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

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!