UPDATE 1-Biogen moves long-acting Avonex to final trial-CEO

By Deena Beasley

LOS ANGELES, Jan 7 (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) has moved a long-acting version of its multiple sclerosis drug, Avonex, directly into trials designed to meet requirements for regulatory approval, the company's chief executive said on Wednesday.

CEO Jim Mullen said during an investor conference held in New York that the company has completed Phase 1 trials and will study dosing the drug once every two weeks as well as once monthly.

"I think we've got a good chance of similar efficacy as interferons," he said.

Patients in the trials will be treated for one year with the injectable drug and full results will likely be available in two years, Mullen added.

Avonex, with sales of $573 million in the third quarter of 2008, is the leading drug for multiple sclerosis, an autoimmune disease in which the body mistakenly attacks the fatty myelin coating surrounding nerve cells.

Biogen, along with marketing partner Elan Corp Plc (ELN.I: Quote, Profile, Research), also sells MS drug Tysabri, which was taken off the market after its 2004 introduction when it was linked to a potentially fatal brain infection, but reintroduced beginning in 2006 because there were so few good options for patients with MS.

Mullen said investors continue to underestimate the newer drug's sales potential: "We have a much more bullish view on Tysabri than the Street does."

"We've got a 40 share of the overall MS market, which could easily go to 50," the CEO said.

He said other discrepancies between Biogen's outlook and that of Wall Street include the company's "more bullish view on the sustainability of Avonex," growth potential for the franchise surrounding non-Hodgkin's lymphoma drug Rituxan, and additional opportunities for trimming costs.

Mullen said Biogen will no longer report new cases of progressive multifocal leukoencephalopathy, the brain infection associated with Tysabri, through filings with securities regulators, but will instead issue weekly updates on its Web site. (Reporting by Deena Beasley; Editing by Andre Grenon and Matthew Lewis)

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Elan seeks deals to raise cash

Tue Nov 18, 2008 6:11pm EST

NEW YORK (Reuters) - Elan Corp Plc (ELN.N: Quote, Profile, Research, Stock Buzz)(ELN.I: Quote, Profile, Research, Stock Buzz) aims to cut costs, close locations and raise up to $500 million as it seeks to strengthen its balance sheet and offset slower growth of its multiple sclerosis drug Tysabri.

Elan, which expects to generate revenue of about $1 billion in 2008, is based in Ireland, but also has facilities in San Francisco, New York, Boston, Pennsylvania, Georgia and Tokyo.

Chief Executive Officer Kelly Martin said on Tuesday at the Reuters Health Summit in New York, that Elan is considering closing two of those locations or reducing its presence there, though the company has not yet decided which ones.

"We are currently going through a process where we are evaluating where we can take costs down and reallocate and reduce," he said. "There are a couple of locations we can potentially exit entirely."

In the nine months ended September 2008, Elan posted a net loss of $240.5 million. It is burning cash at a rate of more than $300 million a year, and it has $1.7 billion in debt that comes due over the next five years.

Elan's U.S. stock has fallen over 80 percent since early July to $6.06 late Tuesday afternoon, hurt by safety concerns over Tysabri and disappointing results from a mid-stage trial of its experimental Alzheimer's disease vaccine.

The company is on track to run out of money in less than two years if it doesn't take firm action.

To that end, Martin said he wants to raise between $300 million and $500 million within the next six to eight months, and he expects to do that by selling the rights to some of its experimental products.

Elan recently tried to sell its drug technology business, worth about $1 billion, but the credit crisis killed off a hoped-for sale to private equity and a sale is now unlikely for at least a year, Martin said.

"I'm not optimistic the markets will get back to normalcy any time soon," he said. "Our plans are not to wait around for a transaction but to run the business."

Kelly said the business is profitable but is not central to its portfolio of neurology drugs, and the company still hopes to sell it once the market improves.

For now, the company will focus on raising money by selling rights to experimental drugs in areas such as cancer and rheumatoid arthritis, products that are in early stages of development.

"By the middle of 2009 you can expect us to do something with our pipeline," he said.

Martin said the company is determined to keep its pipeline of drugs for neurological disorders, including experimental products to treat Alzheimer's disease, Parkinson's disease and Parkinson's disease.

Elan and its U.S. partner Biogen Idec Inc (BIIB.O: Quote, Profile, Research, Stock Buzz) have said they expect 100,000 patients to be taking Tysabri by the end of 2010, a figure Kelly said would represent around 20 percent of the market, but some analysts consider that over-optimistic.

Martin said it will begin to become clear over the next few quarters whether the companies can reach that figure, as they will reflect physician responses to the latest cases of PML, a potentially deadly brain infection that caused the drug to be temporarily withdrawn in 2005.

In the third quarter, Biogen said sales of Tysabri had slowed, though it maintained it can still meet the patient target of 100,000. For that to happen, growth will have to accelerate.

Tysabri was reintroduced in 2006, with stricter warnings, and physicians had started to become more comfortable with the drug. Then, at the end of July, two more cases of PML were reported. And another was reported in October.

That has once again cast doubt on the ultimate sales potential for the drug, but Martin sounded optimistic.

"We are hoping the emotion and rumoring around PML is beginning to fade away a little bit," he said. "I think a 20 percent market share for the drug is a very achievable number over time."

(For summit blog: summitnotebook.reuters.com/))

(Reporting by Toni Clarke, Ben Hirschler; Editing by Richard Chang)

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Biogen, Elan shares fall as third Tysabri patient suffers brain infection

30 October 2008

Biogen Idec and partner Elan Corp have suffered a slide in their respective share prices after a new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri, was disclosed.

In a filing to the US Securities and Exchange Commission, Biogen said that the relevant regulatory agencies had been notified of a confirmed case of PML, a potentially deadly brain infection, in a patient suffering from MS in the USA who had been on Tysabri (natalizumab). The disclosure comes after Biogen and Elan reported in July that two cases of PML had emerged in Europe.

In the latest case, the filing reveals that the patient received 14 injections of Tysabri. The patient has a history of prior disease-modifying therapies including beta-interferons and Texa’s Copaxone (glatiramer acetate) and he/she had also been treated with methotrexate for a rheumatology condition. The individual is now under the care of their treating physician, Biogen said.

PML has played a major part in the history of Tysabri. These recent cases are the first to be recorded since the reintroduction of natalizumab in the USA and approval in Europe two years ago. Biogen and Elan had voluntarily withdrawn the drug a year earlier after three patients developed the brain infection.

Since reintroduction, sales of Tysabri have soared – by the end of September there were 35,500 patients using the drug worldwide and in the third quarter of this year, 3,700 new patients were added. It has also now available in the USA as a treatment for Crohn's disease and Biogen and Elan expect that 100,000 MS patients will be taking the drug by 2010.
.
Biogen and Elan have a strict monitoring programme in place for the therapy and the reintroduction of Tysabri was based in part on the number of PML cases not exceeding the level acceptable to the US Food and Drug Administration (one in every 1,000). As only three cases have been reported, the treatment is well within that limit but the news has certainly spooked investors.

In after-hours trading last night, Biogen shares had fallen by as much as 15%, while this morning Elan stock has been hit. At 9.40 UK time, the Irish firm’s shares were down 18% to 4.80 euros.

Ian Hunter, an analyst at Goodbodys in Dublin, has issued a research note this morning saying “we believe that this new case should do little to projected numbers of patients on Tysabri, given that the considerable pull back in momentum after the first two cases…will have accounted for the majority of those patients and physicians wary enough of the PML risk” to consider not taking or prescribing the drug. However, the fact that this patient was on the drug for 13 months and the other two were on it for 14 and 17 months “may suggest that there is a timing issue and that it takes over a year on Tysabri for the interaction between drug and patient to lead to the development of PML”.

By Kevin Grogan

Tysabri PML Cases Cause European Regulators to Recommend Stronger Warnings

September 29th, 2008

The European Medicines Agency, an advisory body for drug regulators in Europe, recommended last week that the warning label for the multiple-sclerosis drug Tyasabri be updated following new reports of users developing a rare brain disease known as PML, or progressive multifocal leukoencephalopathy.

Tysabri (natalizumab) is an intravenous injection given every 28 days to treat Crohn’s Disease or multiple sclerosis (MS). It has been shown to prevent relapse, cognitive decline and vision loss which could be associated with multiple sclerosis.

Shortly after Tysabri was introduced in 2004, it was associated with side effects that could lead to PML, which is a potentially fatal brain infection. After three cases of PML resulted in two deaths, a Tysabri recall was issued in 2005, and the drug was re-introduced the next year with stricter guidelines for usage and more prominent warnings about the possible Tysabri PML side effects.

European and American drug regulators have been re-examing the risk of progressive multifocal leukoencephalopathy in recent months, after new reports of PML among Tysabri users surfaced in July 2008. According to filings with the SEC, the drugs makers, Biogen Idec and Elan Corporation, identified two PML cases in Europe, which were the first new diagnosed Tysabria PML cases since 2006.

On September 25, 2008, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) called for drug regulators to strengthen the Tysabri progressive multifocal leukoencephalopathy warnings in Europe. They recommended that the drug’s prescription information be updated and strengthened to highlight the potential Tysabri side effects for patients with relapsing-remitting multiple sclerosis (MS).

The European regulatory committee did not call for a Tysabri recall, as they indicated that the benefits of the drug still do outweigh the risks. However, in light of these new PML cases, they felt that the current warnings in Europe need to be strengthened to raise awareness about the risk of the brain disease from Tysabri.

In August 2008, the FDA issued a MedWatch Alert regarding the new reports of PML associate with Tysabri. They indicated that the prescribing information in the United States would be revised to include information for prescribers and patients about the cases of PML that occurred among patients taking Tysabri as a monotherapy. The U.S. drug regulators also recommended that doctors should monitor their patients for signs and symptoms of PML.

that they are investigating the reports to determine what, if any, regulatory actions are necessary regarding the Tysabri side effects.

Progressive multifocal leukoencephalopathy is a rare viral infection which causes inflammation at multiple locations in the brain, leading to progressive brain damage. Symptoms could include loss of vision, impaired speech, paralysis, cognitive decline and weakness. There is no known cure for PML, but the disease can sometimes be slowed or stopped by reducing immunosuppression. In many cases the brain infection is fatal.

TYSABRI® DEMONSTRATES SUSTAINED IMPROVEMENT IN FUNCTIONAL OUTCOMES IN MULTIPLE SCLEROSIS PATIENTS ACCORDING TO NEW POST-HOC ANALYSIS

TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability

Montreal, Canada - September 19, 2008 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.

"These results show that TYSABRI treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients. This finding from a post-hoc analysis of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM trial that TYSABRI is associated with an improvement in quality of life as well as anecdotal evidence of recovery of function in some patients." said Frederick E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State University of New York at Buffalo. "While, like TYSABRI, other therapies have shown a slowing of progression in disability, this analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy."

Post-hoc Disability Analysis of Phase III AFFIRM Study

The proportion of patients exhibiting sustained improvements in physical disability in the AFFIRM study was determined based upon the Expanded Disability Status Scale (EDSS) over two years in patients with relapsing MS. EDSS is one of the oldest and most widely utilized methods of quantifying disability in MS.

Post-hoc analysis of AFFIRM patients assessed sustained improvement in disability among patients with a baseline EDSS score ≥ 2.0. Improvement in disability was defined as a one-point decrease in EDSS score sustained for 12 weeks. The cumulative probabilities of 12-week sustained improvement in disability at two years were estimated using the Kaplan-Meier method. Treatment effects were analyzed using the Cox proportional hazards model adjusted for baseline EDSS score. The distribution of sustained improvement by baseline EDSS score for each treatment group was also examined.

TYSABRI produced significant results on the cumulative probability of sustained improvement in disability in those treated over two years compared with placebo. In patients with a baseline EDSS score ≥ 2.0, the probability of achieving sustained improvement was 29.6% with TYSABRI (n=417) compared with 18.7% with placebo (n=203) (p=0.006). In patients with an EDSS score ≥ 2.0 and highly active disease at baseline, the difference between groups was even greater, 35.5% for TYSABRI (n=103) and 15.4% for placebo (n=40) (p=0.045).

The submitted abstract for this study, entitled "Natalizumab significantly increases the cumulative probability of sustained improvement in physical disability" (ID #P474), is available on the World Congress’ website.
About TYSABRI

TYSABRI is a treatment approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

TYSABRI was approved in early 2008 to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. According to the US full prescribing information, among patients who responded to TYSABRI, 54% sustain their response through every visit for one year compared to 20% of patients receiving placebo (p<0.001), for a treatment difference of 34%.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.

TYSABRI is approved in more than 35 countries. At the end of June 2008, more than 31,800 patients were on commercial and clinical TYSABRI therapy worldwide. Patients on TYSABRI therapy have continued to increase. An update will be provided in October in conjunction with Biogen Idec's third quarter earnings release.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.
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.
About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

For more information contact:

Media Contacts:

Biogen Idec
Shannon Altimari
617-914-6524

Elan
Jonathan Birt
212-850-5664
or
+44 20 7269 7205

Niamh Lyons
Ph: +353 1 663 3602

Investor Contacts:

Biogen Idec
Eric Hoffman
617-679-2812

Elan
Chris Burns
+ 353 1 709 4444
800-252-3526

David Marshall
Ph: +353 1 709 4444

Tysabri PML patient deteriorates - researcher

By Reuters
September 19, 2008

BOSTON—One of two European patients, who developed a potentially deadly brain infection after taking the multiple sclerosis drug Tysabri, is deteriorating and likely to suffer brain damage, according to a researcher involved in their care.

The other patient diagnosed with the infection in July is recovering, the researcher said Friday.

The drug, made by Biogen Idec Inc and Elan Corp , was temporarily withdrawn from the market in 2005 after being linked with three cases of an often lethal infection known as progressive multifocal leukoencephalopathy, or PML.

Due to its advantages over older MS treatments and patient willingness to take on the risks, Tysabri was reintroduced with stricter warnings in 2006. No new cases were reported until the end of July, when Biogen announced that two patients had developed the infection.

Biogen said on Friday that no further new PML cases have been confirmed and its shares closed up 6 percent. Elan shares closed up more than 1 percent.

Dr. Ralf Gold of Ruhr University Bochum, Germany, said in an interview that a German patient, hospitalized near the town of Freiburg, is close to a coma and being fed through tubes, though he is breathing on his own.

The other patient, a 37-year-old Swede, is in a rehabilitation center near Stockholm and suffering only from mild weakness on one side of his body.

Gold said the 52-year-old German patient was not diagnosed until at least three months after developing the disease, whereas the Swedish patient's condition was identified in less than a month. As a result, the German patient had a higher level of the virus in his brain.

The two were treated through plasmapheresis, a procedure in which a patient's blood is removed, cleared of the drug, and replaced.

Gold presented an update on the two cases at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal.

Investors have been watching the patients' progress to see whether PML can be reversed. They are also watching to see how many cases of the infection develop among patients taking the drug, which is considered a critically important growth driver for both companies.

Tysabri had second-quarter sales of $200 million, but its fortunes have been inextricably linked to PML concerns.

"The drug's strong efficacy profile should keep it as a preferred agent, in our opinion," Leerink Swann analyst William Tanner wrote in a research note.

In a report ahead of Gold's update, Geoff Porges, an analyst at Sanford Bernstein, said that if the disease becomes manageable through plasmapheresis then the impact of these cases will be blunted.

He said experts interviewed at the meeting have confirmed that in Europe and North America there are a number of patients with suspected PML whose physicians discontinued Tysabri use.

"We believe it is incumbent on Biogen to disclose this information to physicians in order for them to fully evaluate and disclose the risks associated with the product," he said.

Biogen spokeswoman Naomi Aoki said, "We have disclosed the only two cases of diagnosed PML that we have seen so far."

Gold added that while certain databases pick up cases in which a doctor suspects PML and discontinues Tysabri, the cases have not been confirmed either through an MRI or any other scientific measures.

Gold said the virus appears to be leaving the German patient's brain, but he is suffering from brain damage brought about by a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.

It is most likely the patient will be permanently brain damaged, Gold said. The only question is by how much.

The patient was started on a course of corticosteroids on Friday, the standard treatment for IRIS.

It typically becomes clear within a few days whether such a treatment is likely to work, Gold said. In the meantime, the patient is in a critical condition but not in intensive care.

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Biogen Idec MS pill found to slow damage

Bloomberg News / September 19, 2008


NEW YORK - Biogen Idec Inc.'s experimental pill to treat multiple sclerosis prevented brain lesions associated with the disease from getting worse, a study found.

The pill, called BG-12, reduced the conversion of new spots of inflammation into permanent damage in a trial of 56 patients, Biogen said yesterday at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal.

In MS, neurons are stripped of an insulating coating known as myelin by the immune system, causing the cells to malfunction. That leads to MS symptoms such as muscle weakness and loss of coordination, according to the Mayo Clinic. Biogen has received approval from US regulators to speed the review process for its pill, the company said yesterday. If cleared for sale in the United States, BG-12 could be the first oral medication for MS patients to reach the market.

"There are two elements: You want to keep the lesions from forming in the first place and then, even if a lesion developed, you want to know the damage is reduced, and that's what you're seeing," said Mike Panzara, the chief medical officer for Cambridge, Mass.-based Biogen in a telephone interview yesterday. "Even if a lesion does develop on BG-12, injury is less because it's less often the lesions become permanent."

About 29 percent of the lesions in the brains of patients on BG-12 turned into signs of permanent damage, compared with 44 percent of those in the placebo group, the study showed.

The company began final-stage testing on BG-12 in January. The trials, on more than 2,000 patients with a recurring form of the disease, will last two years. The drug is being compared with a placebo and with Teva Pharmaceutical Industries' Copaxone, an approved treatment for the disease.

Biogen Idec sells the MS drugs Avonex, which is given as a once-a-week injection, and Tysabri, an infusion given once a month in a doctor's office or hospital clinic. About 1 million people worldwide suffer from MS.

© Copyright 2008 Globe Newspaper Company.

NEW LONG-TERM DATA SHOW THAT PATIENTS TAKING AVONEX® FOR UP TO 15 YEARS EXPERIENCE REDUCED DISABILITY PROGRESSION AND IMPROVED QUALITY OF LIFE

NEW LONG-TERM DATA SHOW THAT PATIENTS TAKING AVONEX® FOR UP TO 15 YEARS EXPERIENCE REDUCED DISABILITY PROGRESSION AND IMPROVED QUALITY OF LIFE

MONTREAL, CANADA - September 18, 2008 - Biogen Idec (NASDAQ: BIIB) today announced that data was presented from the ASSURANCE (ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs) study, showing the long-term benefits of AVONEX® (interferon beta-1a IM) therapy in patients with relapsing multiple sclerosis (MS) for up to 15 years. The ASSURANCE study represents the long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG), the original Phase III pivotal trial from which AVONEX was approved. Data from this study were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.


MONTREAL, CANADA - September 18, 2008 - Biogen Idec (NASDAQ: BIIB) today announced that data was presented from the ASSURANCE (ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs) study, showing the long-term benefits of AVONEX® (interferon beta-1a IM) therapy in patients with relapsing multiple sclerosis (MS) for up to 15 years. The ASSURANCE study represents the long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG), the original Phase III pivotal trial from which AVONEX was approved. Data from this study were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.

"As a physician, my goal in treating my MS patients is to delay disability progression and help them maintain their normal lifestyle for as long as possible," said Robert Bermel, MD, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic. "This follow-up study identifies a group of patients who achieved benefits from long-term treatment, and underscores the importance of starting on and continuing an effective therapy for MS."

The data from the study show that patients currently taking AVONEX for up to 15 years (range of 3 - 15 years) versus those not on AVONEX therapy reported:

* Significantly lower disability progression as measured by a mean change in Expanded Disability Scale Scores (EDSS) of 2.3 vs. 3.3 (p=0.011) from MSCRG baseline;
* Lower disability progression to EDSS milestones four (64% vs. 83%, p=0.06), six (32% vs. 62%, p=0.008) and seven (9% vs. 33%, p=0.008);
* Greater quality of life as measured by the physical component score of the SF-36 (p<0.0001);
* Significantly greater sense of independence in self care (p=0.0019); and
* Significantly more independent living (p=0.031).

ASSURANCE was an open-label, retrospective, patient-reported, multicenter, 15-year follow-up study that included patients with relapsing MS who received ≤ 2 years of treatment in the pivotal Phase III trial (n=172). One hundred thirty-six of a possible 172 patients enrolled in the study. Patients were categorized as current AVONEX users and non-AVONEX users. Forty-six percent of those patients were currently taking AVONEX, with median treatment duration of 13.3 years. Patients not currently on AVONEX were treated with a number of other disease-modifying therapies, with 24 percent of patients undergoing treatment with TYSABRI® (natalizumab).

"This level of impact on disability and quality of life over the course of 15 years reinforces the real-life benefits and proven clinical effectiveness of AVONEX," said Thorsten Eickenhorst, MD, Vice President of Global Medical Affairs, Biogen Idec. "We pride ourselves on providing a treatment that is not only efficacious now but will continue to offer patients the support they need for as long as possible."
About AVONEX

AVONEX is the most prescribed treatment for relapsing forms of MS worldwide, with more than 130,000 patients on therapy. It was launched in the U.S. in 1996 and in Europe in 1997 for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX has been proven effective in clinical trials for up to three years. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003.

The most common side effects associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain, and asthenia.

AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. For more information, visit www.AVONEX.com
About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

For more information contact:

Media Contacts:

Shannon Altimari
617-914-6524

Investor Contacts:

Eric Hoffman
617-679-2812

Europe assessing Tysabri brain disease reports

14 August 2008
Europe’s medicines agency yesterday said it is currently in the process of assessing the two additional reports of the rare brain disease progressive multifocal leukoencephalopathy in multiple sclerosis patients receiving Elan Pharma’s Tysabri (natalizumab).

The two cases reported at the end of July occurred in patients who had been receiving Tysabri for more than 12 months, but renewed old fears for investors and the firm’s share price – along with that of its US partner Biogen Idec – sank on the news. The Ireland-based firm crashed almost 75% - reflecting the sensitivity and importance of the medicine to its future prospects, though it was also impacted by concerns over its Alzheimer’s disease drug bapineuzumab being developed with Wyeth.

The agency has also asked Elan to provide any additional information it may have, at which point its scientific advisory panel will decide whether the medicine’s product labeling needs updating. Tysabri has been under intense scrutiny since it was reintroduced in the USA and approved in Europe two years ago – and these are the first new cases to surface since that time. It was originally withdrawn from the market in 2005 after three patients developed PML, but following its reintroduction has gone on to be a big earner – pulling in some $200 million in the second quarter of this year alone. Almost 32,000 patients were receiving Tysabri as of the end of June.

Most analysts do seem to remain convinced of the value of Tysabri – certainly the firms do not intend to withdraw the drug again, stressing the stringent safety monitoring programme in place.

Icahn takes stake in Biogen on Tysabri woes
And rather than backing off from the stock, maverick investor Carl Icahn has seen the dip in Biogen’s value as an opportunity to snap up some cut-price shares – increasing his stake in the company to 6% from 4.3%. All eyes are on his movements: earlier on this year he criticised the board for not looking hard enough to find a buyer as well as its decision to take down the ‘for sale’ sign in December last year month after no serious offers were made. He could be gearing up to push for another sale.

CARIS REITERATES SELL ON ELAN

On July 31, Biogen (BIIB) and Elan (ELN) reported two new cases of brain disease in multiple sclerosis [MS] patients treated with Tysabri. Caris analyst David Moskowitz says despite a number of PML reports in FDA's Adverse Events database, Elan continued to posture that these incidences were of no concern. In fact, he says the company's recent strategy has been to push drug aggressively.

Moskowitz says today's cases should not be a surprise. He believes that if the drug is not withdrawn from market, sales growth is likely to be severely hampered, given this news and the likelihood that more cases will emerge.

He cuts in-market sales estimates for the product to $781 million from $876 milion in 2009 and to $934 million from $1.39 billion in 2010. With his peak sales estimate for Tysabri declining from $3.6 billion to $1.34 billion, he lowers price target on shares from $15 to $9.

Tysabri Product Use Disclaimer

EDITORIAL COMMENTARY

August 1, 2008

As many of you know, and believe me, I am not patting myself on the back, I was an early opponent of Tysabri and was early in predicting the removal of Tysabri from the market in 2005.

As many of you also know, I was vehemently opposed to the FDA's decision to approve Tysabri, for re-introduction in the U.S., even with the so-called "black box label." The fact that European drug agencies had approved the drug for the treatment of multiple sclerosis (MS) did not provide me any comfort.

Please, please, take note of the following press release from Biogen-Idec and Elan, manufactures/marketers of Tysabri:

http://www.bloomberg.com/apps/news?pid=conewsstory&refer=conews&tkr=BIIB:US&sid=a40u7vb1OLaw

In short, progressive multifocal leukoencephalopathy has now been found among a small number - very small at this point - of patients taking the drug for MS. Many prominent neurologists - many whom I deeply respect - have been supporters of this "treatment." Again, despite this, I have remained adamantly opposed to the use of this drug.

Why? I am sorry. But the risk of developing a deadly brain virus, even if the manufacturers quantify the risk at very low percentages, just seems a bit too HIGH for me relative to a) the fact that MS, itself, is not deadly, and b) there are other options. AND, while those options are not yet perfect, there are several new drugs in late stage clinical trials, including oral medications, that so far are proving far more effective in treating MS.

Biogen-Idec and Elan state that they have no intention of voluntarily pulling Tysabri from the market - once again.

As the news report from Bloomberg, a major business news sources, reports, the companies still plan to have 100,000 people on Tysabri by 2010. However, as of today, the stock market has made the assumption, by dropping the prices of the stocks, that the market for Tysabri will soon evaporate. As, in my humble opinion, it should.

For far too long, people with MS and others diseases, have been used as a guinea pig population, with the FDA permitting companies to rush new compounds to market. There is a trade-off here. I understand that. People want treatments. They want effective treatments. Many people that suffer from diseases such as MS want new treatments because they feel increasingly feel frustrated - and rightly so (being one of them) - with the persistent march of their illnesses and the negative impacts on the quality of their lives.

I understand all of that. I also understand that two pharmaceutical companies, Merck and Pfizer, that have performed clinical trials on very inexpensive drugs - statins - for the potential treatment of MS, seem to have no interest in pursuing the MS market with those soon-to-be off patent protection Pfizer's Lipitor), or already off patent protection (in the case of Merck's Zocor/simvastatin) drugs. After all, the MS market is far more lucrative if you can offer a new drug for $2,000 - $4,000 monthly instead of $23 - $100 a month. Keep in mind, in the U.S., there are only about 400,000 known cases of MS. So it's not a huge market.

I hope that you can take time to pass this Tysabri news on to people that may be interested.

Let me see. The possibility of death vs. living with MS. For me, however small the risk of progressive multifocal leukoencephalopathy, I will happily live with MS.

Sincerely,

Cary J. Polevoy

Biogen, Elan stand by MS drug after illnesses

The Associated Press
Published: August 1, 2008


NEW YORK: Biogen Idec Inc. and Elan Corp. defended their multiple sclerosis drug Tysabri on Friday after reporting two new cases of a potentially fatal side effect, saying the treatment is still worth the risk to patients.

There are no plans to pull the drug off the market, and the company said its current monitoring program for cases of a rare but sometimes fatal brain disorder is adequate.

The announcement of two new cases of the rare viral infection called progressive multifocal leukoencephalopathy, or PML, sent shares for both companies plummeting and reignited already simmering concerns about the drug's sales potential. It was pulled from the market in 2005 after being linked to the rare brain disease but was reintroduced under restricted sales conditions in mid-2006.

"These cases underscore the importance of continued clinical vigilance so PML can be discovered and managed appropriately," said Dr. Cecil B. Pickett, president of research and development at Biogen.

He and several other executives tried to allay concerns over additional cases during a conference call with financial investors and analysts Friday morning. The company said it would also hold calls with several physician and patient groups.

The risks associated with the drug are clearly labeled, the company said, and all patients are not only notified but have to sign a waiver acknowledging the risks. PML almost always occurs in people with a severe immune deficiency, as is the case with most patients taking Tysabri.

Multiple sclerosis is an autoimmune disorder that results in physical and neurological damage.

There are about 32,000 patients on Tysabri worldwide, with 17,800 in the U.S., the company said. It would not comment on its financial outlook, but did say future cases of Tysabri were anticipated and factored into the goal of eventually getting the drug to 100,000 patients worldwide.

The companies maintain the drug still has a favorable risk-reward profile, meaning it is more helpful than hurtful, and monitoring programs are set up in the U.S. and Europe to catch any potential cases of PML early. Those systems rely on physicians to test for the condition if they start to see symptoms. Biogen and Elan would not comment the number of suspected cases, only confirmed cases.

Both new cases came out of European, with the first patient having been on Tysabri for 17 months. Another, who is still hospitalized, had been on Tysabri for 14 months. Still, the company said it can count about 6,600 patients on the drug for about 18 months now, reinforcing its stance that the treatment is worth the risk.

Food and Drug Administration officials could not immediately be reached for comment as of Friday morning.

The broader market, meanwhile, remains concerned over the impact on sales, which nearly tripled to $200 million during the second-quarter. The treatments costs about $30,000 per year.

"We do not believe that Tysabri will be withdrawn, based on this data, but it is likely to spook investors as the true rate of PML in Tysabri monotherapy is unknown," Goldman Sachs analyst Stephen McGarry said in a note to Elan investors.

Shares of Cambridge, Massachusetts-based Biogen fell to $50.28, their lowest point in more than a year, while shares of Ireland-based Elan fell to $10.67, their lowest point in nearly three years.

Biogen, Elan Report Brain Infection in Tysabri Users

By Tom Randall

July 31 (Bloomberg) -- Biogen Idec Inc. and Elan Corp. reported two confirmed cases of a deadly brain infection in patients taking the multiple sclerosis drug Tysabri, the first since the drug was reintroduced in the U.S. in 2006.

The report sent shares of both companies tumbling. The two patients were in the European Union, Biogen said today in a regulatory filing. The cases of the disease, progressive multifocal leukoencephalopathy, were confirmed this week, according to the company's statement.

Biogen and Elan voluntarily pulled the drug from the market in February 2005 after three patients unexpectedly contracted the disease, which caused two deaths. Tysabri was reintroduced in July 2006 in the U.S. and sold for the first time in the EU at the same time. One patient had been taking the drug for 17 months and the other took it for 14 months, Biogen said.

``This is going to be fairly disruptive to sales in the United States,'' said Mark J. Schoenebaum, an analyst with Deutsche Bank Securities in New York, by telephone. ``There is a real fear of the unknown here, and I think some patients and physicians are going to take a drug holiday'' until the company discloses more details.

More than 31,800 multiple sclerosis patients use Tysabri, Biogen spokeswoman Naomi Aoki said. About 14,000 patients have taken Tysabri for more than a year, and 6,500 patients have taken it for 18 months or longer.

Anticipated Cases

``We've said ever since the reintroduction that we anticipate seeing additional cases,'' Aoki said today in a telephone interview. ``Withdrawing the drug is not under consideration.''

The condition was included in the prescribing information on the drug as a possible side effect in 1 of every 1,000 patients taking the drug, Aoki said. One patient is clinically stable and is at home, Biogen said. The other patient is hospitalized.

The shares of Biogen, which is based in Cambridge, Massachusetts, fell by $14.06, or 20 percent, to $55.60 at 7:20 p.m. New York time, after the close of regular trading on the Nasdaq Stock Market. American depositary receipts of Elan, which is based in Dublin, fell by $7.98, or 39 percent, to $12.07. Each receipt equals one ordinary share.

``We expect the stock to open sharply down on Friday, but would not be buyers as we think investor sentiment could continue to weaken,'' Schoenebaum said in a note.

Goal of 100,000 Patients

On July 22, Biogen reported second-quarter net income rose 11 percent to $207 million on sales of Tysabri, its fastest- growing treatment. Biogen has estimated 100,000 patients will be taking Tysabri by 2010, a goal critical to the company's future growth, Thomas Weisel analyst Ian Somaiya said in a note to clients at the time.

Tysabri was approved in the U.S. in January to treat Crohn's disease, an inflammatory intestine and bowel disorder.

Shares of Elan, Ireland's biggest drugmaker, already were battered this week after Wyeth and Elan's experimental treatment for Alzheimer's disease, bapineuzumab, was linked in a study to a brain-swelling side effect.

To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net
Last Updated: July 31, 2008 19:29 EDT

BIOGEN IDEC AND ELAN PRESENT NEW TYSABRI® DATA AT THE 60th ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide

Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years

Chicago, IL - April 15, 2008 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI® (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN).

"These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.

"Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.

According to data available as of the end of March 2008:

In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;

Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;

In global clinical trials, more than 600 patients were on TYSABRI therapy; and

There have been no cases of PML since re-launch in the US and launch internationally in July 2006.

Cumulatively, in the combined clinical trial and post-marketing settings:

More than 36,700 patients have been treated with TYSABRI; and

Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.

TYSABRI is available in the U.S. through the TOUCH™ Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.

The abstract for this study, "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH™ and TYGRIS" (Presentation #S02.002), is available online at the AAN's Web site.

TYSABRI Increases the Proportion of MS Patients Considered Disease Free
Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. In the studies, the proportion of patients considered disease free over two years was significantly higher in the TYSABRI-treated group compared with the placebo group, regardless of how disease free was defined.

Clinically, disease free was defined as no relapses and no progression of disability (as defined by >1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of >1.0, or a >1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.

"The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.

In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free. Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS.

The abstract for this study, "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), is available online at the AAN's Web site.

About TOUCH™ and TYGRIS
Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.

TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.

Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.

About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.

TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. 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 be unable to adequately address concerns or questions raised by the 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, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market. 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.

Biogen Idec Important Information
Biogen Idec and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. Information concerning the interests of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. In addition, Biogen Idec files annual, quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy statements and other reports, when available, can be obtained free of charge at the SEC's web site at www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully any proxy statement filed in connection with the Company's 2008 annual meeting of stockholders when it becomes available before making any voting or investment decision. The Company's proxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at info@innisfreema.com.


For more information contact:

Media Contacts:
Biogen Idec
Shannon Altimari
617-914-6524

Elan
Jonathan Birt
212-850-5664

Elizabeth Headon
+ 353 1 498 0300

Investor Contacts:
Biogen Idec
Eric Hoffman
617-679-2812

Elan
Chris Burns
+ 353 1 709 4444
800-252-3526

Biogen's Tysabri to get liver warning in Europe

Thursday, March 20, 2008 - 2:57 PM EDT

On the heels of a similar decision by the U.S. Food and Drug Administration, European regulators have concluded that patients should be warned about possible liver damage related to the Biogen Idec drug Tysabri.

Tysabri, which Massachusetts-based Biogen Idec (Nasdaq: BIIB) makes at a facility in Research Triangle Park, is a drug used to treat multiple sclerosis.

On Feb. 27, Biogen and its Irish partner on Tysabri, Elan Corp., posted a letter to the FDA's Web site. The letter, addressed to doctors, says patients have developed signs of liver injury as soon as six days after taking their first dose of the drug. It tells doctors that they need to monitor Tysabri patients for potential liver damage and warn them about the risk.

Now, the European Medicines Agency is addressing the issue. In a statement Thursday, it also says that Tysabri patients need to be monitored for and warned about liver damage.

Tysabri is Biogen's fastest-growing drug. It was pulled from the market in 2005 after it was linked to a rare but fatal brain infection. U.S. regulators allowed it to return under a monitoring program in 2006, however, after they decided that the drug's effectiveness outweighed its risks.

EMEA says Elan and Biogen's Tysabri should carry liver injury warnings

03.20.08, 12:44 PM ET

LONDON (Thomson Financial) - The European Medicines Agency EMEA has announced the labels for Elan and Biogen's Tysabri should include warnings about liver injury on its product information.

The EMEA's Committee for Medicinal Products for Human Use has requested that Elan (nyse: ELN - news - people ), the marketing authorisation holder for Tysabri, submits a variation to the marketing authorisation to implement these changes.

Last month Elan and Biogen announced some patients suffered liver injury after taking the multiple sclerosis treatment.

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Biogen Idec CEO predicts more brain disorders in Tysabri patients

Tuesday, March 18, 2008

The CEO of Biogen Idec told investors Tuesday that he expects to see more cases of a rare, fatal brain disorder in patients taking the drug Tysabri, Reuters reported Tuesday.

But James Mullen, the executive, thinks the problems are unlikely to create more regulatory problems for Tysabri, a multiple sclerosis drug pulled temporarily from the market in 2005 thanks to the brain disease.

James Mullen told investors that "we anticipate there will be some additional cases of PML," according to Reuters. PML is the abbreviation for the brain infection seen in two Tysabri patients three years ago. Biogen Idec (Nasdaq: BIIB), which makes the drug at a facility in Research Triangle Park, voluntarily pulled the treatment from the market.

Tysabri has since returned under a patient-monitoring program, however, with no new cases of PML. Biogen hopes to make it a blockbuster, billion-dollar drug by 2010.

New cases of PML in Tysabri patients could "create a lot of excitement in the short term given the history of this product," Reuters reported Mullen as saying. But the Biogen chief added that he would see "no regulatory problems." Many patients take Tysabri despite its risks because the drug is highly effective.

Biogen co-markets Tysabri with Elan Corp. of Ireland.

Contact the Editor Need Assistance? More Latest News

Biogen's Tysabri May Cause Liver Injury, U.S. Says (Update2)

By Luke Timmerman and Catherine Larkin

Feb. 27 (Bloomberg) -- Biogen Idec Inc. and Elan Corp.'s multiple sclerosis medicine Tysabri may cause significant liver injury within six days of the first dose, U.S. regulators said.

Patients should stop taking Tysabri if they develop jaundice or other symptoms of liver injury, according to a letter to doctors from the drugmakers that was posted today on the Food and Drug Administration's Web site. Doctors should warn patients about the drug's liver risk, the FDA said.

Tysabri, Biogen's fastest-growing product, generated $129 million in worldwide sales in the fourth quarter and was being taken by 21,000 patients at year-end, according to Biogen. The companies pulled the drug from the market in February 2005 because two patients developed fatal brain infections. The drug was reintroduced in July 2006 after the FDA decided the benefits in slowing multiple sclerosis relapses outweighed the risks.

``At Biogen and Elan, patient safety is our highest priority,'' the companies said in the letter to physicians that is dated this month. ``We are committed to ensuring that health- care professionals continue to receive the necessary information to prescribe Tysabri appropriately.''

Biogen fell 76 cents, or 1.2 percent, to $60.77 at 12:59 p.m. New York time in Nasdaq Stock Market composite trading, after touching $57.95. That 5.8 percent decrease would be the biggest drop in more than two months. The stock has gained 30 percent in the 12 months before today. Elan climbed 11 cents, to 16.59 euros in Dublin trading.

The companies, which market the product together, issued the warning letter after patients developed unusually high levels of liver enzymes in the blood, a sign of liver injury, according to the letter. The injury recurred in some patients after they were given another dose of the drug, ``providing evidence that Tysabri caused the injury,'' according to the letter.

Previous Reports

In July, the FDA cited 28 cases of liver injury associated with Tysabri since November 2004, four of them potentially serious. Elan spokesman Andrew Lewis said at the time the cases were from ``post-marketing experience.'' Tysabri won an additional approval for Crohn's disease in January, after the FDA considered the liver injuries.

Revised prescribing information approved in January includes the liver risks.

Biogen is counting on sales of Tysabri to fuel its growth. The company said this month that it expects 100,000 patients to be taking Tysabri by the end of 2010, which translates to about $2.8 billion in annual sales at current prices.

Biogen is based in Cambridge, Massachusetts. Elan is based in Dublin, Ireland.

To contact the reporters on this story: Luke Timmerman in San Francisco at +1- ltimmerman@bloomberg.net ; Catherine Larkin in Washington at clarkin4@bloomberg.net .

Multiple Sclerosis Drug May Be Linked to Melanoma

Doctors report 2 cases of the deadly skin cancer developing in patients taking Tysabri

By Amanda Gardner
Posted 2/6/08

WEDNESDAY, Feb. 6 (HealthDay News) -- Almost immediately after a 46-year-old woman with multiple sclerosis received her first dose of the drug Tysabri, a mole that had been on her shoulder for years suddenly took on a dangerous new character.

It turned out to be a melanoma that spread like wildfire. The woman now has just a few months to live.

At almost the same time, a 45-year-old woman who also has multiple sclerosis developed melanoma in her retina after receiving several doses of Tysabri. She had a family history of melanoma and also had atypical moles on her body; the mole on her retina went back at least nine years.

Although these are just two -- albeit dramatic -- examples, the authors of a letter in the Feb. 7 issue of the New England Journal of Medicine are cautioning doctors who care for MS patients to keep this potential risk in mind.

"Neurologists who have patients who report a family history of melanoma or have funny moles should send them to a dermatologist first. Don't just start them on drugs [Tysabri]," said Dr. John Thomas Mullen, co-author of the letter and a surgical oncologist with Beth Israel Deaconess Medical Center, in Boston.

"I can't say it's cause-and-effect definitively because it's just an observation, but the first patient had had that mole forever. She took the drug and almost instantaneously the lesion changed," added Mullen, who saw both patients.

"We don't know if the two are related right now," said Patricia O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society. "There are so many people taking Tysabri, we should go forward with caution... One should always consult with their doctor and go over their personal family history and decide what is best."

Tysabri (natalizumab), a monoclonal antibody that helps treat autoimmune disorders such as MS and Crohn's disease, has had a clouded history. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.

In June 2006, the FDA allowed the drug back on the market but with strict conditions governing its use.

Just last month, the FDA approved Tysabri to treat people with a moderate to severe form of Crohn's disease.

But there is basic science to support Mullen's observations.

One of the participants in an earlier study of Tysabri had developed (and subsequently died of) a metastatic melanoma that appeared as soon as he got his first dose of the drug, Mullen said.

And in a study done before Tysabri received FDA approval, melanomas in mice that were given the drug had an increased tendency to detach from the primary tumor and spread.

Tysabari may have a dampening effect on the immune system that encourages the formation of the potentially deadly skin cancer, the letter stated.

And now that Tysabri has been approved for people with Crohn's disease, more people may be at risk, although those with no family history of melanoma and no moles probably don't need to worry, Mullen said.

"Doctors should ask for a family history of melanoma and do a quick skin check," he said. "Tysabri isn't the only drug in our arsenal. You could give the patient something else if you were concerned about that."


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