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

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Tysabri had been withdrawn from the U.S. market in February 2005, just three months after its introduction there, after three users of Tysabri in clinical trials contracted a rare and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.
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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?