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Originally posted by kingofthehill
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wow, excellent info, king! -
I've read the report and find it to be very encouraging. It looks like a good bet that Ty will be back, but without Avonex.Comment
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we "investors" never wanted the combo
We always saw it as a way for Biogen to double dip, without benefiting the patient.
I will enjoy the summer and wait for our day to comeComment
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Yes...and our day will be here soon.Originally posted by kingofthehillComment
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Very Nice pop this morning......Gotta love the big board!Comment
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a lot of investors must have read that report last night!Comment
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http://www.sbpost.ie/breakingnews/br...y5798x&n=31580 57&x=
Tysabri relaunch mooted for next year
07/07/2005 - 12:55:06 PM
In a report prepared by NCB Stockbrokers, senior analyst Dr Orla Hartford has reviewed the data available in Elan drug Tysabri's Biological License Application (BLA) in an attempt to understand why PML developed in two multiple sclerosis patients on Tysabri and AVONEX combination treatment.
The analysis revealed that, after a relatively short period of combination treatment, AVONEX had a significant effect on the accumulation, clearance and half-life of Tysabri and essentially led to almost double the intended Tysabri concentration after only 20 weeks of treatment.
Patients on Tysabri alone did not accumulate the drug.
Dr Hartford said: “This suggests to us that over a sustained period of Tysabri and AVONEX treatment, the trends of accumulation and reduced clearance of Tysabri leads to an "overdosing" of patients with Tysabri.
Given Tysabri's mechanism of action, we suggest a possible explanation for the occurrence of PML in patients on combination treatment. The absence of confirmed cases in the monotherapy group (without a complicating factor) gives us comfort in our thesis.”
“We believe that the potential oversuppression of the immune system in patients on Tysabri and AVONEX combination treatment will form a central plank of the case made to the FDA for the re-launch of Tysabri (as a monotherapy).
“The efficacy of Tysabri in treating multiple sclerosis is undeniable and we continue to believe that Tysabri will return to the market as a significant therapy.
“We are assuming a re-launch in 2006 with the product achieving 10% market penetration in the multiple sclerosis market in the US and in Europe by 2009.”Comment
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Our day is getting closer King...Comment
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This stock is making a nice move lately......... definetly on the watch listGotta love the big board!Comment
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Spike whats your read ?
I like the price movemnt of late ..looks goodComment
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Yep, me too. My last 2 posts nailed the perfect entry (just quietly hehe)Originally posted by kingofthehill
and since then it gapped up and has been nicely meandering North for us.
As of today, there's no channel resistance until 8.11 and rising and there was a nice channel turn up 2 days ago. I can feel a high volume bullish day coming soon.......
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Saturday, July 16, 2005
Betting on Tysabri
on february 28th, elan and biogen idec pulled tysabri from sales and clinical trials. 2 patients who had been taking a combination of avonex and tysabri (avonex is an ms treatment by biogen) developed PML, a rare disease that causes destruction of brain tissue. since then, i've been dilligently following the developments as the two companies review the drug for a possible reintroduction to the market.
my opinion is that the situation is greatly misunderstood by investors because of prejudiced coverage by the media and institutions. the purpose of this post is to put into perspective what has happened and for me to provide commentary to help you understand what is really going on.
PML CASE #3
during the sgcowen health conference in mid-march, ceo kelly martin estimated that reviews would be completed by "the end of summer." at this time, the stock was trading around $7. on march 31st though, the stock tumbled from ~$7 to ~$3 overnight (taking me down with it). a 3rd confirmed case of PML was announced by the 2 companies. the 3rd patient was diagnosed with pml post-mortem (he died in 2003). the 3rd pml case had been on tysabri monotherapy in contrast to the first 2 pml cases who were on combination therapy (avonex+tysabri).
the significance of patient 3 is that s/he was discovered to have been on other immunosuppressive drugs. the key fact to keep in mind is that PML is already known to arise in immunosuppressed patients. since there have been no confirmed cases in tysabri monotherapy (cases 4 and 5 are unconfirmed), it can be speculated that combo therapy could be the culprit.
ELAN AGM
elan's AGM, which took place at the end of may, was very upbeat. kelly martin stated that it was a matter of "when, not if" tysabri would find a path back to ms patients. i listened to this AGM webcast live and believe me, it inspired a lot of confidence and excitement in my investment w/ elan. if you're new to elan, you should definitely listen in to the recorded AGM.
the important thing to get from the AGM is that it was the last time that ELN officially briefed investors on tysabri. outlook on tysabri has been pretty grim lately, but keep in mind that nothing has officially changed. things brings us to PML "cases" 4 and 5.
PML "CASES" 4 and 5
a few weeks after ELN's successful AGM, and 1 day suspiciously before BIIB's AGM, jeff krasner of the boston globe published a frontpage article which bore the headline: "A fourth death may be tied to Biogen's MS drug." this article alone caused eln stock to plunge from ~$8 to as low as $6.10 the next day. elan's PPS has yet to recover from the damage done by this article. shouldn't someone be held responsible for the losses sustained by shareholders like me?
this "case" has since been rejected by biogen over a CC. in fact, there exists an article saying that the patient referred to as the '4th case' was shopping when she found out that she had "died." considering its been over a month since this report, we can assume that this case is not valid since ELN and BIIB would have been required by the SEC to report it officially. the same can be said about the '5th case' which was brought up by the WSJ (i dont have a subscription to read about it). so, in other words, there have been 3 confirmed cases of PML so far. 2 are combination therapy patients and the other is a monotherapy but immunosuppressed patient.
SALE OF BIOGEN'S OCEANSIDE PLANT
biogen recently sold its drug manufacturing plant in oceanside, ca to genentech. a lot of critics claimed that revealed biogen's lack of faith in tysabri return (oceanside was slated to produce tysabri). however, it is important to point out that biib has also developed a high titer method of manufacturing tysabri, meaning a higher production capacity for the drug. also keep in mind that the oceanside plant was part of biogens acquisition of idec.
SIGNS OF A COMPANY IN TROUBLE?
awhile ago, eln's chairman of the board, kylan mclaughlin, purchased 90K shares of eln. investors approved of a sharebuyback program during the AGM. eln posted very positive crohn's trial results a few weeks ago. eln will post breakeven EBITDA even without tysabri in its pipeline. eln has a very promising drug for alzheimers in phase2 that can be a even greater blockbuster drug than tysabri. eln is retiring some of its 1billion dollar debt that is due in 2008. elan's nanotech is starting to take off. the new england journal of medicine is considering the possibility of tysabri's return from a scientific standpoint.
are these signs of a company in trouble? with the exception of NCB and a few other brokerages, everyone seems to love to hate elan. but hey, at least now they're actualy considering that tysabri will back. a few months ago, pretty much every analyst on wallst claimed that there was no chance tysabri would ever return.
WRAP UP
this is a great drug with great potential. for now, all signs point to tysabri monotherapy. as avonex combo therapy becomes singaled out as the culprit, and as avonex goes generic, biogen and elan will have to share tysabri as their sole flagship MS drug. the patient reviews should be finished any week now, and a risk/benefit profile revised by the fda. the speculated timeframes for the completion of reviews range from as early as Q3 2005 to as late as Q1 2006. kelly martin and jim mullen seem to continue to stand by their "end of summer" timeframe.
if you'd like to read about tysabri/pml from a very scientific and medical standpoint, go over to the yahoo msg boards and search for posts by 'pinvestment' and 'neuro11111', both very well-versed scientists who graciously share their knowledge on the situation. during the writing of this post, i found the tixx webpage to be very helpful. they have a lot of cool documents on the site too. check out their site if you'd like to continue researching elan.
good luck betting on tysabri. thanks for reading.Comment
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Interesting read webs, I'm still holding strong. Looks like we are getting some good action again today.Comment
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And good news, after the bell!Originally posted by TormentosComment
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Elan Corporation: Combination treatment hits endpoints
After the US close last night, Elan and BiogenIdec reported the two-year Phase III data from the SENTINEL study involving Tysabri in combination with AVONEX. Although this combination trial achieved the primary endpoint of slowing the progression of disability in patients with relapsing multiple sclerosis (24% reduction in the risk of disability progression compared to interferon alone) along with a 56% relative reduction in the rate of clinical relapses compared to that provided by AVONEX, we continue to believe that a combination of Tysabri with AVONEX will not be an option for MS patients. This view is based on the observation that the presence of AVONEX has a significant effect on the accumulation, clearance and half-life of Tysabri and essentially leads to almost double the concentration of Tysabri after only short-term treatment. Furthermore, we believe that the accumulation of Tysabri when AVONEX is present leads to localised immunosuppression in the brain leaving patients potentially at risk of developing PML.
Serious infections occurred in 2.9% of AVONEX plus placebo-treated patients and 2.7% of AVONEX plus TYSABRI-treated patients. In addition, two patients on long-term combination therapy developed PML. Over the next 1-2 months the findings of the safety review involving the 3,000 patients in the Tysabri clinical trials are expected to be presented to the FDA. Only at this point do we expect to get an update on the path forward for Tysabri.
Tysabri alone reduces the rate of clinical relapses compared to placebo by approximately twice the level of current therapies. Over and above the safety concerns of combination therapy, we see little incremental benefit in incorporating AVONEX as an additional therapy given the efficacy of the monotherapy alone along with the fact that combination therapy requires a weekly injection on top of a monthly infusion, use carries the associated side-effects of interferon therapy and is significantly more expensive.
Despite the positive efficacy data achieved in the SENTINEL trial, we believe that the effect that AVONEX has on Tysabri's pharmacokinetics will prevent combination use. We are expecting Tysabri as a monotherapy to be available as a treatment option for MS patients in 2006 with the product achieving 10% market share in the US and in Europe in 2009. This level of market penetration can support a revenue potential of c.$1bn for use in MS alone implying a sum-of-the-parts value of $9.74-$11.95. The stock remains high risk and speculative.Comment
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