ELAN - 1.000 % for the LONG-time - 500 Beiträge pro Seite (Seite 18)

[Birgit.Tersteegen]

I`m going back to the meeting but
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/07/06 11:41 am
Msg: 943416 of 943688

one of the panelists asked the FDA reviewers if the number of deaths associated with Tysabri in the clinical trial setting was inordinate or striking and two FDA folks answered negative for a MS trial. The deaths are to be expected. This is exactly why a halt was needed.

By the way, the panel adjourned for a 15 minute break, the chair damn near had to start without them after 25 minutes. These guys and gals were in the hall. Good thing that Parkinsons deal is coming. Perhaps they were just comparing handicaps! :-)!!!

We are fine so far.

[Birgit.Tersteegen]

Re: HOW MANY MS PATIENTS DIED W/ PLACEB
by: poke1221
Long-Term Sentiment: Buy 03/07/06 11:46 am
Msg: 943423 of 943697

In the MS trials there was a lower incidence of death in patients taking natalizumab than in patients on placebo. I quote from the AC clinical review document
"In MS placebo-controlled studies, there were two deaths among subjects who received
natalizumab (2/1617; 0.12%) and three deaths among subjects who received placebo
(3/1135; 0.26%).

[Birgit.Tersteegen]

Re: FDA`s risk management presentation
by: brita0997a
Long-Term Sentiment: Buy 03/07/06 12:15 pm
Msg: 943512 of 943706

<<FDA wants tracking of each vial. Not presently in plan.

Also no immune supressing drugs.

Also, FDA wants no off label sales. Wants it so MD will be required to state patient has MS. unclebake. >>

I had more of an impression that these are the things that the FDA wants guidance from the comittee on, not that they necessarily will require it. She made a point to say that the risk program should be designed to maxamize Tysabri benefits.


Posted as a reply to: Msg 943460 by unclebake

[Birgit.Tersteegen]

Thoughts on the morning process...
by: darrelldemello 03/07/06 12:54 pm
Msg: 943662 of 943729

No Doubt that TYSABRI is coming back ...
a. with a warning about use in combo and in immunocompromised patients.
b. With a patient monitoring system in place
c. With a defined Product tracking system in place (IMO: this may be a result of the challenges the FDA faced when some batches of Avonex were contaminated, and BooBie did not have a good vial tracking systm in place... and there must be a lot of FDA heartburn .. again I do not know the full story ... but reading between the lines this is IMO)

So far everything that has been said is very very balanced ... everything has been put out on the table fo discussions by the members of the AC ... the questions being asked by the AC members is IMO `NORMAL`, one would like all the tough questions to come out publicly now .... so that BooBie can provide clarifications if necessary or a revised plan of action if necessary ...and the AC when they meet in private tomorrow afternoon ... they can make their decisions with all the information - good, bad and ugly ... out on the table.

CYA - by the FDA ... wanting recommendations from the AC...

The biggest thing there `seems to be a disconnect` between what ELAN would have done vs what BooBie is doing ... but BooBie is in charge of the licence... and the sBLA application.

Now am waiting for the patients` testimony ...I do have to leave at 1.30pm for a meeting and should be back at 3.30pm...

Hope this helps...

[Birgit.Tersteegen]

Richert says accept more risk
by: indiana_lewis 03/07/06 01:00 pm
Msg: 943682 of 943762

In his published testamony before the AC John R. Richert, NMSS, seemed to say approve TY even if there is more risk.

http://www.nationalmssociety.org/tysabri_richerttestimony.as…


"For the past 12 years we have been extremely fortunate that the approved disease modifying agents for MS have been extraordinarily safe. Similar degrees of safety are not seen among the medications available for treatment of most other autoimmune diseases. Medications approved by the FDA for use in the treatment of rheumatoid arthritis, Crohn`s disease, systemic lupus erythematosus, psoriasis, ulcerative colitis and ankylosing spondylitis include those with degrees of known risk that include fatalities. These medications include Enbrel, Humira (adalimumab), Kineret (anakinra), Remicade (infliximab), and Celebrex. . .

Similarly, the amount of effort required on the part of patients and their physicians to become knowledgeable about their treatment options will need to become more in line with what people dealing with other autoimmune diseases have been facing. There are a number of other drugs that are currently in the MS pipeline, including several new oral medications. The kinds of decisions being faced today with Tysabri will likely be faced again and again as new generations of medications are developed. The risks of the medications will need to be weighed against the risk of doing nothing."

[Birgit.Tersteegen]

Competitors` weasel now...
by: roymulus
Long-Term Sentiment: Strong Buy 03/07/06 01:27 pm
Msg: 943766 of 943769

...pleading for continuing that which does not work. He says there is no crisis in MS care.

[eliasesteban]

nabend,Birgit,du bist aber engagiert,strong lob!

[bernie55]

...stimmt...

Super - Strong - Lob

[Nostarowie]

jo unsre Birgit is ne richtige Threadmami

[bernie55]

...Threadgirlie....

[Birgit.Tersteegen]

meeting as a whole
by: pinvestment 03/07/06 02:03 pm
Msg: 943893 of 943932

normally these meetings are pretty hard on the presenting companies - FDA seems to be largely in agreement with BIIB - AC panels don`t seem to have any great issues - this looks very very good

[Nostarowie]

...hab ich wohl verwechselt in meinen wortgewaltigen emotionalen Beitrag....

..girlie natürlich

[Birgit.Tersteegen]

[posting]20.561.217 von Nostarowie am 07.03.06 20:00:36[/posting]Nosta,Du IGLUBAUER--wehe hier "Threadmami"---sonst denk ich mir noch was richtig gemeines aus....(Allerdings heute nicht mehr....)

:kissANKE für das Lob

[Birgit.Tersteegen]

1st Pt. on Video: No therapies stopped
by: rowerx1 03/07/06 02:14 pm
Msg: 943942 of 944241

attacks, only TY

TY patient "more than willing" to undergo testing etc

Much greater risk of NOT having TY

Put it back in the arsenal

"I pray you never have to experience" MS

[Birgit.Tersteegen]

Young Pt: TY "Profoundly more effective
by: rowerx1 03/07/06 02:22 pm
Msg: 943971 of 944246

Urging FDA to permit TY to be available as first-line therapy

well aware of the NEJM articles

[Birgit.Tersteegen]

Re: Head of NMSS
by: neuro1111 03/07/06 02:25 pm
Msg: 943987 of 944305

The NMSS was never against Tysabri. They just didn`t vocalize the support as much or as early as many on this board would have liked. The NMSS is scientifically based. The peer reviewed efficacy papers published in NEJM last week finally allowed the NMSS to publicly state what they were privately saying for months. Timing could not have been more fortunate.

[Birgit.Tersteegen]

MS Patient motivated by son
by: rowerx1 03/07/06 02:32 pm
Msg: 944007 of 944311

TY was a miracle for me " on 1st dose

More energy...looked toward future

INFs not helping - currently on copax

TY worked when all others failed

VERY emotional to heqar

[Birgit.Tersteegen]

Doctor who treats 150 MS...
by: roymulus
Long-Term Sentiment: Strong Buy 03/07/06 02:34 pm
Msg: 944016 of 944313

...patients and has MS himself. Breaking up on stand as he relates his hopes and fears for his patients and for himself.<br><br>We want our Tysabri. Now.

[Birgit.Tersteegen]

Pt Advocate Speaking - Forceful pro-TY
by: rowerx1 03/07/06 03:35 pm
Msg: 944242 of 944340

"100% chance MS patients will perish woith the ship"

"TYSABRI should have never been taken off the market"

FDA overcautious in post-Vioxx hysteria

Should be indiv. pts decision knowing current info on Risk/Benefits

Pts "should have more control on how they fight for their lives"

Catastrophe of antiquated statistical analysis methods (ASIDE: there`s a new can of worms!)

Statistical errors in evaluating rotavirus treatment as example of above

FDA "must understand patients need to be put first"

(forceful though not the best speaker)

[Birgit.Tersteegen]

Re: My take from today
by: jjf342001
Long-Term Sentiment: Strong Buy 03/07/06 04:10 pm
Msg: 944373 of 944375

<BOOB did a shitty job; they need people who know the data better, particulary this point that Smith did not have MS. This lack of knowledge may leave AC with impression that BOOB is not able to do proper risk management, which might force AC to recommend stricter guildelines>

This has been my point all along! BOOB wants stricter guidelines to make Ty a second line therapy. That is also why they focus on the 1/1000 instead of 0/3000, and state things like "no way of knowing PML risk", etc. They do not have ms patients or our interests in mind.

[MrPitt]

[posting]20.563.214 von Birgit.Tersteegen am 07.03.06 22:12:11[/posting]Möchte Dir aber auch den anderen ein Kompliment für diesen Thread machen, der locker aber engagiert und seriös geführt wird. Wenigstens kann man den Eindruck gewinnen,
dass es nicht nur ums "Zocken" sondern auch um die Möglichkeit eines medizinischen Fortschritts gehen könnte.
Die Auflagen für Neuzulassungen sind nach "Vioxx" zu recht von der FDA höher gesetzt worden, doch wird natürlich keine
Blockade ausgeübt.
Die von Birgit eingestellten Kommentare zur Anhörung sind
spannend, vermisse aber "Kontra-Beiträge".
Bleibt bitte weiter "am Ball"- und habt etwas Geduld!
Viele Grüsse

[Birgit.Tersteegen]

[posting]20.564.468 von MrPitt am 08.03.06 00:32:05[/posting]Hi Mr Pitt!

Willkommen!!und Dank für Deine Rückmeldung!

This is far from over.
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/07/06 05:01 pm
Msg: 944533 of 945354

This panel has BIIB on the hot seat. Tysabri will be vindicated tomorrow with the vote. There was no concern from the panel, with regards to the efficacy of Tysabri. They were far more concerned with the potential misdiagnosis of Mrs. Smith. If the efficacy does fit, you must aquit!

March 9th is payday.

[Birgit.Tersteegen]

Re: This is far from over.
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/07/06 05:20 pm
Msg: 944579 of 945361

A misdagnosis in two Tysabri related deaths, Mrs. Smith, and the astrocytoma patient suggest PML NOT MS as the original problem.

That would be the end of this whole thing right there. I am quite anxious to see if they continue down tah road tomorrow or let their peers off the hook. It could get ugly for the profession, but good for Elan.

KM is smiling from ear to ear right now. I just know it.


Posted as a reply to: Msg 944553 by nangasimon

-----------------------------------------------------------

RRESPONSIBLE
by: boiling.point 03/07/06 05:23 pm
Msg: 944586 of 945363

Katz`s statement today is irresponsible and not evidence-based. The available data to date suggest that tysabri in combination w/ avonex and other immunosuppressants appears to be associated w/ PML. There are NO proven cases of PML when tysabri was used as MONOTHERAPY. He can say that "we don`t know if there will be additional cases of PML w/ tysabri monotherapy" or "we are concerned that there may be additional cases of PML w/ tysabri monotherapy, but we do not have enough data to tell us for sure." Unfortunately, "we fully expect additional cases of PML, many likely to be fatal" is NOT grounded in facts and is an opinionated statement that should not be coming out of the mouth of someone in Katz`s position at the FDA.

[Birgit.Tersteegen]

FDA will approve Tysabri with black box
by: speedrunner199 03/07/06 05:56 pm
Msg: 944673 of 945365

Based on today`s events, objective results of Tysabri trial, and the medical needs of MS patients, tysabri will be approved by the FDA with cautionary warning. Anyone thinking otherwise is not realistic and do not understand the FDA approval process. To not have tysabri available for MS patients that need this therapy to have meaningful life is worse than death sentence or any perceived risk of PML. The job of FDA panel is to assess benefit versus risk. The risk of depriving Tysabri for advancing MS patient is far worse than the risk of developing PML. Conversely, the benefits of tysabri is far too compelling in rafractory patients to deprive them of the therapy in the face of uncertain risk of developing PML with monotherapy. PML is extremely rare complication and was only present in 1 in 1,000 patients when they received multiple immunosuppressive therapy. No one receiving tysabri allone has developed PML and may never develop it. It is completely speculative and without any scientific proof to assume that tysabri monotherapy will cause PML. JMHO.

[Bernd13090]

[posting]20.564.842 von Birgit.Tersteegen am 08.03.06 07:12:06[/posting]hy birgit, wie ist denn der aktuelle stand, wann kan man mit ergebnissen rechnen.

gruß
bernd

[Birgit.Tersteegen]

A quick note...
by: jtinformed 03/07/06 06:02 pm
Msg: 944693 of 945365

I have been informed that many of you have seen the web cast of todays AC so I won`t rehash anything from there. What you were not privy to, is the meeting held on Monday March 6th with LJD and many others. We had one guest speaker that evaluates Pharmas/Biotechs and new drugs for the likes of Fidelity, Vanguard etc. He has his MD and is very knowledgable in evaluating new drugs and making recommendations to his clients. He has not financial interest in Tysabri but said that it was his professional opinion that Ty would be approved by the AC and subsequently by the FDA. He had a few concerns about the incidence of infection (also highlighted by the FDA today) and the high rate of anaphlactic (sp) responses ie 20 percent. Pin would be the one to further discuss immunogenesis of Tysabri vs other drugs. It has been all about the MS patients for me the last couple of days.Lifting one Mser into my van, discussing their MS experiences and their HOPE for a better tomorrow. I will try to do a better job of describing these events later in the week. Take care, JT

[Birgit.Tersteegen]

Re: Katz is a shameless sellout
by: acricketeer 03/07/06 06:09 pm
Msg: 944711 of 945365

Katz`s job is to play the devil`s advocate. You have to understand these AC Meetings. It`s more like a mock trial (even though people`s lives are at stake). They do this all the time. It`s just theatrics. They fabricate statistics, bring up irrelevant points, intentionally obfuscate the obvious.... these are all rehearsed techniques designed for one purpose, to provoke a rebuttal. Companies that pass this test gain alot of respect in the medical community. It forces them to focus their presentation and convince the panel of the clinical utility of their drug with total conviction.

[Birgit.Tersteegen]

Re: Marketing for Black Box - Pin, Okz?
by: pinvestment 03/07/06 08:19 pm
Msg: 945047 of 945372

black box has no effect on marketing - you see those enbrel folks dancing around on tv? yes , enbrel has a black box and they promote its use on national TV - makes that black box seem very dangerous huh? a black box is a right of passage for a drug with a new mechanism of action

the key is too understand the dynamic of the MS market - at some point most MS patients will move to a more effective drug because they realize the other drugs aren`t working - also the word of mouth and stories of reversal of disability should also help

[Poppholz]

FDA: Some Patients On Tysabri Would Likely Die

03-07-06 12:41 PM EST
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration official said Tuesday some patients would still die of a rare brain disorder if the multiple sclerosis drug Tysabri were allowed back on the market.

The drug`s manufacturers Biogen Idec Inc. (BIIB) and Elan Corp. (ELN) are asking the agency to let Tysabri back on the market with restrictions. The companies pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML and one died. A third patient was later discovered to have PML and also died.

Both the FDA and officials from Biogen said there`s no way to easily test for PML or determine which patients might get the rare and often fatal brain disorder that`s caused by the JC virus. The virus, which is believed to lay dormant in most humans, is believed to become activated again in some patients with immunocompromised systems from underlying disorders for treatments with certain drugs.

"There will be additional cases of PML, perhaps many cases and there will likely be considerable mortality associated with use of the drug," said Russell Katz, the FDA`s head of neurology drug products. He estimated that about 1 out of every 1,000 patients might contract PML if they were being treated with Tsyabri.

Katz made his comments in remarks to an outside panel of medical experts called on by the agency to make recommendations about whether the drug Tysabri should be put back on the market.

But, he noted, that Tysabri appears to be more effective than current MS treatments on the market and the panel needs to weigh the need for better treatments with the risks. The panel won`t make any recommendations until Wednesday. The FDA usually follows its panel`s advice, but is not required to. The agency is expected to make a final decision on Tysabri by March 29.

Burt Adelman, Biogen`s executive vice president, urged the panel to support Tysabri`s return, saying "it`s our intention to assure you that Biogen and Elan in conjuction with the FDA can effectively manage the use of this drug" as treatment for MS.

The company has proposed that the patients and doctors be required to participate in a patient registry in order to receive the drug. The drug - given intravenously once monthly - would also only be administered in clinics that agree to participate in Biogen`s risk management program. Distribution of the drug would also be limited to the approved clinics.

Patients and health-care providers would also have to complete monthly checklists in order to screen for any neurologic changes - which could mark the start of PML or a change in the progression of MS - before they could undergo their next treatment. Patients with any neurologic changes like changes in eyesight or balance would be required to undergo further screening for PML.

The company also proposed that the drug carry a strict "black box" warning that highlight the risk of PML and state that the drug should be given alone rather than with other MS drugs. Two of the patients with PML were also being prescribed Avonex, another Biogen drug, to treat MS.

Biogen also said they would follow 5,000 patients for five years to closely monitor for any adverse events from Tysabri. While Tysabri would be marketed by both Biogen and Elan, only Biogen officials are appearing before the FDA.

Diane Wysowski, an FDA reviewer, said the company should consider following all patients for at least five years. The FDA had raised concerns in documents released Monday about the proposed risk-management plan, many of which were addressed in a revamped plan offered Tuesday by Biogen.

Wysowski said if the panel were to vote Wednesday to allow Tysabri back on the market, the panel would then be asked to vote on the plan including whether the patient questionnaire needs to be longer and whether it should be completed by a doctor rather than a nurse. Wysowski said the panel will also be asked to consider whether Tysabri`s distribution should be even more tightly restricted than proposed, with one vial per patient each month.

Carmen Bozic, Biogen`s vice president for drug-safety and risk management, said the company was concerned that patients might not get their treatments on time under a one-to-one distribution system.

The panel is also scheduled to vote Wednesday on whether the drug should be restricted to MS patients who`ve failed other treatments or have more advanced cases of the disease.

The panel is expected to hear from more than 30 patients with MS, most of whom support the drug`s return, later Tuesday. A few doctors are expected to testify against Tysabri saying the risks of PML are too great to justify the drug`s use until more about the risk is known.

MS is a serious, often disabling disorder that afflicts up to 400,000 patients in the U.S. It`s a progressive disease that affects the spinal cord and brain, and involves damage to nerves that control muscles and vision.

Last month, the FDA lifted a "clinical hold" on Tysabri allowing the companies to make the drug available to patients who were receiving the drug as part of preclinical studies as part of a new trial. That process is expected to continue regardless of how the FDA rules on Tysabri`s return to the market.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]


(END) Dow Jones Newswires
03-07-06 1241ET
Copyright (c) 2006 Dow Jones & Company, Inc.

[Poppholz]

UPDATE:FDA Says Some Patients On Tysabri Would Likely Die

03-07-06 04:41 PM EST
(Updates with comments from public hearing starting in fifth paragraph.)

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration official said Tuesday that some patients would still die of a rare brain disorder if the multiple sclerosis drug Tysabri were allowed back on the market.

The drug`s manufacturers Biogen Idec Inc. (BIIB) and Elan Corp. (ELN) are asking the agency to let Tysabri back on the market with restrictions. The companies pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

"There will be additional cases of PML, perhaps many cases, and there will likely be considerable mortality associated with use of the drug," Dr. Russell Katz, the FDA`s head of neurology drug products, told an outside panel of medical experts being called on to make recommendations to the agency about Tysabri. Katz estimated that about one out of every 1,000 patients might contract PML if they were being treated with Tsyabri. But, he told the panel they needed to weigh the benefits of Tysabri as it appears to be more effective than currently available MS drugs.

The panel is set to recommend Wednesday whether it thinks the FDA should return Tysabri to the market after hearing passionate and sometimes tearful testimony Tuesday from dozens of MS patients who urged the FDA to give them access to the drug. The panel will also be asked to vote on whether the drug should be restricted to sicker MS patients or those for whom other treatments have failed.

"The risk of death is not a reason to deny a desperately needed drug," said Marcy Canavan, a wheelchair-bound MS patient from Accokeek, Md., who says she has stopped reading "because by the second sentence, I forgot the first."

Still, a handful of the people who testified, such as Doug Franklin, the president of the Multiple Sclerosis Association of America, cautioned the agency about returning Tysabri before more studies of the drug are conducted to better determine the drug`s risks.

Both the FDA and officials from Biogen said there is no way to easily test for PML or determine which patients might get the rare and often fatal brain disorder.

But, Burt Adelman, Biogen`s executive vice president, urged the panel to support Tysabri`s return, saying "it`s our intention to assure you that Biogen and Elan in conjunction with the FDA can effectively manage the use of this drug" as treatment for MS.

Biogen proposed patients and doctors be required to participate in a patient registry in order to receive the drug. The drug - given intravenously once monthly - would also only be administered in clinics that agree to participate in Biogen`s risk-management program, and distribution of the drug would also be limited to those clinics. While Tysabri would be co-marketed with Elan, only Biogen officials appeared before the FDA panel.

Patients and health-care providers would also have to complete monthly checklists in order to screen for any neurological changes - which could mark the start of PML or a change in the progression of MS - before they could undergo their next treatment. Patients with any neurological changes such as changes in eyesight or balance would be required to undergo further screening for PML.

The company also proposed that the drug carry a strict "black box" warning that highlights the risk of PML and states that the drug should be given alone rather than with other MS drugs. Two of the patients with PML were also being prescribed Avonex, another Biogen drug, to treat MS.

Biogen also said it would follow 5,000 patients for five years to closely monitor for any adverse events from Tysabri.

Diane Wysowski, an FDA reviewer, said the company should consider following all patients for at least five years. The FDA had raised concerns in documents released Monday about the proposed risk-management plan, many of which were addressed in a revamped plan offered Tuesday by Biogen.

Wysowski said if the panel were to vote Wednesday to allow Tysabri back on the market, the panel would then be asked to vote on the plan, including on whether the patient questionnaire needs to be longer and whether it should be completed by a doctor rather than a nurse. Wysowski said the panel will also be asked to consider whether Tysabri`s distribution should be even more tightly restricted than proposed, with one vial per patient each month.

Carmen Bozic, Biogen`s vice president for drug safety and risk management, said the company was concerned that patients might not get their treatments on time under a one-to-one distribution system.

The panel is also scheduled to vote Wednesday on whether the drug should be restricted to MS patients for whom other treatments have failed or have more advanced cases of the disease.

MS is a serious, often disabling disorder that afflicts up to 400,000 patients in the U.S. It is a progressive disease that affects the spinal cord and brain, and involves damage to nerves that control muscles and vision.

Last month, the FDA lifted a "clinical hold" on Tysabri, allowing the companies to make the drug available to patients who were receiving the drug as part of preclinical studies as part of a new trial. That process is expected to continue regardless of how the FDA rules on Tysabri`s return to the market.

The agency is expected to make a final decision on Tysabri by March 29.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]


(END) Dow Jones Newswires
03-07-06 1641ET
Copyright (c) 2006 Dow Jones & Company, Inc.


http://news.morningstar.com/news/DJ/M03/D07/200603071641DOWJ…

[Poppholz]

2nd UPDATE: FDA:Some Patients On Tysabri Would Likely Die

03-07-06 05:45 PM EST
(Updates with FDA comments starting in fifth paragraph.)

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration official said Tuesday that some patients would still die of a rare brain disorder if the multiple sclerosis drug Tysabri were allowed back on the market.

The drug`s manufacturers Biogen Idec Inc. (BIIB) and Elan Corp. (ELN) are asking the agency to let Tysabri back on the market with restrictions. The companies pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

"There will be additional cases of PML, perhaps many cases, and there will likely be considerable mortality associated with use of the drug," Dr. Russell Katz, the FDA`s head of neurology drug products, told an outside panel of medical experts being called on to make recommendations to the agency about Tysabri. Katz estimated that about one out of every 1,000 patients might contract PML if they were being treated with Tsyabri.

The panel is set to recommend Wednesday whether it thinks the FDA should return Tysabri to the market after hearing passionate and sometimes tearful testimony Tuesday from dozens of MS patients who urged the FDA to give them access to the drug. The panel will also be asked to vote on whether the drug should be restricted to sicker MS patients or patients who fail on other treatments.

Indeed it`s rare for the FDA to return a drug to the market once it`s been pulled, but Robert Temple, the FDA`s director of drug evaluation, said Tysabri deserves consideration because "what we are talking about here is a drug that unequivocally works and unequivocally works well." Still, he and other FDA officials said they are concerned about the risk of PML, and if the drug were to be returned to the market it would only be done under conditions that would allow that risk to continue being studied. The FDA usually follows its panel`s advice and has until the end of March to make a final decision on Tysabri.

Most of the 41 people who testified before the FDA panel Tuesday urged the panel to let MS patients have access to Tysabri. About 400,000 people in the U.S. have MS, a progressive disease that involves damage to nerves controlling muscles and vision.

"The risk of death is not a reason to deny a desperately needed drug," said Marcy Canavan, a wheelchair-bound MS patient from Accokeek, Md., who says she has stopped reading "because by the second sentence, I forgot the first."

But a few people who testified, such as Doug Franklin, the president of the Multiple Sclerosis Association of America, cautioned the agency about returning Tysabri before more studies of the drug are conducted to better determine the drug`s risks.

Both the FDA and officials from Biogen said there is no way to easily test for PML or determine which patients might get the rare and often fatal brain disorder or to halt the progression of PML once it`s found.

Burt Adelman, Biogen`s executive vice president, urged the panel to support Tysabri`s return, saying "it`s our intention to assure you that Biogen and Elan in conjunction with the FDA can effectively manage the use of this drug" as treatment for MS.

Biogen proposed returning the drug under a restricted-access program that would make the drug available to registered patients, doctors and clinics. The drug would be given intravenously once monthly in a clinic. While Tysabri would be marketed with Elan, only Biogen officials appeared before the FDA panel. The companies have also proposed studying the drug in 5,000 patients for at least five years.

Biogen also proposed that the drug carry a strict "black box" warning that highlights the risk of PML and states that the drug should be given alone rather than with other MS drugs. Two of the patients with PML were also being prescribed Avonex, another Biogen drug, to treat MS.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]


(END) Dow Jones Newswires
03-07-06 1745ET
Copyright (c) 2006 Dow Jones & Company, Inc.



http://news.morningstar.com/news/DJ/M03/D07/200603071745DOWJ…

[Poppholz]

MS Patients Want Tysabri Back

By Althea Chang TheStreet.com
Staff Reporter
3/7/2006 6:30 PM EST
Click here for more stories by Althea Chang

A panel of medical experts listened to compelling and often emotional testimony Tuesday from multiple sclerosis patients who say the drug Tysabri succeeded in bettering their lives after other medications had failed.

The testimony was presented on the first day of a two-day meeting before a Food and Drug Administration advisory panel convened to decide whether Tysabri is safe enough to again be sold.

One of the people who appeared before the committee was a woman from Oregon who says she tried three treatments without seeing improvements before Tysabri.

However, after one infusion of Tysabri, she says her muscle spasms stopped. Now the woman, who says she has no financial interest in either of the drug`s marketers, Biogen Idec (BIIB:Nasdaq - commentary - research - Cramer`s Take) and Elan (ELN:NYSE ADR - commentary - research - Cramer`s Take), wants to decide for herself if she should continue taking it, an option that she currently doesn`t have.

Those comments were echoed by other of the drug`s supporters, many of whom said they simply want to have the choice of using Tysabri. In what some patients at the hearing called an overreaction, Tysabri was pulled from the market in February 2005 after being linked to a potentially fatal brain illness.

Much more will be known about the drug`s fate after the advisory committee meeting wraps up Wednesday. The group will make recommendations as to whether the FDA should clear the drug and under what circumstances. Many analysts expect that Tysabri will ultimately return to the market, but that certain restrictions might be placed on its use.

Tysabri was withdrawn after being connected to a disease called progressive multifocal leukoencephalopathy. Two PML cases appeared in MS patients who took Tysabri along with another Biogen MS treatment, Avonex. A patient who received Tysabri during a Crohn`s disease trial was later found to have PML. In two of the cases, the patients died.

http://www.thestreet.com/_tscrss/stocks/biotech/10272320.htm…

[Poppholz]

MS Patients Want Tysabri Back
Page 2


Multiple sclerosis is a chronic, debilitating disease that affects the brain and spinal cord. MS is thought to be an autoimmune disease, and while it isn`t considered deadly, it can severely compromise a patient`s quality of life, possibly leading to numbness, difficulty thinking and coordination and speech problems. People with MS can become severely disabled, but most don`t, according to the National Multiple Sclerosis Society.

Effective MS drugs besides Tysabri do exist, but some patients whose disease has come back after those treatments say they`d rather face the risk of PML than be forced to struggle with their condition.

Biogen laid out plans for following up with patients on Tysabri if the drug gains the FDA`s reapproval, saying everyone who takes it would be tracked to determine the rate at which adverse incidents occur.

Additionally, Biogen said it would query physicians after six months and track patient deaths through a national index and a collection of death certificates. The companies expect to follow 5,000 patients, including 3,000 in the U.S., to monitor for side effects or serious infections. They say they`ll gather information on patients who have problems while using Tysabri in combination with another drug that suppresses the activity of the body`s immune system.

Not all of the testimony before the panel was positive, of course. The family of Anita Smith, a Tysabri patient who died of PML, also spoke at the FDA hearing. Smith was initially treated with Avonex for MS, but after hearing of Biogen Idec`s trial on Avonex plus Tysabri, she enrolled. After her death, her MS diagnosis was questioned, and in turn, so were Biogen`s enrollment procedures.

Following the PML cases, Biogen and Elan undertook a safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS, turning up no new confirmed cases of the disease beyond the three that had been reported. They submitted a new application to regulators for Tysabri, and the FDA said it would expedite its review of the drug.

The meeting of the FDA panel will be key to Tysabri`s future, because the group is made up of medical experts who will decide if the pros outweigh the cons. The committee will then make a recommendation to the full FDA, which isn`t obligated to follow the suggestions of its panels, but it usually does.

http://www.thestreet.com/_tscrss/stocks/biotech/10272320_2.h…

[welke91]

Would Likely Die
scheiss umschreibung

warum ich denke eine final decision heute!

warum stopt Elan den Aktienhandel?
(gut wenn solche dähmlichen News rausgehauen werden)
Warum sollte die FDA noch länger warten?
Dieses Panel empfiehlt Ty oder nicht!
FDA muss den Entscheid bringen warum sollten die nochmal im Rahmen des Reviewprozess länger warten Betonung auf warten!

grüße

[loseit]

Die allgemeine negative Stimmung, die Hilflosigkeit der Ärzte bei Diagnose von PML und die mächtige Konkurrenz machen mich langsam ein bisschen nervös.

Auch im Yahoo-Board nur Spekulationen und Nonsens.

Biogen selbst schlägt gleich am ersten Tag denkbar schwere Restriktionen vor. Auch nicht gerade sehr offensiv.

Mal abwarten...

P.S. Auch wenn Ihr alle Elan-Euphoriker seid:

wo seht Ihr den Kurs bei Nichtzulassung/Auflage weiterer Studien am Donnerstag?

Ich mache mal den Anfang: 5 $

Gruss Loseit

[eliasesteban]

an die profis, funktioniert denn ein "sl" wenns zum schlimmsten kommt??

[Poppholz]

[posting]20.568.746 von eliasesteban am 08.03.06 09:39:30[/posting]SL wird wohl gar nichts bringen, da durch die Kursaussetzung der ersten BID und ASK Kurse entscheiden.

Wenn also Ty nicht zugelassen wird, werden auch die Kaufkurse unten sein und durch den SL werden Deine Aktien bestens verkloppt.

[loseit]

Hier wird vermutet, dass es heute um die Schärfe der Auflagen gehen wird, Zulassung aber wohl kommen wird:

http://www.davy.ie/other/pubarticles/eqbrief20060308.pdf

Gruss Loseit

[Poppholz]

[posting]20.568.643 von loseit am 08.03.06 09:36:31[/posting]BIOGEN wird für Ty noch so einige Hürden bringen, da die ja Ihre eigenen Medikamente kanibalisieren.

Dies weiß auch die FDA.

Unser Vorteil ist, dass eine große Interessengruppe das Medikament wieder am Markt haben möchte.

Wenn die Ergebnisse der Therapien positiv sind und das Risiko verhältnismäßig gering ist, wird die FDA keine unnötigen Hürden einbauen.

Allerdings wird es Auflagen geben.

[loseit]

Nach Goodbody soll Elan auch bei neu-therapierten Patienten eingesetzt werden:


Elan (Buy, Closing Price $12.70); Benefit-Risk weighting key in level of Tysabri return recommended by FDA Advisory
Committee.
Analyst: Ian Hunter T [phone] E [e-mail]
Over 350 people attended the first day of the Advisory Committee meeting to consider its recommendation on Tysabri and its potential
return to the market. By the end of the day it was clear that almost all participants had no doubt on Tysabri’s efficacy and that that efficacy
is greater than any drug currently on the market. There is also, however, little doubt that use of the drug will increase a patient’s risk of
contracting PML. It is the perception of the benefit-risk balance that will, therefore, determine the degree of return to the market
recommended by the Committee this evening. A large factor in determining that balance that has yet to be crystalised is the patient risk
management plan (RiskMAP), which continues to be a work in progress. Mandatory patient registers, physician sign offs and registered
infusion centres are a part of the package already agreed, but look for further suggestions from the Advisory Committee by the end of
tomorrow. Elan and Biogen Idec have proposed a wider than anticipated level of return for the drug. They would like it prescribed for:
(i) those suffering relapses under current medication (expected); (ii) those that quit medication due to side effects and/or ineffective
drugs (expected); (iii) for naïve (new to drug therapy) patients where disease activity is high (unexpected); and (iv) for other cases where
deemed appropriate on an individual benefit-risk assessment (unexpected). We still believe that the Advisory Committee’s
recommendation at the end of today will see Tysabri back on the market in Q2’06 and that despite the additional monitoring and safety
plan obligations, its efficacy will see it gradually gain market share. There was nothing in yesterday’s meeting that would trigger any
changes to our current projections, which have sales peaking at $1.9bn in 2009.

[loseit]

Hiernach 80% Wahrscheinlichkeit Zulassung mit schweren Restriktionen:


On Feb. 28, 2005, the day the drug was suspended, the companies` shares plummeted, wiping out $17.8 billion in combined market value. At stake for Biogen and Elan is the future of what was once one of their most promising drugs. Tysabri had been seen as the best hope in a decade for the world`s 2.5 million MS patients, with potential annual sales of $3 billion.

FDA officials said yesterday they have been working with Biogen and Elan to strengthen a proposal for limiting patients` risk of contracting progressive multifocal leukoencephalopathy, known as PML. The plan, which would include distribution controls, restrictions on prescribing and patient tracking, would be aimed at educating patients and limiting use to those who are aware of the potential dangers.

`Ongoing Discussions`

``We`ve had ongoing discussions with the company in an attempt to resolve some issues so that, pending tomorrow`s committee recommendation, we can move forward as fast as possible,`` said Russell Katz, director of the FDA`s division of neurology drug products, in a press conference yesterday. The committee will be asked to weigh in on some of the restrictions, he said.

Tysabri`s prescribing information should include the FDA`s strictest warning, outlined in a black box, that the drug is associated with an increased risk of PML, Biogen said yesterday. Doctors would be instructed to immediately suspend treatment if patients show signs of PML, and they should begin testing for PML and the virus that causes it.

The drug would be administered at a registered infusion center, and Biogen would implement strict distribution controls, the company told the panel. Patients would be required to participate in a registry and would have to read and sign a form confirming they understand Tysabri`s risks. Biogen would then assign each patient an authorization number.

There`s as much as an 80 percent chance that the drug will be re-approved without additional clinical trials, said Eric Schmidt, an analyst at Cowen & Co. in New York, in an e-mail yesterday.

`Got Tysabri?`

``There`s no chance the drug comes back with an unrestricted label, and perhaps a 20 to 30 percent chance more clinical data are requested prior to launch,`` Schmidt said. ``Typically panels try to form decisions based upon the cold, hard facts as opposed to the human element. I`m sure the panel will be impacted on some level by the testimony`` of patients.

One after another, patients told stories of how Tysabri reversed the decline in their symptoms, restored mobility, got them out of the house, enabled them to engage in basic activities of daily life. Some pleaded for a resumption of Tysabri sales with their presence at the meeting, some in wheelchairs with signs that said ``Got Tysabri?`` Others handed out t-shirts saying ``Please allow patients to choose Tysabri to treat MS.``

``I would risk taking this drug to have the quality of life I crave,`` 45-year-old MS patient Barbara Crooks told the panel. ``All the other drugs helped only temporarily. Then there was Tysabri"

[mikel_ann]

[posting]20.568.746 von eliasesteban am 08.03.06 09:39:30[/posting]Bin zwar kein "Profi", aber SL ist wahrscheinlich uninteressant,
da der Kurs am Anfang u.U. am tiefsten
ist und genau dann deine Aktien fliegen.

Meisten steigt die Geschichte etwas später wieder.

Ne ich glaube man muss hier einfach die Richtung aussitzen.
U.U. halt auch etwas länger.

[Poppholz]

Novartis: FTY720 offers gold standard MS potential 7th March 2006
By Staff Writer

Novartis drug to become preferred front-line agent for the treatment of multiple sclerosis.
Phase II trial results have already highlighted the potential of Novartis` oral multiple sclerosis drug FTY720. Assuming that phase III results confirm this efficacy data, the drug candidate has the potential to dominate the MS market over the longer-term. Indeed, upon approval in 2010, Datamonitor forecasts FTY720 to generate revenues of $338 million, growing to $1.1 billion in 2014.

AdvertisementMultiple sclerosis (MS) is characterized by significant unmet need, with no cure currently available. Treatments are used to modify the disease?s course, treat exacerbations, and manage symptoms. However, most patients still suffer from some attacks and subsequent disability. Furthermore, the efficacy of currently approved MS agents tends to diminish over time and the American Academy of Neurology (AAN) estimates that 35-50% of MS patients do not have an optimal response and, therefore, may benefit from alternative therapies.

Novartis` FTY720 was highlighted for particular attention after the once-daily, oral agent demonstrated a 55% reduction in relapse rates and an 80% reduction in lesions compared to placebo after six months.

The potential market opportunity awaiting new MS agents has increased following the market withdrawal of Tysabri. Although the FDA recently ruled that Biogen Idec and Elan can resume clinical trials of Tysabri, questions still surround the drug and its future role in the treatment of MS.

FTY720 also stands to gain as a result of its delivery method. With a superior administration profile compared to currently injectable MS agents, Datamonitor expects oral pipeline agents to gain significant market share upon their approval. Use of beta-interferon agents for the treatment of relapsing-remitting MS (RRMS) will decline sharply upon the approval of oral MS formulations, with oral MS agents accounting for 43% of the RRMS market by 2014.

FTY720 is the most promising of the five oral MS agents currently in the late stages of development, some of which may yet struggle with significant regulatory and development hurdles. In addition, where data is available, efficacy associated with all other oral MS agents in development have thus far been inferior compared to phase II FTY720 results.

Providing that data from the phase III trials, scheduled to start in early 2006, are comparable to those shown in phase II, FTY720 is set to become the preferred front-line agent for the treatment of RRMS post-approval in 2010. Datamonitor forecasts FTY720 revenues in RRMS of $338 million in 2010, growing to $936 million in 2012 and $1.1 billion in 2014.

For more information on this and similar research, please contact Datamonitor at [phone] or visit www.datamonitor.com/healthcare

http://www.pharmaceutical-business-review.com/article_featur…

[Poppholz]

Users ask FDA panel for return of Tysabri
By Diedtra Henderson, Globe Staff |
March 8, 2006

GAITHERSBURG, Md. -- Dozens of multiple sclerosis patients told a Food and Drug Administration advisory panel yesterday that they should be allowed to take Tysabri, a promising treatment for MS pulled from the market last year after it was linked to a rare but deadly brain disease.

Biogen Idec of Cambridge and its Irish partner Elan Corp. PLC, the drug`s makers, said they have developed a risk management plan that could allow Tysabri`s return as a treatment for a small group of patients.

The advisory panel will vote on Tysabri`s fate at the conclusion of today`s session. The FDA often follows its advisers` guidance.

Yesterday, advisers heard often heart-rending testimony from MS patients and their families.

Heather Smith, 36, said Tysabri gave her more energy and allowed her to move about without a wheelchair, which she is now forced to use again. Smith sobbed so frequently while describing how her symptoms worsened since Tysabri was withdrawn that she was cut off before she finished.

Another patient, Pamela Sue Clark, 41, testified that the drug helped her feel well enough to walk to a pond near her home with her 5-year-old sons.

``And I did smile more often," Clark said. ``That is what hope does."

Advisers were also scheduled to hear from Walter Smith, who is suing Biogen Idec because his wife, Anita, 46, died from the brain disease, progressive multifocal leukoencephalopathy, after taking Tysabri in a clinical trial.

Walter Smith, however, was too overcome with emotion to deliver his statement. Instead, the couple`s daughter, Beth Smith, spoke and said the family was ``never told" Tysabri could lead to her mother`s death.

Gregory Shoukimas, a doctor who reviewed Anita Smith`s medical records after her death, said she did not meet the definition of an MS patient. The decision to include her in a trial for a drug that led to her death raises ``serious concerns that Biogen Idec is incapable of proceeding in a safe manner with future clinical trials," he said.

Tim Hunt, a Biogen Idec spokesman, declined to comment. But the advisory panel still peppered company representatives with questions about whether Anita Smith had MS.

``I did not see the patient," said Dr. Alfred Sandrock, Biogen Idec`s vice president of neurology. ``I don`t like to second guess my colleagues."

Biogen Idec told the panel it can reduce risks of PML by ensuring patients are carefully selected, fully informed of risks, and closely monitored for neurological changes. It also volunteered to add a black box -- the FDA`s most serious warning -- to the Tysabri label, and would instruct doctors not to give the drug to patients with compromised immune systems.

Under the company`s plan, doctors who prescribe Tysabri and patients who receive it would participate in a mandatory registry to ensure the right patients get it and know its risks. Patients could only get monthly infusions at registered centers.

The stakes for Biogen Idec and Elan, and for competitors offering rival drugs, were high enough to draw a standing-room-only audience in the hotel ballroom where the two-day hearing is being held.

One MS patient arrived in a cherry red wheelchair sporting yellow fuzzy dice. Another`s wheelchair was emblazoned with ``Got Tysabri?" in glitter.

Although it typically approves such drugs after two-year trials, the FDA gave speedy approval to Tysabri in November 2004 based on one year`s data, because its efficacy was ``so robust." The drug was taken off the market voluntarily by the companies in February 2005 after they learned of two cases of PML. The company later confirmed a third case. Two of the three patients died. Until then, the drug was expected to attain blockbuster status potentially reaching up to $3 billion in annual sales.

A safety review by the companies did not uncover additional PML cases, and last month the FDA approved Tysabri for patients in a clinical trial.

MS, an incurable disease that predominantly affects young women, turns the body`s immune system against tissues that insulate nerves. It strikes without notice and inevitably leads to disabilities.

Within 15 years, MS patients often need a cane or crutch to walk, and many are wheelchair-bound within 25 years. While not life threatening, MS reduces life expectancy by up to seven years.

Patients taking Tysabri may experience a two-thirds reduction in MS flare-ups, about double the benefits offered by other MS drugs.

Dr. Robert Temple, who oversees the FDA division that handles neurology drugs, stood by the decision to stop sales of Tysabri.

Even if it is allowed to return to the market, he said, the drug will be closely scrutinized for PML risks.

Diedtra Henderson can be reached via e-mail at [e-mail].

© Copyright 2006 Globe Newspaper Company.

http://www.boston.com/business/healthcare/articles/2006/03/0…

[Poppholz]

Für uns Investoren ist es nur wichtig, dass Tysabri wieder an den Markt kommt.

Ganz gleich welche Auflagen damit verbunden sind. Blackbox, Warnhinweise, ect. werden die Betroffenen nicht davon abhalten, das Medikament zu bekommen.

[flow_solver]

Sehe ich genauso, erstmal muss Tsyabri wieder auf dem Markt kommen, egal wie. Dann wird man sehen, ob sich eine Dynamik bei den Verschreibungen entwickelt. Man sollte nicht vergessen, auch für Morbus Crohn etc. ist Tysabri hilfreich. Wenn denn die Mono-Therapie safe ist, dann wird alles schneller gehen, als gedacht.

[Birgit.Tersteegen]

Gibts was Neues?---Und vom wem habe ich dieses TOLLE CARE PAKET BEKOMMEN????BIN GANZ GERÜHRT!!!

[bernie55]

[posting]20.572.625 von Birgit.Tersteegen am 08.03.06 12:29:24[/posting]...jetzt bin ich aber mal gespannt, was da so alles drin ist, Birgit..

..erzähl doch mal.....

[bernie55]

...ich bin so neugierig....

[Poppholz]

[posting]20.572.717 von bernie55 am 08.03.06 12:35:27[/posting]das würde mich jetzt aber auch interessieren.

[Poppholz]

[posting]20.572.717 von bernie55 am 08.03.06 12:35:27[/posting]neugierig sind wir doch alle.

[Birgit.Tersteegen]

Eine exquisite Flache Merlot und leckere Kekse.

Bernie,heute das 2.Mal mit Verlust aus Mologen;WIE BLÖD BIN ICH EIGENTLICH--ich gucke da jetzt nicht mehr hin!:O

[Poppholz]

bei MOLOGEN wird noch mehr schindluder getrieben als bei unserem ELAN Baby.



ist schon ärgerlich, dass es nicht nur objektive Trader gibt.

[flow_solver]

MS Patients Press U.S. to Clear Tysabri
by: odz500 (46/M/N. Ireland)
Long-Term Sentiment: Strong Buy 03/08/06 05:05 am
Msg: 945434 of 945475

Multiple Sclerosis Patients Press U.S. to Clear Tysabri Sales

U.S. regulators are under pressure from multiple sclerosis patients to make Tysabri the second drug to be put back on sale after a safety-related suspension.

More than 40 people with the neurological disease yesterday made pleas, some of them tearful, before a committee that today will advise the Food and Drug Administration on Biogen Idec Inc. and Elan Corp.`s Tysabri. In 2002 the FDA allowed GlaxoSmithKline Plc to resume sales of the irritable bowel drug Lotronex, with restrictions, after a link to patient deaths.

``I think that they will re-approve the drug with very tight restrictions,`` said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in New York, in an interview after yesterday`s meeting. He rates Biogen ``market perform`` and doesn`t own the stock. ``The pressure from patients and physician advocates demanding that this option be available is too overwhelming.``

The drugmakers and multiple sclerosis patients want Tysabri cleared for sale because it is better than existing therapies for a disease that affects 400,000 Americans. The FDA may decide by the end of this month. Committee members today are weighing patients` rights to a treatment that has a severe side effect against the agency`s responsibility to protect the public.

Tysabri was suspended a year ago because of a link to a rare, fatal brain disease. People taking it face a 1 in 1,000 risk of contracting the infection, according to the National Institutes of Health. At issue, the patients said yesterday, is their right to face that risk if they so choose.

Willing to Take Risk

``I know Tysabri works,`` said Heather Smith, a mom from Indiana with multiple sclerosis, in an interview before she addressed the committee yesterday in Gaithersburg, Maryland. ``I know other drugs failed me. I know there`s a risk. It`s a risk I`m willing to take.``

Using the drug gave Smith the ability and stamina to play with her toddler, she said. Now she`s back in a wheelchair as she urges U.S. regulators to make the drug available again.

``The patients raised many issues the committee will have to grapple with,`` said Robert Temple, director of the FDA`s office of drug evaluation, during a press briefing after yesterday`s meeting. ``What we are talking about here is a drug that unequivocally works, and works very well. We have to weigh that against the risk.``

Trading in shares of Cambridge, Massachusetts-based Biogen and Dublin-based Elan was suspended yesterday for the meeting. Elan gained 70 cents, or 6.6 percent, to 11.30 euros yesterday before the trading halt.

Stocks React

The stocks have been reacting to Tysabri news for months. They fell last week after researchers said Tysabri can deplete immune-system cells as much as HIV. Since October, Elan has gained almost two-thirds and Biogen as much as a third as no new cases of the brain disease surfaced and management laid plans to press for a resumption of sales.

[Nostarowie]

Leute auf Bloomberg wird gerade über unsre Apotheke gelabert.

[Nostarowie]

Grad vorbei...diente als negativbeispiel in nem vergleich...

[Birgit.Tersteegen]

Kurz noch ,weiss nicht ob schon reportet hier,muss jetzt arbeiten....SPANNEND HEUTE!!!!!


Goodbody
by: mear_fada 03/08/06 04:12 am
Msg: 945413 of 945534

Elan (Buy, Closing Price $12.70); Benefit-Risk weighting key in level of Tysabri return recommended by FDA Advisory
Committee.
Analyst: Ian Hunter T [phone] E [e-mail]
Over 350 people attended the first day of the Advisory Committee meeting to consider its recommendation on Tysabri and its potential
return to the market. By the end of the day it was clear that almost all participants had no doubt on Tysabri’s efficacy and that that efficacy
is greater than any drug currently on the market. There is also, however, little doubt that use of the drug will increase a patient’s risk of
contracting PML. It is the perception of the benefit-risk balance that will, therefore, determine the degree of return to the market
recommended by the Committee this evening. A large factor in determining that balance that has yet to be crystalised is the patient risk
management plan (RiskMAP), which continues to be a work in progress. Mandatory patient registers, physician sign offs and registered
infusion centres are a part of the package already agreed, but look for further suggestions from the Advisory Committee by the end of
tomorrow. Elan and Biogen Idec have proposed a wider than anticipated level of return for the drug. They would like it prescribed for:
(i) those suffering relapses under current medication (expected); (ii) those that quit medication due to side effects and/or ineffective
drugs (expected); (iii) for naïve (new to drug therapy) patients where disease activity is high (unexpected); and (iv) for other cases where
deemed appropriate on an individual benefit-risk assessment (unexpected). We still believe that the Advisory Committee’s
recommendation at the end of today will see Tysabri back on the market in Q2’06 and that despite the additional monitoring and safety
plan obligations, its efficacy will see it gradually gain market share. There was nothing in yesterday’s meeting that would trigger any
changes to our current projections, which have sales peaking at $1.9bn in 2009.

[Poppholz]

Another Dose Of Elan With An ETF Chaser Matt Rand, 03.08.06, 6:00 AM ET

BURLINGAME, CALIF.-- Northern Orion Resources is up about 60% since Thanksgiving. The company, based in Vancouver, British Columbia, mines gold and copper in Argentina and Cuba. On Monday, it reported fourth-quarter earnings of 13 cents per share, up from a loss of 15 cents per share in the year-before quarter.

The best investors are buying this oil and gas driller at $14.64 while the worst are selling the stock. Click here for details in Marketscope.
The metals stock had started to run ahead of last week`s announcement, and Marketocracy`s best bought in on Thursday in the heat of an 8% rally. Buying in at an average price of $4.06, gurus looked at Northern Orion (amex: NTO - news - people ) as a takeover candidate, like Desert Sun Mining (amex: DEZ - news - people ).

Another commodity buy was the Oil Service HOLDRs (amex: OIH - news - people ), an ETF made up of 18 large-cap oilfield services companies. Its top three holdings are Baker Hughes (nyse: BHI - news - people ), Halliburton (nyse: HAL - news - people ) and Transocean (nyse: RIG - news - people ). Still up 37% over the last 52 weeks, the ETF has pulled back nearly 13% from its late January highs, to $137.01. It was down 4.2% on Monday, amid weakness in its underlying stocks. All of its top holdings were down.

Special Offer: This inland logistics and rail management company is a buy at $54.20. The smartest investors added 34% to their holdings while the worst sold off 13%. Click here for the name and buy limits in Marketscope.

Gurus also added to their holdings of Elan (nyse: ELN - news - people ), the Irish biotech that they`ve been making money off of ever since it tumbled from the upper 20s in February of last year. Now at $12.70 (off of a low of just $3), the stock has been volatile, and investors have been feuding over the prospects of the company`s drug, Tysabri, which it pulled off the market last year on concerns that clinical trial patients had contracted PML, a deadly neurological disease.

The FDA will reconsider Tysabri this week, and in hopes of a positive outcome, gurus kept on buying last week. Their additions pushed the stock up from the ninth highest-ranked holding to the fifth most widely held in all M100 portfolios. Out of well more than 2,000 positions, that is a lot of confidence in Elan. The company trades at 10.9 times sales of $490 million. Interestingly, gurus sold about 12% of their Biogen Idec (nasdaq: BIIB - news - people ) holdings. Biogen (nasdaq: BGEN - news - people ) is a partner of Elan`s for making and marketing Tysabri.

Memphis, Tenn.-based general store Fred`s (nasdaq: FRED - news - people ) was a new buy for the gurus last week. They plowed enough money into the stock to put it into their top 400 holdings. Though it touched $20 briefly this summer, Fred`s is now trading at $13.51, with February sales up 8% to $133.8 million, which was less than analysts expected. Marketocracy`s best bought shares last week at 1.6 times book value. Fred`s owns 646 stores.

Wachovia (nyse: WB - news - people ), the Charlotte, N.C.-based bank, was another guru buy. Fresh off of its merger with Westcorp (nyse: WES - news - people ) and WSF Financial, Wachovia sold $3 billion of new debt on Monday. While this doesn`t directly dilute shareholders, it does decrease their overall claim on Wachovia assets. Of course, for a company with a $122.7 billion enterprise value (market cap plus debt minus cash), this isn`t a terribly big dilution. Wachovia is now in the top 200 holdings for the M100. The stock was down nearly 1% on the news on Monday, to $54.67, or 13 times earnings.

Special Offer: Kelley Wright has been buying into turnarounds in big pharma and telecom for several months now. More action lies ahead for blue chip dividend-payers. For steady growth and yields of 4.5% and up, click here for the "lucky 13" buy list from Investment Quality Trends.
By volume, the biggest guru sell for the week, another Charlotte, N.C.-based bank, remains one of their biggest holdings. Bank of America (nyse: BAC - news - people ) had been the 11th biggest holding, but after a week where gurus unloaded about a quarter of their shares, it`s now down to 29. BAC trades for $45.21, or 10.9 times earnings.

Gurus also dumped two of their top-300 holdings. Bellevue, Wash.-based InfoSpace (nasdaq: INSP - news - people )is a Web company that found its footing with mobile content after its search engine offerings, which included dogpile.com and infospace.com, disappointed. Clipped of well more than 40% of their value in the past 52 weeks, shares are now trading at $23.84, just 5.3 times earnings. But gurus agreed with analysts who predict a stiff 84% earnings decline this year, and sold their holdings.

The other dump was a play on the "global economy meets the homeland" theme: Labor Ready (nyse: LRW - news - people ), the Tacoma, Wash.-based manual labor staffing company. The labor pool outfit trades for $23.94, or 20.8 times earnings. The company has a new CEO in Steve Cooper, but gurus didn`t care. They sold all of their shares.

Special Offer: Wish you had bought Hansen Natural at $10? Oberweis Report subscribers got the buy signal in June 2004 and enjoyed Hansens` return of nearly 650%. Click here for Jim Oberweis` latest four buys in the Oberweis Report.

Denver, Colo.-based alternative energy company Rentech (amex: RTK - news - people ) was another sale. Gurus sold off about 40% of their holdings of the company, which has skyrocketed this year, more than doubling in the last 52 weeks to $4.17, but trading above $5 briefly last month. The volatile stock has also been as low as $1.10 in the past year. With a market cap of $473.5 million, the company trades at 66.2 times sales.

Scottish Power (nyse: SPI - news - people ), a Scotland-based electric utility also does some coal and gas business in western North America, but some consider it a play on alternative energy for its work in wind generation. It`s been trading flat at just over $40 since September, and gurus decided last week to pull out their money and put it elsewhere. They sold nearly 85% of their shares of Scottish Power.

Guru Buys:

Northern Orion Resources
Oil Service HOLDRs
Elan
Fred`s
Wachovia

Guru Sells:

Bank of America
InfoSpace
Labor Ready
Rentech
Scottish Power

Marketocracy.com tracks more than 60,000 stock portfolios that are run by amateur investors. Of those, the top 100 performing portfolios are mirrored in a real life mutual fund, the Masters 100 Fund (MOFQX). Each week, Guru Picks analyzes the buys and sells of this best performing group of investors, known as the M100.

More Guru Picks

Send comments and questions to [e-mail].

http://www.forbes.com/investmentnewsletters/2006/03/07/oih-e…

[bernie55]

[posting]20.573.801 von Poppholz am 08.03.06 13:34:31[/posting]GURUS, bloody well done !!!!

[Poppholz]

Tysabri sales and sclerosis drug
- 08 march 2006 - 10:30


TYSABRI SCLEROSIS DRUG - Tysabri sales and sclerosis drug. Biogen Idec Inc. and Elan Corp. seeking to resume US sales of their multiple sclerosis drug Tysabri. They proposed to restrict the treatment`s use to reduce the risk patients will contract a rare, fatal brain disease. Tysabri two-year phase III multiple sclerosis clinical trial results and safety evaluation published in New England Journal Of Medicine.

Tysabri Currently Under Review with U.S. and European Regulatory Authorities. Biogen Idec and Elan Corporation, plc announced today that two-year results from the two Phase III clinical trials evaluating TYSABRI (natalizumab) for patients with relapsing forms of multiple sclerosis (MS), as well as data from the comprehensive safety evaluation of the product were published for the first time in this week`s issue of The New England Journal of Medicine.


Tysabri sales and sclerosis drug


The two-year data from the Phase III MS trials were previously presented at U.S. and international medical meetings during 2005. Tysabri was suspended a year ago after it was linked to two fatal cases of progressive multifocal leukoencephalopathy, a brain infection known as PML that is caused by a virus. Study results suggested Tysabri is twice as effective as other MS treatments. At the same time, people taking it face a 1 in 1,000 risk of PML, according to the National Institutes of Health.

Data from the Phase III AFFIRM monotherapy trial, the Phase III SENTINEL trial in which TYSABRI was added to AVONEX (Interferon beta-1a) therapy, and the safety evaluation were submitted to the U.S. Food and Drug Administration (FDA) in a supplemental Biologics License Application (sBLA) in September 2005. The sBLA is under Priority Review, and the companies anticipate action from FDA in late March. Similar data have been submitted to European regulatory authorities.

Two-year AFFIRM Phase III monotherapy data published today showed that treatment with TYSABRI reduced the risk of disability progression by 42% (p>0.001), the primary endpoint of the study, and led to a 68% reduction (p>0.001) in the annualized relapse rate compared to placebo. TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. The two-year SENTINEL Phase III data also demonstrated that treatment with TYSABRI in addition to AVONEX had a significant effect on disability progression, relapse rate and brain MRI disease activity compared to AVONEX alone.

Biogen Idec and Elan collaborated with leading experts in MS and progressive multifocal leukoencephalopathy (PML) to complete a safety evaluation of more than 3,000 patients who had received TYSABRI. An Independent Adjudication Committee, established as part of the safety evaluation, today published its findings that concluded there were no new confirmed cases of PML in patients treated with TYSABRI beyond the three previously reported by the companies.

"Data from AFFIRM and SENTINEL, among the largest ever Phase III MS trials, provide compelling evidence of the benefit of TYSABRI. Currently available MS therapies often do not adequately control the disease for many patients, creating a significant unmet need that TYSABRI may help address. It is encouraging to see that regulatory agencies are reviewing data from the clinical trials and the comprehensive safety evaluation to clarify the risk-benefit profile of TYSABRI in MS," said Chris Polman, MD, PhD, lead investigator of the AFFIRM study, professor of Neurology at Vrije Universiteit Medical Centre, and clinical and scientific director of the Multiple Sclerosis Centre at the VU Medical Centre, Amsterdam.

IAC Safety Evaluation

As part of the safety evaluation, the IAC was established to review any suspected cases of PML. The IAC was chaired by Eugene Major, PhD, Chief of the Laboratory of Molecular Medicine and Neuroscience at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. Highlights of the IAC`s findings include:

The safety review was designed to evaluate TYSABRI clinical trial patients and any reports of suspected PML in patients receiving TYSABRI in the commercial setting. Of the 3,826 MS, Crohn`s disease (CD) and rheumatoid arthritis (RA) clinical trial patients eligible for the evaluation, 3,389 (89%) participated (2,046 MS patients, 1,343 CD and RA patients).

Of the participating MS patients, 97% were examined with MRI or neurological exam within three months of the last dose, while 91% of CD and RA patients were examined within 6 months of the last dose. A total of 44 patients were referred to IAC for evaluation, which determined that none of the referred cases met the diagnostic criteria for PML.

About AFFIRM and SENTINEL

Both AFFIRM and SENTINEL were designed to evaluate the effect of TYSABRI on the progression of disability as measured by at least a one-point worsening on the Expanded Disability Status Scale (EDSS) sustained for three months, and on the rate of clinical relapses. AFFIRM was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide. Patients in the AFFIRM monotherapy trial were randomized to receive either a 300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks. SENTINEL was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 124 clinical trial sites worldwide. AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their regimen of AVONEX.

TYSABRI Phase III Safety

The adverse events most strongly associated with TYSABRI therapy compared to placebo in AFFIRM were fatigue and allergic reaction. Adverse events in SENTINEL associated with add-on therapy compared to AVONEX alone were anxiety, pharyngitis, sinus congestion and peripheral edema. The incidence of serious adverse events was not significantly different between the two treatment groups in each trial, and in each trial the most common serious adverse event was MS relapse. In SENTINEL, one of the serious adverse events reported was PML, a rare and potentially fatal, demyelinating disease of the central nervous system. A second patient was diagnosed with PML, and subsequently died during the extension phase of the study. Both cases of PML were observed in TYSABRI plus AVONEX-treated patients. In both AFFIRM and SENTINEL, the proportion of patients with non-serious and serious infections, and the rate of these infections were similar in the two groups.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding the potential and regulatory path forward of TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies` current expectations include the risk that we may unable to adequately address concerns or questions raised by FDA or European regulatory authorities during the regulatory review process, that concerns may arise from additional data or analysis, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies` drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Sclerosis is a hardening within the nervous system, especially of the brain and spinal cord, resulting from degeneration of nervous elements such as the myelin sheath. Sclerosis is a hardening of soft tissues, especially nerves, due to disease.Multiple sclerosis (MS) is a demyelinating disease, a non-contagious chronic autoimmune disorder of the central nervous system which can present with a variety of neurological symptoms occurring in attacks or slowly progressing over time. It has no cure yet and the exact cause remains unknown. Due to its effects of the nervous system, it can lead to long-term impaired mobility and disability in the more severe cases.

http://www.actualites-news-environnement.com/20060308-tysabr…

[Poppholz]

aus dem Yahoo Board ist zu vernehmen, dass die FDA keine weiteren Studien für die Wiederzulassung benötigt.



(ich verstehe das als sehr gut)

[Poppholz]

Q5 ist mit NO beantwortet worden.

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4208-in…

[bernie55]

[posting]20.576.642 von Poppholz am 08.03.06 15:42:39[/posting]YEPP......sehe ich als Laie auch so.....


sogar Cyberhexe schrieb in ihrem Thread:

na also , exklusiv vom AC...keine weiteren Daten erforderlich

[Birgit.Tersteegen]

[posting]20.576.642 von Poppholz am 08.03.06 15:42:39[/posting]POPPI,WO?

[Birgit.Tersteegen]

These people are going to approve..
by: stop_farking_with_me
Long-Term Sentiment: Strong Buy 03/08/06 09:51 am
Msg: 945974 of 945974

with just a few restrictions. They all want it back. They are all Neuros. Most are just like Pin. I told a you long time ago, these people are the `rock stars` of the medical profession. They are smart, independent and trying to HEAL patients.

My faith is restored. The wall street analysts, however.......

[wpdirekt]

Hat irgend jemand eine Ahnung wann derhandel bei Elan wieder aufgenommen wird?
Danke im voraus

[Birgit.Tersteegen]

This grandstanding is ponderous
by: boinked13
Long-Term Sentiment: Strong Buy 03/08/06 09:49 am
Msg: 945969 of 945991

Does anyone else get the feeling that this is all nothing but FDA window-dressing? That their minds were already made up before this meeting even started, yet they needed to make it look good by covering their asses?

Ty is coming back...now it`s just a matter of how high the 6% shorts will drive the share price while covering.

Let`s get this double-speak over with already and start getting Ty to the people that need it.

[bernie55]

[posting]20.576.692 von bernie55 am 08.03.06 15:44:14[/posting]und noch einmal " unsere " CYBERHEXE :

der " worst case" ist abgewendet, jetzt bin ich mal auf das Label gespannt...also Jungens und Mädels jetzt kanns losgehen!

dem sei nichts mehr hinzuzufügen ......


...außer einem

[Birgit.Tersteegen]

Achtung Achtung

Link zur Konferenz mms://wmslive.talkpoint.com/bear002_15147_150k.wmv

[bernie55]

CYBERHEXE ist heute richtig aktiv !!!

Time is brain" for MS patients ...wenn es so weiter geht, dann ist sogar eine Erstmedikation mit Ty wieder durchaus realistisch!

[Nostarowie]

Indikatoren krebsen auch alle im Keller rum, selbst wenn es ein sell on good news geben sollte ist da nicht mehr viel platz nach unten. Aber daran mag ich nicht glauben...

hier ma paar bunte Bilder...

[Birgit.Tersteegen]

LOS LEUTE MIT MEDIAPLAYER SEID IHR DABEI


SUPER!!!!

[Poppholz]

[posting]20.576.904 von Birgit.Tersteegen am 08.03.06 15:51:35[/posting]945890 =>
Q5 - No new study data need to remarket
liv4cycling
03/08/06 09:36 am

945889
Re: Q5...Fantastic... it is a GO
mondoukusai Strong Buy
03/08/06 09:36 am

945888
Q5 (with full text) - Can come back!
eireamerica Strong Buy 2
03/08/06 09:35 am

945887
Q5: answer NO
marryfetter1000 Strong Buy
03/08/06 09:35 am

945886
NO ADDITIONAL DATA NEEDED!!!!
dddctech Strong Buy 7
03/08/06 09:35 am

945885
Question 5 = NO EOM
poke1221 Buy 1
03/08/06 09:35 am

945884
sweeeet :-) <EOM>
dave_n_pam2003 Hold
03/08/06 09:35 am

945883
5 is a no!
gb0743
03/08/06 09:35 am

[bernie55]

[posting]20.577.157 von Birgit.Tersteegen am 08.03.06 15:59:54[/posting]http://wmslive.talkpoint.com/bear002_15147_150k.wmv

[bernie55]

[posting]20.577.290 von Birgit.Tersteegen am 08.03.06 16:03:47[/posting]http://wmslive.talkpoint.com/bear002_15147_150k.wmv

[Birgit.Tersteegen]

Wir sind dabei!!!

[bernie55]

YEPP !!!

SUPER ....GEMACHT , BIGGIE !!!!!

[Nostarowie]

Bin mal gespannt wie sich das morgen auswirkt.

[Birgit.Tersteegen]

kann nicht behaupten viel zu verstehen...

[bernie55]

....hauptsache dabei....

[bernie55]

..dabei sein ist alles....

[bernie55]

...der Olympische Gedanke ist immer und überall....

[Nostarowie]

jo irgendwie kommt kein Ton aus meinem Kasten...aber die Bilder sind schön...

[Birgit.Tersteegen]

oh,Blödmann spricht!Ty nur 2.Linie.Keine Ahnung wer es ist..

[Birgit.Tersteegen]

Abstimmung darüber gab kein Konsens...Gute Laune haben sie aber....

[shareholder4]

Sie haben die Doktoren gefragt, ob sie das Medikament als erstes Medikament an Patienten mit dieser Krankheit zu verabreichen! Ergebnis 7 dafür und 5 dagegen!
Na ja immerhin die Mehrheit

[Birgit.Tersteegen]

First Line = open over $15.00
by: dasbof (38/M/Washington DC)
Long-Term Sentiment: Strong Buy 03/08/06 10:35 am
Msg: 946232 of 946232

That would be huge for patients and investors alike!!!

[Birgit.Tersteegen]

1st line!!!! - 5 more questions
by: pinvestment 03/08/06 10:36 am
Msg: 946236 of 946236

seems like this panel has seen the light

[Poppholz]

dies ist der 5-Tages-Chart von TEVA (die mit dem Tysabri / HIV Vergleich)

[lonesome loser]

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration panel said the multiple-sclerosis drug Tysabri could be given without restrictions, in a precursor vote to the question of whether the drug should be returned to the market.

The drug`s manufacturers, Biogen Idec Inc. (BIIB) (BIIB) and Elan Corp. (ELN) (ELN), pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

The 12-member panel of outside medical experts voted 7 to 5 in favor of allowing doctors to use Tysabri as a first-line treatment, meaning that other MS drugs would not have to be tried first. The panel voted 11 to 1 against requiring that the drug be used in sicker MS patients.



The panel has not yet voted on whether it would allow Tysabri to return to the market. However, earlier the panel said the FDA should not require the companies to conduct additional studies before the drug should be put back on the market, suggesting the panel supports at least a limited return.

The FDA usually follows its panel`s advice, but is not required to. The agency is expected to make a final decision by the end of the month.

[bernie55]

aus CYBERHEXE THREAD

alle bisherigen Abstimmungen:

1) Tysabri als Erstmedikation möglich
ja:7
nein:5

Kommentar: fantastisch

2) Medikation nur bei höheren EDSS-Werten (mit der Leistungsskalla " EDSS" werden neurologische Behinderungsgrade angegeben)
ja:1
Rest nein

Kommentar: fantastisch

3) Medikation ohne RRMS (also andere MS-Formen)
einstimmig nein

Kommentar: erwartet


4) Medikation in Kombi-Therapie
einstimmig nein

Kommentar: erwartet


12:0 !!!!!!!
für die Rückkehr Tysabris auf den Markt

[Poppholz]

Biogen, Elan Win Backing for U.S. Sales of Tysabri (Update1)
March 8 (Bloomberg) --

Biogen Idec Inc. and Elan Corp. won the backing of a U.S. regulatory panel to resume sales of Tysabri, the multiple sclerosis drug withdrawn a year ago because it was linked to a rare, fatal brain infection.

After an emotional, two-day hearing in Gaithersburg, Maryland, a committee of doctors and scientists today voted unanimously that the Food and Drug Administration should allow the drug back on the market as a first-line MS treatment. The panelists acceded to pleas from MS patients and data from the companies showing that benefits outweighed risks for the drug.

Tysabri may be only the second drug to be put back on the market following a safety-related suspension, after the GlaxoSmithKline Plc irritable bowel treatment Lotronex in 2002. The drugmakers and multiple sclerosis patients want Tysabri cleared for sale because it is better than existing therapies for a neurological disease that affects 400,000 Americans. The FDA may decide by the end of this month.

Not using Tysabri to treat some cases of rapidly progressing multiple sclerosis ``would be harmful to the patient,`` said panelist Lilly Jung, medical director of the neurology clinic at Swedish Neuroscience Institute in Seattle, in today`s discussion.

The advisers recommended that Tysabri not be limited to patients that haven`t been helped by other therapies and allow it to be prescribed as a first-choice therapy.

The committee will decide later today on how to recommend that the agency ensure the safety of patients. FDA officials said yesterday they have been working with Biogen and Elan to strengthen a safety proposal.

1 in 1,000 Risk

Trading in shares of Cambridge, Massachusetts-based Biogen and Dublin-based Elan was halted yesterday and today for the meeting. Elan gained 70 cents, or 6.6 percent, to 11.30 euros yesterday before the trading halt.

Tysabri was suspended a year ago because of a link to a rare, fatal brain disease known as progressive multifocal leukoencephalopathy, or PML. People taking it face a 1 in 1,000 risk of contracting the infection, according to the National Institutes of Health. At issue, the patients said yesterday, is their right to face that risk if they so choose.

``I know Tysabri works,`` said Heather Smith, a mom from Indiana with multiple sclerosis, in an interview before she addressed the committee yesterday in Gaithersburg, Maryland. ``I know other drugs failed me. I know there`s a risk. It`s a risk I`m willing to take.``

Using the drug gave Smith the ability and stamina to play with her toddler, she said. Now she`s back in a wheelchair as she urges U.S. regulators to make the drug available again.

Best New Treatment

Before its Feb. 28, 2005, withdrawal, Tysabri was considered the best new treatment for MS patients in a decade and a potential $3 billion-a-year seller for the companies. Study results suggested Tysabri is twice as effective as other MS treatments.

MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis. It affects about 2.5 million people worldwide. In severe MS, people have permanent symptoms, including partial or complete paralysis.

The FDA approved Tysabri on Nov. 23, 2004, based on data showing that the drug reduced MS relapses by two-thirds. Current therapies such as Biogen`s Avonex decrease relapses by one third, according to previous studies. About 8,000 patients took the drug by the time it was withdrawn, including people in clinical trials.

Safety Plan

The companies` proposed safety plan, which would include distribution controls, restrictions on prescribing and patient tracking, would be aimed at educating patients and limiting use to those who are aware of the potential dangers.

``Given the risk, we have to be very clear on the diagnosis,`` said panelist Karl Kieburtz, professor of neurology and community and preventive medicine at the University of Rochester in Rochester, New York. ``We have to be sure people have MS.``

Tysabri`s prescribing information should include the FDA`s strictest warning, outlined in a black box, that the drug is associated with an increased risk of PML, Biogen said yesterday. Doctors would be instructed to immediately suspend treatment if patients show signs of PML, and they should begin testing for PML and the virus that causes it.

The drug would be administered at a registered infusion center, and Biogen would implement strict distribution controls, the company told the panel. Patients would be required to participate in a registry and would have to read and sign a form confirming they understand Tysabri`s risks. Biogen would then assign each patient an authorization number.


To contact the reporters on this story:
Angela Zimm in Boston at [e-mail];
Shannon Pettypiece in Washington at [e-mail].
Last Updated: March 8, 2006 11:12 EST

http://quote.bloomberg.com/apps/news?pid=10000087&sid=aFyUGz…

[Poppholz]

AP
FDA Panel Supports MS Drug`s Market Return
Wednesday March 8, 11:24 am ET FDA Panel Unanimously Supports MS Drug Tysabri`s Return to U.S. Market

WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should allow multiple-sclerosis drug Tysabri back on the market.
The drug`s manufacturers, Biogen Idec Inc. and Elan Corp., pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

The 12-member panel voted unanimously to support the drug`s return.

The FDA usually follows its panel`s advice, but isn`t required to do so. The agency is expected to make a final decision by the end of the month.


http://biz.yahoo.com/ap/060308/ms_drug.html?.v=2

[Poppholz]

FDA Panel Votes Unanimously To Bring Back Tysabri 03.08.06, 11:28 AM ET

New York - A U.S. Food and Drug Administration advisory panel recommended the return of Tysabri as patients and family members pleaded for the return of the multiple sclerosis drug.

The results of the unanimous vote came early on the second day of the two-day meeting in Gaithersburg, Maryland. The FDA is not required to follow the advice of the panel but generally does.

Shares of Elan (nyse: ELN - news - people ) and Biogen Idec (nasdaq: BIIB - news - people ) remained halted during Wednesday`s session but will resume trading upon completion of the meeting.

The companies halted sales of Tysabri in February 2005 after three patients being treated with Tysabri and Avonex, another MS drug Biogen, developed a rare but dangerous central nervous system disease known as progressive multifocal leukoencephalopathy, or PML. Two of the patients died.

http://www.forbes.com/2006/03/08/elan-biogen-tysabri-0308mar…

[Poppholz]

UPDATE 1-MS drug Tysabri should return to market-US panel
Wed Mar 8, 2006 11:48 AM ET
(Recasts with vote)

By Lisa Richwine

GAITHERSBURG, Md., March 8 (Reuters) - Biogen Idec`s (BIIB.O: Quote, Profile, Research) multiple sclerosis drug Tysabri should return to the market with safeguards to closely monitor patients for a potentially fatal complication, a U.S. advisory panel unanimously ruled on Wednesday.

Biogen and marketing partner Elan Corp. (ELN.N: Quote, Profile, Research) (ELN.I: Quote, Profile, Research) voluntarily suspended sales in February 2005 after three patients developed a brain and spinal cord infection known as progressive multifocal leukoencephalopathy, or PML. Two of the patients died.

Members of the U.S. Food and Drug Administration advisory panel voted 12-0 that Tysabri sales could resume if Biogen creates a mandatory patient registry to track side effects and imposes other controls.

Many patients do not find relief with current MS drugs and should have Tysabri as an option, panel members said.

"Most people in (Tysabri) studies did not have a relapse and did not have disability progression," said Dr. Karl Kieburtz, the panel chairman.

The FDA will make the final decision but usually follows advisory panel recommendations.

The panel voted 7-5 that Tysabri could be considered as a first-choice treatment for some MS patients.

Tysabri is a key drug for both Biogen and Elan. It had been dubbed a billion-dollar-a-year seller before the safety concern arose.

Sanford Bernstein analyst Geoff Porges said after the panel votes that Tysabri sales could reach $700 million a year by 2010.

"There`s going to be a real cautionary statement toward patients and physicians, and they`re going to think twice about putting patients on the drug. Initially there are going to be a lot of desperate patients who jump on it, but it`s probably going to be a slow build.

"This is not going to become a routine drug in the next year or two," he said.

Multiple sclerosis causes progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function as nerves lose their insulating sheath. About 300,000 Americans have MS.

(Additional reporting by Bill Berkrot in New York)

http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx…

[Poppholz]

FDA Panel Supports Tysabri Return To U.S. Market

03-08-06 11:20 AM EST

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration panel said Wednesday the agency should allow multiple-sclerosis drug Tysabri back on the market.

The drug`s manufacturers, Biogen Idec Inc. (BIIB) and Elan Corp. (ELN), pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

The 12-member panel voted unanimously to support the drug`s return.

The FDA usually follows its panel`s advice, but isn`t required to do so. The agency is expected to make a final decision by the end of the month.

Earlier Wednesday, the panel said Tysabri could be given to MS patients without certain restrictions. The panel is currently also discussing various elements of a risk-management plan proposed by Biogen and Elan and will make recommendations about whether it should be changed.

The panel voted 7-to-5 in favor of allowing doctors to use Tysabri as a first- line treatment, meaning other MS drugs wouldn`t have to be tried first. The panel voted 11-to-1 against requiring that the drug be used in sicker MS patients.

The FDA panel`s votes come a day after it heard from dozens of MS patients who urged the FDA to give them access to the drug.

It is rare for the FDA to return a drug to the market once it has been pulled, but Robert Temple, the FDA`s director of drug evaluation, said Tuesday that Tysabri deserves consideration because "what we are talking about here is a drug that unequivocally works and unequivocally works well." Still, he and other FDA officials said they are concerned about the risk of PML, and if the drug were to be returned to the market it would be done only under conditions that would allow that risk to continue being studied.

Two of the three patients who had PML were also taking Avonex, another MS drug made by Biogen. However, the panel said Wednesday it believed that didn`t mean the risk of PML occurred only as a result of a combination of Tysabri and Avonex, and that more study is needed.

Biogen proposed returning the drug under a restricted-access program that would make it available to registered patients, doctors and clinics where the drug would be administered intravenously once a month. While Tysabri would also be marketed by Elan, only Biogen officials appeared before the FDA panel. The companies have also proposed studying the drug in 5,000 patients for at least five years.

Biogen also proposed the drug carry a strict "black box" warning that highlights the risk of PML and states that the drug should be given alone rather than with other MS drugs.

About 400,000 people in the U.S. have MS, a progressive disease that involves damage to nerves controlling muscles and vision.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail].


(END) Dow Jones Newswires
03-08-06 1120ET
Copyright (c) 2006 Dow Jones & Company, Inc.

[Poppholz]

Panel Supports Tysabri Return

By Althea Chang
TheStreet.com Staff Reporter
3/8/2006 11:58 AM EST
Click here for more stories by Althea Chang

The Food and Drug Administration advisory panel discussing Tysabri has unanimously decided to recommend that the FDA allow the multiple sclerosis drug from Biogen Idec and Elan to return to the market.

The panel, made up of medical experts, is holding its second day of a two-day meeting on Tysabri. The drug was taken off the market in February 2005 after being linked to a rare and possibly fatal brain illness.

Shares of both companies are halted for trading during the committee`s meeting. Panel members are currently discussing what conditions should be met before Tysabri is given to individual patients.

Many Wall Street analysts expected that Tysabri would again be available for sale, but with certain conditions attached. The FDA isn`t required to follow the advice of its advisory panels, but it usually does.

http://www.thestreet.com/_yahoo/stocks/biotech/10272506.html…

[Birgit.Tersteegen]

PAUSE--das hab ich verstanden---und Ihr??

[Birgit.Tersteegen]

Re: I`ve been at work could anyone..
by: mm99773 (49/SF Bay Area, CA) 03/08/06 12:36 pm
Msg: 947103 of 947106

Yes.

Unanimous vote by Advisory Committee to bring Tysabri back!

Meeting will in progress to hammer out some last details.

Halt is still in progress, but we`re waiting to see when it will be lifted.

Congratulations!

------------------------------------------------------------

ist es jetzt wirklich so????????????????????????????

[mikel_ann]

Biogen/Elan: Tysabri kommt zurück
Das umstrittene Multiple-Sklerose-Medikament „Tysabri“ von Biogen Idec (Nachrichten/Aktienkurs) und der Elan Corporation (Nachrichten) soll in den USA wieder zugelassen werden. Dies hat heute ein Expertengremium der FDA einstimmig beschlossen. Die Zulassungsbehörde folgt für gewöhnlich den Empfehlungen der vorgeschalteten Fachgremien.

Tysabri war einst das wichtigste Medikament der beiden Arzneimittelkonzerne und versprach jährliche Milliardenumsätze. 2005 war das Präparat allerdings vom Markt genommen worden, nachdem sich einige Todesfälle ereignet hatten.

Das medizinische Gremium hat nun entschieden, dass die beiden Konzerne ein umfangreiches Registrierungssystem aufbauen müssen. Durch intensive Beobachtung der Patienten sollen möglicherweise tödliche Folgen vermieden werden. Das Medikament sei allerdings zu wichtig, um komplett darauf zu verzichten. Für viele Multiple-Sklerose-Kranke sei es zu einem Hoffnungsträger geworden.

Analysten gehen davon aus, dass es sich viele Ärzte in Zukunft zweimal überlegen dürften, bevor sie Tysabri verschreiben. Jedoch gebe es in den USA 300.000 MS-Patienten. Bei vielen von ihnen würden die gängigen Präparate nicht anschlagen.

In den USA sind die Titel von Biogen Idec und Elan weiter vom Handel ausgesetzt.

[Birgit.Tersteegen]

Schade, dass wir nicht eine Konferenzschaltung zum gemeinsamen freuen haben.......PUH--erst mit Mologen durch die Hölle und dann mit Elanie in den Himmel.....und dann noch WELKES Paket heute.....IRRE

[Birgit.Tersteegen]

PS Weltfrauentag heute--wundert Euch dann das gute Ergebnis...

PS2 Ganz schöner Film zum "Menschsein" und worum es wirklich geht..."Wie im Himmel"---ein "Muss"!

PS3 Ich freu mich so.....

[Dennie]

Danke für die Deutsche übersetzung,habe ELAN schon über ein Jahr mein Englisch ist aber nicht so gut das ich hier alles gleich schnalle wird bei uns morgen früh wieder gehandelt ? Wo könnte der erste Kurs wohl liegen kann das jemand realistisch schon einschätzen ?

[Birgit.Tersteegen]

Piper Jaffray *UPGRADES* Elan !!! ...
by: hazeleye2 (35/M/North Richland Hills - DF)
Long-Term Sentiment: Strong Buy 03/08/06 12:46 pm
Msg: 947169 of 947312

Tysabri, the multiple sclerosis drug from Biogen Idec (BIIB:Nasdaq - commentary - research - Cramer`s Take) and Elan (ELN:NYSE ADR - commentary - research - Cramer`s Take), has returned to market with no restricts and blockbuster potential says investment research firm Piper Jaffray.

The survey revealed that while 98% of doctors now believe the drug could be a valuable therapy to MS patients, only 83% think Tysabri will be used to treat other ailments before 2007.

Piper Jaffray analyst Deborah A. Knobelman expects the FDA to approve alternate uses for Tysabri drug before end of 2007. The survey involved 140 neurologists, 97% of whom have prescribed Tysabri.

Tysabri was withdrawn over a year ago after being linked to a brain disease called progressive multifocal leukoencephalopathy. It has since been determined that the disease was cause by adverse reactions to Biogens Avonex. As a result, Biogen has now stopped marketing Avonex to concentrate on sales of Tysabri. Since the re-introduction of Tysabri as a mono treatment, their have been no deaths directly linked to the drug.

In the coming months, a Food and Drug Administration advisory committee is scheduled to meet for two days to decide whether Elan might have another blockbuster on its hands with its new Alzheimer`s drug.

Piper Jaffray recently initiated coverage of ELN with a strong buy recommendation and a $60 12-month target. Piper Jaffray also maintains a position in Elan.

Note: this is a future headline.

[Birgit.Tersteegen]

Welkes Merlot im Yahoo-Board...

Bottle of Merlot
by: afret1995 03/08/06 01:07 pm
Msg: 947257 of 947346

I`ve been saving this special bottle for an event like today. Congrats to all fellow longs and to MS sufferers who can return to Tysabri. The wine will indeed taste good tonight.

Any guesses on bid/ask at the open tomorrow?

[Birgit.Tersteegen]

BLOOMBERG GERADE






E-Mail This Story Printer-Friendly Format


Video
FDA Panel Vote on Resumption of Tysabri Sales

Biogen, Elan Win Backing for U.S. Sales of Tysabri (Update2)

March 8 (Bloomberg) -- Biogen Idec Inc. and Elan Corp. won the backing of a U.S. regulatory panel to resume sales of the multiple sclerosis drug Tysabri after patients argued that the treatment`s benefits outweighed its risks.

After an emotional, two-day hearing in Gaithersburg, Maryland, an advisory committee of doctors and scientists voted unanimously today that the Food and Drug Administration should allow the drug back on the market as a first-choice therapy. Tysabri was withdrawn a year ago because it was linked to a rare, fatal brain infection.

Tysabri is only the second drug to be put back on the market following a safety-related suspension. Patients and the companies cited research showing the drug is twice as effective as other treatments against a neurological disease that affects 400,000 Americans. The FDA, which typically follows advisory panel recommendations, may make its final decision on the drug by the end of this month.

``In the next six months, year, two years, Tysabri will be the most popular first-line medication,`` said Mark Gudesblatt, medical director of a comprehensive multiple sclerosis care clinic at South Shore Neurologic Associates in Bayshore, Long Island, in an interview today. He said he will start using Tysabri that way himself.

Shares May Rise

The recommendation that Tysabri be cleared as a first-choice therapy may spur the drug`s use if adopted by the agency. The panel is to decide later today on measures to ensure the safety of patients. FDA officials said yesterday they have been working with Biogen and Elan to monitor the drug`s use and require patients sign a consent form saying they have been advised of the drug`s risks.

MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis. It affects about 2.5 million people worldwide. In severe MS, people have permanent symptoms, including partial or complete paralysis.

The unanimous vote suggesting Tysabri be available to all MS patients is certain to help the companies` shares, which have been hurt since the drug was withdrawn. Before its Feb. 28, 2005, withdrawal, Tysabri was considered the best new treatment for MS patients and a potential $3 billion-a-year seller. Before today`s meeting, analysts said safety concerns might limit annual sales to $200 million to $700 million.

Trading in shares of Cambridge, Massachusetts-based Biogen and Dublin-based Elan was halted yesterday and today for the meeting. Elan gained 70 cents, or 6.6 percent, to 11.30 euros yesterday before the trading halt.

Competing Companies

Shares of Geneva-based Serono SA, maker of a competing MS treatment, dropped after the committee`s vote this morning. The stock fell 29 Swiss francs, or 3.1 percent, to 907 francs at 4:30 p.m. in Zurich. Teva Pharmaceutical Industries Ltd., the Petah Tikva, Israel-based maker of another competing product, gained 10 shekels to 19410 shekels at 3:20 p.m. in Tel Aviv.

``It seems very clear that the panel is biased toward giving the greatest flexibility to doctors and patients,`` said Jason Kantor, an analyst at RBC Capital Markets in San Francisco, in an interview today. He rates Biogen shares ``hold`` and doesn`t own the stock. ``I would have expected a more cautious position.``

Kantor, who declined to give his sales expectation for Tysabri, said he expects Wall Street analysts to increase their estimates.

The only other treatment cleared by the FDA for a resumption of sales was GlaxoSmithKline Plc`s irritable bowel drug Lotronex, which was returned to the market with restrictions in 2002 after a link to patient deaths.

`It`s Real Good`

People taking Tysabri face a 1 in 1,000 risk of contracting a rare, fatal brain disease known as progressive multifocal leukoencephalopathy, or PML, according to the National Institutes of Health. Study results suggested Tysabri is twice as effective as other MS treatments. At issue, patients said yesterday, is their right to face the risk if they so choose.

``We let them know what was happening in the MS population,`` said Mike Barron, 48-year-old former nuclear power plant operator from Phoenix, in interview in Gaithersburg after today`s vote. `People were losing their lives. I think the drug will transform the MS community for the better. It`s real good.``

Some doctors, while still worried about the safety of the drug, said they welcomed the choice of an additional treatment for patients who have few options.

Doctor`s Concerns

``My inclination will be personally, initially, to reserve use of the drug for people who are having a suboptimal response to the other available treatments,`` said Aaron Miller, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mt. Sinai School of Medicine in New York, in an interview today. ``I still have level of concern about the complete safety of the drug as monotherapy.``

The companies` proposed safety plan, which would include distribution controls, restrictions on prescribing and patient tracking, would be aimed at educating patients and limiting use to those who are aware of the potential dangers.

``Given the risk, we have to be very clear on the diagnosis,`` said panelist Karl Kieburtz, professor of neurology and community and preventive medicine at the University of Rochester in Rochester, New York. ``We have to be sure people have MS.``

Tysabri`s prescribing information should include the FDA`s strictest warning, outlined in a black box, that the drug is associated with an increased risk of PML, Biogen said yesterday. Doctors would be instructed to immediately suspend treatment if patients show signs of PML, and they should begin testing for PML and the virus that causes it.

The drug would be administered at a registered infusion center, and Biogen would implement strict distribution controls, the company told the panel. Patients would be required to participate in a registry and would have to read and sign a form confirming they understand Tysabri`s risks. Biogen would then assign each patient an authorization number.


nun gehts weiter...

[Cyberhexe]

[posting]20.581.895 von Birgit.Tersteegen am 08.03.06 19:22:15[/posting]Hallo Birgit...bitte beachte folgenden Hinweis:
this is a future headline

also reine Spekulation, obschon ich davon überzeugt bin, dass der Spekulant Recht haben könnte.

Danke, für das virtuelle Blümchen

ch

[Birgit.Tersteegen]

[posting]20.582.188 von Cyberhexe am 08.03.06 19:34:33[/posting]stimmt....!!(sorry,erst gesehen als es schon verschickt war)

dr. gudesblatt has seen the light
by: pinvestment 03/08/06 01:39 pm
Msg: 947379 of 947430

just imagine what could happen as this again becomes the prevailing opinion

``In the next six months, year, two years, Tysabri will be the most popular first-line medication,`` said Mark Gudesblatt, medical director of a comprehensive multiple sclerosis care clinic at South Shore Neurologic Associates in Bayshore, Long Island, in an interview today. He said he will start using Tysabri that way himself.

[Birgit.Tersteegen]

ELN $40-$50 BY DEC 06! T BLOCKBUSTER
by: dddctech (35/M/dddc headquarters)
Long-Term Sentiment: Strong Buy 03/08/06 02:07 pm
Msg: 947528 of 947528

I bet we will slowly climb to $40-$50 end of the year.

Keep holding long and strong and reap great rewards at the end of the year.

EMEA in Europe will be next to approve Tysabri

Then we have data from Alzheimer Phase II -- $60/share?

[Birgit.Tersteegen]

CNBC - FDA WILL PROMPTLY RETURN TYSABRI
by: hunglikeahorz (33/M/NC)
Long-Term Sentiment: Strong Buy 03/08/06 02:20 pm
Msg: 947609 of 947691

Mike of CNBC intereviewed an FDA official who said "We are very aware of the unmet needs of patients and we will promptly return Tysabri"

[Birgit.Tersteegen]

they are debating on what
by: redox4cancer 03/08/06 02:33 pm
Msg: 947707 of 947710

kind of procedure (i.e. MRI )should be checked in every 2-3-6-12 months?

i think no method right now make sense. no solution right now. This current debate in AC goes no way. only solution is to have the companies to develope a method to check patients` true immune level: that is TY-FREE lymphocytes!!! if patients` true immune level is normal every months. There is no chance that JCV develope into PML.

Hope the companies already take action in that direction. It is painful for those in the AC to debate on this nonsense point

[eliasesteban]

es darf gefreut werden,seh ich das richtig?ich glaub jetzt muss ich auf die piste,so long saludos
eliasesteban

[Birgit.Tersteegen]

[posting]20.584.588 von eliasesteban am 08.03.06 21:13:32[/posting]YYYYYYYYYYYYEEEEEEEEEEEEEEEEEEEEESSSSSSSSSSSSSSSSSSS!!!!!!


Re: When is trading to resume?
by: cwackman
Long-Term Sentiment: Buy 03/08/06 03:18 pm
Msg: 947934 of 947934

Ive read that it resumes tomorrow morning. Possibly in Europe before US?

Any one know?

[Birgit.Tersteegen]

AC members did a great job...KUDOS
by: darrelldemello 03/08/06 03:22 pm
Msg: 947963 of 947964

They analyzed the data, played Devil`s advocate, asked some great questions, were provided with answers that (IMO) EXCEEDED their expectations, and carefully considered the Benefit VS Risk .... with the patients` in mind ... and when EFFICACY of Double currently available therapies is presented ... how can they go against the data?

And they approved the return of Tysabri with no restrictions ...

The patients that presented their sentiments and demonstrated their high level of knowledge, information and education about their disease and the advantages and disadvantages of available therapies ... have to be congratulated ... because it is not easy speaking about a progressive condition ...

A superb ending that could have not been scripted better even by Hollywood!

Thank you to all...

[Birgit.Tersteegen]

No reason
by: boiling.point 03/08/06 03:26 pm
Msg: 947989 of 947995

why this stock can`t go back to its pre-BM level of 30. Maybe not tomorrow but w/i a month or two as WS realizes the potential of tysabri and ELN.

[bernie55]

von unserer Cyberhexe




nun wirds ja immer besser, fast schon unheimlich-angeblich soll eine Studie mit Tysabri bei progressiver MS modelliert werden !

[hechtbarsch]

ich möchte gerne Danke sagen an alle, die sich hier im Thread so gekümmert haben.

hb

[Birgit.Tersteegen]

WIR SIND EIN TOLLES TEAM HIER---meine Freunde sind schon eifersüchtig auf das Bord.....aber mir machts so SPASS!!


WIRD GEHANDELT IN AMILAND 15,46$

[bernie55]

ELAN WIRD WIEDER IN USA GEHANDELT !!!!!!

Kurs aktuell 15,45 USD

[Antevenio]

ich schließe mich dem Dank von Hechtbarsch gerne an, vor allem an Birgit, Cyberhexe und Poppholz! Eure Beiträge waren oft sehr hilfreich, vor allem nach den Rücksetzern in den letzten Wochen! Bin froh, dass ich kein einziges Stück abgegeben habe. Morgen ist payday!

[bernie55]

15,63 USD

[mikel_ann]

[bernie55]

15,70 USD

[Birgit.Tersteegen]

15,80--bin begeistert!

[bernie55]

[posting]20.585.615 von Birgit.Tersteegen am 08.03.06 21:54:49[/posting]...lagen wir doch ganz gut mit unseren Schätzungen, Birgit

[bernie55]

heute noch über 16 USD !!????!!!

[Birgit.Tersteegen]

ooch,das tut mir aber leid....

OH GOD PLEASE HELP ME!!!
by: nuke_em_a1l (42/M) 03/08/06 03:58 pm
Msg: 948346 of 948346

I`m short and I`m margined beyond belief. I did not realize it was trading again. Please please please help me, I`m begging anyone for any advice.

[Birgit.Tersteegen]

Das ist jetzt auch gemein ......

Re: OH GOD PLEASE HELP ME!!!
by: a11ahloveselan 03/08/06 04:00 pm
Msg: 948372 of 948372

What floor are you on? If you are above the 5th floor, you could just through a chair through the window and jump ... all your troubles will be over!

Gook luck!

[Birgit.Tersteegen]

after hour handel geht schon los!

[bernie55]

....bei 15,70 USD bis 15,80 USD gibt es morgen in D:


13,17 € bis ca. 13,25 €

Aktuelle Wechselkurse:
1 EUR = 1,19210 USD (08.03. 22:03)


...na, das sieht doch schon wieder supi aus....

[Antevenio]

Birgit, wo kann man den after-hour-Handel von Eln sehen?

[bernie55]

...so ist das Leben......


die einen gehen unter .....

60` AC Milan (Ita) 4 - 1 Bayern Munich (Ger)


....die anderen stehen auf....

..über 24 % plus....

[bernie55]

[posting]20.585.916 von Antevenio am 08.03.06 22:05:46[/posting]http://www.island.com/bookviewer/javaversion.asp

--und ELN eingeben...

[Birgit.Tersteegen]

[posting]20.585.916 von Antevenio am 08.03.06 22:05:46[/posting]Level2Quotes.com

[bernie55]

[posting]20.585.916 von Antevenio am 08.03.06 22:05:46[/posting]http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[bernie55]

...bis morgen....schlaft gut.....

und träumt süß......


good night

bernie55

[Birgit.Tersteegen]

[posting]20.586.088 von bernie55 am 08.03.06 22:11:59[/posting]sliepp wäll in joer Bettjestell,BERNIE

[Birgit.Tersteegen]

Elan show tomorrow 11:20 AM eastern
by: gainorpain (55/Sonoma, CA) 03/08/06 04:16 pm
Msg: 948537 of 948548

http://biz.yahoo.com/bw/060301/20060301005398.html?.v=1

[Birgit.Tersteegen]

Bloomberg: " FDA to Act `Rapidly`"
by: tekn0wizz (38/M/NL)
Long-Term Sentiment: Strong Buy 03/08/06 04:21 pm
Msg: 948576 of 948587

[ http://quote.bloomberg.com/apps/news?pid=10000103&sid=aFm5n7… dex ]

Biogen, Elan Win FDA Panel Backing to Resume Tysabri MS Drug Sales in U.S.

March 8 (Bloomberg) -- Biogen Idec Inc. and Elan Corp. won the backing of a U.S. regulatory panel to resume sales of the multiple sclerosis drug Tysabri after patients argued that the treatment`s benefits outweighed its risks.

After an emotional, two-day hearing in Gaithersburg, Maryland, an advisory committee of doctors and scientists voted unanimously today that the Food and Drug Administration should allow the drug back on the market for use by all patients. Tysabri was withdrawn a year ago because it was linked to a rare, fatal brain infection.

...

``In the next six months, year, two years, Tysabri will be the most popular first-line medication,`` said Mark Gudesblatt, medical director of a comprehensive multiple sclerosis care clinic at South Shore Neurologic Associates in Bayshore, Long Island, in an interview today. He said he will start using Tysabri that way himself.

FDA to Act `Rapidly`

The recommendation that Tysabri be cleared for all patients may spur the drug`s use if adopted by the agency. The panel discussed measures to ensure the safety of patients and left final details of the plan for the FDA and the companies to work out. FDA officials have been working with Biogen and Elan on plans to monitor the drug`s use and require patients sign a consent form saying they have been advised of the drug`s risks.

``This is a drug that is obviously important to the MS community, said Robert Temple director of the FDA`s center for drug evaluation, in a press conference after the meeting. ``We need to take into account the committee recommendations and reach our own conclusions on the risk management plan. We`re going to do that very rapidly.``

...

The unanimous vote suggesting Tysabri be available to all MS patients is certain to help the companies` shares, which have been hurt since the drug was withdrawn. Before its Feb. 28, 2005, withdrawal, Tysabri was considered the best new treatment for MS patients and a potential $3 billion-a-year seller. Before today`s meeting, analysts said safety concerns might limit annual sales to $200 million to $700 million.

...

Elan`s 7.75 percent note maturing in 2011 rose 3.25 cents to 96.25 cents on the dollar, the yield falling 77 basis points to 8.6 percent, according to Trace, the bond price reporting service of the NASD. The extra yield investors demand to hold the note over government debt narrowed to 385 basis points from 465 basis points on March 3. A basis point is 0.01 of a percentage point.

The note was the most active among institutional investors with 34 trades of more than $1 million as of 2:30 p.m. in New York, according to Trace.

...

``It seems very clear that the panel is biased toward giving the greatest flexibility to doctors and patients,`` said Jason Kantor, an analyst at RBC Capital Markets in San Francisco, in an interview today. He rates Biogen shares ``hold`` and doesn`t own the stock. ``Sales could reach $1 billion`` a year, he said.

Use of Tysabri by patients for whom previous treatments haven`t already failed may raise sales of the drug to as much as $1.25 billion annually from $300 million with tighter use restrictions, said Jennifer Chao, an analyst at Deutsche Bank Securities in New York, in an interview today.

...

`It`s Real Good`

...

``We let them know what was happening in the MS population,`` said Mike Barron, 48-year-old former nuclear power plant operator from Phoenix, in interview in Gaithersburg after today`s vote. `People were losing their lives. I think the drug will transform the MS community for the better. It`s real good.``

[Nostarowie]

nach dem desasterfussball ist das hier ne erholung

pm $15,61 = 13,11€ eben

thx auch an euch allen für die arbeit hier im Thread...

N8 @ all

[Birgit.Tersteegen]

[posting]20.586.780 von Nostarowie am 08.03.06 22:52:37[/posting]Nosta,hab jetzt auch´n ZERTI auf Silber,der,oh wonder, sogar gleich gestiegen ist COMMERZBANK TUBULL WAG...CM0094.Gruss!

[Nostarowie]

Musste nochma lunzen

...oh gott Birgit mach mir nich alles nach das kann im Chaos enden...


so nu aber is umfallen angesagt bin müde.

[welke91]

16$! AH 17:53 Uhr
yes alles richtig gemacht Elanibaby !

[Birgit.Tersteegen]

[posting]20.587.399 von welke91 am 08.03.06 23:54:04[/posting]YEP

[Birgit.Tersteegen]

:kisson`t Sell Longs - HOLD PRECIOUS SHARES
by: taserblast (40/M/Merlin, Neverland)
Long-Term Sentiment: Strong Buy 03/08/06 05:58 pm
Msg: 949120 of 949120

Elan is the stock to hold for years.

[Birgit.Tersteegen]

"Flow Trader"

ELN, BIIB To Shine on Thursday
Posted on Wednesday 8 March 2006

The great rollercoaster ride that has been ELN and BIIB over the past year has taken another twist, as the FDA announced today that they will allow Tysabri to come back to the market. This is obviously huge news for shareholders of ELN and BIIB, as the stocks were destroyed after the FDA pulled Tysabri from the market. Shareholders in both companies needed extreme patience to stay in their positions, and it appears as though that patience is about to be rewarded. ELN opened for trading just before the end of the session, and quickly traded up 25% on heavy volume. BIIB is currently trading up almost 9% in the afterhours session. Expect both companies to set new 52 week highs on Thursday after this news, on extremely heavy volume.

[Birgit.Tersteegen]

Recommend this Post - This post has 33 recommendations Ignore this User | Report Abuse
My Post-AC Wrap-Up
by: rowerx1 03/08/06 11:01 pm
Msg: 950203 of 950349

I was going to title this "my post-GAME wrap-up" but this whole episode certainly has NOT been a game for MS patients and Elan investors.

More than relief, I feel...vindication. In the end, science and common sense prevailed. But I have to wonder, if not for the efforts of LJD and Stealthisalias and those involved with mspatientsforchoice.org "getting out the vote", might we have been on the short end of the 7-5 decision on TYSABRI use as a front-line therapy? The FDA AC apparently DOES hear the patients - if they yell loud enough.

I still maintain that, as a monotherapy, TYSABRI withdrawal was unnecessary in the first place. (A bit more on that in a separate post). However, having watched and learned from the AC process, I have come to the realization that the decision to completely withdraw TYSABRI in 2005 was made based on a biostatistical argument that has continued through the reapproval process. Basically, with PML numbers so low, the FDA and/or BIIB saw not two cases of PML in a combination therapy trial, but two PML cases. Period. It would have been better (not for the patients of course) if there were, say, 5 cases or 10 cases of PML in the SENTINEL trial, because then there would have been unambiguous biological and biostatistical evidence of a drug interaction effect. But with only 2 cases in 5000+ total TYSABRI patients, coupled with no known PML cases in patients given AVONEX over time, both the FDA and BIIB (and Elan, which probably conceded, less willingly) were more-or-less forced to utilize statistical arguments to damn TYSABRI as the agent to be associated with PML development.

And BIIB has maintained that position. Even toward the end of the AC meeting, they were staunchly maintaining that the fact that both PML cases showed up in SENTINEL and not AFFIRM was a quirk of the data. Time will tell, but I predict that we will see FAR LESS than a 1:1000 PML rate with TYSABRI monotherapy. Because common sense and science both indicate to me that, statistics be damned, PML resulted as a drug interaction effect, not from TYSABRI monotherapy use.

I will grudgingly thank BIIB for their efforts in getting TYSABRI back to the market. However, I thought that at times they sounded unprepared for certain questions from the AC. For example, this morning the AC asked for data on adverse effects (PML, opportunistic infections, etc) of other immunosuppressants used in MS patients, for comparative purposes. (Stuff that Pinvestment has written about several times here on the YMB). The BIIB people didn`t have it, but said they would get it by the afternoon. In the end, BIIB still lost out (and rightly so) on combination therapy. Let`s now see how aggressively they market TYSABRI while losing their share of AVONEX patients.

Something else I learned is that, in seeing the FDA in action, they are NOT the bogeymen (or bogeypersons) many of us thought they might be. They really are striving for the best balance between safety and efficacy. Yes, I would like to throttle one or two of the AC members for some of their questions and comments. However, on a whole, it was comforting to see and hear not the FDA Inquisition but very thoughtful, purposeful debate with respect to issues of patient safety, drug efficacy, and the doctor-patient relationship.

But in the final analysis, as PIN and others already familiar with the FDA process have been saying all along, this re-approval WAS a done deal. The last 6 months have been about crossing t`s, dotting i`s, and covering butts. And most everyone should be reasonably satisfied with today`s outcome. And although I think the whole process was less efficient than it could have been, I`m reasonably satisified with the outcome, too.

Rx1

------------------------------------------------------

Ty potential MUCH larger than before
by: scubapop2
Long-Term Sentiment: Buy 03/08/06 10:36 pm
Msg: 950124 of 950385

When going into the ac... ty was targeted at 100,000 patients that were eligible related to all other drugs failed them. BUT, since TY was approved for FIRST line treatment (voted 7 to 5), that moves for a QUADRUPLE number of patients 400,000. So, in other words... ELN has potential after earnings with TY to QUADRUPLE. NOW DO YOU GET HOW MUCH OF BOMB THIS APPROVAL WAS!!!!!!!!!!!!!!!!!!

Scubapop2
--------------------------------------------------------

Marketocracy Alert:
by: sojourner43 (60/M/Cincinnati) 03/08/06 10:25 pm
Msg: 950097 of 950391

From an investment standpoint, the immediate potential market for Tysabri just quadrupled from
100,000 patients in the U.S. for whom all other drugs have failed, to all 400,000 U.S. multiple sclerosis
patients. The additional 300,000 potential Tysabri patients are all currently on competing MS drugs that
collectively generated about $5 billion in sales last year for their manufacturers:


The complete report:

http://www.marketocracy.com/media/pdf/researchreport/Elan_03

0806.pdf


---------------------------------------------------------Tommorrow we
by: coolguydupe
Long-Term Sentiment: Strong Buy 03/08/06 10:23 pm
Msg: 950091 of 950394

could see the 20`s. The shorts are in deep shit, have to cover. Daytraders will run this up like mad. Then, the PR machine gears up, for more upside. This will be fun.
-----------------------------------------------------------

100% this year if you buy
by: ryken_mgs
Long-Term Sentiment: Strong Buy 03/08/06 10:11 pm
Msg: 950061 of 950405

under $20, when ELN easily hits $40 this year.

33% if you buy under $30...beating all the averages.
=)
----------------------------------------------------------

ELN Hit 16.83 on January 18
by: acricketeer 03/08/06 10:01 pm
Msg: 950034 of 950430

before the AC Meeting was even scheduled. Now, 7 weeks later, even AH at 16.15 ELN is priced below the January high. This suggests that with uncertainty out of the way, we will go substantially higher in the coming months.
---------------------------------------------------------
VERY IMPORTANT ATTENTION!!!!!
by: tysabri1234
Long-Term Sentiment: Strong Buy 03/08/06 09:37 pm
Msg: 949949 of 950444

Sorry I keep posting this, but I really do want to get the word out as this board gets bombarded with so many posts, it is easy to get lost.

Do NOT sell your stock tommorrow. Tell everyone you know that owns Elan shares to not sell their shares. Shorts are very eager to buy back and cut their losses. Remember, the shorts have to buy back at OUR asking price, so we have all the power this time around. Opening bid should be $20.00 (if sellers are smart) because shorts have to buy back and will be begging to get out of this mess that they got themselves into. Seriously, nobody should sell this stock for less than $30 because the shorts have to buy your stock back at any price you say!!!! Congrats everyone!!!



GUTEN MORGEN @ ALL

[bernie55]

GUTEN MORGEN!!!!

Irgendwie scheint heute in Würzburg die Sonne.....obwohl es total bewölkt ist.....


...so macht MORGEN Spaß.....


...und für alle, die noch müde sind, hier nun ein paar Muntermacher.....


Keep the faith, hold on to your shares, you`ve got an E ticket on the best ride in the park, next stop... Alzheimer`s station!!!


..und so weiter und so weiter.....

Grüße bernie55

Elan is the stock to hold for years

``In the next six months, year, two years, Tysabri will be the most popular first-line medication,``

nobody should sell this stock for less than $30 because the shorts have to buy your stock back at any price you say!!!!

[bernie55]

....na ja, so wach bin ich doch noch nicht.....

[bernie55]

TIME: 19:59:35

16,15 USD bei Volumen 3.624.114

...nicht schlecht für eine halbe Stunde Handel !!!!


Aktuelle Wechselkurse:
1 EUR = 1,19280 USD (09.03. 08:18)


13,54 € !!!!

[Poppholz]

Guten Morgen alle miteinander,

hier schon einmal eine Kurseinschätzung für BIOBGEN:

Finanzen.net
Biogen Idec buy
Donnerstag 9. März 2006, 08:15 Uhr
Rating-Update:
Die Analysten von Deutsche Securities stufen die Aktie von Biogen Idec (ISIN US09062X1037/ WKN 789617) von "hold" auf "buy" hoch. Das Kursziel werde von 38 auf 63 USD angehoben.

Analyse-Datum: 09.03.2006

(hier sollte beachtet werden, dass Tysabri andere Produkte von BIOGEN kanibalisiert)

[Poppholz]

finanzen.net
Biogen: FDA-Gremium empfiehlt Tysabri zur US-Wiederzulassung
Mittwoch 8. März 2006, 21:37 Uhr

Wie am Mittwoch in den USA bekannt wurde, hat ein Beratergremium der US-Gesundheitsbehörde FDA die Wiederzulassung des Multiple-Sklerose-Medikaments "Tysabri" des amerikanischen Biotechnologiekonzerns Biogen Idec Inc. (ISIN US09062X1037/ WKN 789617) und des irischen Pharmakonzerns Elan Corp. plc (ISIN IE0003072950/ WKN 903801) empfohlen.
Das Medikament war nach einer kurzen Prüfphase Ende des Jahres 2004 auf den US-Markt gekommen, musste dann aber bereits im ersten Quartal 2005 wieder zurückgezogen werden. Damals hatte es in Zusammenhang mit dem Produkt zwei Todesfälle gegeben. Der eine betreffende Patient war bereits im Jahr 2003 verstorben.

Tysabri ist der erste Inhibitor in der neuen Wirkstoffklasse Selektive Adhäsions-Molekül-Inhibitoren (SAM-Inhibitoren). Das Präparat wurde bereits vom Markt genommenen und wird derzeit überprüft, ob es eine Gehirnstörung verursachen kann.

Die Biogen-Aktie notierte zuletzt bei 45,50 Dollar.

[Poppholz]

08.03.2006 22:47
Biogen/Elan: Kurssprünge nach Tysabri-Entscheid

Die Titel von Biogen Idec (Nachrichten/Aktienkurs) und Elan Corp. (Nachrichten) konnten sich heute deutlich verbessern. Zuvor hatte ein FDA-Expertengremium die Freigabe des Medikaments „Tysabri“ zur Behandlung von multipler Sklerose befürwortet (wir berichteten). Tysabri war 2005 vom Markt genommen worden.

Die Papiere der beiden Unternehmen waren an der NYSE heute zunächst bis zum späten Nachmittag vom Handel ausgesetzt worden. Danach zogen Biogen Idec um 7,69 Prozent an und verbessern sich im nachbörslichen Handel derzeit um weitere 8,95 Prozent auf 49,57 Dollar. Elan schossen um 24,49 Prozent nach oben auf 15,81 Dollar; geben nachbörslich aktuell aber wieder 1,27 Prozent auf 15,59 Dollar ab.

Quelle: BÖRSEGO

[Poppholz]

09.03.2006 06:49
Elan, Biogen`s MS drug Tysabri should return to market - FDA panel

BOSTON - Shares of Irish drugmaker Elan Corp PLC (Nachrichten) and its U.S. partner Biogen Idec (Nachrichten/Aktienkurs) rocketed late Wednesday following a vote by an FDA advisory committee to allow their recalled drug Tysabri back on the market.

Shares of Elan closed up 25% at $15.81. The stock, which resumed trading Wednesday afternoon, had been halted since Tuesday morning, pending the outcome of the FDA meeting.

Biogen Idec shares, which had also been halted since Tuesday, did not resume trading until after market close. Shares were recently up 9% at $49.95.

Earlier Wednesday, an FDA panel of experts voted unanimously to recommend that Tysabri be put back on the market to treat patients suffering from a relapsing form of multiple sclerosis, or MS. While the FDA is not bound to the decision, it generally follows the recommendations of its experts.

The FDA is expected to make a formal decision by the end of the month on whether to allow Tysabri back on the market.

Tysabri, which has been shown to be highly effective in treating MS, was pulled abruptly from the market last spring after three users were found to have contracted a rare but deadly brain disease called PML. Two of the patients died. Tysabri had only been on the market since November 2004.

Before it was pulled from the market, some analysts estimated Tysabri could eventually have sales upwards of $3 billion.

A subsequent review of about 3,000 MS and Crohn`s disease patients who took Tysabri revealed no new cases of PML. Elan and Biogen applied last fall to the FDA to have the drug put back on the market, albeit with restrictions. The FDA will now have to determine what those restrictions will be.

In a release Wednesday afternoon, Biogen and Elan said they would work closely with the FDA to create an appropriate risk management plan for the drug.

This story was supplied by MarketWatch. For further information see www.marketwatch.com.

[e-mail]

jlw

COPYRIGHT
Copyright AFX News Limited 2005. All rights reserved.

[Poppholz]

Top Worldwide

European Stocks May Rise on Oil; DaimlerChrysler, Elan May Gain
March 9 (Bloomberg) -- European stocks may rebound from three-week lows as a slide in oil prices cuts companies` energy costs. DaimlerChrysler AG and Nokia Oyj might gain.

U.S. shares snapped this year`s longest losing streak as crude fell to a three-week low, sparking the first advance in five days.

``The oil price and the rally on Wall Street will definitely help us move higher today,`` said Lex Bouwmeester, the head of trading at Delta Lloyd Securities in Amsterdam.

Elan Corp. may gain after a U.S. regulatory panel approved a resumption of sales for its multiple sclerosis drug. PPR SA may be active after its 2005 earnings that lagged analyst estimates.

February futures on France`s CAC 40 Index rose 30 to 5000 at 7:07 a.m. in London. The U.K.`s FTSE 100 Index may add 23 to 5835, according to Cantor Index, a betting firm. Germany`s DAX may rise 50 to 5723, according to Cantor.

The Stoxx 600 has slid 0.9 percent since the European Central Bank on March 2 raised rates for the second time in three months, adding to concern of higher borrowing costs. It has lost 2.3 percent since touching a 4 1/2-year high on Feb. 27.

The Bank of England is likely to keep interest rates unchanged for a seventh month amid signs economic growth is accelerating, a survey of economists shows.

Japanese stocks rallied to their highest in two weeks, leading an advance in Asian markets, after the Bank of Japan determined the economy is strong enough to end a five-year policy of fighting deflation.

Oil Stockpiles

Oil traded near a three-week low in New York after U.S. inventories jumped and OPEC said it will keep pumping the fuel at full capacity.

Stockpiles rose 2 percent last week, the most in more than a year, the U.S. energy department said yesterday. Oil was recently trading at $60.05 a barrel.

American depositary receipts of DaimlerChrysler, the world`s fifth-largest carmaker, rose 0.6 percent from its close in Frankfurt. Nokia, the world`s biggest cell-phone maker, gained 1.4 percent from the stock`s close in Helsinki.

PPR, the French retailer that owns Gucci Group, may be active after saying profit rose 11 percent to 539 million euros ($642.5 million) last year as its luxury division benefited from increased demand from Asia. The median estimate was 557.9 million euros, according to a Bloomberg survey of eight analysts.

Shares in Elan may rise after Ireland`s biggest drugmaker and its co-developer Biogen Idec Inc. won the backing of a U.S. regulatory panel to resume sales of Tysabri, the multiple sclerosis drug withdrawn a year ago because it was linked to a rare, fatal brain infection.

Industrial Production

Fortis, Belgium`s biggest financial-services company, may be active after Chief Executive Officer Jean-Paul Votron said the company has started dismissing some of its 3,000 top managers to improve leadership and make savings.

German industrial production probably increased for the first time in three months in January as expansion accelerated in Europe`s largest economy, a survey of economists shows.

Production may have increased 1 percent from December, when it dropped 0.5 percent, according to the median of 44 estimates in a Bloomberg News survey. The Economy and Technology Ministry will release the report at noon today in Berlin.

To contact the reporter on this story:
Martin Boer in Amsterdam at [e-mail]

http://quote.bloomberg.com/apps/news?pid=10000087&sid=a6.HkK…

[Poppholz]

Business News Bulletin
FDA Panel OKs Tysabri For Market
Jennifer Lee 03.08.06, 1:20 PM ET

In the headlines at midday, a U.S. Food and Drug Administration panel voted unanimously to recommend that the agency allow Biogen Idec and Elan to return their controversial multiple sclerosis drug Tsyabri to the market. The drug was pulled after apparent links to a rare brain disorder. The agency is expected to make its final decision by the end of the month.

Former Enron Chief Financial Officer Andrew Fastow is on the witness stand for a second day of testimony in the fraud trial of his old bosses, Jeffry Skilling and Kenneth Lay. Fastow is testifying for the prosecution as part of a plea deal. On Tuesday, he testified that Skilling knew he was covering up the company`s crumbling finances. Fastow has yet to talk about his dealings with Lay or be cross-examined by defense attorneys.

In the markets, stocks fell amid increased worries about rising interest rates. Oil prices fell below $61 a barrel following OPEC`s announcement that production will remain at current levels.

Shares of the New York Stock Exchange began trading today. The Big Board ended 214 years as a not-for-profit organization after closing its $10 billion acquisition of rival Archipelago Holdings on Tuesday.

Lexar Media (nasdaq: LEXR - news - people ) stock jumped on news the maker of flash memory chips will be acquired by Micron Technology (nyse: MU - news - people ) for $688 million in stock. Micron is the biggest U.S manufacturer of computer memory chips.

Exxon says its spending exploration and production will jump from $18 billion to $20 billion in the next four years. The company says it hopes to boost output capacity by 2 million barrels a day by 2015.

And there`s much more on the Forbes.com Video Network. Check out the latest in travel, real estate and vehicles.

Be sure to check out our next report at 5:15 P.M., and stay logged on to Forbes.com.


http://www.forbes.com/markets/2006/03/08/tysabri-enron-nyse-…

[Poppholz]

Pharmaceuticals
The Tysabri Game Plan
Peter Kang, 03.08.06, 4:15 PM ET

By Peter Kang

New York - Patient demand may have played a role in an advisory panel`s unanimous vote to bring Tysabri back to market, but the fate of the halted multiple sclerosis drug still lies firmly in the grasp of federal health regulators.

Earlier today, a U.S. Food and Drug Administration advisory committee recommended the return of Tysabri, as patients and family members pleaded for the return of the multiple sclerosis treatment.

The FDA is not required to follow the advice of the independent panel but generally does.

Tysabri was pulled from the market by the companies in February 2005 after three patients being treated with Tysabri and Avonex developed progressive multifocal leukoencephalopathy, or PML. Two patients died.

Many Wall Street analysts expect the FDA to allow the drug to return to the market this year and say shares of Elan (nyse: ELN - news - people ) and Biogen Idec (nasdaq: BIIB - news - people ) are currently pricing Tysabri`s re-entry into stock prices.

Still, a number of uncertainties linger for the former can`t-miss blockbuster drug. Analysts are divided on how big the market will be should the drug return, and how restrictive an FDA warning label may be.

One thing they agree on, however, is that sales will be significantly less than previously thought.

Current Street estimates are just a fraction of the annual sales forecast for Tysabri prior to the drug`s sales halt; targets range from about $700 million to $1.2 billion in peak annual sales worldwide. A little over a year ago, the consensus Tysabri sales estimate was north of $2 billion.

Some analysts, such as Deborah Knobelman of Piper Jaffray (nyse: PJC - news - people ), expect the FDA to approve a re-entry of Tysabri but with significant restrictions. Her firm`s recent survey of 140 neurologists revealed that doctors continue to be wary of safety risks: More than three-quarters of the neurologists polled said they would prescribe the drug--but to just 10% of their patients.

Still, with a hefty price tag of about $23,500 for one year of treatment, even 10% of multiple sclerosis patients translates roughly to 34,000 patients in the U.S., according to Piper Jaffray. This bodes well for Elan, since it needs about 20,000 patients on Tysabri to stay out of the red, said Chief Financial Officer Shane Cooke in January during the company`s fourth-quarter earnings call.

Biogen Idec and Elan intend to implement a PML safety monitoring system to try to catch early cases, should they occur. "Comments from the FDA on the Drug Safety Risk Management Action Plan pose the biggest downside risk in our view," wrote Geoffrey Meacham of J.P. Morgan Securities, in a March 6 note to clients.

Indeed, the focus will now shift to the FDA`s potential restrictions on Tysabri; the agency is pushing for a detailed registry of patients, including information on how many cumulative doses the patient has received. In addition, Tysabri use could be limited to a subgroup of MS patients called "relapsing remitting," one of four main variations of the disease.

And while the FDA usually follows the advice of advisory committees, it`s not always a slam-dunk. This was seen after an advisory panel`s February 2005 blessing of painkillers Celebrex, Bextra and Vioxx, a class of drugs known as COX-2 inhibitors.

Two months after the committee said the drugs should be made available despite increased risks of heart attacks, the FDA banned Pfizer`s (nyse: PFE - news - people ) Bextra and placed its strongest warning label on the company`s other drug, Celebrex, while Merck`s (nyse: MRK - news - people ) hopes for a Vioxx return were dashed.

Despite all the questions, Elan`s current share price indicates investors are counting on significant profit. But just exactly how much upside Tysabri can muster is the billion-dollar question.

One scenario that hasn`t been discussed much by analysts is a potential price increase. Before it was pulled, Tysabri cost more than Avonex or Copaxone, a treatment marketed by Teva Pharmaceutical Industries (nasdaq: TEVA - news - people ). But since then, the price premium has decreased after Biogen Idec raised the price on Avonex 9% last December.

An Elan spokeswoman declined to comment regarding potential price increases for Tysabri, saying it was "too premature to discuss" at this point. Biogen Idec also declined to comment.

Not surprising, said Alex Hittle of A.G. Edwards, given the nascent stage of Tysabri`s comeback. "I think that would be a PR black eye for them now," the analyst said. "What we are hearing from the companies is that they intend to keep pricing where it is right now. I think that if Tysabri comes through and is showing up fairly clean, then they will be in a position to raise prices."

But it will be at least a couple of years before enough safety data is collected in order to deem Tysabri effective enough to validate the risks of PML. Recent clinical studies of more than 3,000 patients indicate the risk of contracting PML is roughly 1 in 1000, given the three confirmed cases. Patients in the trial took Tysabri for a year and a half, on average.

"From a scientific standpoint, we`re not going to know what the lay of the land is regarding risk for a couple of years," said Hittle.

However, physicians "may be underestimating the willingness of patients and their conviction to take a medication that appears to be more effective," said Hittle.

"If you are looking for upside, I think it is the possibility of patient demand. The pull on that side will be very strong," he said. "What needs to happen in the near term is that patient demand drives rapid uptake."

http://www.forbes.com/sciencesandmedicine/2006/03/08/tysabri…

[Poppholz]

Market Scan
Tysabri Seen As Potential First-Line Treatment
Peter Kang, 03.08.06, 4:51 PM ET

Biogen Idec

Deutsche Bank Securities upgraded shares of Biogen Idec to "buy" from "neutral" as the research firm anticipates better-than-expected labeling for multiple sclerosis drug Tysabri.

Earlier today, an independent advisory panel unanimously recommended Tysabri return to the market in some form. In addition, the 12-member committee voted 7-to-5 in favor of Tysabri as a first-line treatment.

The Food and Drug Administration is not obligated to follow the panel`s vote but historically acts in concert.

"While we would expect Tysabri to be used predominantly as second-line treatment, the importance of opening up for first line use would allow physicians flexibility to use Tysabri in more difficult-to-treat cases earlier on and allow faster penetration into the non-responder market," wrote Jennifer Chao of Deutsche Bank, in a report sent to investors on Wednesday afternoon.

Chao raised the price target on Biogen Idec (nasdaq: BIIB - news - people ) to $63 from $38. She expects the FDA to approve Tysabri by late March and projects 2006 and 2007 sales of $125 million and $325 million, respectively.

Tysabri was pulled from the market by Elan (nyse: ELN - news - people ) and Biogen Idec in February 2005 after three patients developed a rare brain disorder known as progressive multifocal leukoencephalopathy, or PML. Two of the cases were fatal.

The analyst said a critical factor in determining the scope of potential Tysabri treatment will be the safety monitoring system planned by the companies.

"We continue to be watchful of a likely extensive `risk minimizing system` for tracking safety and clinical events which could as a gating factor to treatment," the analyst said.

http://www.forbes.com/markets/2006/03/08/biogen-idec-elan-03…

[YoungRich]

Hat jemand Kurse ?

Tx
Young

[Poppholz]

Elan Corp FDA Recommends Reintroduction Of Tysabi

03-09-06 02:34 AM EST
Edited Press Release

LONDON -(Dow Jones)- Biogen Idec and Elan Corporation, said Thursday that the peripheral and central nervous system drugs advisory committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis ( MS).

The committee`s recommendation is advisory to the FDA, and the agency is not bound by this recommendation.

The FDA has designated Tysabri for priority review, a status for products that are considered to be significant therapeutic advancements over existing therapies that address an unmet medical need.

Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead with the goal of making Tysabri available.

Discussions with FDA will include, among other things, finalizing the details of the Tysabri risk management plan. The companies anticipate action by the FDA by March 29.


(END) Dow Jones Newswires
03-09-06 0234ET
Copyright (c) 2006 Dow Jones & Company, Inc.

http://news.morningstar.com/news/DJ/M03/D09/200603090234DOWJ…

[Birgit.Tersteegen]

[posting]20.589.072 von YoungRich am 09.03.06 09:05:23[/posting]13,45-----13,20/13,60 bei 871331

[Poppholz]

[posting]20.589.072 von YoungRich am 09.03.06 09:05:23[/posting]€13,20 in Berlin/Bremen für 70 Stück.

ansonsten ist es noch sehr ruhig.

(ich habe Zeit)

[eliasesteban]

moin,buen dia ,13,45 ean in franfurt

[YoungRich]

Der Kurs ist ja nicht gerade überwältigend :-)

Denkt Ihr der nächste Sprung kommt nei Zulassung, oder wie seht Ihr den künftigen Kursverlauf ? (Ja, ich weiss, blöde frage:-)

Gruss
Young

[Poppholz]

der Kurs wird hoch gehen:

Ende März bei FDA Bekanntgabe, dass Tysabri wieder an den Markt kommt.

wenn ELAN und BIOGEN den Termin für die Wiedereinführung bekannt geben

wenn Tysabri wieder verkauft wird

(jeweils für USA und Europa)

Zwischendurch wird der Kurs immer mal wieder runter gehen. Problematisch ist hier also nur zu wissen, wann die Termine jeweils sein werden und wann genau wieder gekauft wird.

Auch wenn der Reiz groß ist, ich bleibe investiert und hüpfe bei ELAN nicht hin und her.

(hin und her macht Tasche leer)

Da lieber auf Nummer sicher gehen und in zwei Jahren freuen.

[bernie55]

[posting]20.589.251 von YoungRich am 09.03.06 09:16:57[/posting]...sind wir doch erst einfach mal froh, dass alles so super gelaufen ist mit dem FDA Panel Meeting....


...das andere, was wir erwarten, wird kommen..


..erst langsam , dann aber gewaltig !!!!!

[Birgit.Tersteegen]

[posting]20.589.251 von YoungRich am 09.03.06 09:16:57[/posting]25% findest Du nicht doll;da bin ich ganz anderer Ansicht--aber Du kannst doch dann jetzt preiswert einsteigen!

Ich glaube wir werden uns in den nächsten Monaten doppeln!

[Poppholz]

meine Bank zweigt mir Frankfurt gar nicht als Handelsplatz an.

[Poppholz]

halten den Kurs wahrscheinlich für eine Falschmeldung.

[Birgit.Tersteegen]

[posting]20.589.476 von Poppholz am 09.03.06 09:23:50[/posting]Was hast Du denn für ne Bank ,Poppi---das Sofakissen?

[hechtbarsch]

@ young rich##

wir sind bei plus 30 proz. - ist das etwa nix?, Tendenz weiter steigend, behalte deine shares bis jahresende und du wirst sehen.

[Birgit.Tersteegen]

[posting]20.589.534 von hechtbarsch am 09.03.06 09:25:40[/posting]....er hat sie leider schon verkauft--young:JA ,rich:NA JA--

aber ich darf nach meinem Mologen Debakel sowieso nicht lästern...:O

[YoungRich]

Klar sind 30% schön, aber wenn man das Risiko bedenkt....im negativ fall wäre der Verlust vermutlich wesentlich grösser gewesen.

[Poppholz]

Auch von mir noch einmal ein herliches Dankeschön an alle Beteiligten hier im Thread.

Es macht wirklich Spass die Kommentare und Einschätzungen aller Schreiber zu lesen und über die Fragen und Anmerkungen zu "dikutieren".

Da ich mir in den letzten Monaten viele verschiedene Threads auf W O angesehen habe (und auch darin gepostet habe), weiß ich, dass unser Umgang miteinander nicht selbstverständlich ist.

Wenn einer kauft ist das in Ordnung, wenn einer verkauft ist das auch in Ordnung. Da wird keiner Beschimpft oder Beleidigt.

Würde mich freuen, wenn wir das Niveau hier so beibehalten können.

[YoungRich]

Ja, ich hatte einen grossen Teil meiner Position verkauft, das Risiko war mir zu gross.
Es kann ja jetzt wieder mit einem wesentlich kleineren Risiko eingestigen werden, das war es mir Wert ...

[YoungRich]

Auch von meiner Seite her ...mal ein herzliches Dankeschön an alle aktiven Forumteilnehmer hier ..ist wirklich ein super Thread ... Danke Euch, macht wirklich Spass so....

Tx
Young

[Birgit.Tersteegen]

[posting]20.589.783 von YoungRich am 09.03.06 09:32:46[/posting]

[Poppholz]

ing-diba

[Bienenvater]

Nachdem sich hier alle freuen und bedanken, möchte ich mich anschliessen.

Es gibt nicht viele sräds, wo man so sachlich miteinander umgeht.
Ich habe auch überlegt, zu verkaufen und habe es nicht getan.
Gelegentlich zahlen sich Risiken auch aus, --leider nicht immer!

[Birgit.Tersteegen]

[posting]20.589.908 von Bienenvater am 09.03.06 09:37:44[/posting]Willkommen Bienenvater--bist Du Imker?

[mikel_ann]

[posting]20.589.907 von Poppholz am 09.03.06 09:37:41[/posting]Ja die haben nur München ... -> Sammelklage ? Poppi

Bin dabei !

[lonesome loser]

...ich bin seit 3,5 Euro dabei und denke bei
dausend Brotzent nehm ich mal Gewinne mit!
Danke für den sehr informativen Thread.

[posimist]

Nachdem die Akte Ty im Prinzip durch ist,wird die bedeutendere Alzheimer-Story mehr und mehr in den Fokus der Anleger kommen.Die anstehenden Feten könnten kein Ende nehmen!

posimist

[Poppholz]

INTERVIEW: Serono: Tysabri Will Be Used As "Last-resort"

03-09-06 03:26 AM EST
GENEVA -(Dow Jones)- Swiss biotechnology company Serono SA (SRA) expects multiple sclerosis treatment Tysabri, which rivals its own drug Rebif, to be used as drug of "last-resort," when other treatments have failed, its Senior Vice-President of Scientific Affairs Andrew Galazka said Thursday.

On Wednesday, a U.S. Food and Drug Administration panel unanimously recommended the FDA re-approve Tysabri. The panel`s recommendations are not binding, though the FDA usually follows them.


(MORE TO FOLLOW) Dow Jones Newswires
03-09-06 0326ET
Copyright (c) 2006 Dow Jones & Company, Inc.

[Poppholz]

JP Morgan Cuts Serono Target; Tysabri Return

Thursday, March 09, 2006 3:56:28 AM ET
Dow Jones Newswire

0738 GMT [Dow Jones] JP Morgan slices Serono`s (SRA) target to CHF875 from CHF878 after a panel of experts recommended the FDA approves Tysabri, a competitor to Serono`s Rebif. Analyst says it expects the net effect of Tysabri reentering the market will be Rebif will hold and possibly lose shares as opposed to gaining shares as it has done. "We estimate each percentage point of global Rebif share represents $50 million to $100 million of sales, and 5% of our current earnings estimate." Keeps at underweight. Shaers closed at CHF907. (HJS)


Contact us in London.
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[Poppholz]

[posting]20.591.285 von Poppholz am 09.03.06 10:18:14[/posting]der link:

http://www.newratings.com/analyst_news/article_1224158.html

[Poppholz]

ZKB Reads Tysabri Recommendation To Serono

Thursday, March 09, 2006 3:56:30 AM ET
Dow Jones Newswires

0748 GMT [Dow Jones] An FDA panel recommends that Biogen`s (BIIB) and Elan`s (ELN) drug Tysabri returns to market. Although this isn`t unexpected, the surprise is a majority of the panel voted to use Tysabri as a first-line treatment, says Zuercher Kantonalbank. The read-across for Serono`s (SRA) Rebif is clearly negative, says ZKB, although stock had already dropped 3.1% in Wednesday trade. Because of that, ZKB`s Yasemin Ersan expects fairly smooth trade Thursday, but much higher volatility towards the end of March, when the final decision is taken by the FDA. ZKB rates Serono at marketweight. Serono indicated +0.3% at CHF910 pre-market. (KAB)


Contact us in London.
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[e-mail]

http://www.newratings.com/analyst_news/article_1224164.html

[Birgit.Tersteegen]

[posting]20.590.095 von lonesome loser am 09.03.06 09:44:04[/posting]Nach 1000% änderst Du dann Deinen nick in "social winner",OK?

[Bernd13090]

wollte mich auch hier bedanken für die tollen Beiträge hier. Das war auch der Grund, warum ich nicht verkauft habe.

Birgit und Bernie, wie seht ihr jetzt das Kurspotential.

Gruß aus dem Saarland

[Poppholz]

halte die Kursentwicklung noch für sehr "zurück haltend". Zeigt aber auch, dass kaum jemand seine Teile verscherbeln will.

Warten wir also auf den Start in den USA.

Wo sind eigentlich die Shorties? Sollten die sich an den letzten Tagen schon wieder eingedeckt haben?

4,5 Stunden noch bis Handelsstart in den USA. Dort werden viele den Start gestern nicht mitbekommen haben.

[YoungRich]

Irgendwie hab ich das schlechte Gefühl dass wir die 16$ NICHT knacken werden bevor die Zulassung der FDA definitv kommt ...

Gruss
Young

[Poppholz]

Panel recommends a return for MS drug Final ruling seen by end of month

By Diedtra Henderson, Globe Staff |
March 9, 2006

GAITHERSBURG, Md. -- A federal advisory panel yesterday unanimously endorsed the return of the multiple sclerosis drug Tysabri, prompting cries of joy and tears from MS patients who testified during a crowded two-day hearing.

Dozens of patients urged the panel to allow the drug back on the market. Many said their symptoms had worsened since Tysabri was pulled last year after it was linked to a deadly brain disease.

The Food and Drug Administration is expected to issue a final ruling by the end of the month and usually follows the advice of its panels. Biogen Idec Inc. of Cambridge, which makes Tysabri in partnership with Elan Corp. PLC of Ireland, said the drug could be made available within weeks of a favorable decision.

Seven of the 12 voting members agreed to permit doctors to prescribe Tysabri before patients had tried other drugs already on the market. The panel also rejected a number of FDA proposals that would have severely narrowed Tysabri`s use. How many MS patients will receive the treatment is unclear, but Biogen Idec officials estimated a worldwide market of 100,000 patients. Company officials told the panel they have devised a safety plan to minimize patients` risks.

Trading in Biogen Idec and Elan was halted for most of Tuesday and yesterday, but resumed late yesterday afternoon. Shares in both companies soared. Biogen Idec rose $3.90, or 9.8 percent, to $49.40 in heavy after-hours trading. Elan resumed trading at 3:30 p.m., half an hour before regular trading ended, and jumped $3.11, or more than 23 percent, to close at $15.81. Over 19 million Elan shares changed hands, about twice the normal daily volume, in just 30 minutes. But neither company`s shares have regained the levels they attained before Tysabri was withdrawn. Biogen Idec was trading then at above $65 a share, and Elan was priced at about $30.

Analysts estimate the drug will cost about $24,000 annually for each patient, about the same price as when it was introduced in November 2004. At that time, analysts thought it could quickly reach annual sales of $3 billion. William Tanner of Boston brokerage Leerink Swan now predicts Tysabri could generate $50 million in revenue this year, $150 million in 2007, and $1 billion in 2008. Tanner said Biogen Idec and Elan could easily raise the price as it increases in popularity: ``If you`re going to price the drug based on efficacy, you can go a lot higher before people scream."

MS patients have clamored for Tysabri`s return since Biogen Idec and Elan voluntarily took it off the market on Feb. 28, 2005 after learning two patients taking it in clinical trials contracted progressive multifocal leukoencephalopathy, or PML. A third case was later confirmed, and two of the patients died. Tysabri is given to patients once a month intravenously.

Nearly four dozen speakers testified Tuesday, some using canes or motorized scooters. They told the panel how MS had radically changed their lives. The incurable disease mostly affects young women and turns the body`s immune system against tissues that insulate nerves, disrupting the signals they send to different parts of the body. It strikes without notice and often leads to disabilities. For many patients, MS is characterized by occasional flare-ups followed by periods that are relatively symptom-free.

An Indiana woman said that by the time she was in her mid-30s, the disease had drained her energy and made her incontinent. A New York neurologist who diagnosed his wife`s MS told the FDA advisers that Tysabri had allowed her to stop using a wheelchair. Since the drug was withdrawn from the market, he said, she has talked of committing suicide if a flare-up affects her ability to walk.

Pamela Sue Clark, who traveled from Salt Lake City to testify, let out a loud whoop when she heard about the favorable recommendation during her drive from the airport.

``That`s wonderful news," said Clark, 41, the mother of two preschoolers.

Clark`s Tysabri infusions restored lost energy and hope, she said. Since the drug has been off the market, her doctor has prescribed steroids in an attempt to maintain her health.

The FDA heard the MS patients` messages, said Dr. Robert Temple, who oversees the FDA division that handles neurology drugs. Temple, who was not a panel member, said its unanimous vote suggests it believes patients and their physicians can best decide whether Tysabri`s risks outweigh the benefits.

Temple could not say whether Biogen Idec`s estimate that 100,000 patients would be eligible for Tysabri treatment was correct and cautioned that the debate about the drug`s safety would dampen its popularity. ``Given the concerns about the drug, people are going to think twice about using it," he said.

Patients taking Tysabri can experience two-thirds fewer MS flare-ups, double the benefits offered by current treatments.

Before the hearing, Biogen Idec offered the FDA a risk-management plan that includes a mandatory registry for all doctors and patients and strong warnings on the drug`s label to make patients aware of PML risks.

In a separate vote, seven of the 12 voting members said patients should be able to take Tysabri without first having to try other MS drugs. An analyst said that the vote to allow Tysabri as a first-line treatment was a significant victory for Biogen Idec. and Elan.

``It was a dramatic positive," said Jennifer Chao of Deutsche Bank. ``The pie is bigger and the revenue slope is steeper."

Dr. Justin McArthur, a Johns Hopkins neuroscience expert, said Tysabri was too risky for patients to try first. ``There is obviously decades worth of experience with other agents," he said. ``We know the safety profile of those agents well."

Dr. Lily Jung, a neurologist on the panel representing consumers, disagreed.

Jung, medical director of the Neurology Clinic at Swedish Neuroscience Institute in Seattle, said if a patient is rapidly going downhill, waiting for them to fail to respond to other MS drugs before trying Tysabri ``would be harmful."

Diedtra Henderson can be reached at [e-mail]. Jeffrey Krasner of the Globe staff contributed to this story.

© Copyright 2006 Globe Newspaper Company.

http://www.boston.com/business/technology/biotechnology/arti…

[Birgit.Tersteegen]

[posting]20.591.964 von Bernd13090 am 09.03.06 10:39:39[/posting]...hab heute morgen auch schon daran gedacht,dass Du bestimmt sehr erleichtert bist.Kursziel:Verdoppeln in diesem Jahr.

[Poppholz]

[posting]20.592.282 von YoungRich am 09.03.06 10:55:26[/posting]dann sollten die Kurse ja noch runter gehen (ca. €13,33), wenn wir die $16,- nicht schaffen sollten.

Somit würden weiterhin gute Kaufkurse vorhanden sein, wenn der Kurs dann in drei Wochen nach der FDA Bekanntgabe hoch geht.

[bernie55]

[posting]20.592.462 von Poppholz am 09.03.06 11:01:54[/posting]Zur Information !!!

TIME: 19:59:35

16,15 USD bei Volumen 3.624.114


...die 16 USD sind zumindest schon angeknabbert......


...heute nochmals Kaufpanik !!!!!


PAY ATTENTION !!!!

[Magicbroker]

Die Konkurrenz nimmt es gelassen?


AKTIE IM FOKUS: Schering sehr fest - Tysabri geringe Bedrohung, Charttechnik

FRANKFURT (dpa-AFX) - Schering-Aktien sind am Donnerstag trotz der Erwartung einer Wiederzulassung des Konkurrenzprodukts Tysabri in den USA an die DAX-Spitze geklettert. Händler verwiesen auf eine positive Charttechnik und Käufe von Investoren, die mit fallenden Kursen gerechnet hatten. Die Papiere des Berliner Pharmakonzerns sprangen bis gegen 10.50 Uhr um 4,27 Prozent auf 64,77 Euro nach oben. Der DAX gewann gleichzeitig 0,81 Prozent auf 5.719,41 Punkte.

Händler führten charttechnische Gründe an, nachdem die Aktien auf den höchsten Stand seit Mai 2002 gestiegen sind. Die Nachricht um eine mögliche Wiederzulassung des umstrittenen Multiple-Sklerose-Medikaments Tysabri von Biogen Idec und Elan werde in den Hintergrund gedrängt, sagten Händler. Am Vorabend habe diese noch einige Investoren verschreckt und zu Verkäufen veranlasst - diese deckten ihre Positionen angesichts nicht fallender Kurse wieder ein. Hinzu komme auch das Aktienrückkaufprogramm als leicht positiver Einfluss. Außerdem flammten Spekulationen um eine mögliche Übernahme auf, hieß es am Markt.

Tysabri ist ein Konkurrenzprodukt zu Betaferon von Schering, das in den USA als Betaseron vertrieben wird. Bei einer Wiederzulassung (FDA-Entscheidung am 29.3.06) dürfte Tysabri keine ernsthafte Gefährung für Betaseron darstellen, urteilte HVB-Analystin Isabella Zinck. Wegen der mit Tysabri in Verbindung gebrachten Risiken dürfte das Produkt nur ein Nischendasien führen. Zinck stuft die Schering-Aktien mit "Underperform" beim Kursziel 59,00 Euro ein.

Cheuvreux bestätigte die "Underperform"-Empfehlung mit dem Kursziel 51,30 Euro. Aus Sicht des Analysten wirft die einstimmige Empfehlung für die FDA für das Multiple-Sklerose-Medikament Tysabri werfe einige Fragen über den künftigen Erfolg von Betaferon bei wieder steigendem Wettbewerb auf./fat/tw

Quelle: dpa-AFX

[bernie55]

..nach den letzten spannenden Tagen mal etwas Entspannendes zum Anschauen....




...und ich denke, da sollten wir doch nichts dagegen haben, oder ???

[Mr Ti]

hi freunde des gepflegten elan-invests,

meine devise bleibt: zurücklehnen und genießen.

und wer jetzt noch verkauft, der hat entweder genug und braucht kohle für ne dicke party oder weiß nicht, daß man den fahrenden zug nicht verlassen sollte.

also ich klebe in meinem schlafwagenabteil des elanexpress und schlafe so schön, lese ab und zu eure kommentare und amüsiere mich über die hektiker.

noch knapp 2 monate und ich bin ein jahr dabei und selbst dann denke ich nicht an einen ausstieg, gut - wenn sie bei 50 eu dann stehen, könnte ich schon mal zucken

aber lasst die amis doch mal machen und die analies müssen auch noch mal senf abgeben wie schon bei biogen.

elanvolle grüße an die gemeinde

vom mr ti

[bernie55]

[posting]20.594.284 von Mr Ti am 09.03.06 11:58:45[/posting]YEPP....das sehen einige im Board von uns genauso wie Du , Mr Ti..

Ich denke auch, dass der Zug geade erst in Richtung Norden losfährt...


...CYBERHEXES Kommentar untermauert unser Engagement in ELAN als Langzeitinvestment....

nun erst mal tief durchatmen und dann über Strategien nachdenken, zuvor jedoch noch einmal die Fakten/Risiken ordnen:

- Tysabri wird diesen Monat noch vermarktet und zwar als " first line treatment" , Erstmedikation also möglich
- EMEA wird Zulassung ebenfalls erteilen --> EU-Vermarktung ab 3.Q/06 (BLA bei Elan!)
- Bekanntgabe der ersten Studienergebnisse (Phase III) zu AAB noch in 2006
- Bekanntgabe weiterer Nanochrystal-Abkommen möglich
- Nachfrage nach Tysabri sehr wahrscheinlich über Prognosen

- derzeit keine Tysabri-Medikation, d.h. vorerst sind keine " fatalen Ereignisse" analog " Black Monday" (28.02.05) möglich


Conclusion: momentan ist ein Investment in Elan nicht so riskant wie auch schon; die positiven Nachrichten werden in den kommenden Monaten sehr wahrscheinlich eindeutig überwiegen und den Kurs nach oben treiben (falls erste Tysabri Zahlen überzeugen)
Zudem sind noch 27 Mio Aktien " short" , die wohl vor Bekanntgabe der Alzheimer-Ergebnisse zum grössten Teil abgebaut werden, d.h. es wird auch von dieser Seite ein Nachfrageüberhang geben.
Also, jetzt zu verkaufen scheint mir eine vergebene Chance zu sein, trotz Investitionsgrad > 100%.....

Erst im Sommer wird das Risiko gestreut, so wie es sich für einen seriösen Investor auch gehört.....

...uns allen eine schöne Zeit mit ELAN....

[Birgit.Tersteegen]

[posting]20.594.284 von Mr Ti am 09.03.06 11:58:45[/posting]Mensch Mr Ti--wo warst Du mit Deinen Elanies ,im Exil??

[Mr Ti]

hi birgi,

ne im schlafwagen mit der urenkelin von kostolany

oder so.

also die elanies sind im gepäcknetz habe sie nie angefasst, habe ja die süße im abteil, den taschenrechner habe ich auch weggeworfen und hole ihn vielleicht mal in 2 monaten raus.

[Poppholz]

auf Arcaex wird ELAN zur Zeit mit $16,40 zu $16,70 getaxt.

[bernie55]

[posting]20.594.795 von Birgit.Tersteegen am 09.03.06 12:14:39[/posting].....im Schlafwagen des ELANEXPRESS, Birgit...

[bernie55]

[posting]20.595.312 von Mr Ti am 09.03.06 12:33:30[/posting]..also Gedankenlesen können wir Elannies auch....


..schön, dass du auch noch dabei bist, Mr.Ti....

[bernie55]

[posting]20.595.362 von Poppholz am 09.03.06 12:36:11[/posting]..its only the beginning....

[Poppholz]

Business Wire
FDA-Beratergremium empfiehlt einheitlich die Wiedereinführung von TYSABRI® zur Behandlung rezidivierender Formen der multiplen Sklerose
Donnerstag 9. März 2006, 12:37 Uhr

GAITHERSBURG, Md. 9. März 2006 Biogen Idec (NASDAQ: BIIB) und die Elan Corporation, plc (NYSE: ELN) meldeten heute, dass das Peripheral and Central Nervous System Drugs Advisory Committee der US-amerikanischen Food and Drug Administration (FDA) sich einheitlich für eine Empfehlung der Wiedereinführung von TYSABRI® (Natalizumab) als Behandlung rezidivierender Formen der multiplen Sklerose ausgesprochen hat.

Das Gremium dient als Beratungsorgan der FDA, allerdings sind seine Empfehlungen nicht bindend für die Behörde. Die FDA hat für TYSABRI eine beschleunigte Prüfung angesetzt; dieser Status der "Priority Review" wird an Produkte vergeben, von denen angenommen wird, dass sie signifikante therapeutische Vorteile gegenüber bestehenden Therapien liefern und einen bislang ungedeckten medizinischen Bedarf decken. Biogen Idec und Elan werden in den kommenden Wochen eng mit der FDA zusammenarbeiten, um TYSABRI wieder auf den Markt zu bringen. Zu den Themen der Gespräche mit der FDA gehören unter Anderem die Ausarbeitung der Details des TYSABRI-Risikomanagementplans. Die Unternehmen erwarten eine Entscheidung der FDA bis 29. März 2006.

Über Biogen Idec

Biogen Idec setzt neue Versorgungsstandards in der Onkologie, Neurologie und Immunologie. Als international führendes Unternehmen in der Entwicklung, Herstellung und Kommerzialisierung neuartiger Therapien setzt Biogen Idec wissenschaftliche Entdeckungen zu Fortschritten in der Gesundheitsversorgung um. Pressemitteilungen, Fachinformationen zu Produkten und sonstige Informationen über das Unternehmen gibt es im Internet unter http://www.biogenidec.com.

Über Elan

Die Elan Corporation, plc, ist ein Biotechnologieunternehmen, das sich auf Neuroforschung spezialisiert hat. Das Unternehmen möchte die Lebensqualität von Patienten und ihren Familien verbessern, indem es innovative Forschung durchführt und damit bislang ungedeckten medizinischen Bedarf weltweit erfüllt. Die Aktien von Elan werden an den Börsen New York, London und Dublin gehandelt. Mehr Informationen über das Unternehmen gibt es im Internet unter http://www.elan.com.

Safe Harbour Erklärung / Zukunftsweisende Aussagen

Diese Pressemeldung enthält zukunftsweisende Aussagen über die mögliche und zulassungsorientierte Weiterentwicklung von TYSABRI. Das kommerzielle Potenzial und die zukünftige Zulassung von TYSABRI unterliegen einer Reihe von Risiken und Unwägbarkeiten. Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse wesentlich von den von Seiten der Unternehmen erwarteten abweichen, beinhalten das Risiko, wir möglicherweise die von der FDA oder den europäischen Zulassungsbehörden während des Prüfungsverfahrens aufgeworfenen Fragen oder Bedenken nicht angemessen beantworten können, dass sich aus den weiteren Daten oder Analysen Bedenken ergeben oder dass die Unternehmen anderen unerwarteten Verzögerungen oder Hürden begegnen. Es gibt ferner keine Gewährleistung, dass die Unternehmen die Vermarktung und den Verkauf von TYSABRI wieder aufnehmen können. Wirkstoffentwicklung und Kommerzialisierung sind mit hohen Risiken verbunden. Ausführlichere Informationen über die Risiken und Unwägbarkeiten in Verbindung mit der Arzneistoffentwicklung und anderen Aktivitäten der Unternehmen sind in den von Biogen Idec und der Elan regelmäßig bei der Börsenaufsichtsbehörde eingereichten Unterlagen enthalten. Die Unternehmen übernehmen keine Verpflichtung zur Aktualisierung zukunftsweisender Aussagen sei es als Ergebnis neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen.

Kontakt

Ansprechpartner für Medien:
Biogen Idec
Amy Brockelman, [phone]
oder
Elan
Davia B. Temin, [phone]
oder
Elan
Elizabeth Headon, [phone]
oder
Ansprechpartner für Investoren:
Biogen Idec
Oscar Velastegui, [phone]
oder
Elan
Emer Reynolds, [phone]
oder
Elan
Chris Burns, [phone]

[Poppholz]

erster Kurs auf inet:

RT $16,30

[Birgit.Tersteegen]

[posting]20.594.284 von Mr Ti am 09.03.06 11:58:45[/posting]Na dann musst Du ja jetzt ganz ausgeschlafen sein--oder hat die Enkelin geschnarcht...???



Da wir gerade so nett virtuell zusammensitzen und auch die 13 Euronen schon so WEIIIIIT hinter uns lassen----NAAAAAAAAAAAAAA--Was sollten wir da tun????????????????????????? --Genau---------FEIERN!Nämlich unsere von langer Hand geplante 13 Euro Party!!!!!!!!!!!

ALLE;DIE HIER UND IM SCHLAFWAGEN SIND;SIND HERZLICH EINGELADEN!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!


19.3.06,Steinfurt/Westf.Tagungshaus Karneol




Quatschen,freuen,essen,trinken ,tanzen,spazierengehen oder was Euch noch so einfällt.

Internet user sollen ja so scheu und schüchtern sein --aber da wir das ja dann alle sind-ist es doch auch nicht schlimm!!!!!!!

Wer kommen will und kann,kann doch diesen Aufruf kopieren
und den eigenen Nick druntersetzen .Ich finde wir sollten schon so 6-8 mindestens sein...Am Nächsten Montag ist dann klar ob es jetzt stattfindet oder nicht!

Ansonsten müssten wir im Sommer einen erneuten Anlauf starten--aber das ist für Einige(weiss ich schom aus BMs)auch schwierig....

OK,Fragen per BM an mich--ansonsten:LOS GEHTS


Birgit
Fredo(Mein Liebster und auch stolzer Elan-Aktionär)

[lonesome loser]

DUBLIN -(Dow Jones)- Elan Corp. PLC`s (ELN) (ELN) shares soared 24% Thursday after a special advisory committee issued a long-awaited reprieve for the Irish drug company, unanimously advising the U.S. Food & Drug Administration to return its multiple sclerosis drug Tysabri to market.

The debt-laden company`s future now lies in the hands of the FDA`s final decision - due by March 29. Most analysts say it`s likely to take the committee`s advice, due to the efficacy of the potentially billion-dollar drug.

Tysabri, a joint partnership between Elan and Biogen Idec (BIIB) (BIIB), was Elan`s only would-be blockbuster drug. Without it, market valuations for the Irish- based pharmaceutical company would be slashed.



It was withdrawn from sale in the U.S. on safety concerns in 2005. It had never been approved for use in the European Union or elsewhere.

At 0951 GMT, Elan stock was up 19.5%, or EUR2.20, at EUR13.50 on the Irish Stock Exchange as investors were cheered by the more positive-than-expected recommendation. In early trading, the shares rose almost 25%.

The FDA advisory committee, which released its ruling late Wednesday, advised that the drug be reintroduced as a monotherapy - excluding its use as a higher- risk combination therapy - as requested by Elan and Biogen Idec (BIIB). That restriction would reduce sales somewhat.

However, there were other unexpected bonuses. By a slim majority of 7 to 5, the committee also voted to recommend to the FDA that Tysabri be marketed as a first-line treatment, not just if other MS drugs failed to work.

"This gives the potential for considerable upside," said Goodbody Stockbrokers` Ian Hunter in Washington. "We still have to see if the FDA will follow this recommendation, but the signs from the meeting are positive."

The other upside to expectations was that the committee unanimously recommended that the drug be made available to all MS sufferers, irrespective of the level of the patient`s impairment/disability.

"This is counter to suggestions that the drug would only be made available to patients at certain (later) stages in disease progression and further expands the market potential for Tysabri, if it is accepted by the FDA," Hunter added.

Before it was suspended in 2005, analysts estimated the drug would generate annual sales of between $1 billion - double Elan`s existing turnover - and $2 billion.

While some fund managers see Tysabri only hitting $500 million peak annual sales and criticize the drug`s high cost base, Hunter has "increased confidence" that Tysabri will see peak annual sales of $1.9 billion by 2009.

NCB Stockbrokers` Orla Hartford, who has a buy on Elan, doesn`t believe the lack of combination therapy will dramatically limit the use of the drug: she pointed out that only 25% of patients had used it as a combination drug when it was on the market.

The U.S. decision also bodes well for Tysabri`s European launch. The European Medicines Agency, or EMEA, is currently reviewing data from Tysabri`s 2-year Phase III, a final premarketing study, and Elan expects a decision by mid-2006.

Elan and Biogen Idec (BIIB) suspended Tysabri in the U.S. on Feb. 28 last year after three patients on combination therapy - including Tysabri - contracted a rare neurological disease called PML.

Elan has since then said it expects Tysabri to be reintroduced to the market and that the MS drug could break even with around 20,000 patients, or annual revenue of $500 million, though it expects its market to far exceed that level.

The setback over Tysabri followed a long and arduous recovery for Elan, beginning with a change of senior management in 2002, when its former CEO and Chairman Donal Geaney resigned amid accounting troubles and a falling share price.

Apart from Tysabri, Elan is also pinning its hopes on an Alzheimer`s drug. It expects to know whether its monoclonal antibody AAB-001 will move into Phase III toward year-end, and has said it`s hopeful, given data so far.

Most analysts remain cautious. Merrion Stockbrokers` Robert Brisbourne said he will maintain his hold until the FDA issues its official response - only then will he review his rating and forecasts.

[Birgit.Tersteegen]

Today is payday.
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/09/06 07:32 am
Msg: 950814 of 950835

Our permanent Tysabri license, unanimously endorsed yesterday by the PCNS AC, will be issued very soon. With a PDUFA date of March 26th, and a Priority Review designation on November 17th, one could suggest the FDA is a week ahaead of schedule. This implies through definition that we will receive our "letter" on March 17th. I`m not betting on that day, as my forcasting of FDA related events in regards to Tysabri, are now complete. Tysabri will be approved with a Monotherapy label. It will we designated a first line treatment for RRMS. Tysabri does halt disease progression in people with RRMS, and it will become a blockbuster drug with sales over 1.5 Billion in 2007. The market will price in 2007 sales once these analysts dispatch their assistants to do real analysis through patient and Neurologists` surveys. I hold with my end of year 2006 pps projection of $47 and change based upon a swift Tysabri uptake, EMEA approval and poularity there, AD developments, Drug Delivery advances, and the continued efforts of our awesome Board of Directors, CEO, entire Management team, and last but not least our dedicated and prideful employees. I would bet there was a bit of celebration last night in Elanville and deservedly so. I reserved mine for this evening and am looking forward to seeing the market validate what so many here have known for so long, ELN ADR`s are worth more today than at any point since BM. This again assures us of a sustainable $17+, and suggests a bit more today. Congratulations longs.

[Birgit.Tersteegen]

Heute Nachmittag können wir Elan wieder ganz nahe sein:Pressekonferenz,in die man sich scheinbar über die Elan-Website einhören kann....

Press Release Source: Elan Corporation, plc

Elan Announces Webcast of Presentation at the S.G. Cowen 26th Annual Healthcare Conference
Wednesday March 1, 9:00 am ET

DUBLIN, Ireland--(BUSINESS WIRE)--March 1, 2006--Elan Corporation, plc announces today that its presentation and breakout session at the SG Cowen 26th Annual Healthcare Conference in Boston will be webcast live via the internet on Thursday, March 9, 2006. The presentation will be webcast at 11.20 a.m. Eastern Time, 4.20 p.m. Greenwich Mean Time. The breakout session will be webcast at 12.10 p.m. Eastern Time, 5.10 p.m. Greenwich Mean Time. Interested parties may access a live audio webcast of the presentation by visiting Elan`s website at www.elan.com and clicking on the Investor Relations section, then on the event icon.

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About Elan

Elan Corporation (NYSE: ELN - News), plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

[eliasesteban]

ach ja,bei dir birgit wollt ich auch mal danke für dein angagement sagen !

[Poppholz]

Kurs wurde tatsächlich unter die $16,- Grenze gedrückt.

Die Drücker werden wohl erst nach dem grünen Licht durch die FDA aufhören.

Mich verunsichern die auf jeden Fall nicht.

[Poppholz]

09.03.2006 14:14
AKTIE IM FOKUS 2: Schering sehr fest - Tysabri geringe Bedrohung, Umschichtung

Schering-Aktien <SCH.ETR> (Nachrichten/Aktienkurs) sind am Donnerstag trotz einer möglichen Wiederzulassung des Konkurrenzprodukts Tysabri in den USA auf den höchsten Stand seit Mai 2002 gestiegen. Händler und Analysten verwiesen neben charttechnischen Gründen auf den Einstieg von Investoren, die am Morgen auf einen fallenden Schering-Kurs gesetzt hatten. Zudem profitiere das Schering-Papier von Umschichtungen aus den Branchen, die in den vergangenen Wochen und Monaten gut gelaufen seien. Schering-Aktien hatten sich 2005 schwächer als der Vergleichsindex DAX entwickelt.

Schering-Papiere verteuerten sich bis 14.00 Uhr um 6,50 Prozent auf 66,16 Euro und erreichten damit den höchsten Stand knapp vier Jahren. Der Leitindex DAX <DAX.ETR> gewann gleichzeitig 0,99 Prozent auf 5.729,37 Punkte.

"Schering profitiert zur Zeit von Umschichtungen aus Branchen wie Telekommunikation und Energie", sagte ein Analyst einer großen US-Investmentbank. Zudem sorge das am 1. März gestartete Aktienrückkaufprogramm für einen weiteren Nachfrageschub.

Die Nachricht um eine mögliche Wiederzulassung des umstrittenen Multiple-Sklerose-Medikaments Tysabri von Biogen Idec <BIIB.NAS> <IDP.FSE> (Nachrichten/Aktienkurs) und Elan <ELA.ISE> <DRX.BER> (Nachrichten) werde in den Hintergrund gedrängt, sagten Händler. Am Vorabend habe diese noch einige Investoren verschreckt und zu Verkäufen veranlasst - diese deckten ihre Positionen angesichts nicht fallender Kurse wieder ein. Außerdem kamen Spekulationen um eine mögliche Übernahme.

Tysabri ist ein Konkurrenzprodukt zu Betaferon von Schering, das in den USA als Betaseron vertrieben wird. Bei einer Wiederzulassung (FDA-Entscheidung am 29.3.06) dürfte Tysabri keine ernsthafte Gefährung für Betaseron darstellen, urteilte HVB-Analystin Isabella Zinck. Wegen der mit Tysabri in Verbindung gebrachten Risiken dürfte das Produkt nur ein Nischendasien führen. Zinck stuft die Schering-Aktien mit "Underperform" beim Kursziel 59,00 Euro ein.

Cheuvreux bestätigte die "Underperform"-Empfehlung mit dem Kursziel 51,30 Euro. Aus Sicht des Analysten wirft die einstimmige Empfehlung für die FDA für das Multiple-Sklerose-Medikament Tysabri werfe einige Fragen über den künftigen Erfolg von Betaferon bei wieder steigendem Wettbewerb auf./ep/fat/tw

ISIN DE0007172009

AXC0133 2006-03-09/14:11



http://www.finanznachrichten.de/nachrichten-2006-03/artikel-…

Dann wollen wir doch mal sehen, welches Medikament sich zu einem "Nischenprodukt" entwickelt.

[Poppholz]

wir tanzen in den USA um die $ 16,- Marke.

Mal sehen wie sich der Markt um 15:30 Uhr verhält.

[Birgit.Tersteegen]

Jetzt wirds mal spannend....

[Birgit.Tersteegen]

Irgendwie ist die Richtung noch falsch...!!Das wird sich geben--lange Leitung---

[Poppholz]

da wird der Kurs wieder mit 10.000 12.000 und 14.000 Positionen nach unten gedrückt.

Schätze dass die Käufer noch warten, bis der Kurs noch ein wenig weiter nach unten gegangen ist.

(Die Shorties werden sich schon die Finger verbrennen)

[invest2002]

na da bin ich ja mal gespannt...glückwunsch an die investierten

invest2002

[Birgit.Tersteegen]

find ich DOOF!

[invest2002]

rt?

[Poppholz]

$15,20

(es ist nicht zu begreifen)

[Birgit.Tersteegen]

shorties all over-das gibt sich!

[invest2002]

na das ist ja immer noch ein 2 stelliger kurszuwachs

invest2002

[Poppholz]

ab und zu kommen jetzt sogar 20.000 Positionen ins ASK geflogen.

Werden dann aber schnell wieder zurück gezogen.

reine Panikmache.

(die Käufer freut es)

[Birgit.Tersteegen]

Hang on. Shorts and hedgies
by: whyaskwhyuno (77/M)
Long-Term Sentiment: Strong Buy 03/09/06 09:39 am
Msg: 951337 of 951338

know a lot of MMs...may even be MMs. Major bounce coming soon. Right now its cover time, with the help of MMs of course. Hold those shares. Going major green quickly. Watch for the reversal. anyone who`s traded ELN has seen this crap before. Lots of shorts and they are big shorts.

[Birgit.Tersteegen]

ELAN TSUNAMI
by: mazurek2050
Long-Term Sentiment: Strong Buy 03/09/06 09:24 am
Msg: 951277 of 951439

Well , yesterday all forces that be let loose a tsunami and it is coming your way. please be prepared.This massive wave will cover all shorts because we are headed to higher ground.
There is No escape and everyone knows "HIGHER GROUND" is the place to be.

[Birgit.Tersteegen]

9.52 NBV turns POSITIVE pps $15.40
by: darrelldemello 03/09/06 09:53 am
Msg: 951426 of 951503

looks like the attempt to push the pps down is over ...

[Poppholz]

[posting]20.592.282 von YoungRich am 09.03.06 10:55:26[/posting]und hast Du gekauft, oder hoffst Du auf noch niedrigere Einstiegskurse?

Bisher hast Du ja ganz richtig gelegen mit der Vermutung, dass der Kurs nicht über $16,- steigen wird.

Ist halt nicht so einfach, den richtigen Zeitpunkt zu erwischen.



wünsche auf jeden Fall allen Investierten und denen die es noch werden wollen (oder müssen) viel Glück.

[Poppholz]

die Geschichte mit den Shorties müßte sich langsam zu einem Schneeballsystem entwickeln.

Wenn dann die Kaufpanik losgeht, ist für den Kurs kein halten mehr.

Normalerweise würde kein Investor zu diesem Zeitpunkt verkaufen.

Es sei denn, er nutzt den Kursdruck aus und nutzt diesen Vorgang, um sich noch einmal zu verbilligen.

[YoungRich]

Ich hab heute in Irland noch ein paar Positionen zu 13.5 gekauft. Mein Gefühl gab mir ja Recht, werd jetzt mal abwarten und um die 15$ nachlegen ... mal schauen ..

[Birgit.Tersteegen]

[posting]20.599.448 von Poppholz am 09.03.06 16:12:42[/posting]yepp!

[YoungRich]

Aber für mich ist das ganze einfach nicht begreiflich .....aber wie ich Euch schon mal gesagt hatte, solange ich in einer Aktie drin bin geht da nichts :-)

Gehe ich raus zündet die Rakete :-)

[eliasesteban]

dann aber nix wie raus!!

[Birgit.Tersteegen]

[posting]20.599.726 von YoungRich am 09.03.06 16:25:23[/posting].....heisst einfach,Du bleibst nicht lange genug drin!

Wie heisst das Zauberwort diesen Threads.....G....d !

[Birgit.Tersteegen]

Register for Eln webcast (60 min left)
by: darien.wwoz
Long-Term Sentiment: Strong Buy 03/09/06 10:21 am
Msg: 951597 of 951653

www.elan.com

Elan presentation and breakout session at the SG Cowen 26th Annual Healthcare Conference in Boston will be webcast live via the internet on Thursday, March 9, 2006.
The presentation will be webcast at 11.20 a.m.
The breakout session will be webcast at 12.10 p.m.
To access a live audio webcast of the presentation visit Elan`s website at www.elan.com and click on the Investor Relations section, then on the event icon.

…. Elan in the past has said that important data from the trials (AAB-001 treatment) would be ready in the early part of 2007. But in an interview with The Sunday Business Post, Lars Ekman Elan’s global head of research and development, said that the results could be delivered as early as this year.
http://www.thepost.ie/post/pages/p/story.aspx-qqqt=MARKETS-q… 12117-qqqx=1.asp

[Poppholz]

[posting]20.599.726 von YoungRich am 09.03.06 16:25:23[/posting]Jetzt kannst Du auch drin bleiben, "schlimmer" kann es eigentlich nicht mehr werden.

[Nostarowie]

Oh man hatte heute keine Zeit bis jetz und bin fast gestorben vor neugier...

muß erst ma lesen ...

hier können wohl einige keine gewinne laufen lassen in Amiland ...naja hat wenigstens auch der letze Dussel ne Chance reinzuhüpfen.

[bernie55]

[posting]20.598.672 von Birgit.Tersteegen am 09.03.06 15:38:53[/posting]..... dass ich nicht zur ELAN Party kommen kann ???

..I`m sorry..

[Birgit.Tersteegen]

[posting]20.600.142 von bernie55 am 09.03.06 16:41:14[/posting]...this will be not excepted....!

[bernie55]

[posting]20.599.726 von YoungRich am 09.03.06 16:25:23[/posting]aber wie ich Euch schon mal gesagt hatte, solange ich in einer Aktie drin bin geht da nichts.....

Gehe ich raus zündet die Rakete




...also, youngRich, dann frage ich mich, wie du überhaupt mit Aktien Geld verdienen willst.......

...aber vielleicht bist du in deinem Innerem ein echter " SHORTIE" und du weißt es noch nicht....

[Birgit.Tersteegen]

[posting]20.600.121 von Nostarowie am 09.03.06 16:40:33[/posting]hör mal mit Deiner biolitec Charttechnik ist das ja auch so´ne Sache...von wegen um 8 rum kaufen...

[bernie55]

[posting]20.600.207 von Birgit.Tersteegen am 09.03.06 16:44:05[/posting]...but a only little bit......

[Nostarowie]

meine Charttechnik funktioniert der Markt hält sich nur nich daran

[Birgit.Tersteegen]

[posting]20.600.310 von bernie55 am 09.03.06 16:47:43[/posting]sorry;it´s expected-but not accepted!--15,22$

[bernie55]

[posting]20.600.382 von Nostarowie am 09.03.06 16:50:24[/posting]

[bernie55]

[posting]20.600.417 von Birgit.Tersteegen am 09.03.06 16:51:41[/posting]..with visa card ???

[bernie55]

[posting]20.600.417 von Birgit.Tersteegen am 09.03.06 16:51:41[/posting]..or with American Express ?

[Birgit.Tersteegen]

[posting]20.600.466 von bernie55 am 09.03.06 16:53:35[/posting]only cash!

@Nosta,Du musst dringend Deine Marktmacht ausbauen!!!

WRONG - Pros buy and sell
by: beldar59
Long-Term Sentiment: Strong Buy 03/09/06 10:52 am
Msg: 951729 of 951738

To control price, investment houses and hedge funds trade among and between themselves negotiating price for deals that reflect the planned increases or decreases in price.

It can be done between accounts in a single institution, for example the retail and commercial divisions. This is why some analysts predict gloom and doom while the institutional traders are net buyers.

It can be done between companies but they must be careful to avoid collusion.

Its the volume of shares in the deals that must vary depending on the open buy or sell interest and the desired effect on market price. If volume is light then a trading program of both buying and selling would involve frequent low volume trades. Price varibility between trades in the program is normally set low to avoid wild price swings. However, should open interest be lower than expected or should multiple program traders be involved, price can move more dramatically. In this case the exchange can halt program trading.

The program trading strategies employed are finely tuned with the highest degree of mathematical and statistical certainties.

All it takes is money, the desire to control prices for personal gain and weak regulatory oversight. We have all three in play here.

[Birgit.Tersteegen]

auf der www.elan.com kann man sich eigentlich registrieren für den CC in 20 minutos.Bei mir tut sich aber nichts-vielleicht noch zu früh?Versucht Ihr das mal?Thanks!

[Nostarowie]

Da is jetz natürlich en mords gap entstanden das wird attackiert von den shorties...das könnte nochmal geschlossen werden

[Birgit.Tersteegen]

[posting]20.600.773 von Nostarowie am 09.03.06 17:08:10[/posting]ja ja Du Chartie---ich glaub nix ....mehr

[bernie55]

[posting]20.600.773 von Nostarowie am 09.03.06 17:08:10[/posting]...wir nennen Dich von nun an :

> CHARTA NOSTA <

...funktioniert wie ein Paternoster, mal rauf , mal runter...und natürlich nicht das Aus und Einsteigen vergessen....

[Nostarowie]

kannste glauben mußt aber net.

[bernie55]

[posting]20.600.773 von Nostarowie am 09.03.06 17:08:10[/posting]..nichts fur ungut, Nosta

[Nostarowie]

Das verhalten von Chaotischen systemen kann man nur verstehen wenn man analog derselben handelt...

...

[bernie55]

[posting]20.601.127 von Nostarowie am 09.03.06 17:24:02[/posting]

...der war gut....es sei dir verziehen für deine GAPS...

[bernie55]

15,28 USD

[invest2002]

bei mir läüft die konferenz jetzt aber ohne bild...woran liegt das???

invest2002

[Birgit.Tersteegen]

hier ist der richtige link

http://phx.corporate-ir.net/phoenix.zhtml?c=88326&m=BasicWeb… =1216358&WebCastId=518450&StreamId=663686#

[Birgit.Tersteegen]

[posting]20.601.197 von invest2002 am 09.03.06 17:27:05[/posting]ist nur audio;gibt kein Bild!

[invest2002]

[posting]20.601.341 von Birgit.Tersteegen am 09.03.06 17:34:04[/posting]ok...danke

invest2002

[Birgit.Tersteegen]

700,000 patients in us and europe...
by: dallas769 03/09/06 11:40 am
Msg: 951887 of 951887

50% unstable--350k for t therapy

[Birgit.Tersteegen]

wird über die ganzen Pipelines von Elan gesprochen---gut dass wir Gaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaanz
looooooooooooooooooooooooooooooooooong
sind!

[Birgit.Tersteegen]

4 1/2 million Alzheimers patients in
by: pepsicokman
Long-Term Sentiment: Strong Buy 03/09/06 11:46 am
Msg: 951908 of 951915

the US and growing very rapidly. Huge market potential here for ELN, even bigger than MS market. Research going very well and should have updates this year. Going over product pipeline now. 4 products in the market, using their nanotechnology. Nanotechnology is the way to gooooooooo. ELN will be lucky if they aren`t bought out this year. The pipeline is growing; working on over 70 compounds.

[DanubeTiger]

wir sind schon fast wieder da wo es gestern aufgehört hat...RT 15.62

[Birgit.Tersteegen]

70 Drugs being tested in Nano!!!!!
by: pfaffova 03/09/06 11:48 am
Msg: 951920 of 951926

Now that is bloody BIG!!! I wonder how many companies that represents? This is very big news, as it shows us that they are presently prioritising the possible partners from a drug safety, efficacy and profitability level! I`m now totally sold on Nano`s potential.

[Birgit.Tersteegen]

Conference Notes
by: classicat6 (50/F/Phoenix)
Long-Term Sentiment: Buy 03/09/06 11:52 am
Msg: 951942 of 951943

Below are my notes. I typed as I listened. Excuse any typos or errors.

Ty:
Infusion Centers Ready
Distribution stronger than last year
Education stronger

Patients?

Physician: Mono-therapy, enrolled, informed about PML. Relapsing with disease activity, intolerant of current meds, those who opt to use Ty.

In parallel process with EU. Moving along. Have been ongoing. Expect decision by mid-year - on-track. Expect launch by mid-year.

Roughly 700,000 patients - 350,000 treated - 50% unstable - and fit Ty. 100,000 have quit. 50,000 new patients every year.

Will wait to see which patients will use - hear from all - high interest especially from those in decline.

Alzheimer’s - AAB-001 - half way through Phase II - AAC-001 - progressing - AAB-002 in clinic at end of year. Think data AAB-001 by end of year. Will validate whole approach as we go forward.

ALZ - 4.5 mil patients - growing exponentially due to demographics. In 10 years 35-40 mil patients if no treatments. We’ve spent 15-20 years investigating.

Technology - Nano - can change chemical composition of most compounds today. Four products in market today. Each are doing very well. Not just a pie in the sky.

5-6 additional transactions. Will continue to make announcements - either in partnerships or our own. Cash flow.

70 compounds of our own - which ones can we change the most - improve the most - many diffferent therapy areas - pain, cardiac…

Went from manufacturing to royalty - traction - trend - grow over time - grow from therapeutic - with very little cost.

Tysabri - journey difficult - MS is not the end - just one of the pieces. ALZ - very important part. Very significant payback and patient importance.

Nano - slower but also very important

[Birgit.Tersteegen]

Zur Erinnerung


eintragen,wer kommen würde




#8707 von Birgit.Tersteegen 09.03.06 13:04:13 Beitrag Nr.: 20.595.862
Dieses Posting: versenden | melden | drucken | Antwort schreiben ELAN CORPORATION PLC






Da wir gerade so nett virtuell zusammensitzen und auch die 13 Euronen schon so WEIIIIIT hinter uns lassen----NAAAAAAAAAAAAAA--Was sollten wir da tun????????????????????????? --Genau---------FEIERN!Nämlich unsere von langer Hand geplante 13 Euro Party!!!!!!!!!!!

ALLE;DIE HIER UND IM SCHLAFWAGEN SIND;SIND HERZLICH EINGELADEN!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!


19.3.06,Steinfurt/Westf.Tagungshaus Karneol




Quatschen,freuen,essen,trinken ,tanzen,spazierengehen oder was Euch noch so einfällt.

Internet user sollen ja so scheu und schüchtern sein --aber da wir das ja dann alle sind-ist es doch auch nicht schlimm!!!!!!!

Wer kommen will und kann,kann doch diesen Aufruf kopieren
und den eigenen Nick druntersetzen .Ich finde wir sollten schon so 6-8 mindestens sein...Am Nächsten Montag ist dann klar ob es jetzt stattfindet oder nicht!

Ansonsten müssten wir im Sommer einen erneuten Anlauf starten--aber das ist für Einige(weiss ich schom aus BMs)auch schwierig....

OK,Fragen per BM an mich--ansonsten:LOS GEHTS


Birgit
Fredo(Mein Liebster und auch stolzer Elan-Aktionär)

[Birgit.Tersteegen]

Zur Erinnerung


eintragen,wer kommen würde




#8707 von Birgit.Tersteegen 09.03.06 13:04:13 Beitrag Nr.: 20.595.862
Dieses Posting: versenden | melden | drucken | Antwort schreiben ELAN CORPORATION PLC






Da wir gerade so nett virtuell zusammensitzen und auch die 13 Euronen schon so WEIIIIIT hinter uns lassen----NAAAAAAAAAAAAAA--Was sollten wir da tun????????????????????????? --Genau---------FEIERN!Nämlich unsere von langer Hand geplante 13 Euro Party!!!!!!!!!!!

ALLE;DIE HIER UND IM SCHLAFWAGEN SIND;SIND HERZLICH EINGELADEN!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!


19.3.06,Steinfurt/Westf.Tagungshaus Karneol




Quatschen,freuen,essen,trinken ,tanzen,spazierengehen oder was Euch noch so einfällt.

Internet user sollen ja so scheu und schüchtern sein --aber da wir das ja dann alle sind-ist es doch auch nicht schlimm!!!!!!!

Wer kommen will und kann,kann doch diesen Aufruf kopieren
und den eigenen Nick druntersetzen .Ich finde wir sollten schon so 6-8 mindestens sein...Am Nächsten Montag ist dann klar ob es jetzt stattfindet oder nicht!

Ansonsten müssten wir im Sommer einen erneuten Anlauf starten--aber das ist für Einige(weiss ich schom aus BMs)auch schwierig....

OK,Fragen per BM an mich--ansonsten:LOS GEHTS


Birgit
Fredo(Mein Liebster und auch stolzer Elan-Aktionär)

[Birgit.Tersteegen]

caregivers saying aab-001 working?
by: pinvestment 03/09/06 11:58 am
Msg: 951965 of 951979

wow!

thats all i can say - are caregivers telling people that aab-001 is reversing AD? i guess that is what the jist of these questions are

should make ELN very very interesting as more of these anecdotal reports come in

[Birgit.Tersteegen]

briefing.com
by: markettwain (32/M/Metairie, LA) 03/09/06 12:04 pm
Msg: 951989 of 951991

Today`s In Play






12:03 ELN Elan: On conference at SG Cowen Health Care conference (15.52 -0.28) -Update-

At the SG Cowen conference the co mentions the co mentions the Advisory committee`s recommendations: Tysabri should be available to some subset or some type of patients, Tysabri will not be limited to second line therapy, and should not be a combination therapy. The co says they will be working with the FDA to finalize the label and they risk mgmt with the FDA, noting the March 29th PDUFA date. The co mentions they are working on all the re-marketing issues with Biogen and are in preliminary reimbursement discussions in recent months. The co says infusion centers are up and running. The co says the education process is very important for physicians and patients, patients and doctors will be told about the risks of PML. The co expects a regulatory decision in the EU by mid year; so far things are progressing well. The co expects to launch in the second half of this year if they get a positive ruling in E.U. Co speaks of their 3 Alzheimer programs, which they are partnered with Wyeth (WYE). They are making good progress; they think they will have AAB 001 data by the end of this year. The co mentions the number of patients with Alzheimer`s is 10 times the number of patients with M.S, growing exponentially. The co plans to continue to make announcements in its Nano technology business, and will continue with their Nano tech pipeline.

[Birgit.Tersteegen]

Importance of tracking NBV /NSV volumes
by: darrelldemello 03/09/06 12:16 pm
Msg: 952035 of 952077

Wow, caregivers saying aab-001 working!

So caregivers are telling people that aab-001 is reverses AD in the patients that they are looking after.

So what Happens?

As more of these anecdotal reports get circulated between the circle of influence of the patient being treated, these caregivers and the associated physicians, their relatives, relatives of patients and their brokers/ financial consutants all get excited and start buying up the stock of the company that is providing the drug, especially if the company is public.

So there is a steady and consistent buying and therefore a steady increase in NBV in this company`s stock.

This happens much before the `real good news` is released and the pps actually runs up.

If there is `real bad news` one will see a steady sell off for no reason at all....

This is the IMPORTANCE of tracking NBV / NSV volumes.

This is what teadowner has been trying to share as a tool...

JMHO.

[Birgit.Tersteegen]

12.24pm NBV +729.9k shares
by: darrelldemello 03/09/06 12:26 pm
Msg: 952079 of 952080

At 12.24pm pps $15.51

Buy Volume = 10,098,600 shares

Sell Volume = 9,305,700 shares

Indeterminate Volume = 5,643,400 shares

NET BUY VOLUME = NBV+792,900 SHARES

[welke91]

Fredo? wer ist eigentlich Fredo?

15,45 $ die wollens nicht wahr haben die Amis!

[[KERN]Codex]

[welke91]

hey Cody biste aufgesprungen?

[Birgit.Tersteegen]

[posting]20.602.461 von welke91 am 09.03.06 18:37:13[/posting]Fredo ist mein "endgültiger Lebensabschnittsgefährte"....

Best CC yet IMHO! AD all the way!!!
by: pfaffova 03/09/06 12:31 pm
Msg: 952089 of 952153

It was truely exciting stuff w.r.t. Alzheimers. You could hear that they are alot more excited than they could actually admit. I believe McLaughlin 200,000 purchase a few weeks ago probably had less to do with TYS and more to do with Caregiver titbits! Roll on!

[Birgit.Tersteegen]

Re: Forbes article just printed BUY ELN
by: REdginton (40/M/NYC, New York)
Long-Term Sentiment: Strong Buy 03/09/06 12:58 pm
Msg: 952157 of 952160

Here`s the article, note the recommendation is to buy without equivocation, this is a triple buy recommendation !!!

New York - We are issuing this alert because Elan jumped 24.5% in about 30 minutes of trading Wednesday to close at $15.81 when trading resumed on the New York Stock Exchange after the U.S. Food and Drug Administration advisory committee meeting on Tysabri concluded that afternoon.

Click here to download Ken Kam`s ten-page research report on Elan for free.
The recommendations and discussions coming out of the meeting were extremely positive for Tysabri and Elan (nyse: ELN - news - people ). I expect that the stock will continue to rally. The meeting eliminated the final remaining doubt Wall Street had about whether Tysabri would be reapproved, which accounted for a large portion of the initial price increase. Several things discussed at the meeting, however, lead me to believe that Tysabri`s potential is now even larger than before.

Recommendation (based on your portfolio):

* If you do not already own Elan, buy some at the current price.

* If you currently have a small position in Elan, add to your position.

* If Elan already represents more than 10% of your portfolio, you may have an opportunity to trim the position on this run-up.

[Birgit.Tersteegen]

Arcamex kommt wieder ins Spiel...

[welke91]

[posting]20.602.841 von Birgit.Tersteegen am 09.03.06 18:58:33[/posting]guten Morgen,

ja die Liebe die Liebe,....

Gegenüber der Presse sagten die Experte und auch Vertreter der FDA, man rechne fest mit dem Auftreten der PML-Erkrankungen, die mit einem Tysabri Outreach Unified Commitment to Health (TOUCH) genannten Risk management plan erfasst werden sollen. Geplant ist eine Registrierung von Ärzten und Patienten, die über Risiken aufgeklärt werden müssen. Dann sollen die Medikamente nur zentral abgegeben werden. Schließlich sollen alle neuen Fälle erfasst und umgehend an die FDA gemeldet werden, um der Behörde eine rasche Intervention zu ermöglichen, sollte es doch zu mehr PML-Fällen kommen, als derzeit angenommen wird.

Das positive Votum der externen Berater wurde durch die ebenfalls in der letzten Woche im New England Journal of Medicine publizierten 2-Jahresergebnisse zweier Zulassungsstudien ausgelöst. In einer Studie hatte eine Monotherapie mit Natalizumab die Krankheitsprogression um relativ 42 Prozent abgeschwächt (NEJM 2006; 354: 899-910). In der zweiten Studie hatte die Kombination aus Natalizumab mit einem Beta-Interferon die Krankheitsprogression gegenüber einer Monotherapie mit Beta-Interferon um 24 Prozent vermindert (NEJM 2006; 354: 911-23). Beide Studien belegen die gute Wirksamkeit des neuartigen Wirkstoffes, auch wenn streng genommen unklar ist, ob Natalizumab den Beta-Interferone (oder dem ebenfalls in der Indikation zugelassenem Wirkstoff Glatiramer) überlegen ist, da ein direkter Vergleich bisher nicht durchgeführt wurde.

Dennoch schätzen die US-Experten die Vorteile von Natalizumab offenbar so hoch ein, dass sie mit 7 gegen 5 Stimmen für die Zulassung von Tysabri als First-Line-Therapie, also ohne Vorbehandlung mit anderen Mitteln, votierten. Ob die FDA diese Ansicht teilt, wird Ende März feststehen. Dann fällt die Behörde ihre Entscheidung. Wenn sie dem Votum der Gutachter folgt, was in der Regel der Fall ist, dann wäre dies in der Geschichte der Behörde erst das zweite Mal, dass ein aus Sicherheitsgründen vom Markt genommenes Medikamente erneut eingeführt wird.

Das erste Mal war dies 2002 der Fall, als das Medikamente Lotronex® (Wirkstoff Alosetron) zur Behandlung des Colon irritabile wieder eingeführt wurde. Es war im November 2000 vom Markt genommen worden, nachdem es zu lebensgefährlichen und in einigen Fällen tödlichen Komplikationen (ischämische Colitis) gekommen war. Damals wie heute musste sich die US-Behörde nicht nur mit den sachlichen Bewertungen der Gutachter befassen, sondern auch mit den teilweise sehr emotional vorgetragenen Wünschen der Patienten sowie den Bedenken der Verbraucherschützer. /rme

[Birgit.Tersteegen]

MOIN@all!

Über den Conference Call von gestern und die Super Perspektive unseres Babies....

CC my take
by: nangasimon (36/M) 03/09/06 05:03 pm
Msg: 952897 of 953661

this cc had a different feel from others. the questions were quite good and seemed from informed people.

there was nothing new on MS. just a review of the AC.

Alot of the conference discussed AD. At the end I felt much clearer about where the positive vibes are coming from and its not (unfortunately) any unblinded data. That said, there are clearly rumours around (which must be more internal than external as I havent heard them) of improvements in the AAB-001 trial. AS I have said before, rumours from physicians and caregivers would be the first signal of a dramatic therapeutic response. It surprises me that they are prepared to talk about this even in response to a question so there must be a pattern of rumour.

We also got clarity that the interim look will be at 9 months. Trial started recruiting 11 months ago with a three dose level escalation (at three monthly intervals I understand). This puts the unblinding well into H2.

They do have PI data. I dont know how many patients and we got no idea whether any optimism comes from this. However we did hear that the phase I data will be made public in H2: what data are these? we know it was safe so was there an efficacy signal here? acute cognitive improvement like with IVIg I wonder?

Nano clarified alot. So many compounds to even out the risk. There is an awful lot of basic science data coming out on rapamycin - its use in stimulating the autophagy pathway that may be important in neurodegenrative diseases. Felt restimulated by the strategy here.

Today Im feeling better about my money than ever. There seems little downside over the next nine months.
1. Ty is coming back there might be a lag in uptake but it will be bigger than most expect (at least 100,000). Negligible chance that PML will be >1:1000
2. AD - if we dont here in H2 get worried and sell at Christmas. We won`t hear a negative this year, we might hear a strong positive, FDA rush to approval, treatment of all cohorts on ethical grounds - what a thing to say at this stage!
3. Nano - so many rolls of the dice its not going to be down to good or bad luck

Note to self: must stop being so smug in my investments!

[Poppholz]

Dow Jones
Biogen Idec erwartet Wiederzulassung von "Tysabri" im Juni
Freitag 10. März 2006, 08:12 Uhr

BOSTON (Dow Jones)--Die Biogen Idec Inc geht davon aus, dass sie ihr Medikament zur Behandlung von Multipler Sklerose "Tysabri" von Juni an wieder in den USA verkaufen kann. Dies sagte CEO Jim Mullen am Donnerstag auf einer Fachkonferenz in Boston. Einen genaueren Zeitpunkt der Wiedereinführung könne er nicht nennen, da die US-Gesundheitsbehörde FDA die Prüfung der Unterlagen noch nicht abgeschlossen habe. Für Prognosen zum möglichen Umsatz sei es noch zu früh, ergänzte er.

Bisher habe man die Wiedereinführung des Mittels in den USA im ersten Halbjahr 2006 angekündigt, sagte Mullen. An dieser Vorhersage habe sich nichts geändert.

In Europa rechne das Unternehmen mit der Wiedereinführung im zweiten Halbjahr 2006.

Eric Schmidt, Analyst bei Cowen, veranschlagt den Umsatz mit Tysabri in den kommenden vier Jahren auf bis zu 800 Mio USD. Davon dürfte rund die Hälfte in den USA erzielt werden. Insgesamt hat der Markt für MS-Medikamente laut Biogen ein Volumen von rund 5 Mrd USD. Vor dem Rückzug des Produkts vom Markt hatten Beobachter Umsätze von bis zu 4 Mrd USD pro Jahr in Aussicht gestellt.

Der Kurs der Biogen-Aktie zog in Reaktion auf die Aussagen des CEO am Donnerstag um 4,5% an. Biogen Idec und ihr Partner Elan Corp hatten das Medikament im Februar 2005 vom Markt genommen, nachdem während einer klinischen Studie drei Patienten an der hirnschädigenden und häufig tödlich verlaufenden Krankheit progressive multifokale Leukenzephalopathie (PML) erkrankt waren. Am Mittwoch dieser Woche hatte ein Beratergremium der FDA die Wiederzulassung von Tysabri empfohlen. Mit einer endgültigen Entscheidung der Behörde werde Ende März gerechnet.

-Von Val Brickates Kennedy; Dow Jones Newswires, [phone], [e-mail] DJG/DJN/bam/jhe

[Birgit.Tersteegen]

Ty -bald in Pillenform--INTERESSANT!


Elan`s Biogen Bomb
by: [e-mail]
Long-Term Sentiment: Strong Buy 03/09/06 05:14 pm
Msg: 952931 of 953664

Lars was speaking today at CC about the small molecule, in response to a question about Elan`s tablet form of Tysabri, now in development, I believe.

Why would `partner` Biogen want to do anything but `slow walk` reintroduction of Tysabri. Off patent for Avonex is a long ways away from right now. Avonex sales are huge for Biogen NOW, it`s clear that unsatisfied Avonex patients will switch to Tysabri, and they CANNOT take Avonex in combo as per new scrip requirements for T.

If FDA is looking at minimum of 5 years of follow-on for new Tysabri patients, Biogen loses on reduced Avonex sales as soon as T hits the market, and when Elan comes thru with T in pill form, which they own exclusively, Biogen is no longer a `partner`.

I don`t have any idea how soon Elan could bring out T in pill form, but if it is going to happen, surely it will occur prior to next 5 years of Tysabri MS market hegemony.

One other thing, I was pleased that the Elan shareholder attending the CC told it like it is about TEVA and other competitors and thier `surrogates` as he stated it, continuously spreading outright lies and deception to cast Elan/T in a bad light with investors AND the reading public.

While I appreciate KM `taking the high road`, Elan desperately needs an Investor Relations department to counter this chronic corporate character assasination. Just `taking it` in silence encourages continuation of this slander, we all learned this on the schoolyard, right? If KM is not up to it, delegate, it is the CEO`s job to protect the positive image of the corporation for the shareholders benefit.
JMHO
vocex1

[Poppholz]

Finanzen.net
Biogen Idec outperform
Freitag 10. März 2006, 08:36 Uhr

Rating-Update:
Die Analysten von RBC Capital Markets stufen die Aktie von Biogen Idec (ISIN US09062X1037/ WKN 789617) von "sector perform" auf "outperform" hoch. Das Kursziel werde von 54 auf 64 USD angehoben.

Analyse-Datum: 10.03.2006



(langsam können die Analysten auch mal unser ELAN Baby empfehlen)

[Birgit.Tersteegen]

Dr Temple signals approval...
by: stellarbeautysuperiorbrilliance 03/09/06 11:51 pm
Msg: 953585 of 953667

Apologies if this has been hashed over, I only had time to skim the board.

From a newspaper article by Lauran Neergaard, AP medical writer:

"The FDA usually follows its advisers` recommendations, and agency drug chief Dr. Robert Temple signaled Wednesday that it would do so with Tysabri."

Is this Dr Temple a key person regarding the FDA decision ? If so, is his statement significant ?
---------------------------------------------------------
Re: Dr Temple signals approval...
by: twob2frank 03/10/06 02:51 am
Msg: 953667 of 953667

Dr. Robert Temple- Director of the FDA Center for Drug Evaluation. I`d say he`s key-

[Poppholz]

Finanzen.net
Biogen Idec overweight
Donnerstag 9. März 2006, 17:08 Uhr

Rating-Update:
Die Analysten der HSBC Investmentbank stufen die Aktie von Biogen Idec (ISIN US09062X1037/ WKN 789617) von "neutral" auf "overweight" hoch. Das Kursziel werde von 51 auf 68 USD angehoben.

Analyse-Datum: 09.03.2006

[welke91]

[posting]20.608.223 von Birgit.Tersteegen am 10.03.06 08:49:54[/posting]das wäre natürlich für unsere Krankenkassen ein Segen,

selbst Herceptin wird nur von hiesigen Krankenkassen bewilligt unter einem Leistungsgutachten bzw. schwere des Falles.

[Birgit.Tersteegen]

An investor`s point of view
by: KimoKane
Long-Term Sentiment: Strong Buy 03/09/06 06:54 pm
Msg: 953156 of 953691

I have only posted a few times here and not in a long time. Since my background is on the investment professional side (OK everybody give me the raspberries), I had little to offer on Elan since the whole story was about the return of Tysabri. Now that Tysabri will return, I thought I might try to explain some of the behavior of the street and why they are wrong. In full disclosure, I held 6500 shares of Elan on Black Monday, I held 22,000 before the advisory panel met and I bought an additional 1000 shares today.

Pininvestment wonders if he is too qualified to be a Wall Street analyst. Well, he certainly knows too much about Elan to be a Wall Street analyst and that would probably go for at least the top 100 posters on this board. I`ve met hundreds of Wall Street analysts and like every other occupation, about 10% to 20% really know their stuff but the rest are a waste of time.

But even with those 10% to 20% there are factors you have to consider. One, and a favorite of the Elan Message Board, is that they are basing their position based upon some form of economic incentive-be it investment banking, proprietary trading book or even more nefarious purposes. Every time you see an opinion that seems out of tune with common sense or logic you get to wondering if this person is getting paid off somehow. I think that we saw even some of that being done by an MS society at the FDA panel.

The second reason is I think the dominant reason. Wall Street is a bunch of sheep or lemmings with little ability to think for themselves. No one wants to stand out, and if you said Tysabri was going to return, boy did you stand out. So once you join the rest of the sheep and make the easy decision to say Tysabri won`t return based on a fatal brain disease, a catastrophic move in stock price, an FDA under fire for Vioxx, plus Elan`s sketchy history concerning accounting and a failed Alzheimer`s drug, you feel very comfortable with your fellow sheep. And the institutional buy side (where I was at Northern Trust) is 10x`s worse. All of the sheep (at least those not harmed in filming of Brokeback Mountain) then become anchored. In Behavioral Finance or in regular psychology that just means that once you accept an idea it is very difficult to move away from that idea (In investments if you buy Elan at $15 that might become your anchor from which you base a lot of your future investment decisions).

So these sheep on both the buy side and the sell side have trouble moving away from the herd even though there was a lot of evidence to support that Tysabri would return. In fact,the evidence was so strong that the panel voted 12-0 in favor of returning this killer drug owned in part from that shady Irish company and that other company with the chief counsel inside trader. And that is even with some doctors on the panel with economic interests tied to the competitors. That shows how overwhelming the evidence is about the efficacy and safety of Tysabri. That shows that most of Wall Street on both the buy side and the sell side don`t have a clue. Don`t worry if they don`t upgrade right away. The sheep are stunned. It will take them some time to come to their senses.

[Birgit.Tersteegen]

NEW PARADIGM>>>
by: creedster_99
Long-Term Sentiment: Strong Buy 03/10/06 02:16 am
Msg: 953657 of 953693

Once again...reread the part about AD after having heard about today`s CC comments...

Tomorrow starts a new paradigm.

Return to Feb 2004 when Elan announced that they were going to be given permission by the FDA to file for accelerated approval for Antegren (Ty) for MS with one year data. The price ran from $8 to $20 in 2 weeks. That was 3 mos BEFORE SUBMISSION and 9 mos before approval.

Since that time, we now have all the 2 yr data showing tremendous efficacy and reversal of disability in MS which no competitors drug can claim!

PML was a quirk and in monoRx will likely not be seen for a very, very long time since use will be restricted in immunosuppressed pts. Also, combo Rx won`t be allowed.

Further, we now have the AC not only recommending 12-0 for approval but they have given their blessing (7-5) to allow it to be a first line Rx. This expands the potential US market alone from 100,000 to 400,000 est patients. Double that when you add the EU.

EU approval will likely come in the next 3-4 mos. Markets always look ahead!

So, when it finally starts to sink in that Elan and BIIB are going to start selling the snot out of a tremendously safe and efficacious new drug which works twice as well as the currently available drugs which collectively sell $5B/yr, some institutions are going to start to rush to buy Elan just like they did in Feb 2004.

Additionally, as we all know, Nano is much further along, now with $200-300M in royalties expected in 2006.

Oh did I forget to mention that we have 2 Phase II studies in AD showing "tremendous promise" acc to Lars Ekman who went so far as to say that he thought the potential market for an AD treatment showing a disease reversal is greater than $10B and that Elan was "currently well positioned to become that first company"?

We also have rights to buy into Lilly`s Phase II drug for AD if we choose to becs of certain patent rights issues.

Lastly, we have another Phase I drug under study with a modified vaccine of AN-1792 which showed disease reversal in humans.

Sorry one more... oral VLA blockers similar to Tysabri will possibly be submitted this year for an IND. It will be more specific than Tysabri and can be used in RA pts, prob without the fear of PML becs of it`s greater specificity.

So, we have a paradigm shift in information and attitude about Tysabri`s chances for return to market and in potential market (up from 200,000 to 800,000 in US and EU) and I haven`t even touched on the Crohn`s indication in EU which was initially submitted in Fall 2004. But, that`s for another day. Can`t give you guys all the info...

Time for newbies to do a little DD.

Congrats to all the long longs with big swinging brass ones! You deserve it!

BTW, with this new shift, I am now firmly of the belief that Elan will see low $20`s before this summer. We did it in 2004 WAY before all the new stuff above developed!!!

[Poppholz]

FDA-Ausschuss empfiehlt Biogen-Mittel Tysabri erneut zur Zulassung
10.03.2006 - (dpa-AFX) -

Das umstrittene Multiple-Sklerose-Medikament Tysabri der beiden Biotechnologie-Unternehmen Biogen Idec und Elan soll nach Einschätzung eines Beraterausschusses der amerikanischen Gesundheitsbehörde FDA wieder in den USA zugelassen werden. Dies teilte der Ausschuss mit. Im Februar 2005 musste Tysabri wegen eines Todesfalls nach nur wenigen Monaten Zulassung in den USA vom Markt genommen werden.

Für eine erneute Zulassung verlangt der Ausschuss jedoch Sicherheitsvorkehrungen wie die Beobachtung der Patienten auf mögliche lebensbedrohliche Komplikationen, hieß es in dem Beratungsgremium der FDA. Die Mitglieder des Ausschusses votierten zwölf gegen null Stimmen dafür, dass Tysabri wieder vermarktet werden soll. Eine Auflage, die der Ausschuss vorsieht, ist die Bedingung, dass Biogen für eine Registrierung der Patienten sorgt und somit mögliche Nebenwirkungen verfolgen kann. Die FDA folgt üblicherweise den Empfehlungen ihres Beratergremiums. Vielen Patienten würden die auf dem Markt befindlichen Medikamente nicht ausreichend helfen. Daher sollten sie auch Tysabri als eine Option haben, sagten Ausschuss-Mitglieder.

Tysabri, dem einige Analysten einen weltweiten Umsatz von jährlich mehr als 3 Milliarden Dollar zutrauten, wurde im Februar 2005 vom Markt genommen, nachdem ein mit dem Mittel behandelter Patient an einer seltenen Erkrankung des Zentralen Nervensystems (PML) gestorben war. Danach wurden zwei weitere Fälle bekannt. Einer verlief auch tödlich.

http://www.bionity.com/news/d/52961/6806C/-0123456789

[Poppholz]

erster Kurs USA

$15,20

RT
$15,25

[DanubeTiger]

werden wohl die 14 wieder sehen heute..

[Birgit.Tersteegen]

[posting]20.614.603 von DanubeTiger am 10.03.06 14:49:22[/posting]och nööö

[DanubeTiger]

aber was spielts auch für ne Rolle - wir wissen ja dass es es mittelfristig in die andere Richtung geht...und wenn Elan kräftig wächst, müsste sie auch aus dem Schatten von Biogen treten und etwas mehr Publikum kriegen..

[Poppholz]

würde mich aber trotzdem über einen schöneren Kursverlauf freuen.

Ansonsten kommt man ja doch noch in die Versuchung das Spiel mitzuspielen.

[DanubeTiger]

ja würde auch nicht nein dazu sagen...habs auch lieber gründ als rot...

[Birgit.Tersteegen]

[posting]20.614.838 von Poppholz am 10.03.06 15:00:02[/posting]...und führe mich nicht in Versuchung,denn Dein Reich komme.....

[DanubeTiger]

jetzt wirds aber biblisch..

[Birgit.Tersteegen]

Jungs,WIR WISSEN DOCH WARUM WIR HIER INVESTIERT SIND,OOOOOODDERR??

Lassen wir uns also doch unsere Elanie-babies nicht billig aus den Händen nehmen--oooder?


KM Holdin ALZ card tight to his Chest
by: hunglikeahorz (33/M/NC)
Long-Term Sentiment: Strong Buy 03/10/06 08:41 am
Msg: 953816 of 953887

When you listen to the CC, KM and Lars were saying "officially, we can`t say anything because of the double blind review."

But if you listen carefully ....

- Both KM and Lars sounded very enthusiastic and you can ascertain that from the tone of their message about AAB-001 data coming out this year.

- Lars was also asked what endpoints were necessary for Phase III to start. And he articulated very clearly that they may have to start dosing ALZ patients (who are still on placebo) with the real thing to combat the Alz disease and stop it. He said it was an ethical thing to do if they see the vaccine effectively working.

- Lars said that they have different pipelines for ALZ that will attack the Alzheimer disease from different angles. I believe that ELN`s scientist are the best of the best. KM also confirmed ath WYE CEO did address the White House on Alz and alluded to the fact that this will have HUGE government backing. FDA will be pressured to fasttrack ELN/WYE Alz program because there`s currently no drug out their for this disease.

... And 4.5 million patients (and growning) ... WOW .. Tysabri`s $2 - $5 billion sales will look peanuts compared to ALZ pipelines.

[DanubeTiger]

ja klar darum hab ich auch 2-3 shares zum Schnäppchen Preis gekauft ....billig, billig

[DanubeTiger]

ich glaub der pennt..

Friday, March 10, 2006 5:08:15 AM ET
Deutsche Securities

NEW YORK, March 10 (newratings.com) - In a research note published yesterday, analyst David M Steinberg of Deutsche Bank Securities maintains his "buy" rating on Elan Corporation (ELN.NYS), while reducing his estimates for the company. The target price has been raised from $8 to $15.

[Birgit.Tersteegen]

News of interest
by: elechdret50 (49/M) 03/10/06 09:24 am
Msg: 953928 of 953930

As some of you may recall,I have an employee who`s wife has MS.She had been dosed 1 time with Tysabri and was 2 days away from receiving her 2nd when Tysabri was recalled on 2/28.Wednsday..after work I let him know how the vote went per the AC and he told me that his wife had an appointment that day with her neuro...well Thursday slipped by , but had chance this morning to visit with him.

She is a patient at the UNO..(University of Nebraska of Omaha Hospital.At time of recall,they had around 300 patients dosed and more waiting on paperwork.This was also I believe one of the trial sites.Her neuro is THRILLED and so is she.

The doc told her ,their ready to go NOW,but that it probably going be a couple months before her 1st infusion (we all kinda knew that already),but the REALLY SIGNIFICANT part is that her neuro said ALL 300 or so WANT BACK ON TYSABRI ASAP.!!!not 10%...not 50%...ALL of them ..!!...Lord only knows how many who were awaiting the paperwork will also.I warned him that there has to be training of the neuro`s to be able to spot PML quicker and that all patients will have to be registered and tracked..hence couple months till infusion....so uptake again ,if this site is any indication,should be brisk.

She "was" a rebif patient since recall...doc warned her that she will need 30 day clearence before restarting Ty.She`s ready....even though she only dosed once,she never felt that good before and was tired of being sick the day after her 2 injections weekly of rebif....

Thank goodness the AC saw thru the BS just how important ,this effective treatment is, for MS`ers.

JR>.

[eliasesteban]

die arbeitsmarktzahlen von amiland sind heute raus und ---sehr gut,dürfte es unserem baby vielleicht etwas leichter machen?!

[DanubeTiger]

..und wir sind unter 15 USD..RT

[Poppholz]

[posting]20.615.045 von Birgit.Tersteegen am 10.03.06 15:09:21[/posting]natürlich lasse ich mich nicht auf das Niveau der Shorties herab.

Bei meinem Glück würde ich dann auch schön den Rückkauf verpassen.

[YoungRich]

15$ ....habs doch gewusst .. denke wir laufen auch noch gegen die 14 zu, dann die Wende :-)

Kann meine Shares ja bald wieder zurückkaufen :-)

Gruss
Young

[rotie1]

Wer will eigentlich mit purer Gewalt verhindern, dass Elan steigt??
Wenn man sich das Realtime-Orderbuch ansieht, ist es ja sowas von offensichtlich!
Will man den Kurs untenhalten, um bei gegebener Zeit Elan zu übernehmen?? Biogen vielleicht?
Hat jemand eine Erklärung für diese Drückerei, oder eine andere Theorie?
Außerdem ist es ja wohl dumm, die Aktien so billig auf den Markt zu schmeissen! ...es sei denn, man kauft sie selber zurück!

[eliasesteban]

am handelsanfang usa gehts immer abwärts,bin zuversichtlich das es heute aufi goit!

[DanubeTiger]

naja meine Theorie sagt, ELN ist immer noch zu klein und somit ein Spielfeld für alle Zocker und Traders..und die bestimmen nun mal den Preis - wie lange das nocht geht weiss keiner, aber ohne "signifikanten" News / Marktdaten wird der Kurs so volatil bleiben wie er ist...aber natürlich kann auch alles anders kommen und meine Theorie is eh für die Füchse......

[Birgit.Tersteegen]

[posting]20.616.005 von YoungRich am 10.03.06 15:45:22[/posting]....interpretiere es als Deine ZWEITE Chance!!

[YoungRich]

Ja Birgit, vielleicht werde ich ja doch noch reich :-)

Im Prinzip sollte man bis zur Zulassung jeden Tag ein paar Stücke kaufen, egal ob der Kurs aktuell steigt oder fällt ... nach der Zulassung werden wir bestimmt höher stehen ! Und das Risiko gegen unten sollte nicht mehr allzugross sein ....

Was denkt Ihr zu meinem Plan ? :-)

Gruss
Young

[Poppholz]

[posting]20.615.366 von DanubeTiger am 10.03.06 15:22:32[/posting]ich sehe in der Kurszielsteigerung von $8,- auf $15,- durchaus etwas positives.

Eine Erhöhung des Kursziels von ca. 90% !!!!!!!!!!!!!!!!!!

[Birgit.Tersteegen]

[posting]20.616.412 von YoungRich am 10.03.06 15:59:53[/posting]Was sind denn "ein paar Stücke" für Dich?

Wenn man 1 Jahr halten will, sind die Centbeträge nicht so entscheidend...

Gruss Birgit

PS.Du bist doch jung und hast ZEIT um reich zu werden...

[Poppholz]

ELAN sichert uns unsere Rente mit 50.

[Birgit.Tersteegen]

Auf alle Fälle wollen sie in AMILAND billig covern und mich ärgert, dass ihnen das gelingt!Ich verstehe warum man jetzt kauft,aber nicht warum man JETZT VERkauft!

Aber am ENDE IST ES AUCH WIEDER TOTAL EGAL.....

[DanubeTiger]

ja, klar - denke bloss der Heini bei der D-Bank hat`s einfach verschlafen und musste seinen Senf auch noch dazu geben...

[Birgit.Tersteegen]

[posting]20.616.555 von Poppholz am 10.03.06 16:05:32[/posting]dann müsste Elan für mich explodieren....wäre auch ok...!

[YoungRich]

Hmmm, ein paar Stücke :-) Das kann ich doch jetzt nicht einfach so öffentlich kommunizieren hier im Board :-)

Und sooo jung bin ich auch nicht mehr ... wurde dieses Jahr 29ig ...

Gruss Young

[YoungRich]

..und ich wollte eigentlich jung reich werden, nicht erst mit 50ig :-)

[Birgit.Tersteegen]

My broker predicts ELN will be at 27$
by: asiansjose
Long-Term Sentiment: Strong Buy 03/10/06 10:20 am
Msg: 954130 of 954261

Yeah My Broker at Charles Schwab told me to buy ELN at this price. He confidently predicted that ELN will pass 27$ range easily..
It`s more than 12 dollars gain at this level
With the launch in Europe ELN share will go much higher also

-----------------------------------------------------------

long and strong!

[Birgit.Tersteegen]

Elan Corporation, plc (ADR): Stock Rating Summary

Elan Corporation, plc (ADR), a mid-cap company in the health care sector, is expected to significantly outperform the market over the next six months with average risk.

10 is the best possible rating.

Quick Summary
Details

Pro
The StockScouter measure of relative price change and consistency is high. Positive
Previous day`s closing price for ELN was slightly above its 50-day moving average. Positive
One or more analysts has modestly increased quarterly earnings estimates for ELN. Positive
Con
Shares are being heavily sold by financial institutions. Neutral for a large company like ELN

Short-term Outlook

Over the next 1-2 months, StockScouter forecasts that mid-cap stocks will be neutral and health care stocks will be neutral.
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Page generated 3/10/2006 11:05:53 AM eastern time

[Nostarowie]

[mikel_ann]

Da ist aber imo Abverkauf , oder sieht das nur so aus ?

[Nostarowie]

Die wolln wo das Loch zumachen und dann is noch Freitag.
Schon so oft erlebt bei dem Teil da kommt mir,s Gähnen.

[VauAcht]

[posting]20.616.714 von YoungRich am 10.03.06 16:11:33[/posting]"... Und sooo jung bin ich auch nicht mehr ... wurde dieses Jahr 29ig ... "

... alter Sack

[mikel_ann]

Müsste dann wieder Pulver sammeln, um bei 11 zuzuschlagen.

[Nostarowie]

Eindeutig Shortunholde und gewinnmitnahmen, die Indis steigen

[mikel_ann]

Meistens läuft aber ELN eh davon abgekoppelt

[Nostarowie]

Stimmt auch wieder

[Birgit.Tersteegen]

Nach anstrengenden Arbeitsstunden so´n Chart....Ist was passiert ???

[mikel_ann]

[posting]20.621.462 von Birgit.Tersteegen am 10.03.06 19:50:38[/posting]Hatte ich nicht schonmal mit sowas gerechnet

Aber besser als ohne Ty, sonst wären die deutlich einstellig.

[Birgit.Tersteegen]

Aber was soll das -billiges covern+sortattacken Einzelner+Hedgefunds??

[mikel_ann]

Glaube ich nicht. Dazu fallen sie zu langsam.

[mikel_ann]

Gerade dachte ich warum es nur so ruhig ist in FFE.

Nun isses aber wirklich Zeit zu gehen

Machts gut.

[Dennie]

Habe bei 12,55 € nachgekauft war hoffentlich kein Fehler ist doch komisch bei positiven News kleines Plus bei Negativen News hätten wir 50% verloren bekommt man echt ein Depri

[Birgit.Tersteegen]

[posting]20.622.810 von Dennie am 10.03.06 21:04:46[/posting]Viel Angst der Kleinanleger und viel Marktmanipulation--das wird sich geben!

Tysabri Inventor will be written
by: mstone94080
Long-Term Sentiment: Strong Buy 03/10/06 03:09 pm
Msg: 955125 of 955125

in the medical history book as other greatest inventors in medicine.

Elan will be much bigger company than its giant neighbor.

Accoumulate the stock of elan while you can at this rediulous price, five years later you may be millionair easily.

[Birgit.Tersteegen]

What you are seeing is a game of
by: burntbuttflesh 03/10/06 03:50 pm
Msg: 955238 of 955314

CHICKEN.

A game of chicken between (A) a whole ton of short-term money (i.e. daytraders and swing traders) that has been buying into this pullback, and (B) the shorts.

The short-term money has "intercepted" a whole ton of stock that the shorts were hoping to cover with. The short-term money is holding millions of shares right now, expecting to sell it back to the shorts next week at or near the January high.

How could this happen? Because the real long-term, institutional money didn`t buy on the news. They will be buying throughout the rest of the month as they get comfortable with the sales projections. The initial entrance of the long-term money into the game next week is exactly what the daytrading/short-term money is counting on to win this game of chicken.

Now the shorts are running out of time. Next week they will have to compete for shares in the first wave of long-term, institutional buying. The short-term money knows this and can afford to sit on its position, restricting the amount of stock in the market. Short-term money doesn`t usually have this kind of attention span or act this way---its only happening because of the potential for a short squeeze.

By the way, this isn`t due to specific collusion. It happens naturally based on the circumstances. And it will work as long as the shorts can`t print stock forever.

Just an opinion, based on watching this market and its players closely.

[Birgit.Tersteegen]

14,56--die Amis spinnen!

[mikel_ann]

oder hamm die Vogelgippe ?

[mikel_ann]

Oups, kann ich nach ein paar Bierchen nur NVAX emphehlen.
(Sicher aber auch ohne)

[mikel_ann]

Birgit, eoy sehen wir die 20$, aber ich will schliesslich auch noch ein paar mehr haben und darauf arbeiten die eben hin.

[Birgit.Tersteegen]

[posting]20.624.625 von mikel_ann am 10.03.06 22:32:08[/posting].....da könnte was dran sein ;short sein führt wahrscheinlich zur Schwächung der Immunabwehr und damit nicht zu PML---aber zu "diversen"Grippen (ih wie gemein....)

[Birgit.Tersteegen]

Moin

BIIB
by: goodtoreadthis (59/M/Boston, MA) 03/11/06 12:48 am
Msg: 955800 of 955815

BIIB has driven most of us crazy with their tepid, convoluted, now you see it now you don`t type, supply capacity statements.

Most of the time we have puzzled about why BIIB has seemed to leave tysabri vulnerable to analyst bashing.

Watching BIIB at the AC - they were superb- 10X the quality of Ectrims presenters, I had to smile when the AC started to chase Al Sandrock on Anita Smith case. To understand what BIIB does you need to know that BIIB tells you - the questioner- what BIIB thinks BIIB wants you to know. Your Q does not matter- BIIB decides what you should know and that`s all you get.

In Nov 04 I asked BIIB about 7 Qs at an analysts meeting and BIIB actually answered only one of the Qs. The rest they acted like I had no need to know the stuff I was asking about so they parryied each Q.

Anita Smith was the first PML case - the woman died. The issue in the press and in the testimony in court was - was Smith given T becuase BIIB failed to check to see if she had MS BEFORE tysabri was used. The AC doc asked Sandrock " Did BIIB fail to confirm presence of MS in Ms Smith before she was given tysabri?"

Sandrock literally answered that question by saying " BIIB had no role in that autopsy ? In fact we have not seen that autopsy."

Since an autopsy has nothing to do with the original enrollment decision, the AC doc got very, very angry at Sandrock who kept acting like the autopsy was the controlling document. That exchange went on for about 3-5 minutes. Sandrock finally cornered by an AC doc who said -I am completely surprised by BIIB failure to answer- said "I don`t like to critique my peers."

Sandrock completely avoided answering a very key question. BIIB stood to lose the Smith case in court if Sandrock acknowledged a screw up so BIIB left tysabri hostage to this AC docs rath.

BIIB are superb salesmen. They control the info, the dissemination of info, and they service the heck out of all aspects of the MS marketplace.

BIIB actually sent a security bodyguard with it`s managment team. He told me that BIIB piped the entire AC on closed circuit TV to every BIIB office around the world. Why would they do that ?

Every aspect of company posture on Tysabri, of restrictions on T, on procedures for T, were discussed in detail at that AC. It was a perfect forum for training the worldwide BIIB management and sales team. BIIB executes, executes, executes. I don`t particularly appreciate BIIB`s style; but it works for them and it allows them to CONTROL the entire situation.

[Cyberhexe]

[posting]20.622.810 von Dennie am 10.03.06 21:04:46[/posting]@dennie
nachkaufen...das einzig Richtige! Denn das Risiko mit negativen Überraschungen auf dem falschen Fuss erwischt zu werden, ist derzeit sehr gering. Seit über einem Jahr wird Tysabri nicht mehr angewendet, so dass von fatalen Nebenwirkungen demnächst keine Schlagzeilen zu erwarten sind. Deswegen habe ich bei meiner Bank eine Erweiterung des Wertpapierkredites beantragt. Jetzt geh ich auf die Äste und erhöhe meinen Investitionsgrad auf 125% - all in one, all in Elan!
Ich möchte jedoch darauf hingewiesen haben, dass dies nicht zur Nachahmung empfohlen wird und im Widerspruch steht zu jeder seriösen Anlagestrategie. Allerdings möchte ich ebenfalls darauf hinweisen, dass es zwecklos ist, mir diesen Wagemut auszureden.

good luck
ch

[[KERN]Codex]

Verstehe wer will, da wollen noch einige Adressen einsammeln bevor gezündet wird

[Birgit.Tersteegen]

[posting]20.628.389 von Cyberhexe am 11.03.06 12:10:45[/posting]um Dich mach ich mir da keine Sorgen;im Zweifelsfall können Hexen doch auch zaubern,oder??!! (Nicht dass ich denke dass das bei unserem Elanie-Baby nötig wäre....)

[Birgit.Tersteegen]

Re: what happened?
by: princesslarkin 03/11/06 10:24 am
Msg: 955938 of 955938

History is repeating itself, and giving us all another chance at cheap shares! Don`t you see?

Look at a one year chart. Look at the second week of August in `05. You`ll see the same kind of spike we had on Wednesday of this week! And what caused that spike? THE NEWS THAT TY WAS COMING BACK. And right after that spike, what did we observe? THE STOCK SPENT OVER A WEEK GOING DOWN, DOWN, DOWN. And what happened after it was done going down, down, down? I think you know.

Why, you wonder, does a stock go down, down, down, after terrific news?

It`s market psychology 101 - People sitting on profits react to the news like this: "It`s not gonna get any better than this for a while, I`M OUT" And we get selling. Lots of it. And the price per share goes down.......for a while.

The profit takers will finish their dance, probably this week. It all ready looked like it was evening out late Friday. If you`re long, hang tough, your time is very near. If your on the sideline, start accumulating. I sure as hell am.

THANK YOU GOD FOR THIS SECOND CHANCE!

[Birgit.Tersteegen]

Re: Hush`s NUMBERS
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/11/06 09:19 am
Msg: 955892 of 955941

Aggggggggghhhhhhhhhhhhhhggggggggggghhhhhhhaaaaaaaaaaaaaaaaaaaaaaaaaaammmmmmmmmmmmmmmmm............

Man alive, I don`t want you anywhere our business. I doubt anyone else would either. Why do you require so much help?

Firstly, BIIB and ELN will raise the price of Tysabri to reflect the additional expense associated with the RiskMap inititives. They will cloak that expense to include the time value of our wait in the holding pattern.

Secondly, that royalty is roughly 3% to PDLI, with the balance recirulating to BIIB`s manufacturing division and ELN`s share routing back to Dublin. The R & D expense has not been spent, therefore it`s not an expense. The Cost of Goods sold numbers are arbitrary at best, already include internal manufacturing expenses, and are based on previous downstream manufacturing quatities. The Sales, General, & Accounting are the salespeople`s commissions as that is the only thing not already there. Perhaps add .5 of 1% for additional personel. That would shake like this in the real world, which is where I live.

$100 Tysabri sales US

3% PDLI royalty
5% Sales expense
6% SGA
12% Cost of Goods

Annual Tysabri expense $23,500
Wholesale discount 2,000
Net $21,500

Expenses (26%) (6,110)

Gross Profit $15,390

100,000 Patients @ $15,390 each = Profit $1,539,000,000

$1,539,000,000 x 50% = $769,500,000

That my good contrarian friend is $1.74 per share EBITDA

Now, give that Mr. Martin has successfully acheived a neutral EBIDTA previous to this cash storm, we are going north this year. It is not unrealistic for analysts to pick up one year forward sales projections. That`s wht it`s labeled a "forward P/E"

At the average Bioworld P/E of 21.4 that`s a pps of $35.49.
Add $10 for Drug Delivery and AD PIII enrollment rumors and you have a year end pps of $45 and change. This has been my target for quite some time. History here proves it. Talk to me on December 31, 2006. Period.

These are opinions and estimates only. Jucisquirrell and BBB, do not read this post. Just keep talking while the rest of us get rich.

[Birgit.Tersteegen]

New poll from MS World -3/9/06
by: lrn151
Long-Term Sentiment: Strong Buy 03/11/06 10:45 am
Msg: 955951 of 955952

Will use TYSABRI - 28%

Will stay on interferon but switch to TY if worsens - 9%

Will stay on Capaxone but switch to TY if worsens - 18%

Will never use Ty - 6%

Unsure - 34%

Will stay on interferon - 6%

will stay on Capaxone - 6%

no RX - 3%

It looks like Ty will get at least 50% of the market from the outset. Biib better start ramping up production.

[Dennie]

Mein Englisch reicht nicht aus kann man einiges von wichtigem ins Deutsche übersetzen ? Danke

[Bienenvater]

Hallo ELAN-Fans,
will mich hier mal bei BirgitT bedanken, die mich per BM zu der "sagenhaften" ELAN-Party eingeladen/animiert hat.
Ich wohne im Odenwald, Nähe Heidelberg und das ist doch ein schönes Stück zum "Ort des Schreckens"..

Ich finde die Idee aber super und hoffe, das Ganze findet statt....wenn auch ohne mich.

Ich hoffe, dann hier einiges zu erfahren, damit ich mir wegen meines Nichterscheinens ordentlich in den Hintern beissen kann!

Aaaaalsooooo....viel Spass

SW

[Nostarowie]

http://www.witze-welt.de/videos/showvideo.php?id=49

[YabbaDabbaBroker]

Für Dennie

Neue Umfrage von MS-Welt vom 09. März 2006
(wobei MS wohl für Multiple Sklerose und nicht für Microsoft steht)

- Werde Tysabri benutzen 28%
- Benutze Interferon werde aber Ty benutzen, wenn sich die Krankheit verschlimmert 9 %
- Benutze Capaxone werde aber Ty benutzen, wenn sich die Krankheit verschlimmert 18 %
- Werde niemals Ty benutzen 6 %
- Weiß noch nicht 34 %
- Werde bei Interferon bleiben 6 %
- Werde bei Capaxone bleiben 6 %
- gar keine RX (RX?, schätze mal gar keine Medikamente) 3 %

Zählt man alles zusammen kommen 110 % raus. Hoffentlich ist die Umfrage nicht ganz so fragwürdig, wie die 110 %.

Trotzdem scheint die Party für einige Spekulanten zu Ende zu sein. Frei nach dem Leitsatz: "Verkaufen, wenn das Ereignis eingetroffen ist". Ich weiß nicht, ob das nicht ein Fehler ist. Wenn man sich die letzte Meldung von W : O anschaut, sieht das doch so aus, als ob ELAN es selbst ohne Tysabri schaffen würde, schwarze Zahlen zu schreiben. Wie viel eher muss dies geschehen, wenn Tysabri wieder zugelassen wird. Bisher ja nur die Empfehlung (Schlagzeile aus Finanzen-Net.:FDA-Gremium empfiehlt Tysabri zur US-Wiederzulassung). Ich hatte gedacht, dass der Kurs wieder den Kurs erreichen würde, den Elan hatte, als man Tysabri vom Markt genommen hatte. Ich überlege auch nachzukaufen.

@Cyberhexe: Mutig, mutig. Bei dir trifft wirklich der Song von Harald Juhne zu: "Barfuß oder Lackschuh".

[Cyberhexe]

[posting]20.648.007 von YabbaDabbaBroker am 12.03.06 12:54:07[/posting]unter Rx versteht man verschreibungspflichtige Medikamente

[Birgit.Tersteegen]

javascript:smilie(``)
javascript:smilie(``)Executive Appointments

aus "The business online"
Serono in turmoil as Glaxo quits bid
By Lauren Mills
12 March 2006

THE $15bn (£8.7bn, e12.5bn) sale of Serono, Europe’s biggest biotechnology company, was this weekend plunged into turmoil with a decision by GlaxoSmithKline, the UK drugs giant, to abandon talks to buy the Swiss group, The Business can reveal.

GSK, which is keen to strengthen its position in the fast-growing world of biological medicine, hoped to land a cut-price deal to buy Serono after the company failed to sell itself in a $15bn auction earlier this year. Soon after the 20 January deadline for bids, GSK indicated that it was interested in resuming negotiations with Serono, but that it was willing to pay no more than $11bn for the company.

But the British group, advised by Morgan Stanley, has walked away from the deal because Ernesto Bertarelli, Serono’s chief executive and controlling shareholder, refused to accept GSK’s much lower price. GSK, led by Jean Pierre Garnier, declined to comment on its position.

Serono’s hopes of a sale faded further late last week after it became clear that the group’s lead product would soon face increased competition. Rebif, its key multiple sclerosis treatment, will be forced to fight for market leadership with Elan Corporation’s Tysabri. This is because an US Food and Drug Administration advisory committee has given the green light for the previously recalled product to go back on the market.

Tysabri, co-developed with Biogen Idec of the US, was withdrawn a year ago after it was linked to a rare, life-threatening brain condition.

Serono had hoped that Rebif would become the global market leader for multiple sclerosis, but its aspirations will be harder to achieve with Tysabri back on pharmacy shelves. Despite the setback, Serono said last week it remains confident that Rebif will become the market leading treatment over the next 10 years.

But analysts believe the group’s assurances are unlikely to be enough to revive talks to sell the company.

Serono put itself up for sale last November in an auction that attracted interest from some of the world’s leading pharmaceutical companies. But the potential bidders, including GSK, Johnson & Johnson and Novartis of Switzerland, dropped out of the process in protest at the high price demanded by Serono’s founding Bertarelli family, which control 62% of the group.

[Birgit.Tersteegen]

EU to Rule on MS Drug Approval

By Antonio Ligi and Angela Zimm Bloomberg News Service

A Biogen Idec Inc. executive said the company and partner Elan Corp. may get a decision by midyear on European approval of their Tysabri multiple sclerosis drug, which had been pulled from the U.S. for safety reasons.

A European Union advisory panel may release its decision by as early as next month, with a final ruling coming a couple months later, Hans Peter Hasler, a senior vice president of Biogen, said Friday in an interview in Zurich. The medicine hasn`t been on the market in Europe.

Earlier this week, a Food and Drug Administration panel voted to urge that the agency let Tysabri back on the U.S. market a year after it was withdrawn because of links to a rare brain infection. Biogen Chief Executive Officer James Mullen said Thursday he plans to introduce Tysabri in the U.S. by June. Biogen`s shares on Thursday rose 4.5 percent, while Elan`s shares were up 15 percent.

"The recommendation to the FDA could accelerate the process in Europe," said Hasler, who oversees Biogen`s international operations. "If everything goes well, we could get a final decision by the EC this summer."

To persuade the U.S. panel, patients and the companies cited research showing Tysabri is twice as effective as other drugs against a neurological disease that affects 400,000 Americans. Investors had anticipated Tysabri would be limited to people not helped by other drugs. The less restrictive approval may allow annual sales to reach $500 million to $1 billion in four years, said Eric Schmidt, an analyst at Cowen & Co.

The timing of Tysabri`s introduction will depend on how quickly the company and regulators can complete a program to manage the risk of progressive multifocal leukoencephalopathy, or PML, the rare, fatal brain infection linked to Tysabri, Mullen said. The FDA is supposed to make a decision by March 29.

Tysabri`s prescribing information will include the FDA`s strictest warning that the drug is associated with death and disability caused by PML, Biogen said Thursday. Doctors will be instructed to immediately suspend treatment if patients show signs of the disease, and they should begin testing for PML and the virus that causes it.

Tysabri sales were halted on Feb. 28, 2005, on the first reported death from PML, wiping out $17.8 billion in combined market value for Biogen and Elan. More extensive reviews revealed that two patients died and a third developed PML and survived.

Tysabri had been seen as the best hope in a decade for the world`s 2.5 million MS patients, with potential annual sales of $3 billion. MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis.

[Birgit.Tersteegen]

Reuters.com - No Spin. No Agenda. Just the Facts. As they happen.

advertisement
Biogen says Tysabri, new pill to keep it MS leader
Fri Mar 10, 2006 9:15 AM ET

By Tom Armitage

ZURICH, March 10 (Reuters) - U.S. biotech firm Biogen Idec (BIIB.O: Quote, Profile, Research) is banking on the relaunch of its Tysabri medicine and an experimental oral drug to help maintain its lead in the treatment of multiple sclerosis over the next decade.

Bolstered by the backing of an FDA advisory panel, the firm is expecting U.S. regulators to decide by the end of the month whether to allow its MS drug Tysabri back on the market, Biogen`s head of non-U.S. operations said on Friday.

The product, co-developed with Elan Corp. (ELN.I: Quote, Profile, Research), was withdrawn a year ago after it was linked to a rare, life-threatening brain condition.

Hans Peter Hasler, Head of Biogen International, told reporters Biogen expected to keep its lead in the U.S. market for multiple sclerosis drugs this year through sales of Avonex, an older biological drug launched in the mid-1990s.

Rival multiple sclerosis drug maker Serono (SEO.VX: Quote, Profile, Research) hopes to become global market leader thanks to demand for its Rebif product but Biogen`s Hasler said he thought his firm would remain dominant in the disease area for years to come.

"We will try to maintain market leadership for the next 10 years," he said, while acknowledging there would be competition.

"Biogenerics could be there in three years` time and then there is other competition for BG-12," he said, referring to the oral multiple sclerosis treatment which Biogen licensed in from unlisted Swiss biotech firm Fumapharm AG.

With generic competition on the way for older biological drugs like Avonex, Hasler said Biogen was already looking for other products to plug the gap in the market below Tysabri.

Avonex, a beta-interferon, generated $1.5 billion in sales in 2005, with over $600 million outside the U.S.

Some analysts estimate that Tysabri could generate over $1 billion in annual sales.

"We would like to also be there with the oral products," Hasler said, predicting the firm would be part of the race to be first to market with a pill to treat the debilitating disease.

Swiss drugmaker Novartis (NOVN.VX: Quote, Profile, Research) is currently conducting Phase III tests on its FTY720 drug to be used as an oral treatment for MS, while Serono also has an oral version of its cladribine drug in late-stage clinical trials.

Biogen is planning Phase III trials of BG-12, an oral fumarate. Phase II tests showed that the drug reduced brain lesions within a six months of treatment.

Hasler said that while the drug was not expected to achieve the same levels of efficacy as Tysabri, which has been shown to reduce by 68 percent the number of relapses MS patients have, it would compare to the efficacy of interferon drugs.
© Reuters 2006. All Rights Reserved.

[Birgit.Tersteegen]

Hi @ ALL!

Mit unserer angedachten Elanie-Party am nächsten Sonntag siehts nicht so gut aus....

Die Rückmeldungen,die ich per BM bekommen habe,sprechen für grundsätzliches Interesse---aber für viele Schwierigkeiten mit dem konkreten Termin.Definitiv zugesagt haben nur 2 aus "unserer Truppe",2 waren bei "vielleicht"--der Rest wohnt entweder generell zu weit weg (Bayern/Schweiz),muss Sonntag oder Montag arbeiten oder auf Familienfeier.

ALSO DENKE ICH :AUFGEHOBEN IST NICHT AUFGESCHOBEN--WIR LASSEN DEN NÄCHSTEN SONNTAG AUSFALLEN UND ICH STARTE IM SOMMER(SZENARIO BOOTFAHREN;GRILLEN;SCHWIMMEN an der Werse in Münster)EINEN NEUEN VERSUCH!

Ich finde es schade-hätte bestimmt Spass gemacht--aber dann müssen wir uns doch eben noch "virtuell"miteinander freuen/leiden...

Netten Abend! Birgit

[Birgit.Tersteegen]

Please read...this is a TRUE story
by: roynorm
Long-Term Sentiment: Strong Buy 03/12/06 10:38 am
Msg: 956687 of 956935

I live on Long Island in New York. Yesterday I was walking my dog and there was a neighbor of mine talking to a middle-aged woman on a "medical scooter". I stopped to speak with my neighbor but waited till their conversation stopped. The woman was telling my neighbor about her MS condition and that how a "miracle drug" was just re-approved. I immediatley knew what she was talking about and told her that I was quite familiar with the drug, as I had invested in the company last year. She told me that a very good friend of hers, also with MS, went on Tysabri last year (before it was pulled) and that after just one treatment, within a week, there were dramatic results. She went on to tell me that she and her friend "cannot wait to get the drug - and that the deaths that occurred were people that were NOT on monotherapy". They are very excited - as I am!
GO ELAN GO!

[[KERN]Codex]

Danke für die ganzen Infos @birgit und co

Wünsche noch einen schönen Sonntag

[Birgit.Tersteegen]

[posting]20.654.382 von [KERN]Codex am 12.03.06 22:16:21[/posting]

[Poppholz]

Guten Morgen allen miteinander,

schaut Euch doch mal den (theoretischen) Chart von stock100 an:



Selbst wenn diese ein wenig "sehr optimistisch" ist, halte ich den momentanen Kursverlauf auf jeden Fall für nicht gerechtfertigt.

Aber die Zeit spielt für uns, wir haben so weiterhin die Möglichkeit, günstig nachzulegen.

[bernie55]

[posting]20.657.879 von Poppholz am 13.03.06 10:53:50[/posting]HI....gerade aufgewacht , Poppholz ????....

...auf jeden Fall habe ich nichts gegen den " optimistischen " Chart-Verlauf einzuwenden....

Grüße bernie55

[YoungRich]

Genau Poppholz, so machen wirs :-)

Muss jedoch zuerst noch einwenig laden bei 14$, dann kanns losgehen

Gruss
young

[Poppholz]

[posting]20.659.315 von YoungRich am 13.03.06 12:29:04[/posting]viel Erfolg bei Deinem Plan.

Mir sind die Kursverläufe bis Mitte des Jahres egal, da ich frühestens dann verkaufen könnte.

Aber selbst dann werde ich die Aktien halten, da die Zukunft einfach zu schön aussieht.

[Poppholz]

US panel unanimously recommends Tysabri return
10th March 2006
By Tom Neilson

An advisory panel to the FDA has voted unanimously in favor of the reinstatement of Biogen Idec and Elan Corporation`s multiple sclerosis treatment, Tysabri.

All 12 members of the panel recommended that Tysabri should be re-launched with warnings about the safety concerns associated with the drug.

The drug was pulled from the market a year ago having been available for only three months before two patients using the drug were found to have contracted an extremely rare but deadly brain disease known as progressive multifocal leukoencephalopathy (PML).

An extensive safety review conducted by the companies in the light of the safety concerns now seems to have brought Tysabri within touching distance of a return to market. Should the drug ultimately be re-approved by the FDA, analysts predict that its sales could top $1 billion per year.

The eventual FDA decision, expected by the end of March, will take into account the appeals of patients with multiple sclerosis who would like to be given the choice as to whether to risk the possible side effects.


http://www.pharmaceutical-business-review.com/article_news.a…

[Poppholz]

Tysabri Return Limits Serono`s Bid Chances

Monday, March 13, 2006 5:41:14 AM ET
Dow Jones Newswires


0928 GMT [Dow Jones] Lehman Brothers sees Biogen Idec.`s (BIIB) Tysabri relaunch to take a 10% market share from Serono`s (SRA) Rebif, and "can only reduce the changes of an acquisition by large pharma." Serono`s target price downside is CHF30 if Tysabri is relaunched, but Lehman Brothers waits to change numbers until the formal FDA decision expected at the end of March. So long, keeps equal weight rating and CHF890 share price. Shares trade -0.9% at CHF911.50. (SWZ)


Contact us in London.
[phone]
[e-mail]

[Birgit.Tersteegen]

Hi @ all--bin krank und mit laptop im Bett(von meinen Mitarbeiterinnen dorthin geschickt...)

hoffen wir mal dass die Instis bald genug gekauft haben und der Kurs wieder steigen darf...

Fidelity adds 2,3M shs owns 5,55%
by: multiplural2 (45/M)
Long-Term Sentiment: Strong Buy 03/13/06 07:00 am
Msg: 957251 of 957268

Fidelity have just filed owning 21.963.200 shares equal to 5,55%. Up from the latest filed 19.684.500 or an addition of 2.278.700.
Let´s see if not other institutions will follow after FDA comes out later this month.

[bernie55]

[posting]20.660.213 von Birgit.Tersteegen am 13.03.06 13:33:17[/posting] GUTE BESSERUNG......


liebe Grüße bernie55

[bernie55]

Tysabri News Lifts Drug Stocks

Peter Kang, 03.13.06, 7:00 AM ET


The Amex Pharmaceutical Index (DRG) closed the week up 1.3%, while the Nasdaq Biotechnology Index (NBI) posted a weekly decline of 1.7%.

A U.S. Food and Drug Administration advisory panel recommended multiple sclerosis drug Tysabri be allowed back on the market last Wednesday. This boded well for the shares of co-marketers Biogen Idec (nasdaq: BIIB - news - people ) and Elan (nyse: ELN - news - people ), which rose on the news, up 5% and 16%, respectively. A.G. Edwards reiterated a "hold" rating on Elan on March 9 and expects the FDA to approve Tysabri by the end of the month. "In light of the moving patient demands made during the first day of the meeting that they should be the ones determining whether or not to take the risk of Tysabri, our bet is that the FDA will allow first-line use on the label," wrote analyst Alexander Hittle, in a client note.

The analyst expects Tysabri sales of $1.8 billion in 2009, up from his previous forecast of $1 billion.

[Birgit.Tersteegen]

[posting]20.660.245 von bernie55 am 13.03.06 13:35:17[/posting]DAAAAAAAAAAAAAAAAAANKE!!

[Poppholz]

wir starten in USA bei $14,60, fallen dann auf $14,25 und steigen wieder auf $14,50.

alles innerhalb von 4 Minuten.

(das wird ja anscheinend wieder ein "interessanter" Tag.

[bernie55]

[posting]20.660.898 von Poppholz am 13.03.06 14:20:29[/posting]...wie immer, Poppie ...auf und ab...


..aber das ist doch schon alles Routine für uns, nicht wahr ....


Grüße bernie55

[Birgit.Tersteegen]

An analyst says 1.9B in 2009. That`s
by: ipar4s2
Long-Term Sentiment: Strong Buy 03/13/06 08:41 am
Msg: 957326 of 957364

about 1.5 years behind the curve. That implies through definition we will see Tysabri sales of over 2B in 2008. That implies through definition we will see Tysabri sales of over 1.5B in 2007. That implies through definition we will see Tysabri sales of over 750mm in 2006. That implies through definition, with a 75% bottom, and a price point of $25,000, a close 2006 pps of $45.

Now, who does one believe so as to further due dilligence on the Company to self validate this hypothesis? Newbies that cry, naive traders that rewrite history every time they are wrong, or the intelligent balance of the ELN ymb, and many at the tixx site? Oh, and by the way, there is one other entity that also has tipped their hand. It`s a small biotech from Cambridge Mass. It`s ticker is BIIB. See traders, when guys like PK, and JM, in addition to the balance of upper management there, produce 80,000 annual patient doses of a drug, they do it for a reason. Watch and learn boys. LMAO!!!

[Birgit.Tersteegen]

[posting]20.660.898 von Poppholz am 13.03.06 14:20:29[/posting]och nööööö! lieber so

Back over $15 today folks.
by: askseriousquestions (45/M/NY)
Long-Term Sentiment: Strong Buy 03/13/06 09:23 am
Msg: 957375 of 957375

Expect to see some good news coming from ELN soon about some of their other research. ELN is no one-trick pony and they`re going to show the world that. They`ve been working on making ELN profitable even without tysabri. With Ty, it becomes hugely profitable until they get their Alzeimers drug going. Then they go off the radar on profitablility.

[Poppholz]

[posting]20.661.879 von Birgit.Tersteegen am 13.03.06 15:25:46[/posting]anscheinend geht der Kurs echt nach oben.

Vielleicht schlafen die Shorties aber auch noch und kommen erst zum Mittag mit Ihren Drückerpositionen.

Die Käuferseite tastet sich auf jeden Fall langsam an die höheren Kurse, immer in der Hoffnung, dass doch noch einer seine Teile günstig auf den Markt schmeißt.



Mal sehen: RT $´14,70

[Birgit.Tersteegen]

Wir wissens ja--also für die Newbies hier

Always Remember this!
by: fusionrobot
Long-Term Sentiment: Strong Buy 03/13/06 10:20 am
Msg: 957486 of 957486

Specilists, big boys, institutions, short hedge funds` ONLY weapon is to drive down share prize in order to scare the hell out of you! Know their game and believe in your investment! How do they acheive that?

Fault news
Paid ANALysts
Paid bashers in this board
Passing the ball technique
Massive manipulation

[Poppholz]

RT $14,85

und noch immer keine Drückerpositionen zu sehen.

Sollte das der Boden gewesen sein?

Kann es jetzt endlich zu einem "realistischen" Kurs hochgehen?

Bin gespannt.

(bin froh, dass ich schon so lange investiert bin und nicht mehr auf den optimalen Einstiegszeitpunkt lauern muss. Das ist ja Stress pur)

[Birgit.Tersteegen]

[posting]20.663.209 von Poppholz am 13.03.06 16:34:11[/posting].....kannst Dir den Stress als zukünftiger Häuslebauer und "Vati" auch nicht mehr leisten!! 14,78

[Poppholz]

[posting]20.663.302 von Birgit.Tersteegen am 13.03.06 16:37:38[/posting]allerdings würden so ein paar Euro mehr pro Aktie den Hausbau auch um einiges entspannter gestalten.

Je höher der Kurs, um so geringer die Eigenleistung.

[bernie55]

[posting]20.663.426 von Poppholz am 13.03.06 16:43:08[/posting]Je höher der Kurs, um so geringer die Eigenleistung.

..AHA...

[bernie55]

Je höher der Kurs, um so größer das Auto



..........

[Poppholz]

[posting]20.663.477 von bernie55 am 13.03.06 16:45:25[/posting]großes Auto bekomme ich im Familienrat nicht durchgesetzt.

Hier scheitere ich mit 2 zu 1 Stimmen.

(meine Freundin übernimmt bis zur Volljährigkeit unseres Sohnes dessen Stimmanteile)

[Poppholz]

USA macht heute eine wirklich gute Figur:

[bernie55]

[posting]20.663.519 von Poppholz am 13.03.06 16:47:38[/posting]Hier scheitere ich mit 2 zu 1 Stimmen.

..dann wird es Zeit, dass du deinen Sohn davon überzeugst, schneller volljährig zu werden.......

[bernie55]

[posting]20.663.519 von Poppholz am 13.03.06 16:47:38[/posting]...mein Sohnemann ( 8 Jahre) hat sich schon für einen entschieden....

[Birgit.Tersteegen]

[posting]20.663.477 von bernie55 am 13.03.06 16:45:25[/posting]....mein Baum,mein Haus,mein Gartenzaun...

und beim Richtfest bist Du froh und wir arm;massiver Kursrutsch ist die Folge wenn Du Deine Aktienpakete auf den Markt schmeisst.....

Tja Poppi,müssen wir leider alle bei Dir einziehen...

[bernie55]

[posting]20.663.712 von Birgit.Tersteegen am 13.03.06 16:56:31[/posting]....mein Baum,mein Haus,mein Gartenzaun...

[bernie55]

[posting]20.663.712 von Birgit.Tersteegen am 13.03.06 16:56:31[/posting] beim Richtfest bist Du froh und wir arm;massiver Kursrutsch ist die Folge wenn Du Deine Aktienpakete auf den Markt schmeisst.....

[bernie55]

[posting]20.663.712 von Birgit.Tersteegen am 13.03.06 16:56:31[/posting] Tja Poppi,müssen wir leider alle bei Dir einziehen.

[Birgit.Tersteegen]

[posting]20.663.775 von bernie55 am 13.03.06 16:58:57[/posting]jetzt ist er sprachlos und bereut zum ersten Mal sein Elanie-Investment...

[Poppholz]

[posting]20.663.775 von bernie55 am 13.03.06 16:58:57[/posting]wie gesagt, es steht noch nicht fest, ob ich überhaupt jetzt schon Anteile verkaufe oder nicht.

Würde am liebsten hiermit noch einige Monate warten, bis sich der Kurs auf eine faire Bewertung bewegt.

[Poppholz]

[posting]20.663.654 von bernie55 am 13.03.06 16:54:08[/posting]wünschen darf ich mir natürlich auch einen und somit habe ich mir auch schon einen ausgesucht, aber ...

[bernie55]

[posting]20.663.872 von Poppholz am 13.03.06 17:03:27[/posting]Würde am liebsten hiermit noch einige Monate warten, bis sich der Kurs auf eine faire Bewertung bewegt


....tja, ich bin vollkommen deiner Meinung..
..und dann versteht es sich natürlich von selbst, dass alles steuerfrei geschieht....

[bernie55]

wünschen darf ich mir natürlich auch einen und somit habe ich mir auch schon einen ausgesucht, aber


...ich würde sagen, ohne wenn und aber .....

[Poppholz]

[posting]20.664.042 von bernie55 am 13.03.06 17:10:54[/posting]bei entsprechender Kursentwicklung erhöht sich ja auch mein Argumentationsportfolio, so dass sich meine Chancen proportional zum Elan-Kurs entwickeln.

[Birgit.Tersteegen]

[posting]20.664.042 von bernie55 am 13.03.06 17:10:54[/posting]Bernie,aufpassen--auch Deine Frau kommt bald wieder (...nicht zu frech werden...!)

[bernie55]

[posting]20.664.115 von Poppholz am 13.03.06 17:14:35[/posting]


HHIIILLFFFFEEE, ich kann nicht mehr....

[bernie55]

[posting]20.664.122 von Birgit.Tersteegen am 13.03.06 17:14:42[/posting]........................

[bernie55]

..so, ich muss jetzt mal meinen " entscheidungsfreudigen " Sohn abholen....


...ich meine den, der sich schon für ein Auto entschieden hat....

[bernie55]

.....also, B und P


.....Haltet die Stellung ....

[Birgit.Tersteegen]

Mal was Ernstes.....hört sich irgendwie etwas merkwürdig an,oder....Bisher kann ich diese Vogelgrippe noch nicht so ganz ernst nehmen--schade dass da TY wohl nicht wirkt...


DJ VOGELGRIPPE/IWF: Schwere Pandemie könnte Finanzsystem..belasten

FRANKFURT (Dow Jones)--Der Internationale Währungsfonds (IWF) ist in
Sorge über die Folgen einer möglichen Pandemie des Vogelgrippe-Virus
für das globale Finanzsystem. In einer am Montag vorgestellten Studie
schreibt der Fonds, eine schwere weltweite Grippeepidemie könne zu einer
höheren Liquiditätsnachfrage führen und berge erhebliche
konjunkturelle Risiken. So sei ein temporärer Anstieg der Risikoaversion
" sehr wahrscheinlich" , was zu einer entsprechend höheren
Liquiditätsnachfrage - insbesondere nach Bargeld und mit geringen Risiken
behafteten Anlagen - führen werde.

Diese " Flucht in Qualität" werde sich wiederum zu einem
vorübergehenden Rückgang der Vermögenspreise und einer
Ausweitung der Risikoaufschläge für Unternehmensanleihen und Anleihen
aus Schwellenländern niederschlagen. Abschläge dürften sich dem
Fonds zufolge aufgrund einer geringeren Gesamtnachfrage auch bei den
Rohstoffpreisen ergeben. Dies werde aber möglicherweise durch
angebotsseitige Störungen wieder ausgeglichen. Der Rückgang der
Vermögenspreise könne die Bilanzen von Finanzinstitutionen unter
Druck bringen mit der Folge, dass es diesen Akteuren schwierig werde,
aufsichtlichen Anforderungen zu genügen.

Zwar seien Vorhersagen hinsichtlich der Folgen einer Pandemie
grundsätzlich großer Unsicherheit unterworfen, doch werde eine
schwere Epidemie vermutlich " erhebliche" konjunkturelle Effekte mit sich
bringen. Störungen dürften nach dem Urteil des IWF vor allem durch
die Abwesenheit von Mitarbeitern ausgehen, da Arbeitnehmer wegen
Ansteckungsrisiken zu Hause blieben oder dort Angehörige pflegten. Daneben
seien Störungen in den Bereichen Transport, Handel, Zahlungsverkehr und
Versorger zu erwarten, was einige finanziell anfälligere Unternehmen in
die Pleite treiben könne.

Auf der anderen Seite sei eine stark verringerte gesamtwirtschaftliche
Nachfrage vorstellbar, da die Konsumausgaben zurückgehen und Investitionen
aufgeschoben werden könnten. Allerdings rechnet die Organisation auch
damit, dass sich die Wirtschaftsaktivität nach dem Ende einer Pandemie
vergleichsweise rasch erholt. Sowohl Konsum wie auch die geleisteten
Arbeitsstunden könnten zeitweise spürbar über dem Niveau vor dem
Ausbruch einer Epidemie liegen.

Mit Blick auf grenzüberschreitende Effekte will der IWF nicht
ausschließen, dass es vor allem in offenen Volkswirtschaften zu
stärkeren Ungleichgewichten in den Leistungsbilanzen kommt. So könne
der Tourismussektor wegen Reisebeschränkungen und der Angst vor Ansteckung
stark betroffen sein, während der Außenhandel unter Handels- und
Transportrestriktionen ebenso wie unter einer geringeren globalen Nachfrage
leiden könne.

Sollten Zahlungsbilanzprobleme in " begrenztem Ausmaß" auftreten, sei
der IWF " ausreichend" gerüstet. Bei Problemen von weitreichenderer Natur,
etwa mehreren gleichzeitig auftretenden Kapitalbilanzkrisen, seien aber
Schwierigkeiten zu erwarten. Gegenwärtig fänden Gespräche auf
internationaler Ebene statt, um möglichen Problemen durch eine Pandemie
gewappnet entgegen zu treten und bei Eintreten einer Epidemie die
Arbeitsabläufe aufrecht zu erhalten.

Ein Sprecher der Bundesbank erklärte im Gespräch mit Dow Jones
Newswires, die Institution verfüge über Notfallpläne für
Katastrophen und sei aktuell dabei diese für den Fall einer
Vogelgrippe-Pandemie zu überarbeiten. Problematisch an einer
Vogelgrippe-Epidemie wäre aus Sicht von Experten, dass in einem " worst
case" -Szenario bis zu 30% der Bevölkerung von dem Virus infiziert werden
könnten. Zudem könne sich eine Pandemie über einen Zeitraum von
mehreren Monaten erstrecken. Die Weltgesundheitsorganisation geht in einem
vergleichsweise konservativ geschätzten Szenario im Falle einer Pandemie
von weltweit zwei bis 7,4 Millionen Toten aus. -Von Christian Vits, Dow Jones
Newswires, +49 (0) 69 / 29725-313,

[e-mail]

DJG/chv/hab

(END) Dow Jones Newswires

[Birgit.Tersteegen]

Re: NBV anyone??????
by: sleepydog107 (42/M) 03/13/06 11:37 am
Msg: 957620 of 957621

+391,000

[Birgit.Tersteegen]

.....und sie drücken wieder

[Birgit.Tersteegen]

ELN under major Accumulation
by: govarga
Long-Term Sentiment: Strong Buy 03/13/06 03:27 pm
Msg: 957904 of 957911

The big boys grabbed the price by the horns and aren’t letting go till FDA approval.

Study the chart.

http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_tic…

[welke91]

@birgit ich hoffe Elan erhält 1 Woche nach dem Commitee das Approval, denn das gibt den Kurs den nötigen Aufwind und dir sehr viele positive Signale die du nun brauchst!

So war es ja auch im November plözlich war se da die FDA Akzeptanz,...
grüße und gute Besserung

[Birgit.Tersteegen]

[posting]20.670.661 von welke91 am 14.03.06 08:15:09[/posting]ja Welke,das hoffe ich auch!! Moin@all

Was haltet Ihr von den Übernahmegerüchten durch Wyeth?

Der link nach dem Beitrag funktioniert nur mit Anmeldung-also kein Beweis dass es stimmt....

Wyeth takeover news!
by: huntmann_je 03/13/06 09:13 pm
Msg: 958149 of 958318

Elan Pharmaceuticals is believed to have been approached by Wyeth Corporation in a cash-only offer for the company. Details have not been finalised but it is believed the offer would include the other 50% of Tysabri in a separate negotiated deal with Biogen Idec. Wyeth has been co-developing a promising Alzheimer treatment with Elan which is currently in Phase 2 testing. A spokeswoman for Elan declined to comment on the speculation.

http://www.ireland.com/newspaper/finance/2006/0314/Elanwyeth

[Birgit.Tersteegen]

lt.Usern die den Zugang zu der Quelle haben,STIMMT DAS GERÜCHT NICHT!Ist auch besser für uns!

[Poppholz]

[posting]20.670.959 von Birgit.Tersteegen am 14.03.06 08:50:41[/posting]hallo Birgit,

ich gehe davon aus, dass an dem Grücht nichts dran ist.

Biogen und Elan haben vertraglich vereinbart, dass für den Fall einer Übernahme eines der beiden Unternehmen, die Rechte an Tysabri automatisch dem anderen Unternehmen zu vollen Anteilen zukommt.

Sollte Wyeth also Elan übernehmen, bekommt Biogen die Rechte an Tysabri komplett. Somit ist der Hauptgrund für eine mögliche Übernahme schon weggefallen.

[Gndlf]

Moin, moin zusammen!
Alles klar an board?

Ich glaube auch nicht an eine Übernahme, aber wer kann das schon sagen. Schaut Euch mal Merk und Schering an. Schering will nicht. Die hatten sich noch vor ein paar Tagen von Morphosys-Aktien getrennt und dann eigene Aktien zurückgekauft, wodurch ihr Kurs angezogen hat. Die hätten das Merk auch billiger machen können.
Elan will wahrscheinlich auch nicht. Aber vielleicht sind es nicht nur die Lehman Brothers, die den Kurs drücken, sondern ein Big Pharma?

[bernie55]

[posting]20.671.026 von Poppholz am 14.03.06 08:57:03[/posting]..Guten Morgen ..

Übernahme ????


Ich bin auch davon überzeugt, dass ELAN besser fährt, wenn es nicht zu einer Übernahme kommt.....



Falls es aber wirklich dazu kommen sollte ( was ich mir nicht wünsche !!!), welche Höhe eines " Übernahmeangebotes " wäre für ELAN überhaupt interessant, gerade im Hinblick auf:

- Abtreten der Rechte von Ty an Biogen


Grüße bernie55

[Poppholz]

kann es sein, dass unser Baby heute noch gar nicht gehandelt wurde?

Sehe irgendwie nur 0 Umsätze.

[Gndlf]

[posting]20.671.730 von Poppholz am 14.03.06 09:46:31[/posting]wieso? Irland Volume 1

[Poppholz]

anscheinend hat sich das noch jemand anderes gefragt.

In Irland ist eben 1 Aktie von Elan gehandelt worden.

[Poppholz]

[posting]20.671.840 von Gndlf am 14.03.06 09:53:45[/posting]habe ich auch eben gesehen.

schon beeindruckend, was unser Baby für einen Staub aufwirbelt.

[bernie55]

[posting]20.671.844 von Poppholz am 14.03.06 09:54:05[/posting]...1 AKTIE...wwwoooohhh.....

vielleicht will dieser Aktionär mit dem einen Papieranteil das Häuschen seines Meerschweinchens auslegen...

[eliasesteban]

[posting]20.671.893 von bernie55 am 14.03.06 09:57:51[/posting]hi,hi ,grins

[Poppholz]

habt Ihr Euch mal das Kaufverhalten in den USA angesehen?





da wurde überwiegend aus dem ASK gekauft und nicht ins BID verkauft.

Freue mich schon auf Ende März, wenn diese Drückerei hoffentlich vorbei ist.

[Cyberhexe]

Zu den ganzen Übernahmegerüchten gilt es folgendes zu bedenken

...mit Biogen existiert ein Stillhalteabkommen, ich glaube bis 2011

...bei einer Übernahme von Elan hat Biogen die Möglichkeit die Rechte von Tysabri voll zu übernehmen

...bei einer Übernahme von Elan hat Wyeth die Möglichkeit das Alzheimer-Programm voll und ganz zu übernehmen

...auch finanztechnische Hürden erschweren eine Übernahme

Meiner Einschätzung nach geschickte Manöver, die eine feindliche Übernahme uninteressanter machen. Einzig bei Wyeth sehe ich eine realistische Möglichkeit einer Aktion. Falls das Alzheimer-Programm tatsächlich erfolgsversprechend bleibt und ein vorzeitiger Übergang in Phase III möglich ist, dann hat Wyeth natürlich eine Infovorsprung und könnte für Elan frühzeitig ein Gebot abgeben.
Tysabri ginge zwar an Biogen aber das vielversprechende AD-Programm ginge zu 100% an Wyeth.

Aber letzlich sind auch meine Überlegungen nur Schall und Rauch...

good luck
ch

[bernie55]

[posting]20.672.653 von Cyberhexe am 14.03.06 10:40:04[/posting]Aber letzlich sind auch meine Überlegungen nur Schall und Rauch...


...aber diese tun uns ELANNIES sehr gut...

[Poppholz]

[posting]20.672.653 von Cyberhexe am 14.03.06 10:40:04[/posting]würde ELAN in einem solchen Fall nicht auch mit entsprechenden Aktienkäufen "reagieren" können und somit den Kurs nach oben bringen?

[bernie55]

[posting]20.673.122 von Poppholz am 14.03.06 11:09:52[/posting]...genauso wie Schering !!

[Poppholz]

[posting]20.673.169 von bernie55 am 14.03.06 11:12:15[/posting]so in etwa.

Nur das Elan viel mehr Aktien kaufen müßte, damit wir einen realistischen Kurs haben.

[Cyberhexe]

zu Erschwernis einer feindlichen Übernahme, anbei der Originaltext aus dem Jahresbericht 2004:

We are a party to agreements that may discourage a takeover attempt that might be viewed as beneficial to shareholders
who wish to receive a premium for their shares from a potential bidder. For example:
• Our collaboration agreement with Biogen Idec provides Biogen Idec with an option to buy the rights to Tysabri in
the event that we undergo a change of control, which may limit our attractiveness to potential acquirers;
• Until 20 June 2010, Biogen Idec and its affiliates are, subject to limited exceptions, restricted from, among other
things, seeking to acquire or acquiring control of us;
• Under the terms of indentures governing much of our debt, any acquirer would be required to make an offer to
repurchase the debt for cash in connection with some change of control events; and
• Our collaboration agreement with Wyeth restricts Wyeth and its subsidiaries from seeking to acquire us in some
circumstances.
Risk Factors
Elan Corporation, plc 2004 Annual Report 131

[Poppholz]

in Irland zieht der Kurs ganz schön an.

Momentan bereits bei €12,50 ($15,-)

[Gndlf]

Wenn was läuft, dann dieses Jahr. Obwohl die Gefahr im letzten Jahr sicherlich größer war. Mal sehen, wie KM sich seinen Job künftig vergüten läßt!


Saturday, April 02, 2005 :

FRONT | IRELAND | SPORT | WORLD | BUSINESS
--------------------------------------------------------------------------------

Only way is down for Elan

Elan chief executive Kelly Martin’s contract includes $5m if Elan is sold this year and $3m if it goes next year, adding to doubts about the company’s survival after the announcement of a third patient death. BRIAN O`MAHONY reports.Unless the group can find a way back quickly, analysts see its days as numbered

In the wake of the announcement of a third death linked to the MS drug Tysabri, Elan chief executive Kelly Martin has seen the company’s shares fall 56% on Thursday to $3.18 from a peak in 2001 of $65.

EVEN the most optimistic are beginning to doubt Elan’s ability to bounce back at this stage, following another shock announcement that a third patient died after using the MS drug Tysabri.

Shares fell 56% on Thursday to €2.40 and to $3.18 in the United States where most of the stock is traded.

Markets saw a 13.3% bounce on Friday to €2.72, but the recovery is marginal and has no significance for the group’s long-term future, analysts said.

In 2001 Elan was flying high, one of the drug companies of the future and the share price peaked at $65.

By 2002 after serious questions were raised about its accounting practices the share price was rocked to its foundations and fell all the way from its high of $65 to $1.05 as the Securities and Exchange Commission in the US called the Irish-based drug group to account.

Having sold off $2.5 billion in assets in the meantime and cut its debt substantially, in 2008 $1.1bn of the debt falls due, but for Elan-watchers that is no longer the issue.

Before Wednesday’s shock announcement, market analysts thought Tysabri was likely to return to the market because of its effectiveness in treating Multiple Sclerosis.

It was also helpful in treating Crohn’s disease, but its major potential was as the new wonder drug to help MS suffers.

Studies showed the combination of Tysabri with Avonex, the Biogen Idec drug, was hugely helpful in the treatment of MS and Crohn’s Disease.

The latest death is linked to the use of Tysabri alone.

The other two deaths that triggered the latest crisis were linked to the combined drug use.

It was hoped that Tysabri on its own might be benign and that it could be cleared in a few months to come back to the market, even if on a restricted basis.

This latest death is linked solely to Tysabri however, and was also being used in this instance for the treatment of Crohn’s disease.

The cause of death in each of the three cases was progressive multifocal leukoencephalopathy (PML), a rare brain disorder that occurs in one out of every 200,000 of the world’s population.

At this stage PML has been caused in three out of 3,000 patients taking a combination of Tysabri and Avonex, as well as to Tysabri on its own.

For Peter Jackson, analyst with Bloxham Stockbrokers, the crux of the matter now is whether Tysabri will be cleared ever to get back to the market.

At this stage it is possible “the company could be ordered to run a complete retrial and that could take three years to complete,” he said.

That decision will not be known for some time and in the meantime the future is beginning to look increasingly bleak.

By the end of three years Mr Jackson reckoned the window of opportunity could be well gone for Tysabri.

“Elan had bet the farm on it and it looks as if it is about to lose the bet,” he said.

Potentially Tysabri stood to be a €4bn-plus market which Elan and its partner Biogen confidently expected to capture by 2009.

For chief executive Kelly Martin, the latest news is a body-blow.

The new case is highly significant in that the patient, who died in 2003, had been using Tysabri alone.

Investors had hoped that the disease was being triggered by an unexpected negative interaction between Avonex and Tysabri, rather than by Tysabri.

But the news this week has scuttled that hope and raises real fears about the ability of the group to survive as an independent group.

Elan said previously it expected to turn the corner to profitability by the end of 2006, largely on the sales of Tysabri.

The drug was expected to have peak sales of about $4bn in 2009, with Elan and Biogen sharing equally in the profits.

According to a note released by Smith Barney, profitability will now be delayed until 2009.

Meanwhile, Elan continues to operate in the red.

In 2004 it reported a loss of $376m, or 96 cents a share, on revenue of $481.7m.

The company has three other products, Maxipime, Prialt and Azactam, on the market and receives royalties on several others. Most of its pipeline focuses on such neurological diseases as Alzheimer’s.

The Irish drug-maker’s financial picture is also clouded by its recent $1bn bond offering, which will come due in 2008. But the company has said it has $1.5bn in cash.

Elan agreed to pay a $15m fine to the Securities and Exchange Commission over charges stemming from its handling of a past joint venture.

It has also set aside $55m to cover costs associated with that case. It also has had several shareholders suits filed against it over Tysabri.

G Kelly Martin walked into the Elan crisis on February 3, 2003 after the shake-up suffered by the company following the SEC investigation into its highly aggressive accounting practices.

For some he was an unusual choice, having spent all of his working life with the financial heavy hitter Merrill Lynch.

He had no experience in the pharmaceutical industry and knew little of Elan when approached about the job.

He was 44 at the time and had never held the post of chief executive prior to that.

He spent his time at Merrill Lynch & Co. fixing up one troubled unit after another.

When he left in December 2002, he was head of its international private-client group.

During his time there he was responsible for turning round the firm’s global debt market from losses of $1.5bn in 1998 to profits of over $1bn by 2001. And Martin had been one of the few executives willing, or able, to defend Merrill publicly.

It was he who testified for the firm in the Senate hearings on Enron Corporation in the summer of 2002.

Why then did Martin select such a troubled group for his first try as CEO?

Elan was once Ireland’s biggest public company.

It was home-grown, innovative, and seemed to be making the difficult transition from biotech to fully-fledged pharmaceutical before being rocked by the SEC revelations in 2002.

It was around the same time that Elan’s highly-anticipated Alzheimer’s drug was found to cause brain inflammation in some trial patients and had to be kicked back to the lab.

By July 2002, the drug-maker’s stock had collapsed, several shareholder lawsuits had been filed, and the CEO and chief financial officer resigned.

Since Martin took over as CEO on February 3, 2003, his experience as a trouble-shooter has given rise to the widespread suspicion that his job is to clean up Elan and sell it.

“People are sceptical he’s in it for the long haul,” said Peter Frawley, an analyst for Merrion Stockbrokers, at the time.

The fact that Martin’s contract includes a promise of $5m if Elan is sold this year and $3m if it goes next year only adds to the doubts about the company’s survival, he said.

Defenders of the deal said he was here because he believed in the group.

The bonuses were simply there to attract him to the job, given his high standing in Merrill Lynch and his potential to climb further up the corporate ladder.

Whatever about that speculation, the third successive failure of Tysabri is a real body blow.

Unless the group can find a way back quickly, most analysts now see its days as an independent pharmaceutical group as numbered and whether Mr Martin gets his generous bonus or not is a side issue.

http://archives.tcm.ie/irishexaminer/2005/04/02/story3071461…

[Poppholz]

die $65,- aus 2001 wären doch ein schönes Ziel für 2007 (2006 muss ja gar nicht sein).

[Poppholz]

erster Kurs USA $14,57

RT: $14,56

[Poppholz]

USA 15:31 Uhr und keiner handelt mit unserem BABY.



Die Luft ist regelrecht "zum zerreißen gespannt".

[Poppholz]

bisher auf inet 600 Aktien heute gehandelt. 100 davon im börslichen Handel.

Worauf die wohl alle warten?

[Poppholz]

Momentan sind wir im grünen Bereich

RT: $14,68

[Birgit.Tersteegen]

Irgendwie "komisches"Orderbuch,oder?

[Gndlf]

heute wird aber anscheinend nicht mehr gebremst. Möglicherweise wird nochmal auf einen etwas günstigeren Einstieg gewartet. Wenn der Kurs langsam aber sicher steigt, springt sicherlich der eine oder andere auch noch auf den Zug auf. Und dann gehts plötzlich ab wie ne Rakete!
Hope the best !

[Birgit.Tersteegen]

[posting]20.677.731 von Gndlf am 14.03.06 15:47:53[/posting]Es sieht GUUUUUUUUUUUUUUUUUUUT aus--wurde auch mal Zeit!

[Gndlf]

[posting]20.677.769 von Birgit.Tersteegen am 14.03.06 15:49:34[/posting]... endlich mal wieder ...

[YoungRich]

Denke Schlusskurs heute > 15 ...was denkt Ihr ?

go, go, go

[yummmy]

So, guten Tag zusammen.

Ich bin seit geraumer Zeit Leser dieses interessanten Threads und habe mich nun endlich auch angemeldet, um den ein oder anderen Senf resp. Fragen hinzuzugeben - so ein Börsenprofi wie einige hier bin ich nämlich leider nicht.

Grüße an alle - insb. an diejenigen, die diesen Thread mit so tollen News versorgen

[Gndlf]

Jaaaa! Jetzt wird in 1000er gekauft.

[Birgit.Tersteegen]

[posting]20.678.013 von yummmy am 14.03.06 16:00:40[/posting]hi yummy--WELCOME!

[YoungRich]

Grüezi Yummmy ... Grüsse aus der Schweiz :-)

[Poppholz]

ALABS ist wieder da.

Mit 25.000 Aktien zu $14,90.

Mal sehen wie lange.

[Poppholz]

und weg sind sie.

Leider kann ich nicht sehen, ob diese weggekauft, oder vom Verkäufer wieder zurück gezogen wurden

[yummmy]

Hi.

Grüße aus Münster zurück.

[DanubeTiger]

tja, ich glaub nicht dass wir die 15 heute als SK sehen...und auch Hallo an Yummy (auch aus dem Land der Schokolade und des Käse)..

[Birgit.Tersteegen]

[posting]20.678.563 von yummmy am 14.03.06 16:24:23[/posting]HEY--dann wohnste ja um die Ecke von mir!

[Birgit.Tersteegen]

ICH WILL DIE 15+!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[DanubeTiger]

und da waren es wieder mal 15 USD - mal schauen wie lange die heute halten...

[Birgit.Tersteegen]

HAB SIE!

[Birgit.Tersteegen]

Hab sie gehabt

[Poppholz]

2.000.000 Aktien in der ersten Stunde gehandelt.

das geht doch.

[Poppholz]

bin auf den Schlusskurs gespannt.

Ist wie jeden Tag "Sekt oder Selter". Das die Aktie wesentlich mehr wert ist, als der momentane Kurs, ist (jedem) bekannt.

Fraglich ist nur, wann der Kurs nach oben zieht.

Spätestens Ende März haben wir wesentlich schönere Schlusskurse.

[Birgit.Tersteegen]

Die Manipulation im Amimarkt ist OHNE WORTE--eben tauchten für 5 Sek 40000 shares erst im Ask und dann im Bid auf und dann waren sie wieder verschwunden......

[Birgit.Tersteegen]

SELLERS REMORSE.
by: jizzchin_is_a_paid_pusher
Long-Term Sentiment: Strong Buy 03/14/06 11:32 am
Msg: 958747 of 958747

Sell in haste, regret at your leisure. You would think there was a prize for giving away shares under $15. We will se the same thing at $20, $25, $30 and so on as Elans share price begins its grinding, relentless, short chopping trek to $100

[Birgit.Tersteegen]

nervig mit der Kursdrückerei--gehe jetzt DOKO spielen!
Bis morgen!

[UserX5]

ELAN (NYSE: ELN) und ENTREMED (NASDAQ: ENMD) haben Mitte Januar eine Lizenzvereinbarung über die geschützte NanoCrystal®-Technologie abgeschlossen.


Der Vertrag berechtigt ENTREMED, die Technologie von ELAN zur Entwicklung des onkologischen Wirkstoffkandidaten Panzem® NCD (2ME2 oder 2-Methoxyestradiol) einzusetzen.

2-Methoxyestradiol ist ein oral aktives Molekül, das mittels verschiedener Wirkungsmechanismen Tumorzellen angreift.

Beide Unternehmen unterzeichneten schon in 2004 einen Liefervertrag für klinische Studien, der die Bereitstellung von Panzem® NCD für Phase I-Studien vorsah. Mit den aktuellen Verträgen werden die Liefervereinbarungen auf Phase II- und nachfolgende Studien ausgeweitet.

[Birgit.Tersteegen]

[posting]20.687.849 von UserX5 am 15.03.06 08:28:32[/posting]Hi!

Von wann ist die Meldung?

[UserX5]

Zeit: 14.03.2006.

http://nano.ivcon.net/modules.php?name=News&file=article&sid…

[bernie55]

[posting]20.688.245 von UserX5 am 15.03.06 09:01:38[/posting]http://nano.ivcon.net/modules.php?name=News&file=article&sid…

[Birgit.Tersteegen]

[posting]20.688.270 von bernie55 am 15.03.06 09:03:51[/posting]Aha,guten Morgen Bernie + all,gestern veröffentlicht also!

Bis später-muss auch mal arbeiten!

[Gndlf]

[posting]20.688.214 von Birgit.Tersteegen am 15.03.06 08:58:43[/posting]Moin Birgit, hast gestern nichts mehr verpaßt hier.
Warste mit DoKo zufrieden?

[bernie55]

[posting]20.688.331 von Birgit.Tersteegen am 15.03.06 09:07:08[/posting]Elan and EntreMed Execute License Agreement for Proprietary NanoCrystal® Technology

DUBLIN, Ireland and ROCKVILLE, Maryland, USA – January 10, 2006

Elan Corporation, plc (NYSE: ELN) and EntreMed, Inc. (NASDAQ: ENMD) today announced that they have entered into a License Agreement in which EntreMed has been granted rights to utilize Elan’s proprietary NanoCrystal Technology to develop the oncology product candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol). Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain clinical, manufacturing, and regulatory milestones. Additionally, Elan will receive royalty payments based on sales of Panzem® NCD.

Under the License Agreement and corresponding Services Agreement, Elan will manufacture EntreMed’s Panzem® NCD, a NanoCrystal Technology formulation with improved bioavailability and absorption. Other marketed pharmaceutical products in the United States utilizing Elan’s NanoCrystal Technology include TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals), and Rapamune® (marketed by Wyeth). In 2004, the parties signed a Clinical Supply Agreement covering the supply of Panzem® NCD for Phase 1 trials. These Agreements extend the Panzem® NCD supply arrangement to Phase 2 and later trials. Panzem® NCD is currently in Phase 1b clinical studies in patients with advanced cancer. EntreMed expects to announce the commencement of multiple Phase 2 trials in early 2006.

Paul V. Breen, Executive Vice President, Elan Drug Technologies, said “We are pleased to extend our relationship with EntreMed. We hope that these agreements will lead to the launch of a new product with unique benefits to cancer patients.”

EntreMed President and Chief Executive Officer, James S. Burns commented, “These agreements continue our relationship with Elan for further development and manufacturing of Panzem® NCD, our lead clinical drug candidate. Interim results from our Phase 1b studies demonstrated that daily dosing with the Elan formulation maintains blood levels of 2ME2 within the desired therapeutic range, allowing us to move forward with Phase 2 clinical trials.”

Mr. Burns further commented, “Expanding the Elan relationship is a logical next step for EntreMed that provides us with access to process improvements and continuity of supply for further scale-up and clinical development. We look forward to working closely with Elan to meet our development goals and move Panzem® NCD towards commercialization.”

[Gndlf]

[posting]20.688.331 von Birgit.Tersteegen am 15.03.06 09:07:08[/posting]Die Meldung hatte ich gestern auch gesehen und ist auch im Januar von mehreren Quellen verbreitet worden. Die gestrige war nur a bisserl spät dran.
Moin all together!

[Poppholz]

Guten Morgen zusammen,

habe mir eben noch einmal 39 (!) DRX in FFM geholt.

Kleinvieh macht ja bekanntlich auch Mist.

[Poppholz]

[posting]20.689.106 von Poppholz am 15.03.06 09:49:14[/posting]somit sind wir mit den DRX schön im grünen Bereich.

[bernie55]

[posting]20.689.122 von Poppholz am 15.03.06 09:50:12[/posting]Poppie, wir danken Dir...



Grüße

[Poppholz]

noch 120 EAN in FFM hinzugeordert.

Dort ist der Kurs auf €12,37 "abgesackt".

[Poppholz]

[posting]20.690.665 von Poppholz am 15.03.06 10:51:18[/posting]immerhin noch grün.

[Poppholz]

habe irgendwie ein gutes Gefühl heute.

Bis zum Ende des Monats hat sich das Investment "auf jeden Fall" gelohnt.

[Birgit.Tersteegen]

POPPI-----LOB!!!!War das für die Dachziegel????

[Poppholz]

[posting]20.694.780 von Birgit.Tersteegen am 15.03.06 12:15:00[/posting]ich brauche doch noch ein Carport.

[bernie55]

[posting]20.694.871 von Poppholz am 15.03.06 12:19:16[/posting]....für dein Fahrrad ????


... halt, wenn ELAN ja bis ca. 40-50 USD steigen sollte, dann kannst du mit deinen 159 neuen Aktien ja schon einiges auf die Beinen stellen, - steuerfrei versteht sich........

[bernie55]

[posting]20.681.301 von Birgit.Tersteegen am 14.03.06 18:25:41[/posting]DOKO gespielt ???

...mit Schweinchen und Ansage ???

...ohne 9er ?????

...zweite Herz Zehn sticht erste ????

...mit Pflichtsolo ??????


- dann kommen wir ins Geschäft, Zockerlady....

[Birgit.Tersteegen]

[posting]20.695.421 von bernie55 am 15.03.06 12:43:39[/posting]Neue Doko -Frauen Runde

"vorsichtig " angefangen die Regeln zu verändern und Schweinchen und Pflichtansage schon mal eingeführt...

Ausbaufähig.....Grüssle!

[Birgit.Tersteegen]

[posting]20.694.871 von Poppholz am 15.03.06 12:19:16[/posting]Also muss Elanie noch für ein neues Auto reichen-sonst brauchste auch kein Carport-----ODER WAR DAS FÜR DAS BOBBYCAR??

[Poppholz]

ein Auto habe ich ja und ein zweites ist in der Planung.

[bernie55]

[posting]20.695.570 von Birgit.Tersteegen am 15.03.06 12:49:53[/posting]vorsichtig " angefangen die Regeln zu verändern und Schweinchen und Pflichtansage schon mal eingeführt...


...ich wusste es..

..Frauenpower mit HerzDame...

[bernie55]

[posting]20.695.698 von Poppholz am 15.03.06 12:55:41[/posting]...genau....und das Thema haben wir ja schon einmal ganz vorsichtig versucht zu eruieren.....

[Gndlf]

[posting]20.695.570 von Birgit.Tersteegen am 15.03.06 12:49:53[/posting]Wir verdoppeln, wenn Herz10en, Kreuzdamen oder Pikdamen im Stich zusammenfallen. Das macht den Ausgang knapper.

[bernie55]

...mannomann und frauofrau

- wie gut geht es uns eigentlich, dass wir nur noch über Dinge sprechen, die uns durch ELAN so einfach zugetragen werden....

[bernie55]

[posting]20.695.877 von Gndlf am 15.03.06 13:03:41[/posting]...ganz was Neues...mmmhhh..

..da bleib ich doch lieber bei ELAN......

[Gndlf]

[posting]20.695.966 von bernie55 am 15.03.06 13:08:16[/posting]das heißt es potenziert sich.
Gut, das ist bei Elan natürlich auch gegeben: MS, Alzheimer und Nano

[bernie55]

[posting]20.696.051 von Gndlf am 15.03.06 13:12:29[/posting]

[Birgit.Tersteegen]

[posting]20.695.877 von Gndlf am 15.03.06 13:03:41[/posting]Nicht unflott!!

Habe mein Studium mit DOKO und Politik verbracht--bin aber mittlerweile nicht mehr so in Übung-----also wirds ja auf denr 30€ Seychellenreise nicht langweilig----DEVISE:Entspannen UND Zocken....ALSO ELANIE AUF ZUR 30!!!

[Birgit.Tersteegen]

Screw FUD-lets look at today
by: stop_farking_with_me
Long-Term Sentiment: Strong Buy 03/14/06 10:53 pm
Msg: 959570 of 959707

I`ve been following ELN`s trading patterns long enough to know that buyers are shaking the trees again, just like they did when ELN was in the $8 area. It`s just amazing to see. I wish I were allowed to day trade ELN (I can`t), because today was the beginning of a move up. Is it going up .20, .50, or more? Don`t know, and yes, it may go down on an intraday basis, but barring any news, the institutions are back in and they are buying whenever a good-sized block comes for sale.

Trend is very likely up from here.

[Poppholz]

[posting]20.696.224 von Birgit.Tersteegen am 15.03.06 13:21:11[/posting]Skat und DOKO spiele ich seit dem Abi.

Dies ist zwar auch schon über 10 Jahre her, aber wir (5 Spieler)treffen uns immer noch regelmäßig (alle 4 - 8 Monate) zum Spielen.

[bernie55]

[posting]20.696.324 von Poppholz am 15.03.06 13:26:32[/posting]...tja, da denke ich sehr gerne zurück ......an die Zeit, in der wir sogar eine ganze Nacht mal durchgespielt haben...


..für einen Eintrag ins Guinessbuch der Rekorde hat es somit nicht gereicht....

[bernie55]

[posting]20.696.224 von Birgit.Tersteegen am 15.03.06 13:21:11[/posting]YEPP.....SEYELLEN - DOKO mit

[Birgit.Tersteegen]

[posting]20.696.324 von Poppholz am 15.03.06 13:26:32[/posting]GNDLF,Bernie,Poppi und ich---das "WINNER QUARTETT"--na super...und wenn Elanie das mit der Alzheimer in den Griff bekommt,können wir noch bis 90 Doko spielen (a.d. Seychellen;versteht sich....)

[Gndlf]

.. und ich spiele schon seit meiner Kindheit. Und seit über 25 Jahren mit der gleich 6-Mann-Truppe alle 4 Wochen. Das prägt!

[Poppholz]

[posting]20.696.291 von Birgit.Tersteegen am 15.03.06 13:24:52[/posting]trifft so ziemlich unsere Auffassung von der momentanen Situation.

[Poppholz]

in zwei Wochen wird die FDA die Entscheidung bezüglich Tysabri bringen. Bis dahin sind es nur noch zwei Wochen. Wer also noch rein möchte wird in den nächsten Tagen anfangen seine Positionen aufzubauen.

Der "Boden" sollte erreicht sein.

Eine Kursdrückerei bis zu den letzten zwei Tagen vor der Entscheidung halte ich für unwahrscheinlich.

(Aber das habe ich bei den bisherigen Drückerverhalten auch schon nicht nachvollziehen können)

[Poppholz]

gehe von einem grünen Start in den USA aus.

[Poppholz]

da ist er auch schon:

vorbörslich: $14,95

aktuell 5.000 Stück zu $14,97 gekauft.

[Poppholz]

und 1.000 Stück zu $14,99

[Poppholz]

da bin ich aber auf die breiten Massen ab 15:30 Uhr gespannt.

[Birgit.Tersteegen]

Ich wills nochmal wiederholen:


W I R W O L L E N G R Ü N S E H E N !!!!!!!!G R Ü N

[Birgit.Tersteegen]

Orderbuch sieht klasse aus!

[bernie55]

[posting]20.697.235 von Poppholz am 15.03.06 14:06:35[/posting]aktuell 15,03 USD...

[Poppholz]

heute wird gut!