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

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Analysts say the future of the Dublin-based company depends on the return of Tysabri, a drug withdrawn from sale in the United States early last year after being linked to a rare, often fatal brain disease.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.
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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