I wonder if any gamblers noticed my post 334 on the GMC thread yesterday.
It looks as though bottom fishing can sometimes pay off.

Sorry misprint on Stockwatch after overnight trading on NY. Only 1.6% now, but worth watching I think.
sd

The big players now in and the sp to rise upwards very soon

Seems to have bottomed out and started to rise after suffering an 80% drop on the strength of a question mark on one product: the doom and gloom certainly appears overdone and now a fantastic bargain in my opinion.
Some interesting posts in the Wall Street Journal which I am studying at the moment.
sd.

Up 10% so far this morning, still good opportunety to add before lift off to previous level.

The Master: Having failed to interest my investment club, and others on this BB in this share, we seem to be the only ones climbing aboard.
Was able easily yesterday to buy 3,500 on line @ comdirect, but today is more expensive and much more difficult: what does that tell us?
sd.

Only the two of us to split the profits with then!

Suidd and The Master - there are 3 of us on this - I am in - good luck - would be nice to double before the end of the tax year.

We bottom fishers are supposed to be solitary creatures, but welcome anyway to the deep.
sd

Question - Why do you guys think the sp collapsed so suddenly? What makes them a buying opportunity right now? Why this stock, Squidd?- I did read your GMC opt-out post, yes.

Poor write up in this week IC - recommended 'Sell' quoting uncertainty following MS drug suspension. Also concerns over ability to service debt & unlikely to meet profit targets in 2006.

g64946: I agree with I.C. about ELA finances, but I think much of this was in the price before the crash, when most brokers were saying 'weak sell'.
And on 9-02-05, incoming chairman, who I believe also heads Dublin's biggest stockbroker, bought 214k of stock at the old price. Now the risks are in the open, we can buy at around 1/4 this price.
Obviously for gamblers, but so was GMC.
sd

markusantonius: I can only answer your query in general terms about recovery plays. In panic selling, as has happened on Wall Street with ELA, owing to a question mark against a flagship drug, the doom and gloom is sometimes overdone and this might produce a bargain situation. Rothschild is supposed to have made his fortune buying what everyone else was selling (and by then selling too soon).
Read all about it on the US news sites who use ELN.L as the epic for ELA.
sd.

Dont be in a hurry to jump in yet - my view. There is still some downside left before the inevitable bounce. Dropped 6% in UK today

You have to jump in at some point as you never know where the end is - if only I had a glass ball I would take your advice daokta.

And now for the comic relief bit as another predator joins us on the ocean floor and circles around ELA.
Hungry US lawyers have filed a class action accusing ELA of exaggerating the value of their drug and talking up the value of their shares pre-crash. Obviously believing that Blair's WMD virus haa spread to the stock market, they are advertising for newly impoverished investors to contact them - toll free.
I'm thinking of asking whether they can recoup my losses on Redstone and Marconi.
sd.

Looking for precedents among other great fallers, came across Cobra Bio which was strongly tipped by Trendwatch in December 03 and was Investors Chronicle 'Share of the Year' for 04. Two profit warning later, it had fallen 80% (same as ELA), and is now being followed upwards, elsewhere on this BB.
So hoping that I.C. got it wrong also with the sell recommendation for ELA. But the fall of 6% on Friday was worrying (CBR only fell 3%). It appears they were buying ELA in LOndon but selling on Wall Street.
Any thoughts on where the stop loss should be?.

ELAN just rated 'Strong Buy' on U.S. STOCKPICK report, (ELN NASDAQ) can be viewed on Yahoo. Hope this counters I.C. views.
sd.

Great news 'Squidd' sp will lift-off when the America wakes up around 2.00pm

We will show them!

I continued to buy this share after the second crash and now, following an upbeat statement from the ceo, it seems to be crawling out of the pit at last.
Any further thoughts out there.
sd.

ELA certainly seems to on the road to recovery as the new chairman makes a huge stock purchase and many medics are saying that with all its faults, their flagship drug Tysabti can't be worse than the disease.
sd.

looks like confidence is returning.

Maybe was that confidence short lived?? The market has not taken the same view as the chairman. Any thoughts?

Have just added in my ISA. Mine was the 3503 buy via comdirect after baling out of ARK. Hope I got it right, but it seems to me that with all the gloom in the AIM market it's safer either to be in cash or in shares that have already plunged.
sd.

according to another site.......Rumour......Elan Corporation (ELN) $5.87 to be bought by WYETH (WYE) for $14 per share.....dyor

Wisemove: Thanks for that titbit; something certainly moved the price today, a bit marred by a hefty sell at the closing bell over here and little movement on the NASDAQ for either ELA or Wyeth. But looking forward to tomorrow.
sd.

squidd....at close US..$6.97/+9.5%

Vivid blue again! And some heavy selling; maybe someone wants these shares.
sQd.

Another day of heavy selling and hefty price rise. Everyone on this BB should now be showing a healthy profit, especially those who bought into the second crash - it certainly brightened up my ISA. Interesting to see what Fri 13th brings - maybe a revelation.
sd.

squidd ELA still looking good on the recovery play front I see I have added KUJ to the recovery list of OSH APH ELA and others we have and along with that UNG is worth a serious look now with bottomed price at below price to book of 1.

The wife is watching casualty and I'm scouring the internet and I'm baffled. According to PUBMED the US National Library of Medicine, the disease for which ELA is taking all the flak - PMLE - was first disclosed in 1958, about 40 years before ELA came on the scene with their new drugs, so how can they be blamed. Are there any medics who can explain.
sd.

Live webcast of today's ELA A.G.M. now playing. Access via elan.com.

Much of the discussion focussed on the latest drugs and directors expressed cautious optimism about the future in this morning's question time at the AGM. They revealed that there are around 100,000 MS sufferers in the US who are currently recieving no medication, and the talk was not of whether, but when their flagship drug Tysabri would return to the market.

agm this morning....excellent news....this is going to go balistic.......sorry....has gone ballistic and the US has even opened yet (pre market +11% and rising!!!!)

I had e-mailed Elan with my query about PMLE [post 31} and had no direct reply, but this was aired in the AGM and the medics put it into perspective - too complex for laymen like me to report here.
Meanwhile they are looking optimistic so far, over on NASDAQ.
sd.

Some new heavyweight board appointments announced today, seem to have brought ELA firmy back onto its recovery course.
sd.

squidd ELA still rising and OSH too so good news all round.

future is looking bright!

PpP: I see that OSH is leading ELA again but allowing for the spread handicap, they are probably neck & neck and both running extremely well.
Some of my TA friends are getting excited about various MA crosses and OBV's for
ELA saying it points to a re-run of last year's big climb. I'm not an astrologist, but would be interested to hear views from any other chartists. Meanwhile, in my view the simple chart and volume are saying it's better than money in the bank, so I'm tempted to dip into my cash pile and add to ELA.

Have sniffed around the RPT crash site to see if there's any worthwile salvage over there but decided to keep away and see what other skeletons might be dragged out.

I am looking very hard at ULT which I think could be a big climber in the NHS health care market. Knowing of your interest in health matters, perhaps see you over there.
sd.

squidd it is neck and neck and with the way they are marking up OSH sometimes on no trades I think they know very positive news is coming with the results next week so will OSH take the lead?

squidd forgot to say some real good news at VLK

suggest you think about getting out temporarily if not already done so due to rumour of new fatality.......the panic may well set in early this afternoon when the US moves....

Wisemove: Thanks for info, have scoured the net in vain for details; fortunately still up on month.
sd.

from another site:

Reuters.com

Elan falls on new report of Tysabri-linked illness
Thu Jun 2, 2005 05:11 AM ET
DUBLIN, June 2 (Reuters) - Shares in Elan Corp. (ELN.I: Quote, Profile, Research) fell as much as 24 percent on Thursday following a report that a fourth patient taking its multiple sclerosis drug Tysabri may have contracted a deadly brain disease.
Elan halted sales of Tysabri on February 28 after a patient died from a rare brain infection, known as PML.

The Boston Globe reported on Thursday that Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) , with whom Elan developed Tysabri, had told the Food and Drug Administration that a fourth patient may have contracted PML.

Shares in Elan dropped to a day low of 4.91 euros and were 15.1 percent lower at 5.35 euros by 0911 GMT.

looks like we'll see a further fall after the US market opens (although the % will have been for the greater part already abosrbed) then a degree of stablization and then a pointer of where we go fom here.

from another site:

Things are not as bad as first thought, so up we go again!

Goodbodys have a buy on Elan:

Elan (Buy, Current Price $6.85)
What is material to Tysabri's progress?
After a day with no communication on speculation around Tysabri, a spokesperson for the FDA would now appear to have confirmed that Elan and Biogen Idec have received a report of a suspected case of PML. Given the lack of response from both Elan and Biogen Idec, we infer that the case referred to has been deemed by all parties involved not to be material to the progress of Tysabri through the approval process. The reference to the Freedom of Information Act in earlier speculation is particularly intriguing though. A Federal body can take 20 days to respond to a request for data under FoI and has the opt-out clause that it will not disclose information that it considers to be commercially sensitive. From this, the inference of a fourth potential case (if from an FoI-driven source) could possibly be from data lodged with the FDA some time over the past few weeks. We consider it inconceivable that, if material, that data were not disclosed to the market during this period. Given the recent corporate action (debt retirement) and bullish stance on Tysabri, both Elan and Biogen Idec's definition of "material" will have been closely scrutinised by all parties in the review process. The inference, therefore, is that if there is a fourth suspected case of PML, it has been agreed by all parties involved to be, as yet, immaterial to the progress of Tysabri through the review process. Undoubtedly, it will be discussed at the Biogen Idec AGM today (15:00 Dublin/London).

Good luck/dyor

www.ninds.nih.gov/disorders/pml
The US National Institute for Neurological Disorders, puts into perspective the rare brain disease that has been linked to ELA's flagship drug. The impression given is that it is much less rare now, being an opportunistic disease that can take hold in the presence of various immuno-suppressor drugs, AIDS victims being especially vulnerable.
ELA seems to be back on the road to recovery.
sd.

wow......the spike yesterday afternoon was pretty impressive......it looks like recovery is well on its way.......it looks as if TY will come back, sooner rather than later perhaps?!....should see an excellent gain today and further hikes over the coming weeks.........dyor.......and good luck all.

ps (spike ref US market....code ELN)

Yes! The latest 2 year Sentinel trials show TY to be successful as a combination drug, and all post-crash investors should now be well in pocket with ELA, perhaps with lots more to come, should TY ever get re-approved.
sd.

With ELA up over 30% and ULT up 16% this morning, I hope all bottom fishers
are celebrating today. Anyone in the Mayflower tonight can have drink with me.
sd.

This is going to fly in the next few days. Keep a close watch and mark 21 Sept in your notebook . The best place to follow the news flow on this is the yahoo MB. look under ELN. as Elan has a lot of different tickers. The MB to look up Elan is the U.S. message board. not the U.K. one.

Can you give any reason(s) why Guinness69?

Looks like time for bottom fishers to celebrate again, but no idea why ELA is climbing.
They have crawled upwards throughout the year, then suddenly spurted recently. The chairman spent 1/3M on shares at the beginning of November and in the last couple of days US brokers have upgraded their rating. There is just a possibility that their flagship drug, Tsybari, is about to be re-approved and if so the sp will go through the ceiling, but I can't find anything - can anybody?
sd.

Wall St AFX News reports that ELA was Tuesday's most heavily traded European stock, even ahead of Vodaphone, on expectations that Tsybari would shortly return to the market. Meanwhile, there's profit taking here today.

Thanks for the nudge on this one earlier in the year squidd, a very nice gain so far.

Good news this morning. The U.S. FDA has recognised the significance of the flagship drug Tsybari and granted it 'priority review status'. Hence the sp jump.
sd.

ELA continuing its upward crawl and has even put on a spurt recently. Now again at a post crash high and everyone should have at least doubled their money. Still more to come I think.
sd.

Another mini leap this morning, over 5% up on opening.
sd.

There was a huge share purchase by the chairman at the beginning of November and now over the past 3 days we are seeing a dramatic rise. I wonder if news is leaking out about re-approval of their flagship drug Tsybari.
sd.

I like the look of this one squidd the end of period cash balances are going up! and losses going down! hope it's not too late to add to my ISA for a profit sorry I missed your posts on it now! I'm holding MDY and hoping as driver has high hopes it will pay off.

I like the look of this too.Never noticed it before looking at this thread and it will be going on my watch list.Do you think its looking overbought at the moment.

Soundings among my medic contacts suggest that there is virtually no other treatment for multiple sclerosis, so if Tsybari were re-approved in could be huge.
Meanwhile, the FDA and the manufacturers keep making optimistic noises.
I've been adding to ELA from sales of AEX, which seems to have temporarily run out of steam
sd.

This looks one of the biggest punts around, based mainly on one single win or bust treatment, but the chart says 20p pdq. Considering a gamble.
Any chance of some charts in the header, thanks for flagging it up squidd, even if i am a tad late in noticing the potential!

hawick: This chart gives the latest picture, though I usually work on a series of Sharescope charts which I find gives a more comprehensive picture, and suggested to me back in March that this was a classic recovery scenario.

moneyplus: Looking at the above mentioned charts for MDY, it looks to me as if it's still in downtrend and hasn't bottomed yet. Worth keeping on the watch list though.
sd.

ELA seems to be gathering momentum, now up 60% since 1st Nov and 25% this month. It has overtaken everything else in my portfolio, even PMK, as my Winter front runner. I think the chairman must have known something about re-approval of Tsybari when he made that hefty share purchase 3 months ago.
Hope there are many of on board.
sd.

And up another 7% on opening this morning; wish I could dig up some news.
sd.

Thanks Squidd, my chart analysis still says 20, after a very brief pause on the way up around 15. Timing is hard but the chart has certain similarities to PMK (I said 25p on it when it was 10p and did nothing about it!), Good luck.

hawick: I agree with you on the chart forecast, but look also at the 10year chart, could ELA return to the glory days of 40? They have streamlined their operations and have a good pipeline of new drugs led by Tsybari; and the pharma industry as a whole must be encouraged by the failure so far of the Vioxx litigants to screw Merck. Even higher risk now it's so far off the bottom, but I'm still buying.
Horrified to hear you didn't get into PMK.

In recent weeks, 2 other drugs that treat MS, one based on on cannabis and the other on goats milk, have had to be withdrawn owing to side effects. Increasingly, Tsybari is emerging as the only treatment for MS and various other illnesses and should it be re-approved, it will undoubtedly be a blockbuster so propelling ELA to new heights.
Meanwhile, a year end spurt in the sp made ELA my top performer of 2005, beating the likes of ULT, AEX and CSB. More to come in 2006 I'm thinking.
Prosperous New Year to all,
sd.

ELA continues its steep climb and is still leading the pack.

Well and truly filling the gap to E20.

Hawick, can you explain 'E20' please

Hampi - filling the gap to 20 euros I guess.

Cheers Frampton, spot on, I haven't got the Euro symbol on keyboard!

AFX news on yahoo finance, reports from the JP Morgan Annual Healthcare Conference held on Wed 11 January, about progress towards re-approval of Tysabri to treat MS. It re-iterates the view that Tysabri is superior to other treatments and implies that re-approval is just a formality, awaiting only agreement with the FDA on new labelling to warn of the side effects of immuno-suppressor drugs. It is envisaged that Tysabri will be back on the market by the middle of this year.
.

Even on a miserable day everywhere else, ELA is still climbing.
There is chatter on the other side of it being tipped in a US tip sheet.

I bought 500 of these at 3.47 euros last april, there was never a chance of tysabri not coming back it was ust a question of when (having taken the drug myself). The latest webcasts all but announce its return. Pharmacutical equities seem to have a life of their own. Last night their trading in NY set new 52 week high. Think I should be selling around the 24 euro mark in march time, although they do have promising work for altsheimers disease, so perhaps i should hang on to them even after a tysabri relaunch? Decisions decisions!

not 52 week high meant year sorry

And today some really smart NY analyst says he doesnt think tysabri will be perscribed by doctors very widely! causing mass panic with elan shares, and they drop 1.5 euros! I mean does this guy know anything about MS? obviously not otherwise he would know Tysabri is at least twice as effective against relapses than any other therepy out there not only that but it also promotes the brain to heal itself meaning a reversal of disability, sounds like a wonder drug? Well I for one know that to be true and in the nightmare world of brain demylination I know the MS community would all gladly take this drug, rather than suffer a slow degeneration of every human function.

So its not a question of wether the docs will perscribe this therepy, but just how fast the patients suffering can get it. take it from me buy this stock, it may take a while to prove the critics wrong but when the profits are announced in a few months time you will probally wonder why you never invested in Elan when they were so cheap.

Crippy: Thanks for your posts. It's amazing that you have experience of Tysabri as I didn't think it had been trialled over here, and my own reading on its value suppports what you have to say. The dip sets back the recovery only by about two weeks as far I can see and I think offers an opportunity to top up. If only I had some spare funds. Meanwhile there is chatter on the other side about Elan's partnership with Wyeth to develop two drugs for Alzheimers, which they say could be very, very big.

Yes squidd i was on the European mono therepy trial here for a couple of years. You could say i am living proof of why the drug is so good. According to the doctors eho were overseeing the trial the problems the drug encountered only occured when used in conjunction with other immunosuppressants, because on its own it is ultra effecient at doing its job. So when combined with other drugs of a similar nature it is to heavy a load for some peoples immune systems to deal with. Hence the only deaths occurred when the drug was being prescribed wrongly. As I am sure you are aware, american doctors are essentially drugs sales people for the various pharma companies, and when a patient asks for a drug they generally get it. With Tysabri it was a shame because 2 people died because they suppressed their immune systems too much, I supose this is a testemant too Tysabris effectiveness, and also shows how poor other MS therepys are because doctors were used to perscribing multiple therepies before because the drugs previously available didnt work very well.

Interesting to hear about the Alzheimers drug, think I may have to scrape together some pennies to up my stake in elan me thinks.

ELA firmly back on the recovery trail after reporting results ahead of market expectations on 31st Jan - even without any contribution from Tysabri, for which they are planning a high profile relaunch in the US, hopefully in the next couple of months. My reading of the newsflow is that the market has yet to price in the likely impact of the new Altzheimer treatments.

This is to advise that I have now SOLD my holding in ELA, giving me, and I hope others on this BB, really excellent gains. I now think that ELA is nearing the end of its recovery phase and faces the hard graft of selling their wares in a competive market: I'm not too certain about the financial well being of the company and think they may struggle. So I won't be posting any more here, but having said that, ELA has in the past proved to be an accident-prone company and may well offer further opportunies for recovery.
Meanwhile, I'm focussing on other recovery/growth stocks, including CW, IOT, ULT, PMK, TAG.
sd.

Great news this evening from the US regarding Elans drug Tysabri, the drug previously withdrawn almost a year ago due to saftey issues. The FDA announced that patients previously recieving the drug in the trials being conducted to evaluate the drugs effectiveness and saftey, are allowed to restart their dosing with the drug. the FDA will rule in late march wether to allow the drug to start being marketed again in America.

The restarting of trials i think can be taken as a very positive step on the path to relicencing Tysabri for sale again, and that the european licence for the drug is only a short period of time away!

I dont know exactly what price I am aming to sell my holdings in this share but perhaps between 18 and 20 euros is a realistic target. i am banking on the fact that even in its withdrawal and saftey concerns,it still remains the most effective therepy currently available for what is a chronic illness, and as such meets an important clinical need. I am aware that the MS community has been queing up for this treatnment dispite its problems. As a new class of drug this is the first of a few therepys using this compound as their base and has proved to be side effect free when used as a monotherepy.

elan PLC closed tonight in new york @ $14.54 the news only just circulating at time of market close. Expect tommorow to see big gains in London for this share. I knew I should have topped up already! Oh well I will enjoy the ride fingers crossed :)

here is a link for the reuters news story:

http://today.reuters.com/investing/financeArticle.aspx?type=governmentFilingsNews&storyID=URI:urn:newsml:reuters.com:20060215:MTFH32479_2006-02-15_18-33-47_N15246655:1

two rather larger than normal sell trades last thing before colse today, interesting. Still hopefull on an FDA approval for relaunch which could see a possible doubling of value of this stock. Personally waiting for the call from consultant confirming the trial is restarting....roll on the happy days!

It all becomes clear now forbes today said that its reasearch from the neurology community indicated 59% of doctors would be unwilling to prescribe Tysabri except as a therepy of last choice given the potential for the PML side effect. Projecting only 10% of MS patients would be given the drug. Fair enough, but given the amazing benefits to be had from the drug, and the fact it is twice as effective as any other therepy, I think the paying american ms community would take their chances, given the alternative of a slow degeneration of brain functions. Plus PML was only detected in two MS patients who were on a dual therepy ( Tysabri taken in conjunction with other immunosuppresents ) and never when tysabri was being used as a monotherepy. So instead of selling tomorrow morning I shall be sticking with ELA and waiting for the FDA decision which is only a few days away (they meet on the 7th or 8th of March and report later in the month) I may ironically enough top up as the price may drop further, and no I have not lost all my sanity, I simply believe in the prouct and have 3+ years experience of it.

Just wish I had more experience of the crazy world of stock market investment, then perhaps I would have seen this coming. Oh the pharma world is a thrilling ride! Then again I could simply bet on the dogs!

and so we come down to it, a year of waiting is nearly over, tuesday and wednesday see the FDA in conference to review Tysabri. They will decide the outcome of a drug that holds much potential, and some think also is the future of elan in the short term. A percentage of the medical community seem to be indicating they expect to see the return of Tysabri to the market but with restrictions over its use.

Market analysts see this company and its short term future as so dependenent on the drugs re-emergence that last week saw the stocks value fall several percent with various stories circulating about the likelyhood of the FDA saying yes or no to relisencing of tysabri.

Obviously I have a personal interest in its future and hope that when, as is expected, Elan reports on its future through its webcast from the Cowan & Co health care conference, the news is good. I expect the FDA will give a green light to the relaunch of the drug, without as many restrictions as might be expected. I will tell you why, because its is at least 60% more effective than any other therepy currently available for MS. It fullfills a huge unmet clinical need and as such will be given the go ahead.

also the unfortunate illness PML was only reported in those who took Tysabri in conjunction with other immunosuppresscents, so I predict as a monotherepy it will be relicensed with the warning not to be used with other immuno therepys. So the sales could still be much more significant than some pesimists anticipate. As a monotherepy it is a great advance on anything currently available and I think the MS community will be clamouring for it to be made available, hence sales will be significant. The problem is there are to many underinformed analysts and writers who comment without fully researching their facts, hence the rollercoaster ride this share price has been enduring over the past few weeks.

there is also hope for the future without even Tysabri, Elans current research has in the phase three clinical trial their Altsheimers drug, inspiringly named, AAB 001 which if you speak to any neurologist tehy will tell you of its massive potential and that it is the first drug of its kind to be trialed and there is no other therepy which has any effect on this condition. so when and if it is approved it will be on its own in the field as an effective therepy against this condition, and that really does mean billions and billions in sales....in the mean time roll on wednesday....

Thanks for that Crippy. I'm holding on, and awaiting the outcome this week, I think it's more likely to be positive than negative.

Thats the spirit Frampton! Found an interseting website extoling the virtues of tysabri:

http://www.mspatientsforchoice.org/

So as you can see its not just me ranting on about how great Tysabri is :)

Noted a large end of day trade on the london market couldnt find out if it was a buy or a sell sorry. about 191,000 in total!

Interesting website Crippy.Last chance to buy or sell, only a few more hours before we are locked in awaiting news....

topped up a bit yesterday @ 10.63 euros seems to be a last rush of buys today and hence price up to 11.47 euros as i write. now as you say frampton its a waiting game....

some latest news from bloomberg....posted 40 mins ago just about sums up the first day in the FDA review....

Biogen, Elan Propose Measures to Control Tysabri Risk (Update4)
March 7 (Bloomberg) -- Biogen Idec Inc. and Elan Corp., seeking to resume U.S. sales of their multiple sclerosis drug Tysabri, proposed to restrict the treatment's use to reduce the risk patients will contract a rare, fatal brain disease.

The drugmakers told a panel of advisers to the Food and Drug Administration that they will monitor Tysabri's use by having the drug administered only in registered centers. Patients would be required to sign a form confirming they understand Tysabri's risks, and doctors would be instructed to suspend treatment if patients show signs of developing the brain infection.

The companies, whose shares were halted today as they have been reacting to Tysabri news for months, told the panel the drug should be made available because it is better than existing therapies for the neurological disease that affects 400,000 Americans. The committee must weigh people's rights to an effective treatment that has severe side effects against the FDA's responsibility to protect the public.

``Although data is limited, we seek to limit death and disability if PML occurs,'' said Carmen Bozic, Biogen's vice president for drug safety and risk management, at a meeting in Gaithersburg, Maryland.

The committee of doctors and scientists heard demands from patients today requesting the drug and will vote tomorrow on whether the FDA should allow Tysabri sales to resume. If the drug gets a favorable review and returns to the market, it will be only the second time a company has been allowed to bring a back a suspended medicine.

FDA, Companies Collaborate

GlaxoSmithKline Plc's Lotronex, the first drug for irritable bowel syndrome, was resurrected in June 2002 after spending 19 months off the market when it was linked to patient deaths. Lotronex won back a limited approval at a lower dose and the FDA set up restrictions for its use.

The FDA has been working daily with Biogen and Elan to craft a monitoring plan that would help control Tysabri's risks, agency officials said today in a conference call. 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.

``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. The committee will be asked to weigh in on some of the restrictions, he said.

Shares React

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.

Shares of Cambridge, Massachusetts-based Biogen rose 1 cent to $45.51 yesterday in Nasdaq Stock Market composite trading. Dublin-based Elan gained 70 cents, or 6.6 percent, to 11.30 euros before the trading suspension at 1:03 p.m. in Dublin. Both stocks fell last week after researchers said Tysabri can deplete immune- system cells as much as HIV.

On Feb. 28, 2005, the day the drug was suspended, the companies' shares plummeted, wiping out $17.8 billion in combined market value. Elan has gained almost two-thirds and Biogen rose as much as a third since October as no new cases of PML surfaced and management laid plans to press for a resumption of sales.

At stake for the companies 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.

Effects of MS

MS robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis. In severe MS, people have permanent symptoms, including partial or complete paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers.

If Tysabri is cleared to go back on the market, safety concerns may still limit sales to less than $200 million in 2008, said Chris Raymond, an analyst at Robert W. Baird & Co. in Chicago, in an interview yesterday. Rodman & Renshaw analyst Michael King in New York said U.S. demand may reach $700 million in 2010.

`Less Promising'

``The risk associated with Tysabri goes beyond just whether or not this drug will be approved,'' Raymond said today in an interview. ``Most folks do believe it will be approved and put back on the market. But I think the drug's commercial outlook is a lot less promising than it was before the risk of PML cases came up last year.''

U.S. regulators on Feb. 15 cleared Biogen and Elan to resume testing Tysabri in patients for the first time since the drug was suspended, raising hopes the advisory committee may recommend resumption of sales. The FDA is to make its decision by the end of March.

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 today. Biogen would implement strict distribution controls, the company told the panel.

Recommended Limits

Biogen and Elan recommend certain limitations, including barring the therapy for patients with impaired immune systems and not giving Tysabri in combination with other MS therapies, Burt Adelman, the Biogen executive vice president for medical research, told the committee today. Patients in two of the PML cases were taking Tysabri in combination with Biogen's Avonex, an older MS drug.

PML occurs when an infection called the JC virus, named with the initials of the first person diagnosed with it, evades the body's immune defenses and penetrates the central nervous system. Tysabri, an antibody-based medicine, was designed to treat MS by suppressing immune cells. Researchers theorize that the drug may subdue defenses meant to keep the JC virus out of the brain.

FDA reviewers raised concerns about other side effects in Tysabri patients, including viral meningitis, respiratory infections and herpes central nervous system infections. About 6 percent of Tysabri patients developed antibodies against the drug, which can decrease its effectiveness.



To contact the reporter on this story:
Angela Zimm in Gaithersburg, Maryland, at azimm@bloomberg.net
Last Updated: March 7, 2006 18:51 EST

Great News the FDA advisory commity have voted 7 to 5 in favor of returning Tysabri to the marketas a first line therepy and 12 to 0 in favor of the drug returning!

heres a link to te story....http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B4547CE3B%2D376F%2D463E%2DA8BD%2D3C8BDCBF126D%7D&dist=newsfinder&siteid=google&keyword=

the use of Tysabri as a first line therepy means that if the FDA take their advisory commities advice, and they nearly always do, then the sales could be as high as first projectd before the news of the two unfortunate deaths. This makes Tysabri only the second ever drug in history that has been reinstated and approved after having been withdrawn. glad i topped up on monday now! there is a possibility that the price of elan could double when trading in their shares resumes!

Fantastic news! Do you Know when they are meant to relist Crippy?

think it is tommorow, they only suspended their trading while the FDA panel was conducting their review yesterday and today

Nice open. Well done on your well timed top up Crippy. There did seem to be some bargain prices around last week, but I didn't take advantage as it was still a gamble at that stage. Wish I had now!

Well its been a few days since the fda panel announced its decision, Tysabris on its way back but due to the problems encountered by the drug its understandable that the price didnt shoot up more than the 20% on the day of the decision. People are just waiting to see the actual hard facts of the relaunch. The FDA will be reporting at the end of the month, the 29th i think so I am hopeing for some movement on that day also when the facts are available. At the moment there is so much uninformed speculation on what the nity gritty of the drugs reapproval will actually entail, that the price is up and down on a daily bais, but hovering around 12 euro mark.

I am still optimistic that the take up of the treatment will be considerable and that it will be a first line treatment, my consultant neurologist certainly thinks so too, and being that he is at one of londons top hospitals for neurology i tend to listen to his informed opinion more than i would certain researchers. I speak of course about the piper analyst who boasted that 90% of the doctors she spoke to would not want to perscribe the drug. She forgot to mention that most of those had no direct knowledge of tysabri and gave their opion on hearsay! I think they may have been vets not human doctors :) joking aside the elan conference call the day after the fda panel anounced what their decision was was most interesting with apparently a considerable number of doctors and patients requesting to be considered for this medication so just that says to me the market for this drug is still huge and the revenues will blow all pesimists out of the water.

its just a shame that there are many vested interests that dont want to see Tysabri on the market let alone as a first line of therepy, and hence i think we may see some more propaganda aimed at shooting down Tysabri but I think the dark days are behind us now and Elan is going to reap us some rich rewards! On the horizon also is the very first treatment for altsheimers which acording to the webcast again is proving as good in the trial stages for treatment of patients as tysabri did for MS.

Important dates for Elan are going to be the 29th of march as explained earlier, the the european decision wether to grant tysabri a licence in june sometime and july/september when the altsheimers phase three data is released........happy days are here again lalalalalalallal etc :)

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced
today that the U.S. Food and Drug Administration (FDA) informed the companies
that the Agency will extend its regulatory review of TYSABRI(R) (natalizumab) as
a treatment for multiple sclerosis by up to 90 days.

The companies have been informed by the FDA that the Agency requires additional
time to review information regarding the TYSABRI risk management plan. Under
this revised timeline, the companies anticipate action from FDA on or before
June 28, 2006.

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

frustrating news this morning...only a tempoary set back I hope, this story from bloomberg....

Elan Says U.S. Regulator Delays Tysabri for 90 Days (Update3)
March 22 (Bloomberg) -- Elan Corp. and Biogen Idec Inc. said U.S. regulators delayed the possible return of the multiple sclerosis drug Tysabri to review the companies' plan to prevent a rare side effect that killed two patients.

The Food and Drug Administration's decision on Tysabri, which was expected by March 29, will now be delayed by as much as 90 days, Dublin-based Elan said in a statement today. Elan and Cambridge, Massachusetts-based Biogen have proposed strong warnings for patients and controlled administration of the drug.

Shares of Elan, Ireland's biggest drugmaker, fell as much as 11 percent, the most in eight months. Tysabri was withdrawn more than a year ago after two patients died from a rare brain infection. Some analysts expect Tysabri to reach annual sales of more than $3 billion if the safety concerns don't cause the FDA to restrict access to the product.

``From here, it is unclear if it will take weeks or the three months for the FDA to agree on an acceptable risk management plan,'' Orla Hartford, analyst at Dublin-based NCB Stockbrokers said. ``We believe that use of Tysabri could be limited for at least three months post re-launch as infusion centers will need to be registered prior to administration.''

Hartford, who has a ``buy'' rating on the stock, has reduced 2006 forecasts in the U.S. to $20 million from $116 million. Her peak sales forecast of $1.8 billion is unchanged.

Shares of Elan fell as much as 1.38 euros, and declined 98 cents, or 8.1 percent, to 11.20 euros at 9:39 a.m. in Dublin. Biogen shares declined 1.32 euros to 39.20 euros ($47.36) after closing at $48.31 yesterday in New York.

Patient Deaths

Tysabri sales were halted on Feb. 28, 2005, on the first reported death from an infection called progressive multifocal leukoencephalopathy, or PML. The recall wiped out $17.8 billion in combined market value for Biogen and Elan that day. More extensive reviews revealed that two patients died and a third developed PML and survived.

The Elan and Biogen product had been seen as the best hope in a decade for the world's 2.5 million MS patients. MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis.

The companies re-submitted the product to the FDA and patients appealed to an agency panel of doctors and scientists earlier this month to permit its reintroduction. The advisory panel voted unanimously on March 9 to support a plan to resume sales for all patients. The FDA usually follows the committee's recommendations.

Tysabri would be only the second drug put back on the U.S. market following a safety-related suspension.

Safety Plan

Elan and Biogen's safety plan for Tysabri includes administering the treatment at registered infusion centers and a requirement that all patients sign a consent form saying they have been advised of the product's risks. The medicine's prescribing information should include the FDA's strictest warning, outlined in a black box, that Tysabri is associated with an increased risk of PML, Biogen said on March 8.

Doctors will be told to suspend treatment if patients show signs of the disease and they should test for PML.

``It's a blow for the stock,'' said Ian Hunter, an analyst at Goodbody Stockbrokers with a `buy'' rating on the shares. He said the delay will mean a ``better thought through risk- management plan for Tysabri and a quicker launch after its approval in June.''

The timing of Tysabri's introduction depends on how quickly the company and regulators can complete a program to manage the risk of PML, Biogen Chief Executive Officer James Mullen said after the advisory panel's decision to back the drug. He said the companies planned to re-introduce the medicine by June.

Tysabri may be used by as many as 100,000 U.S. patients who weren't helped by or stopped taking MS drugs, Mullen said earlier this month. He declined to discuss pricing. Tysabri, given as a monthly infusion, was the most expensive MS drug at $23,500 before the withdrawal.



To contact the reporter on this story:
Etain Lavelle in London at at elavelle1@bloomberg.net.
Last Updated: March 22, 2006 05:19 EST

just means june/july is extra big month for Elan.

Like you say Crippy, a temporary set back. I am feeling confident for the long term, and the decision could come any time in that 90 day period. The price could dip further this afternoon once the US opens.

encouraging news late tonight....

Biogen, Elan retest MS drug, see FDA action by June
Thu Mar 30, 2006 2:40 AM GMT
Printer Friendly | Email Article | RSS

CHICAGO (Reuters) - Biogen Idec and Elan Corp said on Wednesday they have restarted a safety trial of its multiple sclerosis drug Tysabri, which the drugmakers recalled from the market after reports of rare brain infection were linked to the drug.

A U.S. Food and Drug Administration panel earlier this month recommended the drug be returned to the market, with mandatory controls for risks and new cases of the fatal side effect, linked to two deaths.

The companies expect an action by the FDA by June 28, 2006.

elan closed up late in new york....yippee

Glad I bought some more last week.

Sounds like a good addition frampton, recent activities just go to show the jittery nature of the stock, especially as regards reaction to positive and negative news. I tend to think there maybe more of these fluctuations before we get some firm facts on the conditions of a relaunch. But there will no doubt be negative press from rival drug companies, which may result in a dip in price, but the future will be all good. I especially liked the goodbody analyst who put a target price on elan @ $68! which is why i may still add a few more perhaps at the point of any dip in price.

Spoke to the doctor incharge of the tysabri trials in which i was participating this afternoon in an attempt to gain verifification of the resarting of the trials, and was told that the hospital neurology dept is awaiting green light for restart and the protocols under which they are to be conducted. so you can gaurantee that when they call me with an update then I will post here any info I am told. hope this will be soon, and when they restart i will know the full story on what if any restrictions will be put on the use of the drug. i fully expect to have this info within the next month, so I guess any limitations put on the trial and those eligable to participate will be similar if not the same as the limitations put on the drugs use when relicenced. So when I knw this thread will know.

Crippy, I think you're right - this will be very volatile until we know the facts, if I have spare cash and there are any big dips I will be topping up as i'm feeling pretty confident in the long term future, and as you've pointed out before, it's not all about Tysabri, (although current share price movements are). I look forward to finding out what your doctor has to say about restarting trials.
Frampton

found an interesting piece on elan at 'fool' quite a good read....

POST OF THE DAY
Elan Corp., plc

Expectations

Discussion Boards
This Post In:
Elan Corp., plc

By TMFBreakerTinker
March 31, 2006

Posts selected for this feature rarely stand alone. They are usually a part of an ongoing thread, and are out of context when presented here. The material should be read in that light. How are these posts selected? Click here to find out and nominate a post yourself!


Just to put it all in perspective, and yes the FDA delay sucks, but so be it. A lot of things suck and we go on (well not if you have MS and need the best medication available, but not going there). As an investor here are expectations.

To justify the present market cap of ELAN excluding the rest of the business which I've assumed will be EBITDA break even, with $125 million in annual interest payments and $300 million joint expenses on Tysabri, using only U.S. market of 400,000 potential patients, what Tysabri needs to do is reach 10-13% market share. Somewhere between 45-50,000 patients. I did up the price of Tysabri slightly to $24K, which is probably conservative. I did use 75% gross margin, did not include any tax as I believe there will be massive tax loss carry forwards, but otherwise Irish corporate tax is around 12.5%.

What I get to justify the present market cap of $6 billion, utilizing cash flow is between 47,000 and 53,000 patients, depending if the market gives ELAN a 30 or 40 multiple. Using a 400,000 patient addressable market we get 11-14% market share to justify the present market cap.

Is anyone here not comfortable with meeting an 11-14% market share for Tysabri? Plus, given the fixed cost nature of the marketing share and of the interest payments, the higher [the] market share, the disproportionately higher will be the profits.

There can be no assurance at all that Tysabri will even have even 5% market share. We've seen a recent peak Tysabri estimate by one of the brokerages of around $250 million or 2.6% market share; i.e., mere guinea pigs utilizing this drug that is 2x as effective as anything else on the market and likely to be on the market for at least 3-4 years. So people with MBA degrees do differ. Whether it is an honest difference or an influenced by investment banking relationship business who can say, but the difference is there. So there is no certainty, well except for Tysabri coming back to market.

All this said, absent some shocking and egregious restriction placed on Tysabri, it seems to me that on Tysabri alone, excluding all else, using cash flow metrics and a 30-40 multiple thereon, which although high in many respects is not in this field of company and product what Tysabri needs to achieve to not lose us money is 11-14% market share. Exceeding this market share should, should as again no certainty in anything we do here, but mathematically, lead to stock appreciation in excess of $1 to $1 given the fixed fee nature of the expenses to be incurred by ELAN.

If stock picking were as easy as just running numbers everyone would be rich. But I have found that understanding what is valued in your stock greatly reduces your risk. I don't like to lose money and therefore don't like to buy a stock whose stock price poses me great risk of loss even if the company executes. Herein, are what I believe are Tysabri expectations, 11-14% market share which equates to $1.113 to $1.266 billion in Tysabri sales.

Take or leave the hard-core numbers and decide for yourselves if there are better places to put your money on a risk/reward basis. I have personally found another biotech with even lower expectations versus its market potential with an approved drug just now on the market (it is a Rule Breaker stock so I will discuss that one on the Rule Breaker side of these boards) but I cannot say that I feel uncomfortable at all at this time, at this valuation, with ELAN based upon this analysis.

There is still a risk that the FDA restricts Tysabri to second tier. That would be a mistake and an overreaction, and I don't care if I'm a M.D. or not it would simply not be in the public interest to do so. But the chance exists. Nevertheless, Tysabri is going to exceed 11-14% market share I do believe, in fact I believe it will eventually be the #1 MS drug on the market which presently is $1.6 billion per annum with Avonex. Avonex is less expensive, less effective, more painful to administer, but at least better than Copaxone and Rebif in that regard as it is only a once a week injection. Further I do believe that Tysabri expands the market, further I do believe that Tysabri will have very material sales in Europe, and there are no European figures in these totals.

Kool-Aid alert again always appreciated as I feel compelled to redundantly run these sorts of numbers every few weeks until fruition.

Tinker

Think it covers most things quite nicely really....crippy

the trend continued upwards today despite the the anual reports mixed company messages which is I feel a good omen for the coming weks....interesting methinks

a little light reading on the subject of VLA-4 inhibitors....

The Problems Associated With Natalizumab, Coupled With the Withdrawal of the COX-2 Inhibitors in Lat
Apr 06, 06:09 AM


Research and Markets (http://www.researchandmarkets.com/reports/c31740) has announced the addition of the Decision Resources report "Future of VLA-4 Antagonist Drugs and Implications for the Regulatory Process" to their offering.

In March 2005, in response to the development of three cases of a rare opportunistic infection in patients taking Biogen Idec and Elans monoclonal antibody (MAb) natalizumab (Tysabri), the FDA decided to place a clinical hold on another VLA-4 drug in clinical trials, and a second company voluntarily withdrew its VLA-4 drug from development while an investigation on the safety of this drug class is conducted. These safety concerns have affected several drugs in development for treatment of multiple sclerosis (MS), Crohns disease (CD), asthma, and other indications. Given the need for more-efficacious treatments to slow the progression of MS, will the FDA allow natalizumab to return to the market, will it approve future VLA-4 agents, and what are the implications for other therapeutic areas for which VLA-4 antagonists are in development?

In this Decision Resources report, the VLA-4s potential as a drug target is examined, the therapeutic markets most likely to be affected by a halt in VLA-4 development are identified and comment on the likelihood of success for VLA-4 agents in clinical trials is provided. In addition, the potential long-term implications for the U.S. drug approval process in the wake of the problems with natalizumab are discussed.

The development of three cases of progressive multifocal leukoencephalopathy (PML), a rare opportunistic infection, in patients taking the recently approved natalizumab (Biogen Idec/Elan's Tysabri) has prompted a halt on clinical development of some VLA-4 antagonist drugs. VLA-4 is believed to be a promising target for various inflammatory diseases, and these new safety concerns have created obstacles for many emerging therapies in multiple indications.

It is believed that natalizumab's efficacy in the treatment of multiple sclerosis (MS) makes it likely that the agent will reenter the market, although it will likely no longer be a first-line therapy. The future of other VLA-4 antagonists in development for MS will depend on the emerging agents' efficacy and safety profile as well as the companies' ability to wait out the safety investigation.

The future of VLA-4 antagonists for treatment in other therapeutic areas is less certain. Natalizumab was also in development for the treatment of Crohn's disease (CD); however, we feel that increased safety concerns will limit its use for this indication, and other VLA-4 antagonists for CD have been discontinued owing primarily to limited efficacy. More a4 integrin antagonists are under development for the treatment of asthma than for any other therapeutic area, but progress on these compounds has been slow. The safety concerns associated with long-term use and physicians' generally conservative prescribing attitude for this indication make the future of VLA-4 antagonists in this therapeutic market questionable.

The problems associated with natalizumab, coupled with the withdrawal of the COX-2 inhibitors in late 2004, have created increased scrutiny in the regulatory process. In the short term, the FDA will likely begin demanding more-rigorous clinical trials of emerging agents. Other potential changes include increased transparency of clinical trial data and increasing FDA control over labeling and direct-to-consumer advertising.

Tysabri is not an antagonist but an inhibitor so although it is the same class of drug it works in very different way to the recent case of 6 trial patients at northwick park hospital who were in intensive care for a while after receiving a new drug for asthema/cancer/MS.

happy easter elan holders! been as predicted for the shares over the past few weeks, but there have been some interestingn share deals, involving unusually high buys. Now i cant say if someone knows something but from the looks of it someonde does and the positive outcome will reap great rewards.

Add to this the phase one trial results of their altesheimers drug due out in may, and this could be the start of something big. Cheap pharma equity buy now think 12 euro still the right price. Twelve months time will seem like dreamland!

double post sorry

I thought that this is one of the funniest peices of journalism that I have read in a while, yet again the good ole Boston Globe (a name you may recall likened Tysabri to having AIDS! and claimed 90% of doctors would not perscribe it if it returned. (yeah whatever guys! nice try)) having failed to derail the FDA advisary panel in their unanimous vote to return tysabri to the market place by printing unsound peices on the drug itself, now decides to have a pop at the mambers of the panel!

No end to FDA disclosure debate
New waiver law fails to quiet criticism over experts' financial ties to drug companies
By Diedtra Henderson, Globe Staff | April 21, 2006

WASHINGTON -- When a Food and Drug Administration panel of a dozen experts voted to bring back to market the multiple sclerosis drug Tysabri, five had financial ties to the drug's maker, Biogen Idec Inc., or one of its competitors.

The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties.

Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded.

Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.

''All behavior is guided by both conscious and unconscious motives," said Dr. Karl Kieburtz, the Tysabri advisory committee chairman who is also a consultant to Biogen. ''Consciously, I'm not aware of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year."

A neurology professor at the University of Rochester, Kieburtz voted to return Tysabri to the market. The FDA doesn't have to follow the advice of its panels but usually does. Biogen, based in Cambridge, marketed Tysabri with an Irish partner, Elan Corp. The companies voluntarily pulled Tysabri off the market after the drug was linked to a potentially fatal brain infection.

The panel unanimously agreed in early March to bring Tysabri back and said in a 7 to 5 vote that patients could use it first, rather than after trying older therapies. The FDA is expected to disclose its final decision as early as this spring.

The FDA reports panelists' financial ties in broad categories, such as less than $10,001 per year, and from $10,001 to $50,000 per year. The disclosure on the FDA's website says Kieburtz received $10,001 to $50,000 in the prior 12 months from the drug's sponsor and less than $30,000 per year as a consultant for three Biogen competitors.

In an interview, Kieburtz offered more specific information, saying he received no more than $12,000 from Biogen, and that his consulting does not have to do with MS or Tysabri.

Kieburtz said he gave the payments to the University of Rochester or to charities. Another FDA adviser on Tysabri, Dr. Steven DeKosky, the chairman of the University of Pittsburgh Medical School's department of neurology, agrees with the FDA that federal advisers with no experience running clinical trials -- which by their nature are often funded by drug companies -- could do the public a disservice.
DeKosky said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all work he'd done recently for the industry. The FDA advisers report past and present financial ties to drug companies, and future financial interests they are negotiating. On it, DeKosky disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waiver, DeKosky said he did not know a rival MS drug is made by a company that has a financial agreement with Pfizer.

''It certainly didn't enter into any of my thinking. I am supposed to have a reputation as a honest, straight-shooting guy," he said.

The Center for Science in the Public Interest, Washington-based consumer advocates, argues advisers should be independent and the FDA shouldn't grant any waivers.

''Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels," said Merrill Goozner, director of the center's Integrity in Science project.

Dozens of times each year, the FDA empanels advisers plucked from academic institutions, government agencies, and industry. The advisers read stacks of documents before meetings and sit through hours of complex scientific presentations and often emotional testimony from patients. The experts cast votes on such questions as whether to strengthen warning labels for antidepressants and attention deficit remedies taken by millions or whether to lift sales restrictions on silicon gel breast implants. Industry representatives on the panels cast nonbinding votes.

The new law was spurred by high-profile hearings last year on a troubled class of painkillers that included Bextra, Celebrex, and Vioxx. The FDA came under congressional fire for permitting federal advisers who had accepted money from makers of those drugs to vote on whether the painkillers should be sold. In response to the new law, the FDA now posts conflict notices for its advisers on its website in advance of meetings.

Andrew von Eschenbach, the FDA's acting commissioner, said during a recent congressional hearing that the FDA's push to attract the best experts leads to senior scientists who receive drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise.

''I do not believe that it is a process where we simply can exclude or ignore anyone who has remotely been associated with any organization or any program that's relevant to the subject matter," von Eschenbach testified. Barring those scientists would ''undermine the ability to have the best minds make the best decisions."

MS, a disease of young adults, disrupts communication between the brain and other parts of the body, resulting in symptoms that can intensify with little warning. Some have difficulty concentrating, remembering or making decisions. Others are rendered unable to speak, write or walk.

Current drugs and experimental therapies aim to reduce the number of exacerbations in hopes of slowing the progression of physical disability. Because Tysabri worked well in curbing flare-ups, some patients clamored for its return.

Other Tysabri advisers reached by The Boston Globe who received FDA waivers said drug industry funding did not influence their votes.

Dr. Lily Jung, the medical director of the neurology clinic at Swedish Neuroscience Institute in Seattle, received $10,001 to $50,000 in the previous 12 months from Biogen and less than $20,000 from two rivals with competing MS drugs as a speakers' bureau member. Jung, the consumer representative on the panel, said she advocates for MS patients, not the companies selling MS drugs that sponsor her talks. ''I don't think it conflicts at all."

Dr. Ralph L. Sacco, a Columbia University neurologist, did not return several calls seeking comment. According to the FDA, Sacco received less than $10,001 in consulting fees in the previous 12 months from a Biogen competitor.

Dr. Larry B. Goldstein, a Duke University neurologist, received $10,001 to $50,000 in the previous 12 months from one Biogen competitor and less than $10,001 per year from another rival for consulting work unrelated to MS. He said drug company funding did not impact his vote ''one way or the other."

Diedtra Henderson can be reached at dhenderson@globe.com.

Copyright 2006 Globe Newspaper Company.

all i can say is nice try Globe, Tysabri will return and the entire MS community wil rejoyce. its quite sad how many vested interests are having a go at the best MS therepy to emerge ever....the game continues....

more fallout from the FDA panel members debate, shares lower today as the FDA gets flack for having panel members who recieve payments from drug companies and also sit on their advisory commities. Good time to top up I think....on the plus side stage one trial data due out at the begining of May.

Did you get your top up Crippy? Well timed if you did, hopefully we'll get more of a boost when the US opens.

Or prehaps not... that was a short lived rise.

yup doubled my stake :) good news from european drug regulatory agency endorsing use of Tysabri for relapsing remitting MS. Spoke to Biogen idec's head of clinical science on thursday, and he was less than forthcoming about the future of tysabri but i put it to him also that the european position on the drug is was waiting toi see which way the FDA went and he said he couldnt possibly comment, but i suppose that means yes, as shown by yesterdays anouncement, which was promising, but still reserved, i have a feeling that they are waiting for the fda and also to see what limited usage of the drug does for the patients. Also been trying to talk to my consultant, whos secretary was not answering her phone on friday! Frustrating but at least the future looks much brighter now.

That's good to hear!

more news....been abit slack on this one should have posted sooner....

Elan reports smaller 1Q loss of $33.3M
SHAWN POGATCHNIK
Associated Press
DUBLIN, Ireland - Elan Corp. PLC, the Irish biopharmaceutical company whose hopes are tied to a suspended multiple-sclerosis drug, reported a smaller first-quarter loss Thursday and forecast a return to profitability if U.S. sales of Tysabri resume.

Elan said it lost $33.3 million inl;uding stock compensation expenses in the January-March quarter versus a loss of $115.6 million in the same quarter a year ago. It said sales rose 31 percent to $134.3 million from $102.7 million a year earlier.

On the Irish Stock Exchange, Elan's shares initially rose but fell back in a broadly negative market, closing down 8 euro cents (10 cents) at 11.32 euros ($14.26). The company's U.S. shares fell 20 cents, or 1.4 percent, to finish at $14.48 on the New York Stock Exchange.

Analysts say the future of the Dublin-based company depends on the return of Tysabri, a drug withdrawn from sale in the United States early last year after being linked to a rare, often fatal brain disease. The U.S. Food and Drug Administration is expected to announce by June 28 whether Tysabri sales can resume.

Both company officials and market analysts said they expect Tysabri to get the green light.

"We remain committed to making Tysabri available for patients in the U.S. and Europe and are confident that, with the financial leverage we've created over the year, revenues from Tysabri will accelerate our return to profitability," said Elan's chief financial officer, Shane Cooke.

"Once Tysabri is back on the market, momentum will return to the stock," said Ian Hunter, an analyst for Goodbody Stockbrokers in Dublin.

In November 2004 the FDA approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system. Elan and Biogen Idec Inc., its U.S. partner in developing Tysabri, withdrew the drug three months later when three people taking Tysabri in clinical trials contracted the brain disease PML; two died. Both companies subsequently said they found no additional PML cases among other Tysabri users.

The suspension of Tysabri hammered Elan's shares, which fell from above 20 euros to as little as 3 pounds before mounting a gradual recovery over the past year.

On March 9, an advisory panel to the FDA voted unanimously to recommend that the agency should permit Tysabri to be sold again in the U.S., subject to new restrictions. The panel cited the drug's strong ability to help MS sufferers block the recurrence of key effects, such as sudden partial paralysis.

Sorry about the delay but looks as if they are beginning to get their ship in order, at last, perhaps the Tysabri mess could mean a leaner more focused and productive Elan? whats the phrase?....something about a sliver lining? :)

lack of news flow taking its toll on price this weeek. also a jittery NY combines to give an interesting closing price today time for another top up me thinks in morning....but will be watching new york closely @ time of writing ny elan price $14.55 and rising

positive sentiment driving shares upwards. Good to see some market beiief after all this time. Could it be an announcement from the FDA is immenant? think this could be a turning point, on a day that has not exatly been positive on the general market, elan bucks the trend!

Something's going on Crippy. My only blue share for the past two days in a sea of red. I only wished I'd topped up like you the other day, I almost did, but decided it was safer to hang on to the cash, ah well.

Fortune favors the brave or something i guess. I believe in this product, not necessaraly the company :) but when its fortunes rest on Tysabri then my belief in the product was all in needed to tell me anthing under 12 euros was always a bargin. whats the old addage? 'theres is not a price to high or to low just the right price.' I totally agree frampton just wish i knew what was afoot, there has been a distinct lack of news in the last few days, there was the internal share dealing in house so to speak but i thought that was perhaps just a normal option to buy being taken up but perhaps the buyer knew something we dont. Certainly the heavyweight buyers think news is due, so i it will be interesting to see what the next few days bring. Still think under 15 will show profit, bon chance!

more news from the good ship elan plc....

Elan says aims for clarity on Tysabri by June 28

Thu May 25, 2006 6:22 AM ET

DUBLIN, May 25 (Reuters) - Irish biotech group Elan Corp. (ELN.I: Quote, Profile, Research) said on Thursday it was still aiming for clarity on the future of its multiple sclerosis drug Tysabri by the end of June.

Speaking at the group's annual general meeting in Dublin, Chief Executive Kelly Martin said he hoped that the group would have more of an idea of the drug's future prospects by June 28.

Sales of Tysabri were suspended in February 2005 after three patients developed an infection, which led to two deaths. Elan has said it hoped to receive regulatory approval next month and start relaunching the drug in the third quarter.

taken from reuters this morning not much new there but still on track :)

more from the agm....

Elan CEO sees 'headroom' to raise Tysabri's price

DUBLIN (MarketWatch) -- Elan Corp. PLC's (ELN) Chief Executive Kelly Martin said Thursday there is future "headroom" to raise the price of multiple sclerosis drug Tysabri after its anticipated return to the market in the U.S.
The U.S. Food & Drug Administration will make a final decision on Tysabri's re-entry by June 28, and most analysts see it back on the market in the U.S. in the third quarter of 2006.
"Clearly there's headroom and a business legitimacy for one to raise the price," Martin told a press briefing after the company's annual general meeting, adding the issue will be discussed with Elan's Tysabri partner Biogen Idec Inc. (BIIB).
Martin said: "We would need to see the final labeling and risk management dynamic before making any decisions on price." These details are currently being finalized by Elan and Biogen with the FDA, he added.
When the two companies temporarily suspended sales of the drug in the U.S. last year on safety concerns, patients were being charged $23,500 for 13 infusions a year, or 1 every 4 weeks.
Elan has repeatedly said it expects Tysabri to be reintroduced to the market and the MS drug could break even with around 20,000 patients, though the company expects to surpass this figure easily.
Martin said there are over 2.5 million MS sufferers worldwide and, although he wouldn't be drawn on specific figures, he said that Tysabri will play a "very substantial role" in the existing global market.
"We haven't predicted that (the market share) yet," he said, "but 70% of MS patients are declining clinically. When new products are introduced to an existing market, volatility increases and people tend to use the new technology."
Martin said it would be "premature" to make more accurate predictions, but added the company would be in a better position to make forecasts when Tysabri has been back on the U.S. market for at least two months.
He reiterated Tysabri's 68% reduction in MS relapses, compared with 30% for existing therapies and said this is the kind of data that will be highlighted in relation to labeling Tysabri in E.U. countries when the time comes.
The European Medicines Agency's advisory committee has recommended Tysabri be used in the E.U. only as a treatment for relapsing multiple sclerosis patients; the agency's decision is due sometime this summer.
And the U.S. Food & Drug Administration's advisory committee has advised that Tysabri be reintroduced as a monotherapy in the U.S., a first-line treatment for all MS sufferers.
Elan and partner Biogen Idec Inc. (BIIB) suspended their would-be blockbuster drug in the U.S. on February 28 last year after three patients on combination therapy - including Tysabri -contracted a rare neurological disease called PML.
Company Web site: http://www.elan.com

Thanks for the info Crippy.

good spread in the sunday times today about Elan....

The Sunday Times June 04, 2006


Special Report: Green light for drug brings hope to Elan
Approval for new blockbuster Tysabri will seal revival of Irish pharma group. By Paul Durman


IN a shabby hotel in a scruffy suburb of Washington DC, Heather Smith brought a packed room full of doctors, healthcare analysts and pharmaceutical executives to the edge of tears.
The 36-year-old from Indiana, a multiple sclerosis sufferer since 1998, was one of more than 40 patients and other witnesses who had come to Gaithersburg to testify before a panel of medical experts about Tysabri, a drug pulled from the market early last year after two people died from a rare brain infection.



Like others there that day in March, Smith requested the chance to make her own judgment about the risks involved in taking the drug. But she was also motivated by other requests that I hear every day.

Requests such as: You dance with me, momma? You chase me, momma? You carry me, please? These requests from my son Ezra, that I cannot fulfil, are the key to my risk-benefit equation.

Choking back her tears, Smith said that MS had meant she was unable to walk unaided. But after only one dose I felt that Tysabri was a miracle for me. I was able to make outings on my own. My mobility drastically improved.

The best reward was that I had more energy to spend with my son. I no longer had to choose between playing with Ezra or taking a shower. I could freely enjoy each moment of his life with a renewed hope.

I may never be able to carry my son Ezra or chase him or dance with him but he deserves a Mom that is as healthy as possible. Each day without Tysabri is a day without hope.

Smith was given the hope she sought. The advisory committee unanimously voted to recommend the reintroduction of Tysabri. The US Food and Drug Administration (FDA) is expected to ratify its decision any day, possibly as early as this week.

That decision will bring hope, not just to Heather Smith and hundreds of thousands of other MS sufferers, but also to the employees and shareholders of Elan, the Irish drug company that developed the medicine.

The reintroduction of Tysabri, when it comes, will mark the latest upward lurch in a remarkable five-year rollercoaster ride for Elan.

The company nearly went bust, clawed its way back from the brink with the help of Tysabri, but was then thrown to the floor again last year when the product was withdrawn. Can this latest recovery last? Kelly Martin certainly hopes so. Martin, a former investment banker with a liking for woollen sweaters, has nursed Elan through two crises since taking over as chief executive in early 2003. After surviving an attempted boardroom coup last year, he is confidently planning for Elans long-term success.

We have come through a lot of things that most of the world thought we would never get through, he said. Theres nothing like multiple near-death experiences to sharpen the focus.

We want to be one of the leading biopharmaceutical companies in the world in the areas of neurodegeneration (Alzheimers and Parkinsons disease) and auto-immune disease (MS and Crohns disease). We want to be the largest European biotech company in the near term.

Remarkably, after all its travails, Elan is already closing in on this first objective. After the recent run-up in its New York-traded shares, it is valued at $8 billion (4.2 billion), only a little less than Switzerlands Serono, another company that grew rich on the success of a multiple-sclerosis drug.

Elan has harboured big ambitions before. It was arguably Irelands most successful company in the 1990s, reaching a peak valuation of $25 billion as it raced through more than 20 acquisitions in five years. Along the way it took stakes in 55 biotech firms effectively outsourcing its research and development to small, joint-venture partners.

But Irelands most highly valued company came crashing down its stock falling from $65 to $1 when it was realised these opaque joint-venture arrangements flattered profits, and were financed by vast off-balance-sheet borrowings.

Martin, an American banker who was formerly a senior trouble-shooter at Merrill Lynch, set to work to simplify the company and its balance sheet.

Elans 5,000 employees were spread across 35 locations, stretching from Athlone in central Ireland to San Diego. Over the course of two years, all 55 joint ventures were sold, and the cash from these and other disposals was used to pay down debt.

All the while, Martin said, Elan remained focused on helping patients with what he believes is truly innovative science. We continued to invest in our science throughout the restructuring, he said.

In February 2004 Elan received an unexpected boost. Preliminary results from trials of Tysabri were so spectacular that the FDA asked for an accelerated review. This was an indication that the worlds most important health regulator thought the drug could represent an important advance in the treatment of a debilitating disease.

MS is a disease of the central nervous system that affects more than 1m people worldwide. It can progressively cause numbness, loss of balance, disability, blindness and paralysis.

By November the FDA had approved Tysabri for the treatment of MS sufferers. Trial data suggested that the drug, taken by monthly infusion, could reduce the rate of MS relapses (or attacks) by two-thirds. Patients were eager to try the expensive drug, the first new MS treatment for a decade.

In the first 10 weeks we had 7,000 patients on the drug, said Martin. We had 25,000 patients in the queue.

With a course of treatment costing $23,500 a year, after only 10 weeks Elan and its marketing partner, Biogen, a large American biotech company, were selling a drug that was set to take $700m in its first year. From the pit of financial turmoil, Elans shares quadrupled during 2004.

Then, last February, disaster struck again. It was a Friday, Martin said. I had just got off a plane. The chief executive of Biogen called with news that two patients, who had been taking Tysabri in combination with Biogens Avonex, had died of a rare brain infection called PML progressive multifocal leukoencephalopathy.

PML was so rare that even many neurologists had no experience of it. We had spent thousands of hours talking about the risk of opportunistic infections, said Martin. In all these discussions, PML had never come up once.

Elan and Biogen were soon in constant dialogue with the FDA, trying to decide how best to protect patients. We did not know why PML occurred, said Martin. We did not know whether (the problem was) the combination of drugs. We could not rely on neurologists because very few of them had the intelligence to be our front line of defence.

After three days of intense discussions, Elan and Biogen pulled the drug. We needed to protect the patients and we needed to protect the drug, because the drug was spectacular, said Martin. Elans shares slumped sickeningly once more.

The stock dropped from $27 to $3, which is an experience, said Martin, drily. Employees who had seen their savings in Elan shares destroyed by the earlier accounting crisis were once again confronted by the loss of their dreams.

Despite the doubts of investors, Martin was sure from the outset that Tysabri could be saved. I was confident that it would be made available again because of the efficacy of the drug and because patients were declining, he said.

If you know someone with MS and theyre declining, theres nothing they can do. Theyre going to have a cane, and go into a wheelchair, and eventually they stop breathing.

Allison Hulme, head of the Tysabri business, and Ted Yednock, head of global research, set to work to understand what had gone wrong.

Independent experts reviewed the data from nearly every one of the 3,000 patients who had taken Tysabri in clinical trials MS patients, rheumatoid arthritis patients and Crohns disease patients.

Over the course of four months, these patients were given MRI scans, physical examinations and lumbar punctures. To Martins relief, there were no other PML cases beyond the first three identified in February and March.

And Tysabri alone has not been shown to cause PML. It appears the infection was caused by an interaction with Avonex.

Based on the trial data, researchers estimate the risk of MS patients on Tysabri contracting PML is one in a 1,000 small but real. It is this risk that Heather Smith and the other patients who spoke up for Tysabri are prepared to run in the hope of securing a better quality of life.

With its case strengthened by two-year trial data, Elan filed for approval for Tysabri once more, this time as a monotherapy. The two-year data were better, said Martin. Tysabri was shown to reduce the number of brain lesions caused by MS and, in many cases, to slow the diseases progress.

The data make it a better drug, said Martin. Our decision of last February which was very difficult to make is, at the end of the day, going to position Tysabri correctly from a patient-choice point of view and correctly from the long-term business point of view.

When Tysabri returns to the market a European approval is expected to follow shortly after the American go-ahead new patient monitoring and other safety controls will be introduced to limit the risk of PML. The drug will also be restricted to patients with the relapsing form of MS, and not given to those with compromised immune systems.

Although this means the likely patient population shrinks, from 1m to perhaps 600,000, by the strange logic of the pharmaceutical industry, Elan could make just as much money as before.

The price of Seronos Rebif has increased substantially over the past couple of years, and Elan hopes Tysabri will command a significant premium.

Analysts, such as Goodbody Stockbrokers, forecast peak sales of nearly $2 billion a year. This ignores the possible use of the drug in Crohns disease.

Ian Hunter, analyst at Goodbody, is cautious about early sales of Tysabri. Many patients will be wary after last years problems, and will wait to see whether there are any more cases of PML. Hunter said it was therefore unlikely Tysabri would see the explosive take-off it enjoyed in late 2004. Hunter said that if Tysabri proved to be safe when prescribed more widely, demand for the drug would quickly accelerate.

Such a blockbuster success would transform the company that developed Tysabri, but Martin said this medicine was only the start of the Elan story.

We think our science platform is truly unique, he said. We believe we can use that to have an impact on millions of patients around the world.

If we can execute (our plans), the value of the company will take care of itself.


So not really anything we didnt know already but, perhaps the media interest is a sign of the news from the FDA is closer than we know!

Buying more in morning :)

Thanks Crippy, I hope you're right about news soon. I did buy a few more last week, though I'm thinking of selling something and buying a few more...

So Tysabri returns and the share falls - sometimes I can't get my head round the stock market! Glad I didn't get round to buying any yesterday but I might try to pick up a few more soon.

yup sure is an insane world when the very thing the market has been waiting for, Tysabris reintroduction, actually causes a 12% drop in price! I think its because of the conditions attached to the drugs use which are outlined below in the press release. I actually think the drugs use has been given the best chance of uptake by patients that the FDA could have been expected to give after the problems it has had, and the other high profile disarsters the FDA has had to take the flack for from the american press. Also the european drug agency should fall into line and give Tysabri a europe wide licence now the yanks have. So the futures rosie!

(aken from the elan website)

5 June 2006
FDA Approves the Reintroduction of TYSABRI for the Treatment of Relapsing Forms of Multiple Sclerosis
CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--June 5, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for the reintroduction of TYSABRI (natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses. TYSABRI will be available upon the completion of key activities related to the risk management plan, including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel. As such, the companies anticipate TYSABRI will be available in July.

The FDA granted approval for reintroduction based on the review of TYSABRI clinical trial data; revised labeling with enhanced safety warnings; and a risk management plan (TOUCH Prescribing Program) designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize potential risk of progressive multifocal leukoencephalopathy (PML). Because of the increased risk of PML, TYSABRI monotherapy is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.

"Today represents a significant step forward for people with relapsing MS. The reintroduction of TYSABRI offers new hope as an important therapeutic choice for patients living with this disabling disease. TYSABRI has demonstrated compelling efficacy in MS, and we believe the TOUCH Prescribing Program, designed in collaboration with the FDA, will help patients and physicians assess the benefits and risks of TYSABRI and make informed decisions about therapy," said James C. Mullen, Chief Executive Officer, Biogen Idec.

"We are pleased with the FDA's decision to once again make TYSABRI available to patients and their families suffering from this chronic, debilitating disease, " said Kelly Martin, Chief Executive Officer, Elan. "There continues to be a significant unmet medical need where TYSABRI will be an important treatment option. "

Today's action follows a March 8, 2006 unanimous recommendation by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee to allow the reintroduction of TYSABRI. Biogen Idec and Elan voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials in February 2005 based on reports of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability.

TOUCH Prescribing Program

TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program was developed in conjunction with the FDA to facilitate the appropriate use of TYSABRI and to assess, on an ongoing basis, the incidence and risk factors for PML and other serious opportunistic infections associated with TYSABRI treatment. This program represents Biogen Idec and Elan's commitment to making the unique benefits of TYSABRI available in a responsible manner.

Elements of the TOUCH Prescribing Program include:

Revised labeling with a prominent boxed warning of the risk of PML; and warnings against concurrent use of TYSABRI with chronic immunosuppressant or immunomodulatory therapies, and patients who are immunocompromised due to HIV, hematological malignancies, organ transplants or immunosuppressive therapies
Mandatory enrollment for all prescribers, central pharmacies, infusion centers and patients who wish to prescribe, distribute, infuse, or receive, respectively, TYSABRI
Controlled, centralized distribution only to authorized infusion centers
Mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist
Ongoing assessment of PML risk and overall safety
A 5,000 patient cohort observational study over five years, the TYSABRI Global Observation Program in Safety (TYGRIS)
About TYSABRI

Two-year data from the AFFIRM monotherapy trial showed that treatment with TYSABRI reduced the risk of disability progression by 42% (p is less than 0.001), the primary endpoint of the study, and led to a 67% reduction (p is less than 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 data from the SENTINEL add-on trial also demonstrated that treatment with TYSABRI in addition to AVONEX (Interferon beta-1a) had a significant effect on disability progression, relapse rate and brain MRI disease activity compared to AVONEX alone.

TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Three cases of PML occurred in clinical trial patients who were concomitantly exposed to immunomodulators (interferon beta in the patients with MS) or were immunocompromised due to recent treatment with immunosuppressants (e.g., azathioprine in the patient with Crohn's disease). Two of the cases were observed in 1,869 patients with MS treated for a median of 120 weeks. A third case of PML occurred among 1,043 patients with Crohn's disease after the patient received eight doses. The number of cases is too few and the number of patients treated too small to reliably conclude that the risk of PML is lower in patients treated with TYSABRI alone than in patients who are receiving other drugs that decrease immune function or who are otherwise immunocompromised. Healthcare professionals should monitor patients on TYSABRI for any new signs or symptoms that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML.

TYSABRI is contraindicated in patients who have or have had PML or with known hypersensitivity to TYSABRI or any of its components. In Phase III placebo-controlled trials of TYSABRI in MS, the overall incidence and rate of other infections were balanced between TYSABRI-treated patients and controls. Herpes infections were slightly more common in patients treated with TYSABRI. Commonly reported infections with TYSABRI included urinary tract infections, lower respiratory tract infections, gastroenteritis and vaginitis. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of these patients were receiving concurrent immunosuppressants.

The incidence and rate of other serious and common adverse events in clinical trials were similarly balanced between treatment groups. Serious events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), depression and gallstones. Appendicitis was more common in patients receiving TYSABRI with AVONEX. Common adverse events reported in TYSABRI-treated patients include infusion reactions, headache, fatigue, joint and limb pain, abdominal discomfort, diarrhea and rash.

For more information about TYSABRI please visit www.biogenidec.com or www.elan.com.

Webcast

The companies will host a joint webcast for the investment community tomorrow at 8:30 am ET, 1:30 pm GMT, which can be accessed through the companies' websites.

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 TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is 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 other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected delays or hurdles. There is no assurance that the companies will be able to market and sell TYSABRI outside of the United States. 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 and current 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.

Ouch!

Tysabri US approval conference call, interesting listening.

http://www.elan.com/investorrelations/events/webcast_details.asp?eventID=1330611

Elan has raised the price of its drug Tysabri 21%. The buck stops here as they say and that i guess covers the inital loss of the FDA decision to alow the return of the drug but only as second line therepy. news below....

Elan "neutral," target price raised

Monday, June 12, 2006 5:11:22 AM ET
J.P. Morgan Securities

LONDON, June 12 (newratings.com) - Analysts at JP Morgan maintain their "neutral" rating on Elan Corp Plc (DRX.FSE), while raising their estimates for the company. The target price has been raised from 11 to 13.

In a research note published this morning, the analysts mention that the company has announced a 20% increase in the price of Tysabri from $1,808 to $2,184.62 per vial, which amounts to be $28,400 per year with a recommended dose of once every four weeks. Elan is likely to begin reinvesting some of its profits in newer product development, the analysts say. The EPS estimate for 2007 has been raised from -$0.36 to -$0.30.

Humm.... and i thought the FDA anouncement was going to be more significant, suppose i will be in this alittle longer than i bargined for.

great what alittle positive sentiment and news flow can do, ela @ 13.14

any idea how long it will take for Europe to follow suit?

well when i spoke to the head of clinical science at biogen (elans partner for Tysabri) he said, when i put it to him that as soon as the FDA in america made a judgement on the future of Tysabri, the European drug regulation authority would follow suit soon afterwards, he said he couldnt possibly comment, but that the history of drug regulation in europe has historically been reliant on the american FDA first making their judgement with the europeans following their leed.

So I took that as a yes and therefore in answer to your question I think that the european ruling will come potentially anytime now. I think also if we look at the trading history in elans shares imediatley before the american FDA made their decision we can quite clearly see a massive rise in the number of shares traded, and a sharp rise in price in the week before the FDAs decision. So keep an eye on the volume of elan shares traded daily the average amount on the FTSE and NASDAQ is not usually very high compared to many shares, as soon as the average daily ammount traded becomes high for no obvious reason (no new news or announcements forinstance) chances are the decision is immenant. Personally I think July/august is gonna be the time.

EU Approves Sale of MS Drug Tysabri
Thursday, June 29, 2006
By SHAWN POGATCHNIK, Associated Press Writer

DUBLIN, Ireland The U.S. and Irish makers of Tysabri, a highly touted drug used to suppress the effects of multiple sclerosis, said Thursday that European Union authorities have cleared the way for the drug's sale throughout the 25-nation bloc.

"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative,"said Kelly Martin, president and chief executive officer of Elan Corp. PLC of Ireland.

"Today marks an important step forward for the European MS patient community,"said James Mullen, chief executive officer of Biogen Idec Inc. of Cambridge, Massachusetts.

The European Medicines Agency declined to comment immediately. Spokesman Martin Harvey-Allchurch said the agency planned to make announcements on a series of drug decisions at the conclusion of its meeting in London Thursday afternoon.

The two companies said in a statement that EU regulators had decided to permit Tysabri's use only for MS patients whose condition was not improving using other MS-suppressant drugs, chiefly standard interferon drugs,"or in patients with rapidly evolving, severe relapsing, remitting MS."

The EU move follows the U.S. Food and Drug Administration's decision June 5 to authorize the resumed sale of Tysabri in the United States, but with a new regime of restrictions and safeguards that also barred use of Tysabri as a drug of first resort.

Tysabri had been withdrawn from the U.S. market in February 2005, just three months after its introduction there, after three users of Tysabri in clinical trials contracted a rare and usually fatal brain disease called PML; two of those patients died. U.S. regulators permitted Tysabri's relaunch after no new PML cases were detected among several thousand other clinical-trial users. The drug has never before been sold in the EU.

Tysabri, which is administered every four weeks by intravenous infusion, is projected to cost more than US$28,000 (euro22,500) annually in the United States, where about 350,000 people suffer from the incurable neurological disease.

Neither company specified its plans for rolling out Tysabri across the EU. Elan said it planned to begin selling Tysabri in Ireland next month.

Recently published studies found that Tysabri alone or in conjunction with interferon treatment cut the rate of relapse in MS patients by as much as two-thirds after two years and reduced the number of people whose MS got worse. The drug appears to work by blocking destructive immune cells leaving the bloodstream and entering the brain, where they can inflame and damage nerves.
============================================================

HORRAH! happened earlier than i expected but its a good decision none the less. Disapointing that its not first line therepy but at least its out there and when then amazing benefits are seen then I think the therepy will have to be given as a first choice. So perhaps I will be hanging on to these for a bit longer.

but of course there is always a downside, i was trying to find out why the price has behaved so strangely....i mean even before the announcement of FDA and European approval the price was only alittle lower than after the announcement. So what is up, yeah so its not first line therepy but its back on the market, for use in sever cases primarily, but lets face it most MS cases are or become severe, Tysabris usage should be huge.

Found a news snippit that states:

Elan Corp. lost 4.65% after stating that it will take a $542 million charge in fiscal Q3 due to asset sales and lower investment value.

Theres the reason! At least there is one! So fourth quarter and 2007 looking good (fingers crossed, the market has along memory and is unforgiving of past managerial blunders)

On a management perspective perhaps Martin Kelly staying on as the CEO was not a great move after past catastrophies? Could there be a move to oust him or even a take over? I only mention this because recent stock buys have given FMR CORP a 13.88% stake in elan plc.....perhaps its nothing or is normal investement activity? Perhaps a more wise and learned investor may know, i am too green and havent been in the stock game for long.

Whatever the reason i still like this stock and see a rosie future....fingers crossed he he

12.30! shows what i know big trade went through today just over 300k sell. But there was also this news....

Elan "add," target price raised

Friday, July 07, 2006 5:52:05 AM ET
Goodbody Stockbrokers

NEW YORK, July 7 (newratings.com) - Analyst Ian Hunter of Goodbody Stockbrokers maintains his "add" rating on Elan Corporation Plc (ELN.NYS). The target price has been raised from $16.50 to $18.50.

In a research note published this morning, the analyst mentions that the total sales estimate for Tysabri has been raised from $58.6 million to $88.1 million. The analyst expects the use of Tysabri for the treatment of Crohns to increase going ahead. The fully diluted EPS estimates for FY07 and FY08 have been raised by 59.85% to 17.1 and by 24.4% to 44.3, respectively.

In an interesting article from msn money, the potential of elans nano technology drug delivery system is explored:


Elan (ELN, news, msgs) licensed its NanoCrystal technology to Abbott Labs for use in a possible product that combines the active ingredients in Abbott's TriCor and AstraZeneca's Crestor.

TriCor raises levels of HDL (the good cholesterol) and Crestor reduces LDL (the bad cholesterol). The companies believe that combining the two drugs into one pill will create an effective and convenient treatment for many patients.

I've been saying for some time that I thought Elan's NanoCrystal technology was a hidden gem.

NanoCrystal technology is used to create nano-sized particles of drugs without changing their chemical properties. The reason this is valuable is that smaller particles equal more surface area. That means more chemical reactions, which allows for better bioavailability. In other words, more of the drug is actually used by the body and less is available to cause side effects.

To see how this works think of how long it takes a piece of rock candy to dissolve in water. The same quantity of in table sugar form dissolves much faster because the particles are smaller. If you took the same quantity of sugar and pulverized it into nano-sized particles, it would almost instantly dissolve.

So far Elan has used this technology to partner with major drug companies to improve existing drugs. Elan typically earns royalties in the 5% - 8% range on these deals. These are good deals for Elan, but I think they could do much better.

Elan's NanoCrystal technology gives them the opportunity to own the nano-version of a wide range of blockbuster drugs! Instead of funding R&D work on compounds that can take a decade to bring to market, Elan could be working on the NanoCrystal version of blockbuster drugs that will soon be off-patent. These are drugs that have already proven their efficacy, and the FDA approval process for generics is much faster because the manufacturer only has to show chemical equivalence.

With Tysabri (Elan's multiple sclerosis drug) now approved for sale in both the U.S. and Europe, Wall Street is waiting to see how fast Tysabri sales ramp up. I'm watching as well, but this deal confirms my belief that Elan is not a one trick pony.

more positive news today....

Archemix Signs Aptamer Deal With Elan For Up To $350M



By Jennifer Boggs



Staff Writer
In one of its largest deals to date, Archemix Corp. partnered with Irish firm Elan Corp. plc to develop up to three aptamer-based drugs against autoimmune inflammatory disease and could earn more than $350 million in potential milestones.

The companies will work together over the course of three years, with Archemix providing its aptamer technology and Dublin-based Elan contributing its development and regulatory expertise in the autoimmune space. Elan will make an up-front payment of $7 million and handle development and commercialization, with milestone payments and royalties going to Archemix. The deal also includes a co-development option for Archemix on certain products.

"That, for me, was really key to the deal," said Errol De Souza, president and CEO of Cambridge, Mass.-based Archemix, and will allow "us to maintain some of the upsides that would come out of the collaboration."

The co-development option would relate to specific indications in the broad autoimmune space, such as the psoriasis market and non-parenteral routes of administrations, such as oral or topical, De Souza said.

Work will begin by developing an aptamer drug to IL-23, a cytokine that has "really become a hot target," he told BioWorld Today, with a number of publications demonstrating the target's selectivity and ability to mediate chronic autoimmune inflammatory disorders.

"Given the interest in the area, and the fact that we were able to develop selectivity in terms of our aptamer strategy, we really had multiple parties at the table" when it came time to consider collaborators, De Souza said. Elan emerged as the winner due to its experience in the disease area; it has a product pipeline aimed at multiple sclerosis and Crohn's disease, including the MS drug, Tysabri (natalizumab), marketed with Cambridge, Mass.-based Biogen Idec Inc.

De Souza said Archemix and Elan will begin identifying a drug candidate from the IL-23 program and anticipate entering the clinic with the first product in the next year-and-a-half to two years. The companies have not disclosed the remaining targets in the collaboration.

Aptamers, which are oligonucleotides that resemble antibodies in the way they bind to molecular targets, are gaining popularity because they can be produced quickly and result in less toxicity than monoclonal antibodies, De Souza said.

Archemix picked up its aptamer technology, SELEX, from Foster City, Calif.-based Gilead Sciences Inc. in 2001. That same technology created the aptamer pegaptanib, an anti-VEGF drug approved as Macugen in late 2004 for wet age-related macular degeneration. Macugen was created by Eyetech Pharmaceuticals Inc. (now part of Melville, N.Y.-based OSI Pharmaceuticals Inc.), which licensed rights to the compound in 2000.

In 2004, Archemix and Eyetech entered a collaboration to develop aptamer drugs for ophthalmic indications. In that deal, Eyetech agreed to handle development and commercialization in exchange for up-front, milestone and royalty payments. (See BioWorld Today, April 15, 2004.)

Archemix also has an ongoing partnership with Nuvelo Inc., of San Carlos, Calif., to develop anti-thrombin aptamers for use in acute cardiovascular indications. Last fall, the companies decided not to continue development with the first product to emerge from the deal, ARC183, an anticoagulant being tested in patients undergoing coronary artery bypass graft surgery, after early Phase I results indicated that a high dose of the drug was needed to produce efficacy. The partners now are focusing on creating a second-generation molecule.

Terms of the Nuvelo deal, signed in January 2004, call for Archemix to lead development and clinical activities, with the companies sharing development and marketing costs on a 50-50 basis.

On its own, Archemix is building an internal pipeline focused on cardiovascular, oncology and inflammatory indications, including a platelet inhibitor expected to start clinical trials at the end of this year or early next year, and an aptamer against IGE, the same antibody targeted by South San Francisco-based Genentech Inc.'s asthma drug, Xolair.

Archemix, which has raised about $100 million since its 2001 inception, completed its last financing in April 2004 when it brought in $50 million in a Series B round. (See BioWorld Today, April 7, 2004.)

Published July 14, 2006

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all good there then, one wonders why the market is luke warm on this share, oh well i am guessing the boys with the money are waiting to see the figures for tysabri sales, ho hum ;)

I think you are probably right there Crippy - wait until the sales figures come through then there should be some action, lets hope so anyway. Still it does give us the opportunity to buy more....

very true, could be a shrewd thought Frampton, especially if the dow bounces upwards from 10700 then that could take ftse with it and elan could do with some positive sentiment right now. That could see this current price as a real bargin.

I had another thought on why the price maybe dropping for no apparent reason, consider that it could be being priced downwards for a possible takeover? hummm interesting thought methinks???

I'm not feeling too confident about the dow at the moment, so will hold off buying any more till we can see some positive sentiment. Without news, this is just going down with the dow.
I hope there isn't a takeover in the near future, as I am very confident for the future of this company and the bigger rewwards will come from holding longterm.

yes long term looks pretty good, and I really hope Elan can leave their troubles behind them and focus on building some strong sales and profits but i do fear that the market has a long memory and wont forget that easily, which i think is half the problem at the moment. Think as well that the news flow has not been as detailed as it could have been and hence there has been a missunderstanding about the future use for Tysabri when treating MS sufferers.

most cases of MS are severe and as such this in therory alows tysabri to be used in the majority of cases. they (the drug regulators on both sides of the atlantic ) alow usage after other treatments have been tried, and failed, but what most analysts have failed to understand is that all other therepys are only 30% effective and all have nasty side effects. So tysabri in comparison is at least 60% ewffective in the treatment of MS, and with no side effects ( well not unless you combine it with another imune supprescant ) So this is the only product that can claim to actually work well in the fight against this disease. That in itself should see the share price well above the 24 euro mark.

anyway another dissapointing day for ELA but if it goes near 10 euros I am toppimg up straight away. Global events also arent helping things very much, but not as bad as we fear i think longterm. I picked the bulk of these up @ 3.60 so that was the biggest gamble, if you can call it such a thing because I have personal experience with Tysabri and its an amazing drug that literally changes lives.

Lets hope the webcast on aug 1st is good :)

positive day found out a bit more as too why there has been such a slump recently for ELA....

I am quoting from the BB on ADFN user 9darkhorse writes:

"On the negative side:
Im hearing the shorts are at it again. They believe that Elan will encounter more problems with Tysabri (PML) that will result in a very weak market share for BIIB/Elan. I dont agree with this nor does my source (ex Elan) but the shorts have ridden Elan from $65 to $1 and from $30 to $3. They have won huge in the past and are at it again. I understand that Steve Cohen (SAC) and two of his ex prot (Art Cohen & Joe Healy) have big negative positions in Elan. Of course, they are helped by the lousy markets of late.
Heard our nemesis Ron Porges at Sanford Bertstein, very close ties to Serono, held a cc on Friday to blast Tysabri. Porges put out a note that he polled 15 neuros & said most were very negative about the PML risks of the drug. He lowered his 2006 sales estimates to $38m & reduced his year 10 model from $1.5b to $1.1b.
There are no short-term catalysts to propel the share price north and the external storm clouds are ominous.

On the positive side:
I understand that Elan/BIIB have counter market material ready to go.
The call volume @ BIIB Central regarding Tysabri is off the charts.
Independent polls of clinics appear to suggest a strong uptake (company believes the uptake will be good).
The small practices are gun shy but the larger (more sophisticated?) practices are more comfortable with the risks associated with Tysabri.
AAB-001 Phase III is a foregone conclusion. Currently looking at the data. Best guess for announcement is after Labour Day (sometime in September).
I see PIII being very positive for the share price with at least a $5 upside from this level and see the share price getting to $25 by late 2006.

12 month target = $40.
< EOM > "

so that all makes alot of sense, and i even managed to top up today early :)

Thanks for the post and well done on the top up Crippy, I would have liked to have done but didn't really have any available funds. Very happy to hold what I do have though.

elan being driven upwards, comments by elans partner in the Tysabri, Biogen, as they released their 2Q results, were very positive on Tysabri with the predicted uptake and use of the drug being seen as hardly affected by the new guidelines and terms for its usage.

see a little positivity goes a long way, could even be the catalyst to break the 12 euro barrier perhaps???? we shall see....

Great article on msn money today, says it all really....

Tysabri is back, but Elan is down -- time to buy

In our March issue of Marketscope (Subscribers) (Free Trial), I said that Elan's (ELN, news, msgs) competitors would be pulling out all their guns to try to slow Tysabri. Last month, the FDA re-approved Tysabri and on Monday, it was re-released to the market. Now as the market is trying to figure out how profitable it will be, two competitors; Teva Pharmaceutical (TEVA, news, msgs) and Serono (SRA, news, msgs), joined forces and uncorked another shot below the belt.

A report touting a new therapy for multiple sclerosis patients combining Novantrone, a cancer drug, with Copaxone, hit the newswires on Friday. The media focused on the 90% reduction in relapse rate for patients in a clinical trial, lending support to Wall Street's doubts that Elan's newly re-approved MS drug, Tysabri, will ever generate significant sales. In an already weak market, the news helped push Elan's stock price down 5.4% in an already weak market to its lowest level in months.

Beyond the headlines, however, the rest of the story leads to quite a different conclusion. It turns out that the clinical trial consisted of just 27 patients. Although some of the patients experienced an improvement, one developed acute leukemia. Everyone acknowledges that a lot more work needs to be done, and it's going to take time. A three-year study is just now being launched.

I don't think many MS patients are going to hold-off taking Tysabri, which reduces relapses by 68% and is available now, in the hope that in three years, the combination of Novantrone and Copaxone will turn out to be better. As a result, this news should have little impact on Tysabri's launch. But it seems to have scared a lot of people into selling their stock in Elan just when Tysabri is finally coming to fruition.

Competitors react to Tysabri's growing momentum
One way to tell whether a new drug is going to be a success is to look at the reaction of its competitors. It's noteworthy that this story appears first on the newswires, not a respected medical journal. That's how you can tell that competitors, not scientists, are behind this story.

There is no doubt in my mind that both Serono and Teva are afraid of the impact Tysabri will have on their sales.

Serono generated $1.2 billion from the sales of MS drugs (primarily Rebif) almost 50% of their revenue in 2005. Copaxone generated almost $1.2 billion of revenue for Teva in 2005 -- about 25% of their total revenue and probably an even higher percentage of their profits.

But Rebif, and Copaxone are only about half as effective as Tysabri in preventing relapses. Neither drug has been shown to slow the progression of multiple sclerosis, much less an improvement in disability measures, as has Tysabri.

Consequently, both companies have to be concerned that they may lose significant sales now that Tysabri is cleared for sale. From their perspective, the 16 months that Tysabri was off the market was a windfall that enabled them to maintain sales of their existing drugs longer than they expected. Now that Tysabri is back on the market, Serono and Teva are acting as though they are preparing for the worse.

Last year, Serono's board essentially decided to cash out before Tysabri could significantly impact their business. The company hired Goldman Sachs (GS, news, msgs)to help them explore "strategic options." Pfizer (PFE, news, msgs), GlaxoSmithKline (GSK, news, msgs) and Novartis AG (NVS, news, msgs) were rumored to be the likely acquirers. However, the Wall Street Journal reported that in spite of Goldman Sach's efforts, Serono had received no serious offers.

In January, Teva acquired generic drug manufacturer IVAX Pharmaceuticals, financing the big acquisition through a $1.25 billion bond offering by Lehman Brothers (LEH, news, msgs) and Citigroup (C, news, msgs) during a time when Tysabri was off the market and not considered a threat to Teva's Copaxone. Since then, Teva has acted more desperately, trying to reassure investors that Tysabri's growing momentum will not steam roll over Copaxone and affect their debt payments.

Teva seems to be willing to pull out the brass knuckles to maintain Copaxone's sales. On the eve of the FDA Advisory Committee meeting for Tysabri, Bloomberg reported that Teva paid a marketing agent to publicize an unpublished article comparing Tysabri's effect on the human immune system to AIDS. That is a ridiculous comparison. If the best way to protect Copaxone sales is to try to create fear of Tysabri by drawing a ridiculous comparison to AIDS, then Teva must be desperate.

Teva's investment bankers, Lehman Brothers and Citigroup, have also been active. Both firms published research reports citing the risk of PML (Progressive multifocal leukoencephalopathy is an opportunistic infection associated with AIDS and certain cancers) as justification for their low expectations for Tysabri sales. Coming as it did on the day before the FDA Advisory Committee meeting, these two firms proved that their analysis was not going to change no matter what data was presented at the meeting.

I cannot think of a reason why an analyst making an honest assessment of Tysabri would not want to consider the data that was going to be presented the very next day. I can only surmise that the folks at Teva, and their investment bankers, must believe that Tysabri is a threat to Copaxone's sales. I agree with them.

Time to buy
Competitors often hit below the belt. Whenever a new product threatens to reorder a $5 billion-a-year market you can count on it. Watching Serono, Teva and their investment bankers take increasingly desperate steps to slow down Tysabri only increases my conviction that Tysabri will be a homerun for Elan.

Although they succeeded in taking Elan's stock price down, if you can hold onto this stock for the next two years, these shenanigans will not have any impact on your return. I'm taking advantage of this opportunity to increase my position.

I increased my position when it was at 10.69 euro (ELA:LSE) a few days ago ...Have been a reader of these boards for over a year now ...Trading Elan is a game of cat and mouse ...you need to know when to increase and when to dump your holding ....

(Crippy) I would be more bullish and suggest that holding this stock for 1 year will yield great returns ....

Yes I aggree evilratboy

I also found this article from this mornings times, interesting reading....

The Sunday Times July 30, 2006


Irish Agenda: Takeover rumours centre around Elan's other blockbuster
Joe Brennan



ELANS share price gained more than 12% in New York last week to $14.94 (11.72) amid speculation that Wyeth, an American pharmaceutical giant, was considering a bid for the $6.4 billion company.
Market participants say a takeover would be a logical step, given their partnership in a multibillion dollar Alzheimers programme.



But why now? They could have snapped up Elan a year ago when its stock was worth half what it is now, said a Dublin-based fund manager. Is it that the Alzheimers pipeline has thrown up amazing results in trials?

Indeed.

Wyeth declined to comment.

The partners first hopeful treatment for the degenerative disease, AAB-001, is expected to move into Phase III clinical trials later this year, after they unveil the results of the second phase. Phase III is the final stage before pharma companies apply to the regulatory authorities for approval.

A second drug, ACC-001, is to move into Phase II later this year, about the same time that a third treatment is expected to enter clinical trials.

With the hype around Tysabri, the multiple-sclerosis treatment, the Alzheimers programme has been pushed into the background. Goodbody Stockbrokers forecast earlier this year that if the first drugs get the green light, they could account for half of what it predicts to be a $10 billion Alzheimers drug market within the next 10 years. It is currently worth $3 billion.

It would make perfect sense for Wyeth to take Elan out before the market really starts to price its prospects, said one analyst.

But others remain sceptical. Elans share price is notoriously volatile. This is not the first time it has been surrounded by takeover rumours and, I suspect, it wont be the last, said another dealer.

A third analyst said: A move by Wyeth at this stage would suggest it was somewhat shortsighted by spending 1.8 billion building a facility at Clondalkin last year when Elans factory in Athlone is only running at 40% capacity.

It is understood that a partnership agreement for Tysabri between Elan and the American group Biogen contains a clause that if either company is taken over, both sides have to put in a sealed bid for the drug.

LONDON, Aug 1 (Reuters) - Irish drugmaker Elan (ELN.I: Quote, Profile, Research) said on Tuesday it was pleased with the performance of its Tysabri multiple sclerosis drug following the recent relaunch.

"I would say that in the first few weeks of activity we're pleased with what we see," Chief Executive Kelly Martin told reporters when asked about sales of the drug.

Tysabri, which Elan and U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) relaunched in July after last year's suspension over links with a rare and potentially fatal brain disease, is seen as key to Elan's future following a brush with bankruptcy in 2002.


Reuters 2006. All Rights Reserved.

DUBLIN, Aug 1 (Reuters) - Ireland's Elan (ELN.I: Quote, Profile, Research) cut its losses in the second quarter and its battered shares rose on Tuesday as the drugmaker said it was set for a return to profit thanks to the relaunch of its Tysabri multiple sclerosis drug.

"With the approval of Tysabri and the improvements we have made to the business, we are now entering into a new and exciting phase," Elan (ELN.L: Quote, Profile, Research) Chief Financial Officer Shane Cooke said in a statement. "We are confident that revenues from Tysabri will drive our return to profitability."


Elan said it had cut its loss per share in the three months to the end of June to 21 cents from 35 cents in the same period last year, slightly missing the median of nine analysts' forecasts compiled by Reuters, which had put the loss at 18 cents.

The loss was in line with that estimate, however, once adjusted to exclude the impact of share-based compensation.

Total revenues in the quarter rose 15 percent to $136.4 million, in line with analysts' expectations that they would reach $137 million.

"With all eyes focused on the performance of Tysabri now it is back on the market, these results reflect the solid progress the company is making on its core business and will support the current share price," Ian Hunter, analyst at Goodbody Stockbrokers, wrote in a research note.

Shares in Elan, which have see-sawed between 24 euros and 2.30 euros over the past two years, were up 3.4 percent at 12.12 euros by 0832 GMT, compared with a 1.2 percent gain for the broader Irish market Tysabri, which Elan and U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) relaunched in July following last year's suspension over links with a rare and potentially fatal brain disease, is seen as key to Elan's future after a brush with bankruptcy in 2002.

Analysts polled by Reuters expect the drug to generate revenues for the two companies of $56.75 million this year, rising to an annual $1.77 billion by 2010. The drug's troubled past means forecasts vary widely, however.

Jack Gorman, analyst at Davy stockbrokers in Dublin, pointed out that excluding the costs associated with getting Tysabri back on the market, core earnings were positive for the third quarter in a row.

"Although there was no formal change to guidance in the statement, the Q2 result could mean some small tweaking downwards of our full-year loss estimates," he added.


Excluding the impact of Tysabri on costs and revenues, Elan has forecast a full-year loss before interest, tax, depreciation and amortisation of $150 million to $175 million, compared with $216.9 million last year.

so after a fairly positive report yesterday from the CEO which London responded well too, the other side of the pond has brought us right down again. if anyone can explain why i would like to know as i cant find any reason.

there is no explanation ...just a bunch of crooks

very true, i notice that Fidelity Investments have another million and a half declared today. Wonder if they will put in a bid for a buy out soon haveing accumulated such a big lump of ELA?

yep seen that ...very sneakily gobbling up stock without many people noticing ...something is going on ...the only thing is there are so many "men behind the curtain" with this stock that nobody knows what the hell is going to happen ..

I just know that i will be buying on anything under 11 euro ...trust the science ...

Fidelity announced an increase in its elan stake to 14.08% today. Whats their game? is its holding purley for a client, as it does hold stakes in a number of companies? Or is it more molvelant, possibly holding for a client who is considering a buy out?

One guy even speculates on ADVFN that it is buying on behalf of Philips and a bid for Elan will come within two months. I dare say all will be revealed but the mystery is very perplexing, all good fun!

something is definately afoot news soon i feel. dont ask me why just a hunch.

Hope you're right!

well it may not have been news directly about Tysabri, but the announcement last week about Elans nano technology being used as the drug delivery method for EntreMed cancer treatment is certainly welcome, and has provided a friday boost for elan.

Goodbody says: Drug delivery partner patent progress.
Analyst: Ian Hunter
EntreMed, a Baltimore-based biotechnology company, has been awarded a patent for the method of using 2ME2, its lead drug for the treatment of cancer and non-cancer diseases, such as rheumatoid arthritis. This follows on from the award of a patent covering the composition of highly purified 2ME2 as well as the method of obtaining the compound. In January, Elan signed an agreement with EntreMed for the latter to licence Elan's nano-crystal technology, incorporating it into the drug (also known as Panzem) to create a liquid formulation. Panzem is currently in Phase II trials for treating cancer and at the preclinical stage in rheumatoid arthritis.

At least i think thats the reason :)

not such a good day or so for Elan PLC was trying to figure out why the price has fallen by the ammount it has after building up such a good rise over the last couple of weeks. I found this article that perhaps explains it, maybe????

http://www.newstarget.com/020315.html

as you can see from reading it it seems like another piece of well timed opinion designed to hurt elan and tysabri, i wonder wether it is sponsered by Teva or another such rival pharma company. On reading I thought it seemed like another pretty useless bit of subjective comment by the doctor in question., and the reporter for news target jumped on the band wagon with the scaremongering jheadline:

STANFORD DOCTORS SPOTLIGHT FATAL FLAW IN MULTIPLE SCLEROSIS DRUG TRIAL

all very good if your looking for an attention grabbing headline but the content really does leave alot to be desired. Oh well guess its just another case of rivals attempting to bring down Tysabri. Boy they must be scared at the prospect of tysabri actually being the blockbuster it surley must be given a bit of time, just goes to prove i suppose now is a good time to top up :) Maybe even theres is more news from elan around the corner and this is designed to head it off at the pass so to speak! ;)

sorry article just a rehash of old story pre fda approval. need some positve elan news

Just thought i would share some news about elan....its more a personal thing than a market thing but may be relevant....London tysabri dosing restarts this month, This is the continuation of the trial i was on for the past 3 ish years, which was stopped whenb the bad news about PML happened.

I can only assume the restart means that UK availability is up and running and the trial continuation was afterall a condition of the FDA and euro counterparts granting a licence for remarketing of this future block buster drug. guess it all takes time to get things going again and rest assured I shall be asking my neuros on wednesday what their views on the drug and its future are.

will post more wed night.

Thanks for the update Crippy

hi all not posted since i recieved first infusion, had to go through the new protocol as specified with tysabris reintroduction, mri scan, neuro testting etc. The short version is that it all worked out very well and trial runs for 12 months, hope that the people at NICE allow it to be perscribed, fingers crossed.

Anyway during the infusion, which takes an hour I did not have much chance to speak to the doctor at lenght about what the future of the drug was in her opinion, she was very busy as you might imagine, but I did ask how many of the original trial patients had taken up the oppertunity to take tysabri again and the answer was all but one of the 600 or so patients chose tom take the drug. So all the talk in the news about tysabri having a low take up and doctors wouldnt prescribe it is all a bunch of rubish according to the prof in charge of the trial i am on, who unequivically said he would prescribe it without hesitation.

So my opinion is buy now! Price has been brought down by negative publicity and many neysayers all out to damage Tysabri sales and patient confidence which of course affects Elan. todays price close below pre approval level prices. I topped up again today.

Thanks for the info Crippy. I would be buying more also if I had the funds, this share has been preforming disappointingly recently, but I still believe it's a long term winner, your added info on take up has increased my confidence!

Follow the man chaps, follow Mr Wright and get its right.

UK healthcare products developer Maelor is buying Acorus Therapeutics and expects full-year results for the year to 31 March to beat market expectations.

Maelor (MLR) shares added 11.8%, but by 2 pm were just 4% higher at 13.25p, up 0.5p which gives the AIM-listed company a market value of 4.54 million.

The company, which recently moved its offices to Chester from Wales, said the positive trading trend its cited when it reporting its interim results in November has been sustained into the last quarter of the financial year and as a result, the company anticipates a significant reduction in losses for the second half of the financial year. It didnt give specific figures.

Sales of Volplex, a plasma substitute that was Maelors first commercial product, continued to grow during the six-month period, as did sales of its catheter flushing devices, Maelor says in a trading statement.

First listed on the London Stock Exchange in 1997, Maelor has struggled in recent years to become profitable. In October 2005, five months after reporting pre-tax losses of 814,244 for the year to 31 March, the companys board brought in Tim Wright, at that time a 39-year-old vice president of international marketing at Dublin-based Elan, the publicly-traded biotechnology company.

yup its a winner alright, so much going for elan so many non believers must be sick they missed the boat, financial data coming at end of july....hope to see considerable tysabri uptake as docs and patients gain confidence, although any neuro who knows anything about ms knows this is a drug that is head and shoulders above the competition. hence the decision by NICE to allow funding recently!....plus the altheimers drug continues to reach its goals. futures sure looking up 30+ by 2008....good luck all! recent dip just consolidation, good time to get more i reckon!

ELA tanked this morning ,then recovered a bit before 14.00hours,any views.

Whats the chances With elans share price to rally withinn the next few months?

Video presentation with Eland Oil & Gas (AIM-ELA)
Les Blair, Chief Executive Officer
AIM newcomer Eland Oil & Gas, which raised £118 million through its September IPO, is developing OML 40 in the rich Niger Delta are of Nigeria

Click the link below:

http://www.brrmedia.co.uk/event/106553/les-blair-chief-executive-officer

Nice graph recently, benefiting from the increase in the price of oil.

Opuama-10 Update
Eland Oil & Gas PLC (AIM: ELA), an oil & gas production and development company operating in West Africa with an initial focus on Nigeria, through its joint-venture subsidiary Elcrest Exploration and Production Nigeria Ltd ("Elcrest"), is pleased to announce the following update on the Opuama-10 well on Opuama Field, OML 40.

Opuama-10 has been drilled to a total true vertical depth of 8,121 feet, measured depth of 10,135 feet. The rig is currently cementing 9-5/8 casing which will complete today. The well encountered six oil-bearing reservoirs. Total net pay, in the six oil-bearing reservoirs, is 307 feet apparent vertical thickness.

The short string will be completed on the D1000 reservoir with 32 feet of perforation interval. The long string will be completed on the D5000 reservoir from 50 feet of perforation interval. Following completion, under the regulatory guidelines the Opuama production team will conduct a Maximum Efficient Test ("MER Test") incrementally testing the well at increasing choke sizes. It is expected that, following completion of the MER Test, initial gross production from Opuama-10 will be in line with previous guidance, at between 4,000 and 6,000 bopd (1,800 - 2,700 bopd net to Elcrest), with total production from Opuama field expected to reach 30,000 bopd (13,500 bopd net to Elcrest).

George Maxwell, CEO of Eland, commented:
"We are delighted with the significant amounts of net pay encountered by Opuama-10 and look forward to both another strong production performance following completion and testing and reaching our near-term target of producing 30,000 barrels of oil per day from Opuama field.

"The Company continues this exciting period through the second half of 2018 as our active drilling programme will increase production and generate significant revenues for Eland. We look forward to updating our stakeholders in due course."

Commencement of Ubima Appraisal
Eland Oil & Gas PLC (AIM: ELA), an oil & gas production and development company operating in West Africa with an initial focus on Nigeria, through its subsidiary Wester Ord Oil & Gas Nigeria Limited, partnered with All Grace Energy Limited, is delighted to confirm that the appraisal of Ubima field has commenced with the Deutag T-57 land rig re-entering the Ubima-1 well which has been suspended since discovery by SPDC in 1963. The Company has a 40% equity interest in the Ubima field.

A dual string completion is planned for Ubima-1 on four different reservoirs, namely on the D1000 (at 4,908 feet subsea ("ftss")), E1000/E2000 (at 6,778 ftss) and F7000 (at 9,244 ftss). The programme includes two Drill Stem Tests (DST's) on the E1000/ E2000 and D1000 prior to running the dual completion with the objective to obtain accurate fluid, pressure and production data for each separate reservoir. Thereafter extended production testing is planned, which will serve as a solid basis for the full field development plan of the Ubima field.

Interim Results for the six months to 30 June 2018
Eland Oil & Gas PLC (AIM: ELA), an oil & gas development and exploration company operating in West Africa with an initial focus on Nigeria, today announces its unaudited financial results for the six-month period to 30 June 2018 (the "Period").

George Maxwell, CEO of Eland, commented:
"The first half of 2018 has been the most important operational and financial period in Eland's history. With two successful infill wells completed on the Opuama field, average gross production increased threefold to over 17,000 barrels of oil per day and has since hit highest levels to date of nearly 30,000 bopd since period end, and will continue to increase further in the near-term.

The operational successes in the period translated into a transformational financial performance with the Company reporting its maiden profit following record Group revenues. The strong operational cash flow in the Period also allowed for a positive turnaround in the Company's working capital position through a period of considerable capital investment. The significant increase in the re-financed debt opportunity is testament to the improvement in the Company's performance.

We continue with the Ubima appraisal while also targeting first oil on Gbetiokun this year, further significantly increasing the Company's production base. The outlook for the remainder of this year is extremely exciting as we drive towards further record production and financial performance in 2018."

H1 2018 HIGHLIGHTS
Strong operational delivery
· Success with Opuama-8 and Opuama-9 in H1-2018 led to record high gross production from OML 40 of 25,000 barrels of oil per day ("bopd") (Elcrest net 11,250 bopd*).

· Gross production from OML 40 achieved an average 17,146 bopd (7,716 net) during the six-month period to 30 June 2018 in comparison to 5,275 bopd in H1 2017 (2,374 net), an increase of 225%.

· Successful installation of a Lease Automatic Custody Transfer ("LACT") unit at Otumara providing accurate measurements of crude oil delivery from OML 40.

· The Ubima-1 appraisal operations, an asset diversification by Eland outside of OML 40, commenced in H1 with re-entry of the well commencing post period end. Appraisal continues.

· An updated Competent Person's Report ("CPR") for OML 40 in April 2018 increased gross Proved ("1P") reserves by 20% to 39.5 million barrels ("mmbbls") and increased gross Proved plus Probable ("2P") reserves slightly to 83.4 million barrels.

Record financial performance
· Revenue of $67.4 million (1H 2017: $0.8 million) with an average realised price of $69/bbl (1H 2017: $37/bbl).

· Including the effect of the movement in crude inventories in the Period the value of production was $87.9 million (1H 2017 $20.2 million).

· First reported profit in the Group's history with $44.7 million post-tax profit in the Period (H1 2017: $22.4 million loss).

· Strong operating cash flows in Period of $50.6 million (H1 2017: $17.5 million deficit).

· Net current liabilities stood at $17.1 million at Period end (1H 2017: $35.7 million) although excluding the impact of the short term-bank loan net current assets were $8.2 million (1H 2017: $31.3 million net current liabilities).

· Direct OML 40 operating costs of $8/bbl (excluding royalties).

· Liftings in Period of 976,000 bbls (H1 2017: 23,000bbls) generating revenue of $67.4 million (H1 2017: $0.8 million).

· Cash of $29.8 million at 30 June 2018 (H1 2017: $22.3 million).

Post-Period End - continued delivery
· At an advanced stage in securing an initial debt facility of $100 million, with an accordion feature to grow to $200 million based on incremental reserves and production.

· Facility expected to close with $75 million commitment and $25 million due to be syndicated in the near term

· Opuama-10 production testing in progress with production of 6,898 bopd (3,104 net) achieved during testing operations. It is expected following completion of testing stabilised initial production from Opuama-10 will be in excess of 5,500 bopd (2,321 net).

· Aggregate Opuama field production is expected to average above 29,000 bopd (13,050 net) once Opuama-10 testing operations complete.

· Opuama-11 has been drilled to a total true vertical depth of 7,914 feet and the final casing string has been run and cemented. It is expected that initial gross production from Opuama-11 will be between 4,000 and 6,000 bopd (1,800 to 2,700 net) further adding to Opuama field production.

· Following the completion of drilling at Opuama-11 and the receipt of regulatory approvals, the OES Teamwork rig will be moved to the Gbetiokun field, where it will re-enter Gbetiokun-1 followed by drilling of Gbetiokun-3 as part of the initial phase of the field development plan.

· OML 40 twenty-year licence renewal process approved and agreed by all stakeholders. The licence renewal fee has been paid and we await final consent of the Honourable Minister of Petroleum Resources.

· Ubima well testing operations in progress with the F7000 reservoir tested at flow rates of up to 2,500 bopd. At present the D1000 reservoir is being tested with the potential to test the E1000/E2000 to be evaluated.

· Post period end we have received $50.5 million in cash receipts from our July and August liftings totalling 679,000 bbls. A further 350,000 bbls have been lifted in September which will provide an additional $26.6 million cash when funds are received in October.

· Current cash balance of $32.3 million.

Outlook
· Busy H2 drilling programme following the completion of Opuama-11 to include the re-entry of Gbetiokun-1 and drilling of Gbetiokun-3.

· Ubima appraisal is currently underway and on success a significant amount of contingent resources to be converted into recoverable reserves. Four wells are currently planned to develop the main reservoirs.

· H1 2018 has delivered exceptional growth notwithstanding the challenges of the extended drilling programme on Opuama-9. However, the full benefit of production from Opuama-9, coupled with Opuama-10 and 11 will be realised in H2 2018 resulting in further significant increase to both revenue and cashflow.

Eland Oil & Gas PLC (AIM: ELA), an oil & gas production and development company operating in West Africa with an initial focus on Nigeria, is pleased to announce the following operations update.
https://www.moneyam.com/action/news/showArticle?id=6182515

George Maxwell, CEO of Eland, commented:
"We are pleased with what is expected to be another highly successful infill well on the Opuama field and we look forward to further record field production levels once testing has been completed. At current oil prices, these record levels of production from Opuama field are leading to significant cashflows for all of OML 40's stakeholders.

The prolific nature of OML 40 combined with the Company's experienced and resourceful team and supportive stakeholders means that we move development operations swiftly to the Gbetiokun field and the opportunity to increase production by a further 50% in the near-term.

Furthermore, the conversion of Ubima-1 into a producing well following the initial workover is a milestone for the Company and following the test of the E1000 and E2000 reservoirs we shall begin to evaluate monetisation opportunities for production from this well. Further evaluation of the D1000 sands are required to consider options for any full field development and we will update the market as we progress these studies.

We look forward to updating the market on the progress of both the Gbetiokun Early Production System and the evaluation of Ubima."