MY PICK IS ELN

[kingofthehill]

Elan Predicts Suspended Drug Will Return

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AP Online
1:39 p.m. 05/26/2005


DUBLIN, Ireland, May 26, 2005 (AP Online via COMTEX) -- Seeking to reassure its shareholders, Irish drug manufacturer Elan Corp. PLC predicted Thursday that its suspended key product, the multiple sclerosis drug Tysabri, would eventually return to the market.

Addressing investors at the company's annual meeting in Dublin, Chief Executive Kelly Martin said the company was working with its research partner, Biogen Idec Inc. of Massachusetts, to identify the drug's real dangers.

Martin said officials from both companies would meet U.S. regulators to discuss the "path forward for Tysabri" once their internal review was complete by late summer. "It's a question of when and what path that takes, not a question of if," he said.

Martin added that, even in "a worst-case scenario" where Tysabri didn't return to sale, Elan still was on course to break even financially in 2006 - reversing three years of red ink - and would meet debt repayments.

The stock rose on the news. In Dublin, they jumped 15.4 percent to 6.43 euros ($8.06), well off their 2.30 euros ($2.90) low set in March - but still a long way, too, from their 2005 high of 22.40 euros ($28.20) set before Tysabri's withdrawal.

On the New York Stock Exchange, shares rose 13 percent or 96 cents to $8.17.



when they announce the debt repurchase, it will go even higher ... this is going to be fun again !!!!!!!!!

[B.J]

Congrats to all of you

Daggone it, though, wish I had gotten in yesterday

[New-born baby]

No sweat

Congrats to all of you

Daggone it, though, wish I had gotten in yesterday

Don't sweat it. You can jump in after the shorts finish covering today, and the gap fills next Monday. That gap will fill.

[B.J]

Thanks Newborn! And of course I won't sweat it. Plenty of other stocks out there, as well as another opportunity for ELN down the road. Just temporarily frustrated.

[New-born baby]

Post some of your picks

Thanks Newborn! And of course I won't sweat it. Plenty of other stocks out there, as well as another opportunity for ELN down the road. Just temporarily frustrated.

BJ--
KingoftheHill has some of my money in his ELN account. That wild stock has kicked me a few times. I stay clear of it.

Why don't you post some of your picks so I can check them out.

[B.J]

I'm in DIOD (30., VDSI (9.10), QQQQ (37.30), and MM's DW since a while back.

Also bought MCZ (1.55) and FRD (7.04) today. Watching SYMC, and ERS.

[B.J]

I'm trying not to get too excited...but I think I just pissed my pants. It's going higher.

And this time it ain't raining!

[kingofthehill]

spike whats your read on the chart

[Websman]

More good news King. It's headed up again!

[kingofthehill]

SUNDAY IRISH NEWSPAPER

Elan: FDA will be under pressure to resume sale of MS drug Tysabri

29 May 2005
The way Elan tells it, by the end of this summer the safety panel of the US Food and Drug Administrat ion (FDA) will be under immense pressure to let the sale resume of Tysabri.

The multiple sclerosis (MS) drug was withdrawn late last February, with dramatic consequences tohopes of sufferers of MS and Crohn's and to the shareholders of Elan and its partner Biogen. Three thousand patients trialled Tysabri in combination with other autoimmune-suppressant drugs. Three of these contracted a rare brain disease, progressive multifocal leukoencephalopathy (PML).



Two of those who contracted the brain disease died, and one survived. Details of the surviving patient have not been released.

The renewed confidence that the drug wi l l be relaunched, which sent Elan shares climbing 14 per cent last week, is not misplaced, according to the person with the closest knowledge of the Tysabri drug, Lars Ekman, Elan's head of global research and development.

Ekman has overseen the development of the drug, seen as the breakthrough treatment forMS and Crohn's before the FDA ordered that its sales be ‘paused' three months ago. The growing confidence within the company is palpable. It is based on the belief that the PML cases were not, as feared, the tip of an iceberg, and that the FDA will allow the drug's return, with revised patient packaging and warnings.

By this summer, the review of the case histories of the 3,000 patients will be completed and after seven weeks of statistical research, an FDA safety committee will be ready to review the drug. Speaking last week to The Sunday Business Post,Ekman said that his confidence was based not onthe fact thatmore patients have not contracted PML, but that he now understood more about the nature of PML.


No patient has contracted PML using Tysabri as a single treatment. “I think that will be a very important distinction when the FDA looks at the data,” said Ekman. “We know from the first months of Tysabri prescription that the vast majority of patients were given monotherapy, and not a combination with other drugs.”

“The reason I am more confident is because I understand more about PML. At the start of this process we thought that you would go to the literature and find, say, that 80 per cent of patients will die from the PML. But all of that data comes from the Aids situation.

“We have looked at other areas which are more relevant to Tysabri - drug-induced PML, where you have an immune-compromised drug. There, the latest literature suggests if you diagnose very early and take away the drug then you have 100 per cent survival.”

Elan will be hoping to show to the FDA safety committee that the patients who died had PML from the beginning, and that the deathswere not necessarily related to their use ofTysabri.

“Both these patients [the fatalities ] were on other drugs,” said Ekman. “The Crohn's patient was on a severe immune-suppressant for six years, and it was also disclosed that that patient was on a drug which is known to cause PML. [The patient] was on Tysabri for a couple of months. “I do not want to give you the conclusion until we and the FDA have a joint conclusion. I can say that these patients were subjected over many years to very potent immune suppressants other than Tysabri, and they were on Tysabri for a couple of months.”

Elan has also expressed confidence thatTysabri's commercial value will not shrink if it is confirmed that Tysabri is an effective treatment for MS when used without combining it with other drugs. Nonetheless, analysts remain sceptical - even if the drug were to come back, they feel, it could be used less in treatments.

But Ekman said that there there was “a huge discrepancy'‘ between the scientific community andWall Street on the issue. “I have not been overly impressed by Wal l Street's analysis of how you do risk analysis assessments,” he said.

He believes that Tysabri was caught up in the storm at the FDA after the US Congress questioned the regulator about its record in monitoring the safety of high-profile drugs. Merck's painkiller Vioxx was withdrawn last September, before the FDA gave the goahead to market Tysabri after an accelerated trial based on one-year data.
“Congress had a very tough hearing with the FDA executives [onVioxx],” said Ekman. “They came home and there were these two [PML] cases. And that drastically changed the tone of conversation with FDA. So I can imagine there was a very intense discussion in the FDA.” Many observers last February forecast that the renewed focus on safety would rule out the FDA allowing Tysabri to return any time soon.

So are analysts not right to be sceptical, given the new political reality in theFDA? “I do not know whether anybody knows that,” said Ekman. “The FDAwants to show that they take safety seriously.” The FDAwill probably be under pressure because of the large relapse rate for 100,000 MS sufferers in the US who have been on other treatments, argues Ekman.

“We know that they will generate, over the next two years, 53,000 relapses.We also now that if they take Tysabri, that number goes down to approximately 25,000.We also know that 5 per cent of these relapses will lead to severe disability and even cause death,” said Ekman. “The question that theFDA will have to ask is, is the patient better off withTysabri or without Tysabri. MS is a very serious disease.

“It is not like the Vioxx situation where you have a drug and there are 19 alternatives already on the market. There is no alternative today to Tysabri for these patients.”

If Tysabri was reintroduced with new patient warnings, it would be up to neurologists and the patients to decide whether to take Tysabri, said Ekman.

“We have stopped all dosages.We know that after a certainamountof timethe disease will come back, and that will be an important time for 3,000 patients, because the relapses come back. I think that [the FDA] will be very sensitive to that.

[Websman]

Thanks for the post King. I'm liking the way everything is looking. As a matter of fact, I added some more shares on Friday. If Tysabri does get back on the market, my account will be looking good.

[Websman]

Here is a great site by country music star Clay Walker , who has MS.

http://www.bandagainstms.org/index.html

[Websman]

Good news from the Irish exchanges.

Elan (DRX.IR) closed up by .22 Euro. Let's see if this will continue in our markets tomorrow.

[New-born baby]

Euro dropping in value

Good news from the Irish exchanges.

Elan (DRX.IR) closed up by .22 Euro. Let's see if this will continue in our markets tomorrow.

But Euro is dropping in value . . . .

[Websman]

But Euro is dropping in value . . . .

The Euro going down is a good thing. It'll make my Thanksgiving trip to Paris cheaper.