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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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 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, 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.

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

Teva Pharmaceutical's Altered Peptide Ligand Copaxone Boasts the Greatest Patient Share Among First- and Second-Line Therapies for the Treatment of Mu

WALTHAM, Mass., March 11 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Teva Pharmaceutical's Copaxone has the greatest patient share among first- and second-line therapies, and falls short of Merck Serono/Pfizer's Rebif (by 0.2 percent) in third-line treatment. However, in all three lines of therapy, the interferon-beta drug class (Biogen Idec's Avonex, Rebif, and Berlex's Betaseron) outpaces the altered peptide ligand drug class (consisting only of Copaxone) in patient share. Competition between the two drug classes is fiercest in first-line therapy.

"The low volume of patient share attributed to Avonex or Rebif compared with Copaxone in first- and second-line treatment illustrates a significant delay on the part of physicians and/or patients to engage in an interferon- beta therapy within a year of a patient's initial diagnosis for multiple sclerosis," said Madhuri Borde, analyst at Decision Resources. "However, the magnitudes of Rebif's first- and second-line patient shares suggest that some physicians are treating the disease more aggressively than might be expected, as this high-dose, high-frequency agent reaches patient shares close to and surpassing Avonex in first- and second-line treatment, respectively."

According to the new report entitled Treatment Algorithms in Multiple Sclerosis, neurologists note that Copaxone's better short-term and long-term side-effect/safety profile, together with its lower rate of induction of neutralizing antibodies, are critical reasons for choosing Copaxone instead of Avonex, Rebif and Betaseron. Although Copaxone is administered daily, 23-28 percent of neurologists we surveyed indicate that a key reason to prescribe the drug over any of the interferon-beta therapies is the drug's ability to foster greater patient compliance, an attribute that is closely tied to the Copaxone's lower incidence of flulike side effects.

About Treatment Algorithm Insight Series
Decision Resources combines in-depth primary research with the most extensive claims-based longitudinal patient-level data from PharMetrics(R) to provide exceptional insight into physicians' prescribing trends and the factors that drive therapy product choice, from diagnosis through multiple courses of treatment, for a specific disease.

For each disease examined, Decision Resources' Treatment Algorithm Insight Series provide the following:

-- Summary of U.S. medical practice based on interviews with leading experts in the field. -- Qualitative diagnosis/referral/treatment algorithm for the United States. -- Drug usage by lines of therapy (1st, 2nd, 3rd line). -- Discussion of key freeform combinations by lines of therapy. -- Product share (class and specific compound level) within each line of therapy (1st, 2nd, 3rd line). -- Progression of therapy from key 1st line products. -- Pathway to key therapies from previous therapies. -- Qualitative analysis of two-year forecast incorporating upcoming launches, changes in reimbursement, etc.

About Decision Resources
Decision Resources, Inc., (http://www.decisionresources.com/) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact: Elizabeth Marshall Decision Resources, Inc. 781-296-2563 emarshall@dresources.com
Decision Resources

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 .

BIOGEN IDEC AND ELAN PROVIDE UPDATE ON UTILIZATION, SAFETY AND TOTAL PATIENT EXPOSURE OF TYSABRI® IN PATIENTS WITH MULTIPLE SCLEROSIS

More than 21,000 patients on commercial and clinical therapy worldwide

Cambridge, MA and Dublin, Ireland - January 7, 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 late December 2007, more than 21,000 patients were on commercial and clinical therapy worldwide. To date, the safety data continue to support a favorable benefit-risk profile for TYSABRI. These data will be presented today at 4:00 p.m. PST at the 26th Annual JPMorgan Healthcare Conference in San Francisco.

According to data available to the companies as of late December 2007:

In the US, approximately 12,900 patients were on TYSABRI therapy commercially and approximately 2,500 physicians have prescribed the therapy;
Internationally, approximately 7,500 patients were on TYSABRI therapy commercially;
In global clinical trials, approximately 700 patients were on TYSABRI therapy; and
There have been no cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and launch internationally in July 2006.
In addition, as of mid-December 2007:

Cumulatively, in the combined clinical trial and postmarketing settings, up to 30,900 patients have been treated with TYSABRI; and
Of those patients, up to 6,300 have received at least one year of TYSABRI therapy.
TYSABRI is available in the United States through the TOUCH™ Prescribing Program. All US 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.

About TOUCH and TYGRIS
Before initiating treatment, all US 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 3,000 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 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 for MS 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. 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.


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

Drug Combo With Antibiotic May Slow MS Progression

MONDAY, Dec. 10 (HealthDay News) -- Combining an antibiotic with a medication currently used to treat multiple sclerosis may slow progression of the disease, according to researchers at the Louisiana State Health Sciences Center in Shreveport.
Their study included 15 patients (average age 44.5) with relapsing-remitting MS who'd been taking interferon for at least six months and were experiencing symptoms and developing new brain lesions.

For four months, the patients took 100 milligrams daily of the antibiotic doxycycline in addition to their interferon therapy. During the study, they had monthly neurological examinations, MRI brain scans and blood work.

At the end of the four months, 60 percent of the patients had a more than 25 percent reduction in the number of brain lesions. Patients also had lower disability scores. One patient relapsed. Side effects were mild and included only the known side effects of the two drugs individually, rather than side effects caused by combining the two medications, the researchers said.

The study, funded by Biogen Idec Inc., was posted online Dec. 10 and will be published in the February 2008 print issue of the Archives of Neurology.

"There is a growing interest in combination therapy in patients with MS to stabilize the clinical course, reduce the rate of clinical relapses and decelerate the progressive course of the underlying pathologic mechanism," the study authors wrote. "Overall, data from this cohort suggest that the treatment combination of oral doxycycline and interferon beta-1a may be safe and effective in some patients with MS; however, further controlled clinical trials are warranted to demonstrate safety and efficacy in a larger patient population."

Simvastatin Does Not Antagonize Interferon-Beta, Interim Analysis Suggests CME

News Author: Thomas S. May
CME Author: Laurie Barclay, MD


October 15, 2007 (Prague, Czech Republic) — An interim analysis of the Simvastatin as an Add-on Treatment to Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis (SIMCOMBIN) trial has found that simvastatin does not block the anti-inflammatory effect of interferon-beta (IFN-beta) when both of these drugs are taken together by patients with multiple sclerosis (MS).

Results of the interim analysis were presented here by lead investigator Per Soelberg Sørensen, MD, from Copenhagen University Hospital, Righospitalet, Denmark at the 23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS).

Rationale for the Study

SIMCOMBIN is an ongoing double-blind, placebo-controlled, randomized, parallel-group, phase 4 study designed to determine if there is any benefit to adding simvastatin to IFN-beta-1a (Avonex, Biogen Idec) in patients with MS. This large, multicenter trial began in February 2006 and is planned to be complete in November 2009.

"Why combine interferon-beta with statins?" Dr. Sorensen asked rhetorically, as he began his presentation. The reason for this, he said, is that statins are potent immunomodulators and have been found to be beneficial in several studies involving animal models of MS. One small, open-label study using human subjects with relapsing-remitting MS reported a more than 40% reduction in both the number and volume of gadolinium-enhancing lesions, after they were treated with simvastatin 60 mg daily for 6 months, he noted.

The main reason for conducting the interim analysis was because of a presentation of a double-blind, placebo-controlled study of atorvastatin in combination with IFN-beta-1a, presented by Gary Birnbaum, MD, from the University of Minnesota, during this year's annual meeting of the American Academy of Neurology (AAN), Dr. Sorenson said. That study reported an increase in the combined composite endpoint of new and enhancing magnetic resonance imaging (MRI) lesions and/or relapses in patients receiving IFN-beta plus atorvastatin vs those receiving IFN-beta plus placebo.

The authors of that study hypothesized that these results might be because statins block the anti-inflammatory effect of IFN-beta. "So this urged us to do this safety analysis," Dr. Sorensen explained.

Safety Analysis

Among 61 patients that had been randomized in the SIMCOMBIN study by April 2007, the authors performed an interim safety study in 47 patients who had been treated for at least 3 months with either simvastatin 80 mg daily or placebo as add-on therapy to INF-beta-1a given intramuscularly at a dose of 30 µg weekly.

A subgroup of 27 patients underwent a safety MRI during May 2007 and an analysis of in vivo IFN-beta bioactivity. The primary outcome measure was IFN-beta bioactivity, as assessed by mRNA expression of the IFN-beta biomarkers MxA and TRAIL. Secondary outcome measures included the annualized relapse rate, time to first relapse, and gadolinium-enhancing lesion and new or enlarged lesions on T2-weighted MRI.

An analysis of the results showed that all 27 patients had a full in vivo response to IFN-beta in MxA and TRAIL mRNA expression studies. The mean observation time on therapy was 6.9 months. The annualized relapse rate in all patients was 0.36, which is comparable to relapse rates found previously in other patient populations treated with IFN-beta. Additionally, there was no statistically significant difference in the time to first relapse between the 2 treatment groups.

"These results led our data safety monitoring board to conclude that there are no safety concerns regarding the continuation of the trial as defined by the protocol, and we encouraged the steering committee to carry on the study as planned," Dr. Sorensen told the audience. "This recommendation was based on our own interpretation of the relapse and MRI data," he added.

Remove the Concern

This interim analysis "successfully removed a concern" regarding any potential antagonistic effects of simvastatin vs. IFN-beta, according to Roland Liblau, MD, PhD, from Toulouse University Hospital, France, who cochaired the session. "I think they did the job properly, and I think they removed the concern that statins might antagonize interferon beta and vice versa," Dr. Liblau told Medscape Neurology and Neurosurgery.

He cautioned, however, that the study is still ongoing, and no conclusions should be drawn on the efficacy of this approach.

"The interim analysis didn't show any significant difference between the 2 groups, but you don't expect at this stage to find differences," he said. "So, in terms of efficacy, we cannot conclude anything. This study was done to remove doubt, and I think the doubt has been removed properly."

Funding for this study was provided by Biogen Idec, maker of Avonex (INF-beta-1a).

23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis: Parallel Session 7 (85). Presented October 13, 2007.

New Data Suggests Progression of Disability at Two Years Predicts Multiple Sclerosis (MS) Disability Progression at Eight Years

Treatment with AVONEX(R) (Interferon Beta-1a) for Two Years Reduces Probability of Reaching More Severe Disability Milestones at Eight Years

PRAGUE, Czech Republic, Oct. 12 /PRNewswire/ -- A post-hoc analysis from a Phase III clinical trial of AVONEX(R) (interferon beta-1a) and post-randomization eight-year follow up shows that six-month sustained progression of disability at two years, using the Expanded Disability Status Scale (EDSS), is a significant predictor of long-term disability, as measured by EDSS milestones of 4.0, 5.0, 6.0 and 7.0 at eight years, in patients with relapsing-remitting multiple sclerosis (RRMS). The analysis suggests that patients taking AVONEX for two years were less likely to experience disability progression over time (eight years) when compared to placebo. These data were announced today at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Prague, Czech Republic.

The analysis involved 160 patients with RRMS who received at least two years of treatment (81 placebo, 79 interferon beta-1a), in the AVONEX Phase III trial and who were re-examined eight years post-randomization. 45 patients met the criteria for two-year disability progression sustained for six months (n=18 AVONEX, 27 placebo). The analysis revealed:

-- Patients initially treated with AVONEX were less likely than patients initially receiving placebo to progress to EDSS scores of greater than or equal to 4.0 at eight years
-- Six month sustained EDSS progression during the pivotal two-year trial was a significant predictor of disability progression eight years later
-- Almost twice as many patients who had sustained progression in EDSS during the two-year trial progressed to an EDSS of greater than or equal to 4.0 than patients who did not progress (84% sustained, versus 44% unsustained)
-- Almost three times as many progressed to an EDSS of greater than or equal to 6.0 (67% sustained, versus 24% unsustained)

"This new analysis presents further evidence that patients who are treated for two years achieve long-term, clinically significant disability benefits," said Dr. Richard Rudick, vice-chairman of Neurological Institute at the Cleveland Clinic Foundation. "For a person with RRMS, starting and staying with treatment slows disability progression, as measured by EDSS."

EDSS is a common disability outcome measure that is used in multiple sclerosis clinical trials. EDSS greater than or equal to 4.0 signifies relatively severe disability, such as impacting physical coordination or the ability to walk without assistance.

AVONEX is the number one prescribed treatment for relapsing forms of multiple sclerosis (MS) worldwide, and is the only once-a-week MS therapy that is effective after the first attack. AVONEX is also proven to slow the progression of physical disability (as shown by 37% reduction over two years) and reduce the number of relapses. AVONEX has been proven effective
in clinical trials for up to three years.

This study was funded by Biogen Idec.

About AVONEX

AVONEX is the number one 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 later in Europe 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.

Please see complete prescribing information available at http://www.AVONEX.com.

PHASE 2 DATA SHOW DACLIZUMAB SIGNIFICANTLY REDUCED MULTIPLE SCLEROSIS LESIONS IN PATIENTS RECEIVING INTERFERON BETA THERAPY

Phase 2 monotherapy trial to be initiated by end of 2007

Prague, Czech Republic, October 11, 2007 -- Biogen Idec Inc. (Nasdaq: BIIB) and PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) announced today that Phase 2 data demonstrated a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy in patients with active relapsing multiple sclerosis (MS). These data will be presented tomorrow at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

The ongoing Phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial, studies MS patients who continue to have active MS disease while receiving interferon beta therapy. The study patients who received daclizumab 2 mg/kg subcutaneously every two weeks showed a statistically significant 72% reduction in the number of new or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to patients on interferon beta therapy alone. Patients from the CHOICE study were followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.

"Patients who received daclizumab every two weeks experienced far fewer new or enlarged gadolinium-enhancing lesions than the control group, which indicates that the antibody may be a promising option for patients with MS," said Dr. Xavier Montalban, Director of the Unit of Clinical Neuroimmunology at the Hospital Val D'Hebron in Barcelona, Spain. "In addition, we were encouraged to see a trend in the reduction of the number of relapses, or exacerbations, that these MS patients experienced. Further study is warranted."

Daclizumab is a humanized monoclonal antibody that targets the IL-2 receptor on activated T cells. Biogen Idec and PDL plan to initiate the SELECT study, a Phase 2 trial of daclizumab alone in the same relapsing patient population, by the end of 2007.

"We are very pleased to see positive results from the CHOICE study, the first randomized trial of daclizumab in patients with relapsing MS," said Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. "We recognize how monoclonal antibodies have changed modern medicine and see great potential in their ability to treat serious diseases, including cancer and select immunological diseases such as MS. We're very excited to move development of daclizumab forward with our partner Biogen Idec, the acknowledged leader in the MS field."

"Daclizumab represents an exciting opportunity within our growing MS portfolio," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. "MS is a complex disease that requires an arsenal of treatment options for patients. We look forward to advancing the daclizumab development program and initiating the SELECT trial by the end of the year."

Study Results
The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks, or placebo added to ongoing interferon beta treatment.

The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.

Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.

Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.

PDL and Biogen Idec entered into a collaboration agreement in 2005 to co-develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.

About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About Daclizumab
Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune-related diseases. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax under a license from PDL. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. To conduct the CHOICE study, PDL prepared a high concentration formulation of Roche-produced daclizumab for subcutaneous administration. PDL has also developed a high yield manufacturing process and formulation for subcutaneously delivered daclizumab, which is in clinical development for MS by PDL and Biogen Idec. PDL has retained the rights for development of daclizumab for asthma and transplant maintenance.

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 PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. For more information, please visit www.pdl.com.

Forward-looking Statement
This press release contains "forward-looking statements" regarding PDL and Biogen Idec's development of daclizumab that are based on current expectations and assumptions that are subject to risks and uncertainties. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from PDL and Biogen Idec's current expectations include the risk that preliminary results observed in the Phase 2 trial known as CHOICE are based on week 24 data and may not be predictive of the results that would be observed upon review of the full set of data PDL and Biogen Idec plan to obtain through week 72. In addition, these preliminary results may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate daclizumab to be safe and effective in the treatment of patients with relapsing MS, nor can there be assurance that PDL or Biogen Idec will initiate subsequent clinical trials of daclizumab, including the Phase 2 monotherapy trial known as SELECT, which PDL and Biogen Idec are currently planning. In addition, the companies may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve daclizumab; and the companies may encounter other unexpected hurdles. For further information regarding factors, risks and uncertainties that may cause such differences, please refer to the filings PDL and Biogen Idec have made with the Securities and Exchange Commission, including the "Risk Factors" sections of PDL's and Biogen Idec's Quarterly and Annual Reports, copies of which may be obtained at the "Investors" section on PDL's website at www.pdl.com, with respect to PDL's filings, and at www.biogenidec.com, with respect to Biogen Idec's filings. PDL and Biogen Idec assume no obligation to update and specifically disclaim any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

Biogen Idec is considered a trademark of Biogen Idec, Inc. PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc. Zenapax is a registered trademark of Hoffmann-La Roche, Inc.


For more information contact:

Media Contacts:
Biogen Idec
Amy Reilly
Associate Director, Public Affairs
(617) 914-6524

PDL BioPharm
Kathleen Rinehart
Director, Corporate Communications
(650) 454-2543

Investor Contacts:
Biogen Idec
Eric S. Hoffman, Ph.D.
Associate Director, Investor Relations
(617) 679-2812

PDL BioPharm
Jean Suzuki
Manager, Investor Relations
(650) 454-2648

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

Preclinical Study Published in Nature Medicine Shows Anti-LINGO-1 Antibody Promotes Remyelination

Sep 30 2007, 1:01 PM EST

News source: Business Wire

Biogen Idec (NASDAQ: BIIB) announced today the publication of findings from a preclinical study reporting that the anti-LINGO-1 antibody can promote spinal cord remyelination and axonal integrity, suggesting a potential role as a treatment for multiple sclerosis (MS) and other demyelinating diseases of the central nervous system (CNS). The results are published in the October issue of Nature Medicine, and confirm previously published data that suggested a role for the anti-LINGO-1 antibody in CNS myelin repair.

LINGO-1 appears to act as a molecular switch that controls the ability of cells in the CNS to produce myelin, the protective cellular sheath surrounding nerve fibers that assists nerves in conducting electrical impulses. When myelin is damaged by autoimmune diseases such as MS, nerve cells lose their ability to send signals to the body. As this damage progresses, these cells may eventually die, contributing to disability. Although MS therapies can slow the progression of this damage, none are able to repair the lost myelin. Biogen Idec scientists had previously discovered that LINGO-1 may act to prevent myelin repair after injury. In the study published today, by blocking LINGO-1, scientists were able to promote myelin repair and improve recovery in an animal model of MS.

"While preliminary, these findings are encouraging and suggest that the anti-LINGO-1 antibody has the potential to repair some of the damage caused to the CNS. This may be an entirely new approach to treating MS," said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec. "The anti-LINGO-1 program is a key part of our research and development efforts in MS. We have a diverse pipeline of therapeutic candidates targeting multiple pathways and patient needs with the goal of offering a portfolio of options for people living with this devastating disease."

In the study, functional recovery from demyelination was modeled by tracking the disease progression of experimental autoimmune encephalomyelitis (EAE), a widely accepted animal model for studying the clinical and pathological features of MS. The anti-LINGO-1 antibody was administered before disease onset and was found to decrease the severity of EAE across all stages of disease progression, when compared to the control treatment group. In a related study, anti-LINGO-1 antibody treatment resulted in significantly reduced EAE symptoms even when it was administered after disease onset.

The study found that functional recovery, as measured by EAE scores, correlated with improved axonal integrity and axonal remyelination. Physiological improvements in axonal integrity were revealed by magnetic resonance DTI imaging. At the cellular level, the production of new myelin sheaths was revealed by histological staining and electron microscopy.

"This is a very exciting early indication that therapies targeted at myelin repair within the CNS can have a dramatic effect on behavioral functional outcome in models of multiple sclerosis, and opens the door for the identification of additional regulators of myelin repair that might be used to enhance functional recovery in patients with MS," said Robert H. Miller, PhD, Principal Investigator, Myelin Repair Foundation and Director of the Center for Translational Neuroscience, Case Western Reserve University.

Anti-LINGO-1 was discovered by Biogen Idec and is one of several programs in the company's industry-leading research and development efforts in MS. In addition to its two marketed products, the company has four programs in clinical development for the treatment of MS.

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.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding anti-LINGO-1 antibody, which is currently in the preclinical stage of drug development. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec's current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of anti-LINGO-1 antibody at each stage of the clinical trial process; technical hurdles relating to the manufacture of anti-LINGO-1 antibody may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve anti-LINGO-1 antibody; and the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic and current reports that the company has filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

MS treatment Tysabri wins approval in New Zealand

Fri Sep 28, 2007 11:06am EDT

NEW YORK, Sept 28 (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and partner Elan Corp (ELN.I: Quote, Profile, Research) said their drug Tysabri has been approved in New Zealand for treatment of the relapsing remitting form of multiple sclerosis.

The approval was based on favorable results of a two-year late-stage trial of the medicine, the companies said in a release, noting that an estimated 4,000 people in New Zealand are affected by MS.

The progressive disease -- which can lead to varying levels of paralysis, visual problems and other serious complications -- is caused by damage to the fatty myelin sheath that insulates nerves and helps neurons carry electronic messages.

The drugmakers said clinical data show the medicine, after two years of use, reduced by 68 percent the annual number of relapses in flare-ups of the disease compared to placebo and reduced the risk of disability progression by 42 percent.

© Reuters2007All rights reserved

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

TYSABRI® DEMONSTRATES SIGNIFICANT HEALTH-RELATED QUALITY-OF-LIFE IMPROVEMENTS FOR MULTIPLE SCLEROSIS PATIENTS IN STUDY PUBLISHED IN ANNALS OF NEUROLOG

Cambridge, MA and Dublin, Ireland - August 20, 2007 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today the publication of results demonstrating that patients treated with TYSABRI® (natalizumab) showed a significant improvement in health-related quality-of-life (HRQoL) measures when compared to placebo. These results are from the first Phase III multiple sclerosis (MS) studies that have demonstrated improvement on HRQoL measures in patients with relapsing forms of MS. The results have been published in today's issue of Annals of Neurology.

"These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study.

These two-year, randomized, double-blind, placebo-controlled, multicenter, Phase III clinical trials (AFFIRM and SENTINEL) were conducted in 2,113 patients with relapsing forms of MS. The objective was to assess the relationship between disease activity and HRQoL in relapsing forms of MS, and the impact of TYSABRI on these measures.

In the studies, HRQoL was assessed using two different measures at baseline and weeks 24, 52 and 104:

The Short Form-36 (SF-36), a standardized, well-validated survey that has been used extensively in many disease areas, including MS to review health status. The SF-36 is comprised of 36 questions designed to assess physical (Physical Component Summary or PCS) and mental (Mental Component Summary or MCS) well-being from the perspective of the patient.

The Visual Analogue Scale (VAS), a measure of well-being as assessed by the patient and marked on a scale of 0 to 100, with 0 indicating "poor" and 100 indicating "excellent."

Results from the AFFIRM monotherapy trial include:

A statistically significant improvement in SF-36 PCS beginning at week 24 and all subsequent time points compared with a decline in the placebo-treated group.

A statistically significant improvement in SF-36 MCS at week 104 compared with a decline in the placebo-treated group.

Statistically significant benefits using the VAS when compared with placebo at week 52 and at week 104.

Patients showed sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.

HRQoL measures correlated with common measures of MS severity, including EDSS, sustained disability progression, relapse number, MSFC and volume of T2-hyperintense and T1-hypointense lesions.

Improvements on quality-of-life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a). This publication is in addition to a presentation of preliminary results from the same study presented at the 2006 American Academy of Neurology Annual Meeting.

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), 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.

In addition to the United States and European Union, TYSABRI is also approved in 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 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 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

Shannon Altimari
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