Carfilzomib in Europe, which means ramping up from scratch there. My point is that there may not be much synergy associated with marketing these two very different drugs."
That was my entire post on ONXX from which you launched this strange 'micro is negative on ONXX' attack.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58125376
>>If you want to talk about profitability or lack there of, then breakdown expense and revenues. It is disingenuous of you to eliminate profits from the sale of Carfilzomib rights to Japan while including all the expenses accrued for the development of Carfilzomib.<<
Expenses and revenues are broken down right here:
http://www.sec.gov/Archives/edgar/data/1012140/000095012310100148/f56654e10vq.htm
You can see in that 10-Q that ONXX has lost $68m during the first 9 months of 2010, as I said before. That includes all GAAP Carfilzomib revenues and charges. I am not being "negative". That is a simple statement of fact.
Onyx also presents non-GAAP income in which they remove all one-time charges including milestones associated with the inlicensing of Carfilzomib and the rest of their pipeline, as well as non-cash charges such as stock comp and non-cash debt charges.
http://www.sec.gov/Archives/edgar/data/1012140/000095012310100112/f57249exv99w1.htm
That's O.K. But then they add back the *one-time* outlicensing fee that they received from Ono for selling Japan rights to Carfilzomib. It doesn't take a CPA to realize that this treatment is inconsistent and the company is also non-GAAP unprofitable at the present time. Talk to someone that you trust on accounting issues if you do not understand this.
>>Try being honest and analytical sometimes.<<
Huh?
>>Based on your posting record on the onxx board, you seem to be bitter about when you sold it.<<
??? I own close to $800,000 of ONXX at the present time, all of which is firmly in the green. If you think I am lying, bet me a few thousand dollars and I'll provide my account information to Dew.
>>You seem to want to eliminate future revenues from additional rights sales.<<
???
Clearly this discussion is a waste of time for both of us. I'll end it here.
micro
>>How many reps will it take to sell Carfilzomib? I can't imagine much more than 100.<<
I agree - for the U.S. Onyx says they want to market Carfilzomib in Europe as well.
>>you don't need more than one drug to be profitable, you just need the right drug. I guess we'll see if carfilzomib is the right drug.<<
Agreed, rkrw. Carfilzomib is certainly a potential blockbuster. My only point was it is always good for the bottom line to have the same sales force selling multiple products to the same docs - and there won't be much of that happening with Nexavar and Carfilzomib.
micro
Jbog: I replied to your last month's ISRG query via your aol email address. micro
>>Onxx is now profitable from Nexavar<<
They have lost $68m for the first 9 months of the year. If they hadn't sold Japanese rights to Carfilzomib they would have lost $127m for the first 9 months of the year.
Even non-GAAP they lost money for the first 9 months of the year. (The upfront Japanese licensing fee is obviously one-time and therefore should have not been included in non-GAAP earnings.)
>>The Japanese deal recouped about 40% of the entire Proteolix deal that brought Carfilzomib to Onxx, so I expect some nice cash coming from selling rights to the rest of Asia. I do expect Onxx to partner in Europe. The agreement with Bayer changed on Dec 20 , such that Onxx stated any buyout now will not come at the Nexavar profits.<<
What does any of that have to do with the topic we are discussing??
>>I must say you have been pretty negative towards Onxx for sometime and that hasn't been very accurate.<<
Although I have been long for some time, I am not negative or positive toward Onyx. I am realistic. Try it sometime.
micro
ONYX
>>Micro, not sure why you think synergy is a big deal for Onxx when the key is to have a second drug that sells well.<<
Onyx is unprofitable with one drug; it may be unprofitable - or marginally unprofitable with two. So of course sales & marketing synergies are important. If you were a drug company, would you want to spend hundreds of millions of dollars per year on a sales force with each rep only selling a single drug??
>>I expect other deals in Asia and Europe.<<
Onyx plans to market Carfilzomib in Europe and outlicense it in Asia.
micro
>>As for Onyx, it seems like an even worse proposition. If they're able to get a second drug on the market, then I think they reach that sweet spot of really making some money.<<
One thing to keep in mind is that Carfilzomib has to be marketed to a quite different set of doctors compared to Nexavar - hematologists instead of oncologists, hepatologists, etc. Also Onyx plans to do its own marketing for Carfilzomib in Europe, which means ramping up from scratch there. My point is that there may not be much synergy associated with marketing these two very different drugs.
micro
>>The TNF blocking antibodies<<
Thanks for the lesson. So Cimzia and Simponi have essentially the same labels as Humira?
I believe you - but I don't get it. If Cimzia and Simponi came on the scene many years later it would seem that they would at least have had to pass a non-inferiority trial against Humira, similar to Dew's comments regarding Incyte's 050.
micro
>>I would not rule out a finding of non-inferiority based on those numbers.<<
I'm not ruling it out. I'm just saying it doesn't look likely - at least if the SPA primary endpoint involves ACR20. Incyte's best bet might be to move the primary endpoint to ACR50 - if the FDA goes along.
micro
>>INCY’s drug might be able to show statsig non-inferiority, which ought to be good enough for FDA approval with a suitable SPA.<<
Thanks, Dew. Do you think that's likely given the following?
Drug ACR20 minus placebo ACR20:
Pfizer: 39%
Incyte: 20%
Reminder: The ACR20 drug/placebo comparison was Incyte's primary Phase 2B endpoint.
micro
JAK/Incyte
>>As for never being approved in RA, I'm not sure I'll go that far unless there is a requirement that they run any registration trial versus the PFE drug.<<
Well that's something worth discussing. Pfizer's JAK inhibitor (tasocitinib) will have been on the market for about a couple years at the time when Incyte and Lilly are working out an SPA with the FDA ... I would think Incyte would be given two options. For first line (or 2nd if Pfizer gets approved only for TNF failure patients), go head to head against tasocitinib. For 2nd line (or 3rd in the TNF failure case), show that 050 can work in tasocitinib-failure patients.
I think we both agree that 050 would be unlikely to beat tasocitinib head to head, given the data reported thus far.
Would 050 work in tasocitinib-failure patients? 050 inhibits JAK1 and JAK2. Pfizer's drug inhibits JAK1, JAK2 and JAK3. So 050 doesn't inhibit anything that Pfizer's drug doesn't already inhibit. Therefore my guess is that 050 would not work very well in tasocitinib-failure patients, unless many/most of those patients failed because of JAK3-inhibition side effects - which seems unlikely, again from the data we've seen so far.
So that's why my guess is that 050 will not get to the market in RA.
I'd be interested in other opinions.
I'm certainly not an Incyte basher. I think 424 will be a blockbuster in MPDs.
micro
>>Agreed that the INCY data aren't showing anything meaningfully different than PFE.<<
Drug ACR20 minus placebo ACR20 - Incyte's primary endpoint:
Pfizer: 39%
Incyte: 20%
That's using your data.
I think we'll have to agree to disagree. My guess is that 050 will never be approved in RA.
>>One has to presume PFE's first mover advantage will be a meaningful hurdle for JNJ.<<
Did JNJ buy Lilly? ;o)
micro
JAK/RA
>>Off-hand it looks to me like you're looking at old data.<<
Well ... yeah. I was comparing P2 Pfizer data to P2 Incyte data, rather than comparing P3 to P2.
But thanks for the P3 to P2 comparison. Pfizer's drug minus placebo ACR response rates are still higher for all of ACR20, ACR50 and ACR70, although I agree that only ACR20 looks like it might reach statistical significance.
But ACR was the primary endpoint.
micro
Incyte, INCB28050
Was catching up on the past couple months of posts and see that there was a long discussion about the INCB28050 RA results in November.
"INCB28050 data look good" seemed to be the consensus here.
But I don't see anyone contrasting the Incyte results with the compable Pfizer results.
When I made that comparison it seemed to me that the 28050 results were much worse. Here is what I wrote at the time:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=te&bn=9458&tid=18788&mid=18872&tof=38&frt=2#18872
Am I missing something?
micro
>>Microcapfun
It might take you about 15 minutes to scan their results in the 15 yrs or so and you might see that results are there for somebody to see ... Making disparaging comments without actually doing some reading shows how intellectually lazy you have become.<<
Fair enough - though if you hadn't been repeatedly pumping the company on this board I would have kept my intellectually lazy mouth shut.
I went through their investor presentation slides.
http://www.oncolyticsbiotech.com/pdf/ONCY_Investor_Presentation_Oct_21_2010.pdf
Their main justification for going to Phase 3 in head and neck cancer is given in slide 4 in which they claim 8 PRs out of 23 patients in a single arm trial of reovirus + paclitaxel. This is a 35% RR using intent-to-treat, but (surprise, surprise) they throw out 4 patients and write the RR as 42%. Paclitaxel exhibits responses in this indication, and with such a small number of patients, it could well be generating all 8 of them. But the real question is whether median survival increases by adding reovirus to paclitaxel. Amy serious biotech company would carry out a Phase 2b randomized trial with ~200 patients and an OS or at least PFS primary endpoint before going on to Phase 3. Not only would that be perfectly ethical, but going on to Phase 3 w/o doing it is *not* ethical. Instead Oncolytics compares to *historial* median survival data and writes "8+ months (mean, 4 pts still alive)".
Of course mean is not median so there is no comparison; the mean can be much larger than the median due to even one patient who got lucky and lived a long time. They are purposely hiding the median in that trial, which is likely <<8 months and therefore totally unimpressive for this disease - depending on which handpicked patients they put in their 23 patient non-randomized trial.
So red flags and spin all over the place.
If you go back to the old Phase 1 & 2 results in head and neck cancer from Onyx (oncolytic viral therapy) and Introgen (gene therapy), you will see that they had an order of magnitude more Phase 1/2 data - yet both failed to get close to registration.
So while I admit I haven't studied Oncolytics to death, color me totally unimpressed. It looks like a typical hype biotech company to me (which is the conclusion I arrived at many years ago), milking investors for as long as possible with spin and half-assed data just like Introgen did.
It's O.K. if you disagree. But with all due respect, I don't have any desire to discuss the company further - at least not until their Phase 3 fails.
micro
>>As far as their virus not working - its not decided yet.<<
After ~15 years ... that says it all.
Cheers,
micro
>>ONCY - Molecular Cancer therapeutics (holy grail?)<<
Man you like to pump that loser company, DFRAI. What's it been - 15 years and they still haven't started a Phase 3 yet?
Other companies have engineered/optimized oncolytic viruses by starting with promising wild-type viruses and making carefully designed genetic changes to increase selectivity, hasten oncolytic scale-up, reduce the immune response, arm the virus, etc. Yet even they failed. All of them. What are ONCY's chances of succeeding with some naturally occuring stomach virus - particularly after all these years??
If they start a Phase 3, that would probably be a good time to short. Because then they will only be able to stall for so long before they have to show their cards ...
micro
Incyte
>>What's interesting to me is that the option premiums don't appear to be all that high given a stock that is entering a binary event.<< (pgs)
It's not very binary. ;o)
micro
>>microcapfun: Comments on ISRG’s latest quarterly results?<< (Dew)
Oops ... Guess I'm a little late.
No change in my outlook (that you linked to). Intuitive is throwing more sales people at benign hysterectomies, and that procedure is starting to take off again.
"If you recall, last quarter we had called out the fact that there had been some slowing in da Vinci Hysterectomy specifically the benign side and we had called out potentially three reason why that might be, either a reset on the premiums, insurance premiums for potentially high incidence of COBRA fallout and then just the activities that our sales people had in just having a full plate. Well if you looked at it this quarter it was actually a significant move in benign hysterectomy, so it was actually a very strong turnaround. So, if there were trends that we saw they were really favorable on the benign side of the business and I think that speaks also for myomectomy and even the uro and gyn procedures and sacral colpopexy. So the sales people certainly I think we feel that it’s still early, but we’d like the momentum that we are building with the additional feet on the street."
http://seekingalpha.com/article/215749-intuitive-surgical-inc-q2-2010-earnings-call-transcript?part=qanda
This could bring their year-over-year procedure growth up again from the wimpy 36% seen in Q2 to at least the 40's soon.
I think the stock is extremely undervalued. The company is likely to 'own' a very significant fraction of the worldwide surgical market a few years from now, with thousands of dollars going to Intuitive for each of many millions of surgeries performed each year - giving revenues in the tens of billions.
At that point, if they can maintain their whopping profit margin, the market cap would be expected to be in the $100B range.
micro