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 Biogen and Elan had voluntarily withdrawn the drug a year earlier after three patients developed the brain infection.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 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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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.

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

NEW TYSABRI® DATA TO BE PRESENTED AT THE EUROPEAN COMMITTEE FOR TREATMENT AND RESEARCH IN MULTIPLE SCLEROSIS

Study Shows Increased Proportion of Patients Achieve Disease-Free Status with TYSABRI

Separate Study Demonstrates Plasma Exchange May Be an Effective Tool to Accelerate TYSABRI Removal

Prague, Czech Republic - October 11, 2007 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that TYSABRI® (natalizumab) treatment significantly increases the proportion of disease-free patients with multiple sclerosis (MS) according to a post hoc analysis of the Phase III AFFIRM study to be presented on Saturday, October 13, 2007 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic. Also to be presented on Saturday will be findings from the PLEX study which suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from the circulation.

Post Hoc Analysis of Phase III AFFIRM Study
The proportion of disease-free patients in the AFFIRM study was determined based upon clinical and MRI criteria. The proportion of disease-free patients 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 and no new or enlarging T2-hyperintense lesions.

Using clinical and MRI disease-free criteria combined, the most stringent definition of disease free, 36.7% of TYSABRI-treated patients had no relapses, disability progression or MRI activity compared with 7.2% of placebo patients (p<0.0001). In the clinical analysis, 64.3% of TYSABRI-treated patients vs. 38.9% placebo-treated patients(p<0.0001) were disease free or without relapses and disability progression. Using MRI measures, 57.7% of TYSABRI-treated patients vs. 14.2% placebo-treated patients (p<0.0001); were disease free, or without gadolinium-enhancing lesions and new or enlarging T2-hyperintense lesions.

"These data demonstrate the dramatic effect TYSABRI can have on critical measures of multiple sclerosis. In addition to the impact on individual clinical and MRI outcomes, it is striking that more than one-third of patients were free of relapses, disability progression and MRI activity after two years of treatment. This suggests that TYSABRI may offer patients freedom from many of their MS symptoms," said Eva Havrdová, MD, PhD, Director of the Center for Demyelinating Diseases at the First School of Medicine, General University Hospital, Charles University, Prague, Czech Republic.

PLEX Plasma Exchange Study
Results from the PLEX study also to be presented suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from blood serum. Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy (PML), a rare side effect of TYSABRI.

"These data from the PLEX study are encouraging as they show the removal of TYSABRI is faster following plasma exchange. Time will tell whether plasma exchange develops as an effective treatment approach for PML," said Bhupendra O. Khatri, MD, Medical Director of the Regional MS Center, Aurora St. Luke's Medical Center, Milwaukee, WI.

PLEX is an open-label, single-arm, multicenter exploratory study involving 12 patients with relapsing-remitting MS designed to explore whether plasma exchange could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation. Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of serum TYSABRI concentrations.

Plasma exchange was generally well tolerated with no increase in MS disease activity following plasma exchange. There were no study discontinuations due to adverse events and all patients returned to TYSABRI treatment without complications. Further investigations are needed to determine whether plasma exchange holds promise as an intervention in the setting of PML.

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 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.

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 and the PLEX study. 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 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 hurdles. 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.


For more information contact:

Media Contacts:
Biogen Idec

Amy Reilly
Ph: 617 914 6524

Elan

Jonathan Birt
Ph: 212 850 5664

Elizabeth Headon
Ph: 353 1 498 0300

Investor Contacts:
Biogen Idec

Eric Hoffman
Ph: 617 679 2812

Elan

Chris Burns
Ph: 353 1 709 4444
800 252 3526

No new brain infection cases with MS drug Tysabri

BOSTON, Aug 28 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) said on Tuesday that as of mid-July there have been no new reported cases of a potentially deadly brain infection in patients taking its multiple sclerosis drug Tysabri.

The Cambridge, Massachusetts-based biotechnology company made the disclosure as part of a slide presentation for a conference in Belgium.

According to the slide, there have been no new reports of progressive multifocal leukoencephalopathy, or PML, a rare brain disease since mid-July, which means there have been no new reports of the disease since the drug was reintroduced to the market a year ago. Tysabri, developed with Irish drugmaker Elan Corp. (ELN.I: Quote, Profile, Research), was taken off the market in 2005 after being linked with three cases of the infection. The U.S. Food and Drug Administration allowed the drug back last July because it is effective and patients asked for it to be returned.

Through mid-July, 2007, there were about 14,000 patients taking Tysabri worldwide, of which roughly 12,900 were commercial patients and 1,000 clinical trial patients.

Tysabri is available in the United States through a safety-monitoring program known as TOUCH. All prescribers, infusion sites and patients are required to enroll in the program, which is designed to monitor patients for any signs or symptoms of PML.

(Reporting by Toni Clarke)

((Editing by Dave Zimmerman, Reuters Messaging, toni.clarke.reuters.com@reuters.net, 617-367-4165)) Keywords: BIOGEN TYSABRI

(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN28232161

Elan and Biogen Idec Preparing to Appeal Ruling on European Application for Natalizumab for the Treatment of Crohn's Disease

DUBLIN, Ireland & ZUG, Switzerland--(BUSINESS WIRE)--Jul 19, 2007 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.

"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."


An application for approval of TYSABRI(R) (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.

About Crohn's Disease

Approximately one million people worldwide have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications.

Crohn's disease can have a devastating impact on the lifestyle of patients, many of whom are young and active. Currently there is no medical or surgical cure for Crohn's disease. Many patients fail to respond to current therapies, including biological therapies such as agents that inhibit tumor necrosis factor alpha (TNF-alpha). Due to this failure of current therapies in CD, therapies that have novel biological targets are required.

About TYSABRI(R) (natalizumab)

TYSABRI is a treatment approved for relapsing forms of multiple sclerosis (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 (pless than0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (pless than0.001).

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), infections, depression and gallstones. 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.

TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.

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: http://www.biogenidec.com

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding TYSABRI. The commercial potential and regulatory path forward of TYSABRI are 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 concerns may arise from additional data or analysis or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to obtain approval for TYSABRI as a treatment for Crohn's disease. 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 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.

Contact

Media:
Biogen Idec
Jose Juves, +41 41 3921860
Amy Reilly, +1 617-914-6524
or
Elan
Elizabeth Headon, +353 1 498 0300
Matt Dallas, +1 212-850-5664
or
Investor:
Biogen Idec
Eric Hoffman, +1 617-679-2812
or
Elan
Chris Burns, +353 1 709 4444/+1 800 252 3526

U.S. Regulators to Review Tysabri for Crohn's Disease

Associated Press

DUBLIN, Ireland -- Elan Corp. and Biogen Idec Inc., co-makers of Tysabri, announced Tuesday that U.S. regulators soon would review the drug for its possible use by sufferers of the gastrointestinal Crohn's disease.

Both companies said two review committees of the U.S. Food and Drug Administration would jointly consider July 31 whether to permit sale of Tysabri to treat Crohn's, which causes chronic but nonfatal inflammation of the intestines and afflicts one million people world-wide.

Clinical trials of Tysabri -- which last year was approved for use in the United States and European Union to combat the most advanced cases of multiple sclerosis _ have indicated that the drug is effective in preventing inflammatory immune cells from penetrating the wall of the intestine, limiting the damage they can cause.

Tysabri's use for MS patients has been heavily restricted because of its link to a rare, usually fatal disease of the central nervous system called progressive multifocal leukoencephalopathy, or PML. Both companies temporarily withdrew the drug from sale in February 2005 after three patients in clinical trials contracted PML; two, including a Crohn's sufferer, died.

Elan of Dublin, Ireland, and Biogen Idec of Cambridge, Mass., in December applied for FDA approval of Tysabri for Crohn's sufferers.

The disease most commonly develops in people in their teens and 20s and has no cure. It can cause diarrhea, abdominal cramps, fever and bowel obstructions, leading to lost appetite and weight.

The leading current treatment for Crohn's is Remicade, manufactured by Johnson & Johnson. Analysts say, if given FDA approval, Tysabri probably would be prescribed only to those Crohn's sufferers who were not responding to treatment from longer-established, lower-risk drugs.

Copyright © 2007 Associated Press