Well, I am going to cheat and basically cut & paste an email I just sent to a few folks:
Dendreon:
Here we go!! We’ll know the final results by the 28th at the latest. We’re at $6.30 now and it’ll be:
a repeat of 2007, going to $20 or so (on a statistically significant results)
bouncing around between $4 and $10 (if the results are very close to stat sig – they’ve indicated they will refile anyways, if this happens)
drop to $1 or so (if a large miss). I do not see this happening at all because 6 months ago the interim already showed a 20% reduction of risk of death from the drug – and they only need a 22% reduction at the final.
I personally think it’ll be a pretty good result. If we see $20+, you may want to sell half of what you have and let the rest stay for approval.
Elan:
Earnings call are coming up -- BIIB on the 16th and Elan on the 22nd. So we'll know Tysabri numbers. Last known is 37,100 worldwide at the end of 2008. I am actually unsure if this includes the 600 in trials or if it's only commercial? I suspect it is total, as all other reports show it that way.
IF we return to close to 200/week net adds, this would be about 2,400 new patients and put us just shy of 40K. So I view anything north of 40K as pretty spectacular. One thing to keep in mind is that the EU is pretty fragmented and each county has to approve Tysabri and the insurance costs individually. So uptake is slower but starts gathering steam a few quarters after each country finally approves it. We're close to snowballing territory, I think ... may be 1 or 2 more quarters though.
AAB-001 - probably no news. More details of how they are approaching the 2 mg dose of non-carriers that they dropped, but that is just noise. I don't expect anything until end of this year, IF they take an interim and it's good. Still remotely possible that they file a BLA at the end of the year based on the non-carrier phase II results and 6-9 months safety data from the III. I doubt this now, as the dropped 2 mg group was because of vascular edema. Too much safety noise and the 2.0 mg group taken out would be post-hoc. Bummer!
Sale of the company? Partial sale? I don't think they'd release that at an earnings call. I unfortunately still think we'll see a buyout before years end simply because the market cap is too attractive.
I bought more last week at $5.67. It may bounce around but I don’t think it’ll go lower than $4, and I think we’ll start seeing it go up again IF Tysabri numbers start increasing at an increasing rate again (which I view as likely).
Regards,
Trond
Showing posts with label AAB-001. Show all posts
Showing posts with label AAB-001. Show all posts
Friday, April 10, 2009
Thursday, April 2, 2009
Elan and follow up to my volatility trade
Two things tonight:
Elan and Wyeth announced that they are dropping the 2 mg dose in the non-APOE4 gene carrier cohorts of the Alzheimer's Disease drug bapineuzimab (AAB-001), due to safey concerns relating to vasogenic edema. That was the minor brain swelling they encountered in the Phase II - more so in the carrier group than the non-carrier. They already had made the decision to not include that dosing group in the Phase III carrier group.
What this means is simply that those already dosed will continue in the trial and be randomized into the .5 or the 1 mg groups. This is not really news that should move the stock.
We had a pretty good move in the Nasdaq today ... it went from 30.77 to 31.76, or 3% That was enough to move the options as shown below (new prices are what you could sell the contracts for. If I closed out it would make some money, but not at my target, so it continues!
As an aside, I opened up a real time trade near the end of the day when the QQQQ was at $31.93 -- 3 each of the April $32 calls and puts. I will advise when I close out of this trade.
Strike Date . Strike Price . Type . Contract Price . Sell Price
April . . . . . $30 . . . . . . . . .Call . . . . . . . $150 . . . . . 238
April . . . . . .$31 . . . . . . . .. .Put . . . . . . .. $114 . . . .. 62
May . . . . . .$30 . .. . . . . . Call . . . .. . . .$216 . . . . 298
May . . . . . . .$31 . . . . . .. . . .Put . . . . .. . . $181 . . . . 131
IF I closed out of the April trades now, I would have gained 2*88 on the calls and lost 3*52 on the puts... with commissions it would be pretty much a wash. I really need a full doubling of the profit side to close out successfully. It is also obvious in retrospect that one should strive to made the two sides an equal number of calls vs. puts, as the calls need to gain a larger percentage to offset the 150% as many puts.
In the May series, there is a 2*82 gain and a 3*50 loss, again, nearly a wash. I will hold these.
Regards,
Trond
Elan and Wyeth announced that they are dropping the 2 mg dose in the non-APOE4 gene carrier cohorts of the Alzheimer's Disease drug bapineuzimab (AAB-001), due to safey concerns relating to vasogenic edema. That was the minor brain swelling they encountered in the Phase II - more so in the carrier group than the non-carrier. They already had made the decision to not include that dosing group in the Phase III carrier group.
What this means is simply that those already dosed will continue in the trial and be randomized into the .5 or the 1 mg groups. This is not really news that should move the stock.
We had a pretty good move in the Nasdaq today ... it went from 30.77 to 31.76, or 3% That was enough to move the options as shown below (new prices are what you could sell the contracts for. If I closed out it would make some money, but not at my target, so it continues!
As an aside, I opened up a real time trade near the end of the day when the QQQQ was at $31.93 -- 3 each of the April $32 calls and puts. I will advise when I close out of this trade.
Strike Date . Strike Price . Type . Contract Price . Sell Price
April . . . . . $30 . . . . . . . . .Call . . . . . . . $150 . . . . . 238
April . . . . . .$31 . . . . . . . .. .Put . . . . . . .. $114 . . . .. 62
May . . . . . .$30 . .. . . . . . Call . . . .. . . .$216 . . . . 298
May . . . . . . .$31 . . . . . .. . . .Put . . . . .. . . $181 . . . . 131
IF I closed out of the April trades now, I would have gained 2*88 on the calls and lost 3*52 on the puts... with commissions it would be pretty much a wash. I really need a full doubling of the profit side to close out successfully. It is also obvious in retrospect that one should strive to made the two sides an equal number of calls vs. puts, as the calls need to gain a larger percentage to offset the 150% as many puts.
In the May series, there is a 2*82 gain and a 3*50 loss, again, nearly a wash. I will hold these.
Regards,
Trond
Wednesday, October 29, 2008
The ups and downs of Elan
Right on the heels of good Tysabri news comes another PML case.
A little background -- Tysabri was pulled from the market in 2005 after just a couple months. 3 patients from the clinical trials developed PML -- which is a usually fatal infection in the brain caused by the JC virus. Somewhere around 80%+ of us have the JC virus dormant in our system, yet our immune system usually prevents it from penetrating the blood-brain barrier.
Of those 3 patients, it was eventually determined that one probably had had MS misdiagnosed, and the other two were in Avonex/Tysabri combined trials. Further, the misdiagnosed patient and one of the two combo therapy patients had had prior doses of MS drugs which weaken the immune system dealing with the blood-brain barrier. (Further background -- Elan's marketing partner, Biogen, happened to be the maker of Avonex and pushed the combo therapy trials in the US).
Tysabri is about twice as effective as the next best therapy at keeping MS patients from having relapses. The patients basically stormed the FDA and made it clear they were willing to take the PML risk to keep Tysabri -- see some of the quotes at the end of this post!
In August of 2006 theFDA voted to allow Tysabri back on the market, with VERY stringent protocols (called the TOUCH system) designed to keep patients who had used certain immuno-suppressing drugs previously, off Tysabri until those drugs had been washed out of the system.
The label on Tysabri says that the risk of PML is 1 in 1000. As of June 2008, about 31,000 patients were on it in non-trial prescriptions. In July, 2008, 2 patients in Europe were disclosed to have PML. Elan promptly cratered from $21ish to around $9.
Those two patients, however, are still alive. One is doing quite well and is home; the other not so well and in the hospital still. That one, had had prior immuno-suppressing drugs also though -- Europe was not bound by the TOUCH protocols. There is a new therapy for PML called plasma exchange (plex) that strips the Tysabri out of the body very quickly, which allows the immune system to ramp up immediately against the JC virus.
So now we have a third post-re-entry case -- Elan fell in after hours trading from $7ish to $5.50.
It appears this patient was in monotherapy too -- which actually bodes well for recovery. We now have 5 MS patients who developed PML -- 2 on mono and 3 on combo. This is out of nearly 40,000 total users -- 35,500 after the 3rd quarter results and 4,000 in the prior trials and marketed in 2005. Unless another 30 people develop PML in the next quarter, the risk is MUCH lower than 1:1000 -- and PML is no longer a near-certain death sentence.
Tysabri, at the forward one-year run rate, JUST became a blockbuster ($1B in sales). This case may dampen some demand, but the growth of new patients is still happening. Both companies agree they will have 100K patients on therapy by 2010, even counting in PML risk and dropouts. If acheived, that would lead Elan to a share price of $18 - 25 within 2 years.
That allows for no potential in the rest of the pipeline - and you heard it here -- we have AAB-001 in Phase III that will affect a subpopulation of Alzheimer's patients better than Aricept. We should learn more about that late next year of 2010 also -- and THAT would be a game changer with sales potential in the tens of billions.
Reagrds,
Trond
Tysabri quotes
Quotes and snippets regarding MS patients about Tysabri. These come from editorials, a bulletin board from the National MS Foundation, and from online MS bulletin boards.
Some of the quotes are in bold. These are my emphasis. [Trond]
My sister has had MS for over 2 decades. She has slowly gotten to the point where she is 100% bed ridden and needs a catheter. She can't even sit in a wheelchair any longer.She took TY 3 times and it was a miracle. I witnessed her walking on her own out to her mail box some 75 yards from her house. She could cook, eat on her own, use the bathroom ALONE for the first time in years. She had regained her life, her dignity, her future.
Bartira Tibertius of Chicago … received Tysabri for a full 28 months as part of a clinical trial. "I was doing great. I even forgot that I was sick," Ms. Tibertius, a language teacher and translator, tells us. "But now I'm getting very, very scared. It's deteriorating and I know that," describing numbness and tingling in her hands, arms, feet and face. As for any possible risks from the drug, she says, "I'm more scared of not having Tysabri than having Tysabri. If you told me the Tysabri would shorten 10 years of my life I would do it. I want quality of life, not quantity.">>
Talked to my sister this AM about the Avonex story. Here's her reply & I quote; "How many relapses did I had when I took Avonex? I won't take that crap ever again. I want to go back on Tysabri." End of quote. Avonex is toast.
I was in my neurologist’s office for an appointment late last winter and there were these people there, laughing, acting, and looking as if there wasn’t a care in the world. I thought it was a little odd. Why were they there? There didn’t look sick. During my appointment, my doctor told me that they were in the Tysabri study and had come in for their treatment. I had to stop the interferon because of liver complications. I had to stop the chemotherapy because of heart complications. I now have to take daily injections of Copaxone, since we were out of choices, and the MS is progressing, my doctor suggested Tysabri. It WAS my only choice. I was waiting for our insurance company’s approval the morning I heard it was being suspended. I was looking forward to a monthly treatment instead of daily injections that have unpleasant and painful side effects. I was looking forward to something that might offer more promise in managing this disease. I was looking forward to a treatment that offered hope that I might be able to return to some type of gainful employment. I went on Social Security Disability a few months later. I ended up with worsening symptoms on top of having to manage daily injection site reactions. The MS may have progressed any way, but who knows, it might not have. I sure would have liked a shot at it!
I was diagnosed with MS on April 10, 1996 (our Anniversary). At that time I experienced numbness in both of my feet. After both an MRI and a spinal tap my neurologist was able to confirm my condition. This was not what we wanted to hear but I was prepared to fight with all that was within me. Since that time my condition has progressed. It has affected my vision, my mobility (I struggle to walk with a walker now), my thought process, my speech, I now am incontinent, and am very tired most of the time. My quality of life is not good. My numbness is to my knees in both legs and is affecting my hands. My struggle to walk and my frequent falling is affecting my back (I now have 3 bulging disks) causing me to be in constant pain. I also deal with muscle spasms in both legs daily which also causes me to fall frequently.My neurologist has tried many treatments along the way which include Avonex, Rebif( which was a terrible experience), steroids, and many other drugs for specific symptoms. With all of this help my MS continues to progress with more and more relapses occurring much more frequently now. In Feb. ’05 I was given my first and only infusion of Tysabri. This was the most positive response I had ever had!! My fatigue was nearly eliminated (I did not have to lie down during the day for a month or more), my walking improved, my muscle spasms were gone, the vision problems were resolving, my thought processes greatly improved, my speech returned to normal (even my singing voice returned), the incontinence problem was much improved and there was once again hope for a quality of life.
"If I have to I'll take her to Europe for Tysabri if they approve it before the f**king FDA gets off their ass."
A little background -- Tysabri was pulled from the market in 2005 after just a couple months. 3 patients from the clinical trials developed PML -- which is a usually fatal infection in the brain caused by the JC virus. Somewhere around 80%+ of us have the JC virus dormant in our system, yet our immune system usually prevents it from penetrating the blood-brain barrier.
Of those 3 patients, it was eventually determined that one probably had had MS misdiagnosed, and the other two were in Avonex/Tysabri combined trials. Further, the misdiagnosed patient and one of the two combo therapy patients had had prior doses of MS drugs which weaken the immune system dealing with the blood-brain barrier. (Further background -- Elan's marketing partner, Biogen, happened to be the maker of Avonex and pushed the combo therapy trials in the US).
Tysabri is about twice as effective as the next best therapy at keeping MS patients from having relapses. The patients basically stormed the FDA and made it clear they were willing to take the PML risk to keep Tysabri -- see some of the quotes at the end of this post!
In August of 2006 theFDA voted to allow Tysabri back on the market, with VERY stringent protocols (called the TOUCH system) designed to keep patients who had used certain immuno-suppressing drugs previously, off Tysabri until those drugs had been washed out of the system.
The label on Tysabri says that the risk of PML is 1 in 1000. As of June 2008, about 31,000 patients were on it in non-trial prescriptions. In July, 2008, 2 patients in Europe were disclosed to have PML. Elan promptly cratered from $21ish to around $9.
Those two patients, however, are still alive. One is doing quite well and is home; the other not so well and in the hospital still. That one, had had prior immuno-suppressing drugs also though -- Europe was not bound by the TOUCH protocols. There is a new therapy for PML called plasma exchange (plex) that strips the Tysabri out of the body very quickly, which allows the immune system to ramp up immediately against the JC virus.
So now we have a third post-re-entry case -- Elan fell in after hours trading from $7ish to $5.50.
It appears this patient was in monotherapy too -- which actually bodes well for recovery. We now have 5 MS patients who developed PML -- 2 on mono and 3 on combo. This is out of nearly 40,000 total users -- 35,500 after the 3rd quarter results and 4,000 in the prior trials and marketed in 2005. Unless another 30 people develop PML in the next quarter, the risk is MUCH lower than 1:1000 -- and PML is no longer a near-certain death sentence.
Tysabri, at the forward one-year run rate, JUST became a blockbuster ($1B in sales). This case may dampen some demand, but the growth of new patients is still happening. Both companies agree they will have 100K patients on therapy by 2010, even counting in PML risk and dropouts. If acheived, that would lead Elan to a share price of $18 - 25 within 2 years.
That allows for no potential in the rest of the pipeline - and you heard it here -- we have AAB-001 in Phase III that will affect a subpopulation of Alzheimer's patients better than Aricept. We should learn more about that late next year of 2010 also -- and THAT would be a game changer with sales potential in the tens of billions.
Reagrds,
Trond
Tysabri quotes
Quotes and snippets regarding MS patients about Tysabri. These come from editorials, a bulletin board from the National MS Foundation, and from online MS bulletin boards.
Some of the quotes are in bold. These are my emphasis. [Trond]
My sister has had MS for over 2 decades. She has slowly gotten to the point where she is 100% bed ridden and needs a catheter. She can't even sit in a wheelchair any longer.She took TY 3 times and it was a miracle. I witnessed her walking on her own out to her mail box some 75 yards from her house. She could cook, eat on her own, use the bathroom ALONE for the first time in years. She had regained her life, her dignity, her future.
Bartira Tibertius of Chicago … received Tysabri for a full 28 months as part of a clinical trial. "I was doing great. I even forgot that I was sick," Ms. Tibertius, a language teacher and translator, tells us. "But now I'm getting very, very scared. It's deteriorating and I know that," describing numbness and tingling in her hands, arms, feet and face. As for any possible risks from the drug, she says, "I'm more scared of not having Tysabri than having Tysabri. If you told me the Tysabri would shorten 10 years of my life I would do it. I want quality of life, not quantity.">>
Talked to my sister this AM about the Avonex story. Here's her reply & I quote; "How many relapses did I had when I took Avonex? I won't take that crap ever again. I want to go back on Tysabri." End of quote. Avonex is toast.
I was in my neurologist’s office for an appointment late last winter and there were these people there, laughing, acting, and looking as if there wasn’t a care in the world. I thought it was a little odd. Why were they there? There didn’t look sick. During my appointment, my doctor told me that they were in the Tysabri study and had come in for their treatment. I had to stop the interferon because of liver complications. I had to stop the chemotherapy because of heart complications. I now have to take daily injections of Copaxone, since we were out of choices, and the MS is progressing, my doctor suggested Tysabri. It WAS my only choice. I was waiting for our insurance company’s approval the morning I heard it was being suspended. I was looking forward to a monthly treatment instead of daily injections that have unpleasant and painful side effects. I was looking forward to something that might offer more promise in managing this disease. I was looking forward to a treatment that offered hope that I might be able to return to some type of gainful employment. I went on Social Security Disability a few months later. I ended up with worsening symptoms on top of having to manage daily injection site reactions. The MS may have progressed any way, but who knows, it might not have. I sure would have liked a shot at it!
I was diagnosed with MS on April 10, 1996 (our Anniversary). At that time I experienced numbness in both of my feet. After both an MRI and a spinal tap my neurologist was able to confirm my condition. This was not what we wanted to hear but I was prepared to fight with all that was within me. Since that time my condition has progressed. It has affected my vision, my mobility (I struggle to walk with a walker now), my thought process, my speech, I now am incontinent, and am very tired most of the time. My quality of life is not good. My numbness is to my knees in both legs and is affecting my hands. My struggle to walk and my frequent falling is affecting my back (I now have 3 bulging disks) causing me to be in constant pain. I also deal with muscle spasms in both legs daily which also causes me to fall frequently.My neurologist has tried many treatments along the way which include Avonex, Rebif( which was a terrible experience), steroids, and many other drugs for specific symptoms. With all of this help my MS continues to progress with more and more relapses occurring much more frequently now. In Feb. ’05 I was given my first and only infusion of Tysabri. This was the most positive response I had ever had!! My fatigue was nearly eliminated (I did not have to lie down during the day for a month or more), my walking improved, my muscle spasms were gone, the vision problems were resolving, my thought processes greatly improved, my speech returned to normal (even my singing voice returned), the incontinence problem was much improved and there was once again hope for a quality of life.
"If I have to I'll take her to Europe for Tysabri if they approve it before the f**king FDA gets off their ass."
Tuesday, October 21, 2008
Tysabri numbers
Color me happy.
Biogen presented their earnings today and part of that was Tysabri numbers.
Background: Biogen is Elan's marketing partner for Tysabri. In late July it was disclosed that 2 patients in Europe had developed PML -- which Tysabri has a black-box label warning for, estimated at 1 in a 1000 chances of contracting.
We went from 31,800 patients at the end of June to 35,500 patients at the end of September. (#s are totals-- 600 of those are in clinical trials). So we gained 11% patients, in a quarter where we lost over half the market cap due to PML fears.
As usual, most PR coverage was negative - even false. For example, Lisa LaMotta, a Forbes Online columnist, wrote the following (as of 10/21/08 at 9:40 PM it still says this -- I fully expect by tomorrow it will be "updated" / edited ... AFTER the immediate damage has been done.
http://www.forbes.com/2008/10/21/biogen-idec-biotech-markets-equity-cx_lal_1021markets24.html?partner=yahootix
Market Scan
Biogen Bitten By Tysabri
Lisa LaMotta, 10.21.08, 3:45 PM ET
"....Biogen Idec reported earnings that beat expectations mostly due to the sale of its two multiple sclerosis drugs, but investors were disappointed by a slight slowdown from the second quarter in the number of patients taking one of them...
...As of the end of September, more than 35,500 patients were on Tysabri,the mulitple sclerosis drug in question, down from 31,800 at the end of the second quarter...."
1) slight slowdown? The RATE OF GROWTH slowed down. but the number of patients increased!
2) use a spell checker if you are going to call yourself a Forbes journalist!!! (sorry, catty, I know)
3) First time I've heard of 35K being lower than 31K.
Almost sounds like she'd written the hit piece first -- intending simply to fill in the expected bad numbers, doesn't it?
Next -- PML risk; rated at 1:1000.
We have 35,000 on therapy now, and 3,000 from before 2006, with a total of 4 patients contracting PML. It sounds to me more like 1 : 10,000.
Elan is around $9 right now, and SO UNDERVALUED by Mr. Market that is scary. Tysabri sales are increasing and we officially hit blockbuster status -- sales of $1B (granted -- projecting forward revenues).
Before the PML scare in July just on Tysabri Elan was valued around $20. (don't get me started on the Alzheimer's drug AAB-001 and its potential -- a massive Phase III trial nearly a year already underway from it's first dosed patient and a statistically significant showing in a subgroup of gene carriers).
It will probably be one more quarter before the market shows Elan any love -- and coincidentally the next quarter which should show a large increase in quarter-over-quarter sales of Tysabri.
So I would not be surprised if Elan bounced between $8 and $11 over the next three months -- but by February of 2009 I fully expect to see Elan at about $14 - 17; a rather sweet return of 50% or so. If an interim look at AAB-001 comes in positive, then the rocketship ignites.
Regards,
Trond
Biogen presented their earnings today and part of that was Tysabri numbers.
Background: Biogen is Elan's marketing partner for Tysabri. In late July it was disclosed that 2 patients in Europe had developed PML -- which Tysabri has a black-box label warning for, estimated at 1 in a 1000 chances of contracting.
We went from 31,800 patients at the end of June to 35,500 patients at the end of September. (#s are totals-- 600 of those are in clinical trials). So we gained 11% patients, in a quarter where we lost over half the market cap due to PML fears.
As usual, most PR coverage was negative - even false. For example, Lisa LaMotta, a Forbes Online columnist, wrote the following (as of 10/21/08 at 9:40 PM it still says this -- I fully expect by tomorrow it will be "updated" / edited ... AFTER the immediate damage has been done.
http://www.forbes.com/2008/10/21/biogen-idec-biotech-markets-equity-cx_lal_1021markets24.html?partner=yahootix
Market Scan
Biogen Bitten By Tysabri
Lisa LaMotta, 10.21.08, 3:45 PM ET
"....Biogen Idec reported earnings that beat expectations mostly due to the sale of its two multiple sclerosis drugs, but investors were disappointed by a slight slowdown from the second quarter in the number of patients taking one of them...
...As of the end of September, more than 35,500 patients were on Tysabri,the mulitple sclerosis drug in question, down from 31,800 at the end of the second quarter...."
1) slight slowdown? The RATE OF GROWTH slowed down. but the number of patients increased!
2) use a spell checker if you are going to call yourself a Forbes journalist!!! (sorry, catty, I know)
3) First time I've heard of 35K being lower than 31K.
Almost sounds like she'd written the hit piece first -- intending simply to fill in the expected bad numbers, doesn't it?
Next -- PML risk; rated at 1:1000.
We have 35,000 on therapy now, and 3,000 from before 2006, with a total of 4 patients contracting PML. It sounds to me more like 1 : 10,000.
Elan is around $9 right now, and SO UNDERVALUED by Mr. Market that is scary. Tysabri sales are increasing and we officially hit blockbuster status -- sales of $1B (granted -- projecting forward revenues).
Before the PML scare in July just on Tysabri Elan was valued around $20. (don't get me started on the Alzheimer's drug AAB-001 and its potential -- a massive Phase III trial nearly a year already underway from it's first dosed patient and a statistically significant showing in a subgroup of gene carriers).
It will probably be one more quarter before the market shows Elan any love -- and coincidentally the next quarter which should show a large increase in quarter-over-quarter sales of Tysabri.
So I would not be surprised if Elan bounced between $8 and $11 over the next three months -- but by February of 2009 I fully expect to see Elan at about $14 - 17; a rather sweet return of 50% or so. If an interim look at AAB-001 comes in positive, then the rocketship ignites.
Regards,
Trond
Tuesday, July 29, 2008
Elan stumbles
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
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
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
Subscribe to:
Posts (Atom)
