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>>While I'm not poo-pooing the idea of buying biotech's or pharma (i presently hold some), I'm starting to think it might not be the best place to invest at this time.<<
I'm beginning to think that any company expected to burn cash for the next few years is not the best place to invest at this time - or any time!
Such companies are too vulnerable to massive dilution at best and bankruptcy at worst.
Unfortunately, passing over companies expected to burn cash for the next several years removes from consideration the overwhelming majority of the most interesting (from a science/tech perspective) biotech companies.
But thems the breaks ...
micro
PLEASE LABEL YOUR POSTS, PEOPLE!
mcbio,
Would you please be so kind as to put a title at the head of each of your posts? Just a short phrase to let people know the topic so that they can decide whether they want to read or skip and so they don't have to follow the thread back to figure out what the heck is being discussed.
Same suggestion for a few others. Don't mean to tick anybody off!
Thanks much,
micro
Geron
>>I'm just saying that even without a buyout that I think the stock will go a good deal higher from current levels.<<
On what basis do you say that? Not discounted cash flow IMO, because they have only two products in the clinic, one which has apparently failed and the other which is patient-specific and not going to be developed further - according to the company. So there is no reason to expect any significant revenue (let alone profits) for at least a decade. Why in the world should they be valued more than cash?
In this market - once there is dissipation of the near-term hype from the loosened restrictions on hESC NIH funding (which could hurt Geron more than help it) - they could easily trade at half cash. That would be about $1/share.
That's not a prediction ...
micro
>>My investment rationale for GERN hinges not on GERN curing cancer or repairing spinal cord injuries in the next few years (or ever necessarily for that matter) but rather on the fact that you're dealing with what is arguably one of the leaders in embryonic stem cell research among the publicly traded biotechs. And I don't believe GERN needs to get any drugs on the market for this stock to go higher from current levels given their position as one of the dominant players in a promising field.<<
I agree that Geron is somewhat of a gatekeeper in terms of (at least) U.S. ESC IP, and therefore could at any time be gobbled up for ~$1B or more. Analogies would be Merck's acquisition of sirna for $1.1B and GSK's acquisition of Sirtris for $720M.
However buying and holding for an acquisiton doesn't seem to be a good investment strategy in my experience.
micro
>>Then you'll be happier with my add at $2<<
Indeed. I also picked up some more at $2.24 on 11/21, but given that I hold quite a bit more purchased at much higher prices, it gives me no bragging rights.
micro
>>Just so that I am clearer on your example, can you define the "upper middle class" salary that you're using in this example?<<
Well here's a simple example that took me all of 3 minutes to generate from scratch using Excel.
I assumed a starting salary of $50K, increasing by 6%/year until $150K was reached, and then increasing by 3%/year for each year thereafter. If that sounds too rich for your tastes, imagine it is a family income.
I also assumed that 5% of the salary was invested each year in some stock index fund, and that the CAGR for the index fund was 10%. If the index fund is broad enough, I think that 10% is probably on the low side.
After 45 years of working, the example gave rise to $3.43M in retirement investments.
If you want to back out inflation, divide by ~1.02^45 to get $1.41M.
O.K. - I haven't assumed any taxes on the index fund, but for an index fund and with as much of the money as possible shielded in IRAs, that might not be a killer.
Of course if you can save more than 5%/year and/or actively manage a portfolio which generates a much greater than 10% CAGR, you can do much better and retire much earlier. (I have!)
micro
INCY
>>If they could bring back the genomics bubble circa 1999-2000, wouldn’t that do the trick? :- )<<
Since they haven't done anything with genomics for at least 6 years ... no. Apparently Friedman didn't even get any of his drug targets from Incyte's old database. I think they even let most of their 'gene patents' lapse, though I'm not 100% sure about that.
Yes, I realize you were kidding ...
micro
>>i use Pharmawire. their track record on likelihood of drug approvals, PDUFA dates and partnership/M&A insider info is great<<
Er ... did you mean insider information or insider transactions??
micro
>>
>>
For every 100,000 women who were screened regularly, 1,909 were diagnosed with invasive breast cancer over six years, compared with 1,564 women who did not have regular screening.
There are other explanations, but researchers say that they are less likely than the conclusion that the tumors disappeared.
<<
Does anyone care to offer an alternative explanation that the researchers may have overlooked? <<
Sure - easy. If you don't screen for breast cancer you don't find it as early - giving those women time to die of something else before they are diagnosed with the disease ...
micro
>>I don't think this decision is as bad for GERN as it seems at first blush after reading the above release (granted, it's from GERN).<<
Second blush is perhaps more informative than first. Geron's PR basically says that although James Thomson had to destroy embryos - and that's why his original patents were rejected by the EU, later researchers could use already available hESC lines w/o having to PERSONALLY destroy embryos ... so therefore the EU will likely patent their work.
IMO opinion this argument is ridiculous, because the cell lines were still originally obtained by killing an embryo.
Here are Geron's exact words:
>>In reaching its decision, the Enlarged Board of Appeals emphasized the fact that at the time that the priority patent application was filed (in 1995), the only method of obtaining hESCs, as described in the application, required the use of a human embryo. In contrast, following Thomson’s discovery, many hESC lines became widely available through stem cell banks, obviating the need for researchers to culture the cells from embryonic material. Therefore, this decision should not affect patent applications for later-developed hESC technologies ...<<
Geron also says:
>>Indeed the EPO’s own commentary on the decision states that the “decision does not concern the general question of human stem cell patentability.”<<
Well ... d'oh! Adult stem cells can be patented in the EU. iPS cells can be patented in the EU. Because they don't involve killing embryos.
Two additional comments.
1. Of course I think the EU decision is absurd, because I don't think killing a blastocyst containing ~200 cells is morally worse than scratching your back. But my opinion doesn't really matter.
2. I think some of Geron's downstream hESC patents will eventually issue in Europe, but they are among the weakest of Geron's ESC IP because they mainly involve 'recipes', e.g. recipes for making certain cell types from other cell types. Such recipes are a lot easier to work around than fundamental IP like the WARF patents, which - in the U.S. - allow Geron exclusive rights to all therapeutic applications of cardiomyocytes, islet cells and neural cells derived from hESCs.
>>If the stock should experience any further weakness, I'll probably just dollar cost average some more into my position.<<
Given that the company has failed for 20 years to make significant progress toward commercializing any therapeutic, and of their 2 products in the clinic, one has failed to demonstrate molecular activity after >3 years of trying and the company has publicly admitted that they do not plan on taking the other forward ...
... I predict you will have additional dollar cost averaging opportunities going forward!
Best of luck,
micro
O/T >>But this is not the point that PGS was making in #msg-33757407; rather, his point was that having 5% of the populace owning net assets of $1M+ was “unsustainable.”<<
Just a minor late comment on this thread. For someone toward the beginning of their career, sure - $1M in non-real estate equity is quite a bit to contemplate. But for someone near the end of a reasonably successful career (in the financial sense), I would submit that it isn't that much at all.
One way to see that is to consider saving a reasonable amount (say 10%/year after-taxes) of an upper middle class salary by putting it into the stock market every year of employment for ~45 years, and simply assume that over that time the stock market exhibits something close to a 10% CAGR.
Do the math. You'll see that will generate a lot of millionaires - and multimillionaires.* What's not to sustain?
Or you can work backwards. A household with $1M in savings as they enter retirement will probably need to live on ~$30-50K/year during their retirement if they don't want to run out of money. That's not particularly impressive.
So I guess my point is that it isn't that hard to put away $1M by the time of retirement if you have a decent salary and take investing seriously -- and if you don't do that, you might not have a very comfortable retirement ...
micro
* It is amusing to note that only $13,800 growing at 10%/year, exceeds $1M after 45 years, thanks to the 'miracle' of compound interest.
>>I added INCY at 2.36.<<
Well, a 42% gain in one week isn't half bad, pgs.
IMO INCY has gone in ~3 months from >10 to a low of 1.85, not because of any failure or disappointment in their pipeline - quite the contrary - but because investors have decided that a quarter billion dollars in cash ... and ~$400M in converts which look unlikely to convert ... is not enough for them to get to market, despite having a likely blockbuster as lead product and some other promising candidates following behind. It's the old bio catch-22 magnified by the economic/credit crisis situation. You can't raise enough money to get to the finish line unless your stock price is higher, and your stock price won't go higher unless you can convince investors that you can raise enough money to get to the finish line.
The only way out is for INCY to do some significant partnering/outlicensing to raise cash and reduce the burn, which I expect they will do. But there too they will be in a relatively weak bargaining position because of their cash & debt situation.
Friedman and other insiders have been buying shares and Friedman has been whining about his stock price, but the former is unlikely to help much, and the latter is only putting a spotlight on the company's financial weakness. Eventually they are going to have to bite the bullet and do some outlicensing.
micro
>>Either Senator Baucus and President-elect Obama are making promises that can't possibly be kept. Or they're not being honest about their plans for U.S. health care.<<
It would be much appreciated if sources of editorials are indicated ...
micro
[O/T] Retail sales better than expected???
Wal-Mart worker dies after shoppers knock him down
By COLLEEN LONG, Associated Press Writer Colleen Long, Associated Press Writer
NEW YORK – A worker was killed in the crush Friday after a throng of shoppers eager for post-Thanksgiving bargains burst through the doors at a suburban Wal-Mart, authorities said.
At least four other people were injured, and the store in Valley Stream on Long Island was closed.
Wal-Mart Stores Inc. in Bentonville, Ark., called the incident a "tragic situation" and said the employee came from a temporary agency and was doing maintenance work at the store.
"He was bum-rushed by 200 people," co-worker Jimmy Overby, 43, told the Daily News. "They took the doors off the hinges. He was trampled and killed in front of me. They took me down too. ... I literally had to fight people off my back."
Nassau County police said the 34-year-old worker was taken to a hospital where he was pronounced dead at about 6 a.m. The man's name was not released and the cause of death was not immediately known.
A police statement said shortly after the store's 5 a.m. opening time, shoppers "physically broke down the doors, knocking (the worker) to the ground."
A metal portion of the door was crumpled like an accordion.
Shoppers around the country lined up early outside stores in the annual bargain hunting ritual known as Black Friday. Many stores open early and stay open late, and some of the most dramatic bargains are available in limited quantities.
Among the bargains offered by Wal-Mart for Friday were Samsung 50-inch high definition Plasma TVs for less than $800.
Witnesses told the Daily News that before the store was closed, eager shoppers streamed past emergency crews as they worked furiously to save the worker's life.
"They were working on him, but you could see he was dead," said Halcyon Alexander, 29. "People were still coming through."
A 28-year-old pregnant woman was taken to a hospital for observation, and she and the unborn baby were both reported to be OK, said Sgt. Anthony Repalone, a Nassau County police spokesman. Four or five other people suffered minor injuries, he said.
Ellen Davis, a spokeswoman at National Retail Federation, said the group knew of no other incident where a retail employee has died working on the day after Thanksgiving.
Wal-Mart is working closely with police, company spokesman Dan Fogleman said.
"The safety and security of our customers and associates is our top priority," Fogleman said. "Our thoughts and prayers are with them and their families at this difficult time."
http://news.yahoo.com/s/ap/20081128/ap_on_re_us/wal_mart_death
micro
Next ASH and ASCO both in Florida? How boring!
micro
>>It may be time to construct a table of drug/biotech companies who have not had a layoff in the past 18 months. Off the top of my head, I cannot think of many.<<
To my knowledge, 4 of the 5 drug/biotech companies I follow have not had a layoff in the past 18 months: HGSI, INCY, ONXX, GERN.
(BTW - just because I follow a company, it doesn't mean I own it or am bullish about it!)
micro
>>I wonder if anyone has a list of public (I imagine private are hard to come by) companies with products in Phase 3 or beyond who don't have the resources to bring the product to market.<<
That list would probably have a significant overlap with the list of public companies with products in Phase 3 but none on the market.
I.e. pick a typical Phase 3 stage company and it is likely to be hundreds of millions of dollars away from reaching the market with its own sales force - even just its own U.S. sales force. Most Phase 3 stage companies probably don't have that much cash (example: DNDN) - and most of those that do probably have a lot of convertible debt coming due - convertible debt which (thanks to the market crash) is now very unlikely to convert into shares (example: HGSI).
micro
>>Even though Bayer exclusively funded the clinical development in Japan, a 7% royalty rate seems unduly low. I suppose this is the price for ONXX’s having inked favorable economic terms elsewhere in the world.<<
I don't know how that came about, but it might have had something to do with the great difficulty of getting a drug approved in Japan. In fact a separate Phase 3 trial in liver cancer had to be carried out in Asian patients because (as you noted) they are more likely to have HBV rather than HCV. I don't know if Onyx contributed to the cost of that study, but they certainly didn't contribute to the registration and marketing expenses in Japan.
What I find amusing is that at the time Bayer and Onyx signed their agreement, nobody had any clue that the great majority of Nexavar's revenues (unless maybe they get approval in lung cancer at sometime in the future) would come from liver cancer which is HUGE in Japan! Presumably Bayer is happy how that turned out ...
micro
>> ONXX buys (likely) crap pre-clinical drug:
[I personally hate these "value-added" versions of long standing small molecule drugs. <<
If it really does get preferentially taken up by tumor cells through their overexpressed alpha-folate receptor, the drug may turn out to be quite a bit better than the thymidylate synthase inhibitors already in use (including pemetrexed and 5 fluorouracil). What bothers me is that BTG International decided quite some time ago NOT to take this drug into Phase I.
Companies rarely take their less promising drugs forward and leave their most promising drugs behind. So for THAT reason I agree with you that BGC 945 is probably crap.
Another issue is that Onyx has been hanging on Bayer's coattails for too long. I'm not convinced that they have the expertise to take drugs from preclinical through INDs and early-stage clinical trials.
micro
>>
>Is 2009 going to be the year for bios?<
Could well be. The tailwind is in place:
1. Big Pharma are sitting with huge cash hoards on their balance sheets earning a paltry after-tax interest.
[etc.]
<<
But in 2009 there will likely be a large number of extremely cash-desperate biotechs with horribly depressed stock prices and difficulty accessing the credit markets.
If they can avoid bidding wars, Big Pharma can pick these off for pennies on the dollar.
Or at most dimes on the dollar ...
micro
>>The AstraZeneca financed study, known as Jupiter, enrolled more than 15,000 basically healthy people with modest amounts of bad cholesterol (the average LDL level was 104), but high levels of a common marker of inflammation [CRP].
Researchers aimed to see whether Crestor lowered the risk of major cardiovascular events such as heart attack and stroke; the study was stopped early in March because of “unequivocal” benefits for patients who received the drug, but the full results have yet to be released [#msg-28053790].<<
Could it be that CRP had nothing to do with it - i.e. that Crestor's efficacy was due to simply lowering LDL to an even safer level? Many now advise reducing LDL to below 70. Only below about 70 does the amount of plaque actually decrease rather than increase more slowly.
At least that's what I read somewhere ...
micro
ONXX
>>No—only the US was broken out (26% of total sales).<<
Onyx also broke out Japan - but only in dollars.
U.S.: $48M
Japan: $12.746M
Worldwide: 121M euros or ~$181.5M
After Japan provides approval and reimbursement in HCC, they may well generate more sales than the U.S., because Japan has ~3 times as many liver cancer cases as the U.S. However Onyx only gets a 7% royalty from Japan.
micro
ONXX
>>Why is the sales uptake so much slower in the US than in Europe?<<
As pgs indicated, liver cancer is a relatively rare indication inside the U.S. but is much more prevalent in Europe and Asia.
Nexavar is approved in kidney and liver cancer, but is losing ground in the former while still ramping up in the latter (where there is no other approved systemic therapy).
micro
>>Friend is not always right, of course; for instance, he was the impetus behind MRK’s collaboration with Geron which has come up empty.<<
Merck only this month took a telomerase vaccine into the clinic. They licensed the target (hTERT) from Geron - which cost them very little so far. The vaccine platform is their own.
In addition they paid all of $1M for an option to inlicense Geron's vaccine platform to use with the telomerase target, but they let that option lapse w/o exercising it.
I would say that Merck & Friend risked little in the Geron collaboration, and it is too early to say they came up "empty".
micro
>>
>CEGE – With the termination of this trial, is there any value left in CEGE for a potential merger/buyout?<
microcapfun, who knows a lot more about CEGE than I do, evidently thinks the answer is not much
<<
Not exactly. I was basically saying that liquidation would be the best way to return some value to shareholders - if there still are any out there.
If the company can continue to buy back the convertible debt at a discount, if they liquidate/monetize all assets, if they are able to sublet all their property at a reasonable rate, and if they then give all the remaining cash to shareholders ... the result could be *much* more than the ~$0.10/share that the stock is presently trading at.
More likely Sherwin will hang onto the reigns for dear life and play the roll-the-dice biotech game for a few more years until all the cash is gone.
But it isn't clear at this point.
It is interesting that with Sherwin at the reigns, CEGE has taken up and dropped many programs over the past 20 (!) years - including a treatment for HIV and another for hemophilia. Failures are nothing new for the company. (Obvious understatement.) Neither of their present products, GVAX (dead now) or their oncolytic virus in Phase 1, originated at CEGE. Both were inlicensed.
If several years ago Cell Genesys had sold GVAX and kept Abgenix, CEGE shareholders could have done very well.
Of course Sherwin did the exact opposite ...
Starting over would be nothing new for Sherwin. The BOD has little skin left in the game, so liquidation appears unlikely. But given the company's present situation it makes the most sense as an endgame.
Time will tell.
micro
Iceland
Great word choice!
>>As Iceland nationalized a second big bank and abandoned a brief attempt at pegging its tumbling currency, Britain and the Netherlands sought to protect hundreds of thousands of their savers who have money in frozen Icelandic bank accounts.<<
micro
>>So while Obama hopes his "tax the rich" policy will cover his new plans they won't even come close. The tax the rich policy very well could pay for his yearly rebate program but that leaves his education and healthcare programs unfunded. He'll need to produce another "bad guy" and go after them.<<
Obama may be faced with the same sort of situation that Clinton faced when he took office. Out of control deficits from too much spending by the previous administration. His response may be the same. Give up on most grandiose plans and cut spending to reduce the deficit and thereby lower interest rates.
If history repeats we might hope for a positive market response in a few years and surpluses by ~2014 ...
A couple decades ago, the Democrats deserved their bad rap of spending too much. But since then, it has been the Republicans who have spent too much - and then left horrible financial messes for the Democrats to clean up.
micro
>>Even better is if the holders convert and are unable to resell, which is now the case.<<
It would require something as severe as hanging up the Noteholders by their testicles to compell them to convert at $11.22 now, with the stock price at $4.41. Forbidding them from reselling would not seem to be quite as persuasive ...
Are you suggesting that Incyte is attempting to get the Noteholders to convert at the present stock price???
I'm lost.
micro
>>INCY – The converts may be converted into common $11.22/sh at any time.<<
But only after the stock rises above $11.22 for a certain period of time, right? And should that happen, Incyte would love to convert those Notes - which would make it easier for them to raise more cash.
So sorry if I am being dense, but I don't understand how you've addressed the reason for this filing, Dew.
>>DEREGISTRATION OF UNSOLD SECURITIES<<
http://www.sec.gov/Archives/edgar/data/879169/000110465908061495/a08-24536_1posam.htm
micro
>>The motive is to prevent resale of common shares derived from conversion of the convertible notes.
Really? There should be no conversion prior to February 2011.
micro
INCY
Speaking of which ... is this at all unusual??
>>DEREGISTRATION OF UNSOLD SECURITIES
On November 21, 2006, Incyte Corporation (the “Company”) filed its registration statement on Form S-3 (File No. 333-138866) (the “Registration Statement”) covering $151,800,000 aggregate principal amount of 3½% Convertible Subordinated Notes due 2011 (the “Notes”) and the 13,531,224 shares of the Company’s common stock, $.001 par value (“Common Stock”), issuable upon conversion of such Notes to be sold by certain selling securityholders of the Company. On December 8, 2006, the Securities and Exchange Commission (the “Commission”) declared the Registration Statement effective.
Pursuant to Rule 477 promulgated under the Securities Act of 1933 and the Company’s undertaking in Item 17 of Part II of this Registration Statement, the Company respectfully requests that the Commission withdraw the Registration Statement, including all amendments and exhibits thereto, with respect to the unsold portion of securities registered thereon. The Registration Statement was filed in order to register the Notes issued to purchasers in a private placement in September 2006 and the shares of Common Stock into which the Notes are convertible.
The Company is requesting the withdrawal of the Registration Statement because, pursuant to the terms of the Registration Rights Agreement between the Company and the initial purchaser of the Notes, the Company’s obligations to maintain the effectiveness of the Registration Statement under the Registration Rights Agreement have expired.
The Company hereby de-registers the Notes, and shares of its Common Stock into which the Notes are convertible, registered pursuant to the Registration Statement that remain unsold thereunder.<<
http://www.sec.gov/Archives/edgar/data/879169/000110465908061495/a08-24536_1posam.htm
Is the proper interpretation that the company wants to stop the price of these Notes from continuing on a downward plunge?? Would there be any other motive for bothering to de-register these converts?
The Notes are convertible at $11.22/share on 2/15/11, and the stock price is presently $7.41, down from $10.36 a month ago. I don't know the most recent trading price for the Notes.
micro
>>INCY - Microcap??
What's your opinion on the recent released Psoriasis data? tia<<
Answer:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=9458&tid=13580&mid=13589&tof=14&frt=2
That said, I think JAK inhibitors are likely to be a huge drug class with possible applications ranging from myeloproliferative diseases to certain cancers to RA (and maybe even psoriasis!), and I think Incyte will end up with a significant share of the JAK inhibitor markets if they don't screw up.
micro
O/T >>p.s. Your incessant railing against the WSJ is tiresome<<
Only the Editorials and Opinions pages. I read and enjoy the rest of the WSJ.
Hopefully you would say the same about the NYT (????).
micro
>>
>what is your favorite drug in development so far, in terms of blockbuster potential?<
I’ll offer three answers—one for each phase of development. My picks are based on the probability of regulatory approval, the size of the addressable market, and the competition.
Phase-3: Telaprevir
Phase-2: M118
Phase-1: IDX899
JMHO, FWIW
<<
Phase-2: INCB18424
But then I probably follow less than 10% of the drugs that Dew does.
micro
>>Feuerstein also thinks Biopure is a piece of crap. I think he is right and biased.<<
What a surprise.
micro
Feuerstein
>>IF any tangible subscriber revenue were to fall in his lap, it would only serve to empower this schemer to more effectively execute his agendas with varous hedge funds.<<
I keep seeing this claim that Feuerstein is a "hedge fund shill", but I haven't seen one shred of evidence for it. I only read his free stuff, but in nearly every case where he has commented on a company I follow closely, I basically agreed with him, whether he was positive or negative. I agree with Dew that he often is a bit fuzzy on the details, but he has a great rolodex. From my limited experience, he seems to get the big picture right nearly every time, and occasionally he hears something that isn't yet public and reports it - accurately.
I can only guess that you (its_the_oxygen) are so down on Feuerstein because he said something uncomplimentary about this $8M company ...
http://finance.yahoo.com/q/bc?s=BPUR&t=5y&l=on&z=m&q=l&c=
micro
>>This is an extraordinarily bad idea, IMO, but it figures that the New York Times would propose such a thing in an editorial.<<
And here I thought that the Wall Street Journal had a monopoly on extraordinarily bad editorials ...
micro
GVAX, GRN163L
>>The alternative argument promulgated on some message boards—that GVAX expedited the demise of cancer patients by working “too well” in upregulating the immune system—strikes me as a bit far-fetched.<<
That reminds me of a couple of cases where early-stage oncology trials with disappointing results were interpreted by message-board faithfuls to be due to tumor lysis syndrome and therefore indicating that ... THIS DRUG IS GOING TO BE A BLOCKBUSTER!
In the case of Geron's telomerase inhibitor, GRN163L, management actually encouraged such an interpretation. One of the first clinical trial participants exhibited severe side effects, which management claimed were "consistent with tumor lysis syndrome". About that time the CEO began to use the word "cure" instead of cancer "treatment" or "therapy", when talking about GRN163L. But after several cases of severe thrombocytopenia, repeated lack of tumor shrinkage, and no telomerase inhibition (!), use of the word "cure" was discontinued ...
163L has been in multiple clinical trials for 3 years now, and there has still been no evidence of PD let alone clinical efficacy. Most bizarre, after being repeatedly unable to see evidence of telomerase inhibition of their telomerase inhibitor in CLL cells extracted from clinical trial patients, they announced they would start looking in normal hair follicles instead. Still no evidence, apparently, but the trials continue ...
Apologies if this post turned into a rant.
micro
>>Yet Another “Cheap Dollar” Buyout<<
Is the end near?
http://www.forecasts.org/images/exchange-rate/euro.gif
I think bio buyouts have been fueled by three things: 1. Big Pharma pipeline problems. 2. Cheap dollar. 3. Big Pharma cash hordes.
The first is still providing strong impetus, but the dollar is becoming less cheap and maybe Pharmas are beginning to deplete their cash.
Comments?
micro
>>CEGE was testing GVAX for the last 10-14 years. It has never shown positive data.<<
That's not true. For example 3 of the first 7 pancreatic cancer patients in a Phase I GVAX trial were still alive and disease free 8 years later. Also 3 of 33 lung cancer patients exhibited complete responses with GVAX, although I believe all 3 eventually relapsed. 5 of 19 CLL patients with persistent disease after long-term Gleevec achieved complete molecular responses after GVAX was added to Gleevec.
The problem is that Cell Genesys has never been able to replicate results like that. The follow-up Phase 2 pancreatic cancer trial with 60 patients had a Kaplan-Meier curve which started out looking good but then went *below* the historical comparison. (That was with GVAX added to surgery, chemo AND radiation!) The follow-up lung cancer trial was a complete failure. The CLL trial hasn't been followed up yet.
I don't understand the reason for these follow-up failures, but shame on CEGE for never doing randomized Phase 2 trials prior to moving to Phase 3. In fact Vital-2, the randomized Phase 3 trial which was just halted, had no Phase I or II precursor at all! In other words GVAX was NEVER used in combination with taxotere in a Phase I or II trial prior to Vital-2. I am amazed that the FDA went along with the Phase 3 trial, but I guess they figured GVAX was so innocuous, that adverse events weren't an issue. After the 67 vs 47 deaths result, even if that does turn out to be a statistical fluctuation, I suspect the FDA is going to always demand combination therapies be tried prior to Phase 3.
micro