Hi all,
Where to begin tonight? I have to admit I am a little glum, just from the share price point of view. Elan presented the detailed results from their Phase II trial tonight at ICAD – the International Conference on Alzheimer’s Disease – this is one of the two largest AD symposiums in the world (other one is the AAN). In June they had released summary results and by all indications it was a total success.
The trial was for their drug AAB-001 and involved 240 patients. 4 different doses were given, and half got the drug and half got placebo. So really, 30 people got the drug at each dose. Overall, they missed statistical significance on both the cognitive and functional endpoints for the study.
So why do I say it was a success?
First, Phase II trials are still mostly concerned with safety and determining dosing strength, and secondarily with efficacy. After looking through the results, they discovered that the non-carriers of a certain gene (APOe4) got statistically significant cognitive AND functional results from the drug, and even the carriers “trended” towards significance. Carriers of that gene, by the way, have already been proven to be a higher risk to develop AD, so it is not just out of left field to latch on to that subgroup.
How about safety? The largest problem for the carrier group at the highest dose was vascular edema (VE), which is a temporary swelling of the brain. None of the 12 affected patients were harmed and all recovered AND continued in the trial at a lower dose. However, because they “switched” mid-trial, their results were not counted, which hurt the overall trial – 12 extra patients in the denominator but not counted in the numerator! Add to that, the lowest dose was also found in the Phase 1 results to not have much if any impact, but they stayed with that dose in the Phase II trial to confirm – another 30 patients who really did not count except to hurt the overall study.
Yet even with those hiccups, they STILL found significant improvement over placebo in the non-carrier group.
Elan started a Phase III trial last December – 4000 patients worldwide; 2000 in the US and 2000 in Europe. Each of these have 1000 carriers and 1000 non-carriers, so even with the carrier reactions, they still saw enough significance to have them be half of the participants! This is an 18 months trial, again with both cognitive (measurement of mental decline) and functional (how do they actually function in the real world) endpoints.
So – tonight.
They gave all this and the actual numbers and P-values (basically the probability that the result achieved was real and not just a fluke) and some extra safety info. 3 patients given the drug died. Sounds bad, but the trial doctors were all unanimous in that the drug had no affect on those deaths – if they were mugged, they’d still be reported as having died during the trial. Yet the very first headline I saw from Reuters was that “Patients died in Elan’s Alzheimer’s trial”.
The share price was around $34 and sank during after-hours trading down to $23.
The CEO will be speaking right after market open tomorrow on CNBC, and I hope to hear something about pricing and when they might potentially file for an early FDA approval. If not, we may see low $20s for awhile.
All that said, I am still a staunch supporter. I think the drug works, (and with a medium strength dose even for the carriers) and in the worst case there is only 20 or so months for the trial to end. Even if only the non-carriers get approved, that is still tens of billions of profit, which would make it the best selling drug ever, by multiples.
Even without AAB-001, they have Tysabri and their nanotechnology drug delivery unit, which combined would value the company at around $35 per share. They still have a world class pipeline with other drugs for AD, Parkinson’s disease, and diabetes.
I think this is a world-class buying opportunity.
Regards,
Trond
Showing posts with label Alzheimer's Disease. Show all posts
Showing posts with label Alzheimer's Disease. Show all posts
Tuesday, July 29, 2008
Wednesday, June 25, 2008
Websites
The time has come for me to explain why I placed some additional websites off to the side.
In no particular order...
The BMW Method:
No, this is NOT the car. Back when I read the Motley Fool and subscribed to its message boards (oh -- back in the good ol' days before they became a newsletter driven rag... *grin*) the BMW Method board was my favorite hangout.
(The New Paradigms board was good too -- that was where I first heard mention of Dendreon)
Here's another link that explains the methodology (http://bmwmethod.com/about.php) but in a nutshell, BMW observed how the CAGR (Compound Annual Growth Rate) of large, stable, well-managed companies tends to stay at a historical average over long periods of time. The price in the short term fluctuates wildly -- both to the high side and to the low. Using his graphs, it is visually VERY clear to see when a stock is at a compelling buy price, and likewise, when it may be time to sell.
Note - this is NOT charting or technical analysis -- but simply taking the idea of buying low and selling high into a framework of how a company is performing right now.
As an example, the Tylenol scare from Johnson & Johnson would have seen the stock price far below the long term CAGR curve... and after a little due diligence to see that the company's response was a logical and good move, and that the rest of the company's product sales were unaffected, a buy would have been in order. One wonders how some of the present day banking stocks appear on the graphs right now... but I personally would hold off for a couple more months on these financial-type stocks as I think we have some more pain and possibly consolidation to endure first.
Investor Village:
Yes, this is a stock message board. It comes with the obligatory warning that you encounter all sort of rude and idiotic posters, along with obviously paid shills to either pump or pan the stocks. But for all that, you can meet some truly amazing thinkers, scientists, and satirists.
Rule of thumb: when you read the posts on a stock board, do not post yourself for a while; absorb the interactions of the prolific posters and their styles. You don't have to copy them -- but at least understand who are the well known people. If you disagree with someone popular just to have fun, you will probably start a flame war and have people put you on ignore. Yes, it's high school all over again, and things frequently degenerate into stupid arguments.
On the plus side, you will learn some amazing things. Two of the boards I frequent are the Elan and Dendreon boards. I, who if the truth be known, abhored the life sciences in school, have learned much about Multiple Sclerosis, Alzheimer's Disease, and prostate cancer -- and can speak fairly fluently about those ills and the method of action (MOA) of various drugs to treat them. I know how FDA clinical trials are designed, and what kinds of statistical bars are set for them. And, I truly *enjoy* talking about those kinds of things now.
Of course you still have to do your own due diligence, but you can also learn things about the companies you follow that are not really a part of any news item you might read until the stock price has already reacted. For example, the Elan board dissected everything known about the Phase II Alzheimer's trial results (that were released in mid June) and in the majority, hit nearly every major aspect of the summary results squarely on the head -- which in turn meant that those who understood it would most likely be good news were already buying more shares before the release.
(It's no secret that the board consensus is that the full results to be released at the end of July are going to be stellar and bring the stock to even new heights)
As further examples, from the Elan board I have learned that the company has nearly $3 BILLION in losses over the last few years that they can use to write down future profits, meaning enormous tax savings.
And that Ireland treats royalty income ... (*ahem*) ... royally when it comes to taxes -- and they constructed their Tysabri contract with Biogen so that non-US sales are all treated as royalties.
And that they have the ability to simply say, "Now" to Eli Lilly and from that point on, they get to share 50% in costs and revenues for a different, gamma secretase-based Alzheimer's treatment that looks to be very promising also.
On the IV message boards, there are a number of nice features. You can sort by the "most recommended" posts so that you see the truly GOOD posts first and do not have to wade through fluff. You can ignore idiotic posters so that you don't even see their posts. It's easy to add boards and navigate around the site.
I am going to skip a number of people who deserve a mention, but if you look at the Elan board, look for posts from Liposghost, Jivetalkin, Doodah, Pinvestment, and OKZ. On the Dendreon board, Ocyan is the king of the science, and MingtheMerciless is worth reading for his sense of humor.
Marketocracy:
This one is easy and short -- you can create your own virtual mutual fund. To be ranked, you have to follow some simple rules that professional money managers have to follow too -- and here's the kicker: the 100 best portfolio managers actually get paid by the site, which has its own mutual funds based off those portfolios. Fun!
Frugal Upstate:
I've plugged this before, but this blog is written by one of my best friends, who happens to have a wonderful site about living frugally. The point isn't to *not* spend money, but to choose what you are spending your money on, and to enable the lifestyle where you can afford the things you truly want.
The Sanity Check and Deep Capture:
I actually think Deep Capture should be required reading before investing money in individual stocks. I don't want to sound like a conspiracy theorist, but it is totally obvious to me that hedge funds are an enormous threat to small companies, and especially biotechs. The ability to "sell short" shares of a company -- regardless of whether it is "naked shorting" or legal -- caps the stock price of companies that you and I invest in. The SEC and some of the media are unwilling to look at some of the facts and do their job.
Here are a couple examples:
The company Taser has about 60 million registered shares. At a recent annual meeting -- 80 million votes were cast.
Another company, (and the name escapes me at the moment) had one investor buy up the number of registered shares. He watched in amazement as thousands of shares continued trading on the open market over the next few weeks.
... And yet, total silence on the part of the media, Deeply Captured...
The Sanity Check is a blog by the anonymous tipper (called Bobo) who alerted Overstock CEO Patrick Byrne to the naked shorting campaign against his company, and who figures prominently in the Deep Capture story.
Please -- read Deep Capture for yourself and let me know what you think!
Regards,
Trond
In no particular order...
The BMW Method:
No, this is NOT the car. Back when I read the Motley Fool and subscribed to its message boards (oh -- back in the good ol' days before they became a newsletter driven rag... *grin*) the BMW Method board was my favorite hangout.
(The New Paradigms board was good too -- that was where I first heard mention of Dendreon)
Here's another link that explains the methodology (http://bmwmethod.com/about.php) but in a nutshell, BMW observed how the CAGR (Compound Annual Growth Rate) of large, stable, well-managed companies tends to stay at a historical average over long periods of time. The price in the short term fluctuates wildly -- both to the high side and to the low. Using his graphs, it is visually VERY clear to see when a stock is at a compelling buy price, and likewise, when it may be time to sell.
Note - this is NOT charting or technical analysis -- but simply taking the idea of buying low and selling high into a framework of how a company is performing right now.
As an example, the Tylenol scare from Johnson & Johnson would have seen the stock price far below the long term CAGR curve... and after a little due diligence to see that the company's response was a logical and good move, and that the rest of the company's product sales were unaffected, a buy would have been in order. One wonders how some of the present day banking stocks appear on the graphs right now... but I personally would hold off for a couple more months on these financial-type stocks as I think we have some more pain and possibly consolidation to endure first.
Investor Village:
Yes, this is a stock message board. It comes with the obligatory warning that you encounter all sort of rude and idiotic posters, along with obviously paid shills to either pump or pan the stocks. But for all that, you can meet some truly amazing thinkers, scientists, and satirists.
Rule of thumb: when you read the posts on a stock board, do not post yourself for a while; absorb the interactions of the prolific posters and their styles. You don't have to copy them -- but at least understand who are the well known people. If you disagree with someone popular just to have fun, you will probably start a flame war and have people put you on ignore. Yes, it's high school all over again, and things frequently degenerate into stupid arguments.
On the plus side, you will learn some amazing things. Two of the boards I frequent are the Elan and Dendreon boards. I, who if the truth be known, abhored the life sciences in school, have learned much about Multiple Sclerosis, Alzheimer's Disease, and prostate cancer -- and can speak fairly fluently about those ills and the method of action (MOA) of various drugs to treat them. I know how FDA clinical trials are designed, and what kinds of statistical bars are set for them. And, I truly *enjoy* talking about those kinds of things now.
Of course you still have to do your own due diligence, but you can also learn things about the companies you follow that are not really a part of any news item you might read until the stock price has already reacted. For example, the Elan board dissected everything known about the Phase II Alzheimer's trial results (that were released in mid June) and in the majority, hit nearly every major aspect of the summary results squarely on the head -- which in turn meant that those who understood it would most likely be good news were already buying more shares before the release.
(It's no secret that the board consensus is that the full results to be released at the end of July are going to be stellar and bring the stock to even new heights)
As further examples, from the Elan board I have learned that the company has nearly $3 BILLION in losses over the last few years that they can use to write down future profits, meaning enormous tax savings.
And that Ireland treats royalty income ... (*ahem*) ... royally when it comes to taxes -- and they constructed their Tysabri contract with Biogen so that non-US sales are all treated as royalties.
And that they have the ability to simply say, "Now" to Eli Lilly and from that point on, they get to share 50% in costs and revenues for a different, gamma secretase-based Alzheimer's treatment that looks to be very promising also.
On the IV message boards, there are a number of nice features. You can sort by the "most recommended" posts so that you see the truly GOOD posts first and do not have to wade through fluff. You can ignore idiotic posters so that you don't even see their posts. It's easy to add boards and navigate around the site.
I am going to skip a number of people who deserve a mention, but if you look at the Elan board, look for posts from Liposghost, Jivetalkin, Doodah, Pinvestment, and OKZ. On the Dendreon board, Ocyan is the king of the science, and MingtheMerciless is worth reading for his sense of humor.
Marketocracy:
This one is easy and short -- you can create your own virtual mutual fund. To be ranked, you have to follow some simple rules that professional money managers have to follow too -- and here's the kicker: the 100 best portfolio managers actually get paid by the site, which has its own mutual funds based off those portfolios. Fun!
Frugal Upstate:
I've plugged this before, but this blog is written by one of my best friends, who happens to have a wonderful site about living frugally. The point isn't to *not* spend money, but to choose what you are spending your money on, and to enable the lifestyle where you can afford the things you truly want.
The Sanity Check and Deep Capture:
I actually think Deep Capture should be required reading before investing money in individual stocks. I don't want to sound like a conspiracy theorist, but it is totally obvious to me that hedge funds are an enormous threat to small companies, and especially biotechs. The ability to "sell short" shares of a company -- regardless of whether it is "naked shorting" or legal -- caps the stock price of companies that you and I invest in. The SEC and some of the media are unwilling to look at some of the facts and do their job.
Here are a couple examples:
The company Taser has about 60 million registered shares. At a recent annual meeting -- 80 million votes were cast.
Another company, (and the name escapes me at the moment) had one investor buy up the number of registered shares. He watched in amazement as thousands of shares continued trading on the open market over the next few weeks.
... And yet, total silence on the part of the media, Deeply Captured...
The Sanity Check is a blog by the anonymous tipper (called Bobo) who alerted Overstock CEO Patrick Byrne to the naked shorting campaign against his company, and who figures prominently in the Deep Capture story.
Please -- read Deep Capture for yourself and let me know what you think!
Regards,
Trond
Tuesday, June 17, 2008
Alzheimer's relief?
Well, vindication is sweet.
I've been singing Elan's praises for over 2 years now -- starting at around $13 a share in early 2006. (Too bad I didn't see it in 2005 for $3 a share!!!)
If you haven't seen the news (although early news items were unwarrantably negatively slanted) one of the more even-handed articles is shown as a link below.
http://www.reuters.com/article/marketsNews/idINL1769229220080617?rpc=44
If you don't want to wait for it -- basically Elan's Phase II Alzheimer's Disease trial results (the summary info, at least) were released today -- full details will be released at the ICAD meeting in late July. (ICAD is the International Conference on Alzheimer's Disease).
Those results show that based on a gene, you could be helped a great deal by this drug, called AAB-001. People who do NOT carry the APOE gene had improvements in cognition (on two different scales) and also improvements in daily function. The gene carriers did not meet statistical significance. That isn't the whole story, either, as some who carry the gene encountered Vasogenic Edema -- temporary swelling within the brain -- and left the trial, which hurt the trial as they still counted against the participants in the study.
Elan had seen interim data last summer and based off that peek, started a Phase III trial which kicked off December of 2007.
That Phase III trial has two cohorts with carriers and two cohorts with non-carriers (one of each in the US and one external to the US). Each cohort has 1000 patients expected to be enrolled -- and the carrier group has a lower dosing amount scheduled to see if that helps the VE.
Largely unknown at this point, all cohorts are EACH powered to be a pivotal trial by the FDA, and after 6 months of safety data, Elan could file a BLA (biologic license application) for the drug.
I have several other points about Elan (Tysabri, nanotechnology, $3B of losses to carry forward, Ireland's favorable tax treatment of royalty income, multiple other Alzheimer's treatments in the works) but for now -- I truly hope for AD patients that this moves forward, and quickly.
This post is dedicated to my maternal grandfather, Carl H. Carlson, who suffered from Alzheimer's.
Regards,
Trond
I've been singing Elan's praises for over 2 years now -- starting at around $13 a share in early 2006. (Too bad I didn't see it in 2005 for $3 a share!!!)
If you haven't seen the news (although early news items were unwarrantably negatively slanted) one of the more even-handed articles is shown as a link below.
http://www.reuters.com/article/marketsNews/idINL1769229220080617?rpc=44
If you don't want to wait for it -- basically Elan's Phase II Alzheimer's Disease trial results (the summary info, at least) were released today -- full details will be released at the ICAD meeting in late July. (ICAD is the International Conference on Alzheimer's Disease).
Those results show that based on a gene, you could be helped a great deal by this drug, called AAB-001. People who do NOT carry the APOE gene had improvements in cognition (on two different scales) and also improvements in daily function. The gene carriers did not meet statistical significance. That isn't the whole story, either, as some who carry the gene encountered Vasogenic Edema -- temporary swelling within the brain -- and left the trial, which hurt the trial as they still counted against the participants in the study.
Elan had seen interim data last summer and based off that peek, started a Phase III trial which kicked off December of 2007.
That Phase III trial has two cohorts with carriers and two cohorts with non-carriers (one of each in the US and one external to the US). Each cohort has 1000 patients expected to be enrolled -- and the carrier group has a lower dosing amount scheduled to see if that helps the VE.
Largely unknown at this point, all cohorts are EACH powered to be a pivotal trial by the FDA, and after 6 months of safety data, Elan could file a BLA (biologic license application) for the drug.
I have several other points about Elan (Tysabri, nanotechnology, $3B of losses to carry forward, Ireland's favorable tax treatment of royalty income, multiple other Alzheimer's treatments in the works) but for now -- I truly hope for AD patients that this moves forward, and quickly.
This post is dedicated to my maternal grandfather, Carl H. Carlson, who suffered from Alzheimer's.
Regards,
Trond
Wednesday, May 28, 2008
Port 24 Addition
Hi all,
Newest addition to the portfolio is Wyeth. Buy 300 WYE @ $44.06 and sell 3 WYEFI (JUN08 $45) for $1.10.
Wyeth is a huge pharma company with a finger on many different biotechs. I am primarily interested in them because of their collaboration with Elan on their Alzheimer's drug AAB-001 that will have their Phase II results released this summer. Added plus -- Wyeth has a decent dividend too!
Leaves us with:
2000 SUPG (-20), 2000 NBIX (-10), 400 ELN (-2), 2000 DNDN (-10), 1200 TASR (-12), 2000 ARNA (-20), 300 WYE (-3)
Cash = $35660.71
Total account = $102,078 and a 2.08% return so far since mid-May 2008.
Tomorrow: some extra info on covered calls -- and how to make this strategy even safer (I know I tend to go for the volatile small caps and biotechs).
Regards,
Trond
Newest addition to the portfolio is Wyeth. Buy 300 WYE @ $44.06 and sell 3 WYEFI (JUN08 $45) for $1.10.
Wyeth is a huge pharma company with a finger on many different biotechs. I am primarily interested in them because of their collaboration with Elan on their Alzheimer's drug AAB-001 that will have their Phase II results released this summer. Added plus -- Wyeth has a decent dividend too!
Leaves us with:
2000 SUPG (-20), 2000 NBIX (-10), 400 ELN (-2), 2000 DNDN (-10), 1200 TASR (-12), 2000 ARNA (-20), 300 WYE (-3)
Cash = $35660.71
Total account = $102,078 and a 2.08% return so far since mid-May 2008.
Tomorrow: some extra info on covered calls -- and how to make this strategy even safer (I know I tend to go for the volatile small caps and biotechs).
Regards,
Trond
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