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(Posted By: Josi Creek)

Investment bank UBS has predicted there could be a "surge" in the number of patients using Elan's Tysabri multiple sclerosis drug that develop a life-threatening brain disease known to be the most serious side-effect of the treatment. UBS has advised investors to sell Elan shares.

About 46 cases of PML have been detected in patients using Tysabri over the past few years, while 11 people have died from the disease. Some of those who survive are left requiring considerable long-term medical care. Some 50,300 people were using Tysabri as of the end of last month, half of them in the US.

To read the entire story, click HERE

Labels: tysabri

(Posted By: Josi Creek)

Biogen Idec Inc (BIIB.O) said on Tuesday that first-quarter earnings fell 11 percent, hurt by one-time charges and lower-than-expected sales of its multiple sclerosis drug Tysabri.

To read the full story, click HERE

(Posted By: Josi Creek)

An early check of registry data from women with multiple sclerosis who became pregnant while taking natalizumab (Tysabri) does not appear to raise concerns of miscarriages or abnormalities, researchers said here.

To read the full story, click HERE.

Posted By: Josi Creek

-- Data suggests improvement across broad range of functional and quality of life measures --

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(Posted By: Josi Creek)

The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:

• Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.
• Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the
  drug.
• Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.

To read the original story, please click HERE.

(Posted By: Josi Creek)

The following is a video discussing the test which detects antibodies the human body builds up against the JC virus (polyomavirus) which causes PML.

(Posted By: Josi Creek)

The following was sent in a message to Stan:

Stan, There is an antibody test for PML Progressive multifocal leukoencephalopathy being developed by Biogen.

It is being sent to specific MS specialist Dr.'s like Dr. Barry Singer to be tested. He told me in 1-3 months this simple blood test should be available nation wide for testing.

It can detect antibodies the human body builds up against the JC virus (polyomavirus) which causes PML.

To continue reading the story, click here.

Also, visit http://www.facebook.com/StansAngels

(Posted By: Josi Creek)




THIS STUDY WAS PUBLISHED THIS MORNING BY THE STANFORD SCHOOL OF MEDICINE

TWO KINDS OF MULTIPLE SCLEROSIS, TWO DIFFERENT RESPONSES TO BETA-INTERFERON, STANFORD STUDY SHOWS

STANFORD, Calif. — There may be two distinct versions of multiple sclerosis, a study in both animal models and human blood samples suggests.

What’s more, a patient’s responsiveness to the most popular first-line drug for this episodic and all-too-often recurring autoimmune condition seems to depend on which version that patient has.

If these findings are confirmed in larger human studies and by other laboratories, people with multiple sclerosis might someday be able to take a simple blood test to see whether they are likely to respond to treatment with the standard multiple-sclerosis therapy, said senior study author Lawrence Steinman, MD, the George A. Zimmerman Professor of Neurology and Neurological Sciences at the Stanford University School of Medicine.

Public health may benefit, too, Steinman said, as the cost savings from being able to predict in advance which patients will benefit from beta-interferon, a costly bioengineered drug whose global sales come to some $4 billion a year, could be considerable.

Beta-interferon’s overall efficacy is only fair, he said, with perhaps half of all multiple-sclerosis patients experiencing an average one-third reduction in recurrences.

Plus, its discomfiting side effects — flulike symptoms — can make compliance an issue for patients, especially given the drug’s iffy efficacy.

In a study to be published online March 28 in Nature Medicine, Steinman and his colleagues used an established animal model of multiple sclerosis called experimental autoimmune encephalitis, or EAE, which they induced by injecting the animals with myelin in a way that caused the immune system to inappropriately attack the animals’ own myelin nerve-cell coatings.

Many nerve cells in mammalian brains and peripheral tissues must convey electrochemical impulses over great distances, and quickly. Long, wirelike projections that transmit these cells’ signals to other nerve or muscle cells are coated by myelin, a natural substance whose insulating properties sustain the impulses’ strength and increase their speed.

A few years ago while still a PhD student at the University of Alabama, the study’s first author, Robert Axtell, had shown that, as in people with multiple sclerosis, beta-interferon can reverse paralysis in mice with EAE. But it turns out that EAE can be induced by two different autoimmune pathways, characterized by different patterns of secretion by T cells.

Like nerve cells, immune cells also communicate with one another across long distances, but they accomplish this through various chemicals called cytokines that they secrete into the blood. Immune cells on the receiving end of a cytokine “signal” may respond quite differently, depending on the particular type of cytokine to which they are exposed. Two cytokines called gamma-interferon and IL-17, for example, tend to induce the kinds of inflammatory immune-system arousal that can trigger multiple sclerosis.

Axtell (now a postdoctoral scholar in Steinman’s lab), Steinman and their colleagues were able to induce two superficially similar forms of EAE in mice by directing the myelin-attacking T cells to predominantly secrete either gamma-interferon or IL-17, respectively. The researchers found that beta-interferon improved the condition of animals whose EAE had been induced by gamma-interferon-secreting T cells, but exacerbated symptoms in those whose EAE had been induced by IL-17-secreting T cells.

Intrigued, the investigators turned to humans. Another postdoctoral scholar in the Steinman lab, Brigit deJong, MD, the study’s second author, had previously been involved in research in Amsterdam in which multiple-sclerosis patients were treated with beta-interferon and meticulously followed up. The Stanford group obtained blood samples taken from 26 of these patients both before and about two years after the initiation of treatment. Without knowing which samples came from patients who had responded well or poorly to beta-interferon treatment, they went about measuring IL-17 levels in those samples.

Eventually, patients’ follow-up histories were revealed to the researchers and their measured IL-17 levels were paired with their post-treatment progress. A clear pattern emerged. Measurements of a particular variety of IL-17, called IL-17F, clustered at either very high or very low levels in individual patients’ blood. Those with very low detectable blood levels of IL-17F responded well to beta-interferon treatment, experiencing no relapses or instances of required steroids (to quickly shut down a malfunctioning immune system).

But patients with very high IL-17F levels — about one out of three subjects — responded poorly by the same criteria.

In fact, said Steinman, there is some evidence that beta-interferon actually worsened these patients’ conditions.

Steinman cautioned that the results need to be confirmed in larger patient groups, in his lab as well as in others. But, he said, “I think this has the potential to transform the way we take care of people with multiple sclerosis.”

He said a simple, already available blood test could spare many patients the inconvenience and side effects — and spare the health-care system the expense — of a drug that most likely won’t do any good. “The other side of the coin is that beta-interferon, if it’s given only to those who are predisposed to respond to it, could turn out to be a far better drug than we ever imagined.”

Although Steinman and his colleagues do not stand to benefit in any direct way from this work, Stanford University’s Office of Technology Licensing has filed a patent application on the use of the blood test.

Earlier work by Steinman, proceeding from animal models to clinical trials, led to the development of another blockbuster multiple-sclerosis drug, natalizumab, marketed under the trade name Tysabri.

Several other scientists from Stanford and elsewhere co-authored the Nature Medicine study, which was funded by the National Multiple Sclerosis Society. Axtell’s former PhD advisor, Chander Raman, PhD, of the University of Alabama-Birmingham’s Department of Medicine, shares senior authorship with Steinman. More information about Stanford’s Department of Neurology and Neurological Sciences, which supported the work, is available at http://neurology.stanford.edu/.

(Posted By: Josi Creek)

Biogen Idec and Elan Pharmaceuticals have announced the enrolment of the first patient-in-large, well-controlled, head-to-head study of multiple sclerosis (MS) treatments, directly comparing Tysabri to Copaxone (Teva) and Rebif (Merck Serono). The study, called SURPASS, is a global Phase IIIb, randomised, rater-blinded, active-controlled study.

To read the full story, click here.

(Posted By: Josi Creek)

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) disclosed seven more cases of a rare brain infection in multiple sclerosis patients using Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 42 as of last Wednesday.

Another patient with the infection has died, bringing the total deaths to nine in patients that have developed progressive multifocal leukoencephalopathy, or PML, according to the Cambridge, Mass., biotech company.

To read the full story, click here.

(Posted By: Josi Creek)
February 16, 2010

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) disclosed four more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 35.

The number of deaths stands at eight with patients that have developed progressive multifocal leukoencephalopathy, or PML, according to the Cambridge, Mass., biotech company.

To read the full story, click here.

(Posted By: Josi Creek)
February 09, 2010

Feb. 9 (Bloomberg) -- Biogen Idec Inc., the world’s largest maker of medicines for multiple sclerosis, said fourth-quarter profit jumped 48 percent, helped by higher sales of its fastest- growing drug, Tysabri.

Net income increased to $305.6 million, or $1.06 a share, from $206.7 million, or 70 cents, a year earlier, the Cambridge, Massachusetts-based company said today in a statement. Earnings excluding some expenses beat by 16 cents the average $1.04 estimate of 16 analysts surveyed by Bloomberg.

To read the full story, click here.

(Posted By: Josi Creek)
February 6, 2010

WASHINGTON (Reuters) - The risk of a potentially fatal brain disorder with Biogen Idec Inc's multiple sclerosis drug Tysabri increases as patients receive more infusions, U.S. health officials warned on Friday.

The prescribing instructions for Tysabri will be updated to warn of the higher risk with more treatment, the Food and Drug Administration said. Elan Corp co-markets the drug.

To read the full story, click here.

(Posted By: Josi Creek)
February 05, 2010

Feb. 5 (Bloomberg) -- Biogen Idec Inc. and Elan Corp.’s multiple sclerosis drug Tysabri has been linked to 31 cases of a deadly brain infection and eight deaths since it returned to the market in 2006, U.S. regulators said.

That number of infections and deaths won’t change the 1 in 1,000 infection rate currently on the drug’s label, the U.S. Food and Drug Administration said today in a notice on its Web site. The prescribing information will be updated, including a new comparison to infection rates overseas.

To read the full story, click here.

(Posted By: Josi Creek)
January 22, 2010

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech strives to find the right balance in keeping the medical and financial communities updated on that important number.

The situation is closely watched because Tysabri, a highly effective treatment sold with Elan Corp. (ELN), was previously pulled from the market because of its association with progressive multifocal leukoencephalopathy, or PML, a debilitating and often fatal condition. The infection rate has hurt the sales growth of the drug, which is key to Biogen's future and is Elan's biggest seller.

To read the full story, click here.

(Posted By: Josi Creek)
January 21, 2010

NEW YORK (Dow Jones)--As of Wednesday, there have been 31 cases of a rare brain infection in multiple sclerosis patients on Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. (ELN), according to a review by a European regulatory panel.

The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported the cases of progressive multifocal leukoencephalopathy, or PML, in a review of the drug that concluded its rewards outweigh its risks and the drug should stay on the market.

To read the full story, click here.

(Posted By: Josi Creek)
JANUARY 12, 2010, 10:26 A.M. ET

DOW JONES NEWSWIRES


Biogen Idec Inc. (BIIB) said sales of its controversial multiple sclerosis treatment Tysabri surpassed $1 billion in 2009, reaching blockbuster status, as the number of patients using the treatment climbed 30%.

The company estimates that at the end of December, the number of patients using Tysabri was 48,800 globally; including 24,500 in the U.S., 23,700 in the rest of the world and 600 in clinical trials.

The company faces continued pressure from activist shareholders and concerns about the growth trajectory of the controversial multiple sclerosis treatment, sold with Elan Corp. (ELN).

To read the full story, click here.

(Posted By: Josi Creek)

Wed Jan 6, 2010 9:22pm

* Total PML cases at 28 as of Nov. 30, 2009 - Biogen

* Total at end of October was 24

* December figure to be released in week or two

BOSTON, Jan. 6 (Reuters) - Biogen Idec Inc (BIIB.O) said on Wednesday that four more patients taking its multiple sclerosis drug Tysabri had developed a potentially deadly brain infection known as PML in November, bringing the total to 28.

The biotech company said it will release the number for December within a week or two.

To read the full story, click here.

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By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) reported that there were no new cases of a rare brain infection in users of its multiple sclerosis drug Tysabri in the first of its planned weekly Web-based updates on Friday.

The Cambridge, Mass., biotech, which sells Tysabri with Ireland's Elan Plc (ELN), will post the updates in an effort to more consistently disclose incidences of the often fatal condition.

A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Since the relaunch, the company has reported that four people had confirmed cases of PML, with one dying.

This past summer marked the two-year anniversary of Tysabri's re-launch, raising Wall Street's anxiety over PML-related news. The timeline is important because two patients with PML in 2005 were using the drug for more than two years.

Biogen will post an update of PML cases on the investor relations section of its Web site every Friday at 4:30 p.m. EST and will continue to do so until July 24, which is the third anniversary of the drug's relaunch.

"I think it is going to provide a lot of clarity and almost realtime information to the market to really make decisions and evaluate the situation," said Citigroup analyst Yaron Werber.

Werber has criticized Biogen's former policy of disclosing new cases through 8-K filings with the Securities and Exchange Commission as making investors nervous and pressuring the company's shares.

Biogen's stock, which closed up 30 cents, or 0.6%, at $48.25, is down 17% for the last 12 months.

Elan closed Friday down 31 cents, or 3.6%, at $8.39 and is down 67% in the last year. Tysabri is Elan's biggest seller, making it more sensitive to related news, plus it was hurt by disappointing data over the summer from an Alzheimer's disease drug in development with Wyeth (WYE).

Werber expects the regular updates to help ease of the "fear of the unexpected" in Biogen shares. He agrees with stopping the disclosures in late July, when a clear picture of the PML risk in Tysabri should be firmly established. "

At some point they would be wise to cut this off," he said. "Because this sort of information is going to be very good for the competition. You can't go on marketing a product in this situation forever."

easybourse

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	Penn Researchers Find Treatment for MS also Reduces Vision Loss in MS Patients
	First MS Study to Include a Test of Visual Function
		> Researchers at the University of Pennsylvania School of Medicine have found that natalizumab (TYSABRI®) – a drug that slows disability and reduces relapse rates in patients with multiple sclerosis (MS) – also reduces vision loss in patients with relapsing MS.  > Researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people taking natalizumab, compared to those taking placebo.  > The study appears in the April 17 issue of Neurology. (PHILADELPHIA) – According to a study that appears in the April 17 issue of Neurology, researchers at the University of Pennsylvania School of Medicine have found that natalizumab (TYSABRI®) – a drug that slows disability and reduces relapse rates in patients with multiple sclerosis (MS) – also reduces vision loss in patients with relapsing MS.  Vision loss is one of the most common and disabling symptoms of MS. "Not only does natalizumab prevent the worsening of vision loss in people with relapsing MS, but it is also associated with significant reductions in the likelihood of sustained vision loss due to inflammatory demyelination of nerve fibers that connect to the eye, a common cause of visual loss in MS," says Laura J. Balcer, MD, MSCE, Associate Professor of Neurology and Ophthalmology at Penn, and lead author of the paper.  Using low-contrast letter acuity charts, researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people with MS taking natalizumab, compared to those taking placebo. Image Courtesy: Precision Vision, LaSalle IL The researchers analyzed data from two randomized, double-blind, placebo-controlled, parallel group, phase 3 clinical trials involving 2,138 men and women with relapsing MS from clinical centers in Europe, North America, Australia, and New Zealand.  More than half of the participants received natalizumab every four weeks for two years, while the remaining participants received placebo.  Visits were conducted every 12 weeks and visual function testing was performed at each study visit.  Low-contrast letter acuity was measured using low-contrast letter charts (eye charts with gray letters on a white background). Researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people taking natalizumab, compared to those taking placebo.  "Not only do the findings of the study add to our understanding of the effects of natalizumab, but the results provide strong validation for a simple, sensitive, cost-effective, and clinically meaningful measure of visual function in MS," advises Dr. Nicholas LaRocca, Associate Vice President, Health Care Delivery and Policy Research at the National MS Society. The researchers caution that, as with any therapy, the benefits of natalizumab must be considered in the context of potential risks or complications.  In the case of natalizumab, three confirmed cases of progressive multifocal leukoencephalopathy (PML) – a rare, often lethal brain disease – have been reported. Despite the fact that vision loss is a common and important cause of disability in MS, the natalizumab clinical trials were the first to include a test of visual function.  These trials showed that low-contrast letter acuity eye chart testing is an effective measure for assessing visual outcomes, and may be useful in future clinical trials. This study was supported by Biogen Idec and Elan, makers of natalizumab.  Dr. Balcer has received support for consulting from Biogen Idec as well as from other companies for work on developing visual outcome measures for MS clinical trials.

TYSABRI: "Biologic treatment for MS offers hope": Daytona Beach News-Journal

December 18, 2006

Biologic treatment for MS offers hope
By DR. YONG H. TSAI

Susan awoke one day with blurred, obstructed vision along with dizziness and numbness in her legs. A trip to her doctor's office triggered an order for blood tests and an MRI. She was diagnosed with multiple sclerosis (MS), an autoimmune disease involving the central nervous system.

Our brain and spinal cord, that house the main pathway of our body's nerve signals, offer a layer of insulation, called myelin, that surrounds and protects these nerve cells.

Like a plastic cover that surrounds the many wires of an electric cable, myelin covers nerve fibers to ensure that the nerve signals have safe, uninterrupted passage.

With MS, myelin sheaths break down (demyelination), due to inflammation caused by the autoimmune process. Damaged tissue eventually turns into scar tissue (sclerosis), meaning "multiple sclerosis."

Classic symptoms of MS include numbness, visual disturbance, abnormal gait, imbalance, muscle weakness or spasm, urinary incontinence, vertigo, slurred speech and even pain.

There are several forms of MS. Relapsing-remitting MS (RRMS) occurs about 25 percent of the time with intermittent relapses, including worsening of existing symptoms or the development of new ones.

Over the course of 10 to 15 years, more than 50 percent of RRMS will evolve into progressive MS, known for more frequent relapses, incomplete remission bouts and general overall deterioration.

During the past few years, beta interferons such as Avonex, Rebif, Betaseron and Glatiramer acetate, by modifying the inflammatory process, have been used to treat MS.

However, all still have side effects and some have poor results. In November 2005, Natalizumab (Tysabri), a biologic agent, was proven to block the function of key molecules. The process could transport immune cells crossing the brain and blood barrier (BBB), and prevent against an attack on one's central nervous system.

Clinical trials have shown Tysabri, administered by monthly intravenous infusion, is a very effective therapy in reducing relapses and decreasing new brain lesions.

However, the shocking news surfaced Feb. 28 that Tysabri was suspended temporarily from commercial distribution due to three serious, adverse events. Multifocal leukoencephalopathy (PML) occurred in clinical trial patients treated with Tysabri plus Avonex.

However, there have been no reports of PML in patients treated with either Tysabri or Avonex alone.

More recently, Tysabri has been permitted for MS treatment. Tysabri is only indicated as a single-agent treatment instead of in combined therapy with Avonex or other agents. It's for patients with the relapsing form of MS and poor response to traditional treatments.

Though there is some concern with rare side effects of Tysabri, this new biologic agent offers new hope.

Tysabri helps cognition - United Press International

ZUG, Switzerland, Sept. 28 (UPI) -- U.S. firm Biogen Idec and Irish firm Elan said Thursday new data show multiple-sclerosis drug Tysabri helps cognitive ability in MS.

The companies said phase 3 data from the AFFIRM study showed Tysabri "significantly reduced the proportion of MS patients with worsening cognitive function as measured by the 3-second Paced Auditory Serial Addition Test (PASAT 3)."

Specifically, the two-year AFFIRM study, enrolling 942 MS patients at 99 sites worldwide, showed the treatment reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.

"Neuropsychological dysfunction significantly diminishes quality of life in many patients with multiple sclerosis, impacting everything from employment to social interaction. It is responsible for much hardship experienced by MS patients. The important positive effects of TYSABRI on cognitive functioning and quality of life add to the important benefits already reported on progression of disability and relapses," Richard Rudick, director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, said in a statement issued by the companies.

The results were presented this week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

Earlier data on Tysabri showed the drug reduced by 68 percent MS relapse, compared to placebo, and cut by 42 percent the relative risk of disability progression. The therapy has U.S. approval as a monotherapy treatment for relapsing forms of MS.

Elan Extends Tysabri's Reach to Canada [more]
...To put this in perspective, Canada has possibly the highest rate of MS in the whole world. An estimated 55,000 to 75,000 Canadians suffer from the disease -- that's nearly one-fifth the estimated number of patients in the United States.

The fortunes of Elan will rise and fall with the prospects of Tysabri. When the drug was taken off the market early last year, many investors pegged the company for bankruptcy because of its high debt load. Now that the drug has been approved for sale again in the U.S. and also for marketing in the EU, Elan has a chance to start making enough money to stem the company's losses and hopefully begin paring down some of the nearly $2 billion in debt that will be due in varying amounts in 2008 and 2011.....

"MS drug Tysabri back, but only under strict guidelines"
Lindsey Wolf, 49, took the drug for several months two years ago and began taking it again a month ago...'Back then I found it was really helping me from getting worse,' Mr. Wolf said. 'I haven't really noticed anything yet (this time) because I only tried it once. I'm going to wait and see this next time to see how I do next month. I think it will be a pretty good drug........'

TYSABRI 'watched like a hawk': Angelia McCoy hopes she can feel like 'Wonder Woman' again as a test subject....FULL STORY.
"Angelia McCoy waits for registered nurse Judi Greene to administer an infusion of Tysabri, a drug for multiple sclerosis recently re-released after its manufacturer pulled it off the market 1 1/2 years ago amid safety concerns....

Earlier this summer, federal regulators approved the company's plan to reintroduce Tysabri under strict limits. The rules say that it can only be used for people whose multiple sclerosis can't be controlled with other drugs. Also, patients may not take other medications while they are on Tysabri.Before each monthly treatment, they must fill out four surveys that track how they are faring physically and mentally. 'Do you have difficulty understanding what others are saying, or expressing yourself?' one survey asks. 'Do you have any weakness or numbness in your legs?'Each survey must be faxed to the drug manufacturer. A 'yes' answer to any of the questions would lead to an interruption in treatment while doctors check the patient for complications.The drug costs about $25,000 per year, but McCoy's is covered by the manufacturer because she is taking part in

US doctors still wary of Elan drug TYSABRI- survey
US doctors are proving more wary than many had expected about prescribing Elan's multiple sclerosis drug Tysabri, which was relaunched in July after being suspended because of safety concerns.

Over the past month or so, analysts have drawn down their 2006 sales forecasts as it becomes clear that doctors wary of the risk of the rare but potentially fatal brain disease PML are reserving the drug as a treatment of last resort.

The drug, which is made by Elan and its US Biogen Idec, had been expected by some analysts to generate sales this year of more than $100m, but those figures have dropped dramatically.

Ian Hunter, an analyst at Goodbody stockbrokers, said yesterday that he has cut his full-year Tysabri forecast to $25.7m from $78m, partly because of continuing safety concerns and the complexity of reimbursement systems in Europe.

A survey of 63 US neurologists indicates that in 2006 Tysabri will be used in less than 1% of multiple sclerosis patients - translating into revenue of under $30m.

Since July, only 47 of more than 8,500 patients treated by US physicians surveyed had used Tysabri, even though more than 700 patients had discussed using it, according to the report.

And more than 75% of the patients who had used Tysabri prior to its 2005 suspension have decided not to use it since its reintroduction..... MORE

2,800 have registered for Tysabri
In the United States, where Biogen Idec manufactures the drug and Elan distributes it, US$5.4 million (4.3 million) of Tysabri was sold to 1,700 patients, while another 2,800 have registered for potential treatment.

Crohn's Disease...Elan Press Release: TYSABRI® Maintained Remission in Patients with Moderate-to-Severe Crohn's Disease Treated for Longer Than Two Years According to Data Presented This Week Article
TYSABRI Data Support Maintenance Efficacy In Patients Who Had Previously Failed Infliximab Therapy

DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 24, 2006--Elan Corporation, plc (NYSE:ELN) and Biogen Idec (NASDAQ:BIIB) announced today data that show TYSABRI® (natalizumab) maintained remission in Crohn's disease patients (CD) treated for longer than 2 years. These data, presented this week at the 14th United European Gastroenterology Week (UEGW) in Berlin, Germany, and at the Annual American College of Gastroenterology (ACG) in Las Vegas, Nevada, were part of an open label extension study of patients who participated in the ENACT-2 trial.

Ninety-three percent (93%) of TYSABRI patients who were in remission at month 12 of ENACT-2, were still in remission following 6 additional TYSABRI infusions in the open-label extension study (OLE) and 86% were still in remission after 12 additional infusions.

"What is truly exciting is that patients who enter remission on TYSABRI may remain in remission in the long-term without loss of efficacy over time. These data are a significant advance for the field and suggest that TYSABRI may be an alternative biologic outside the anti-TNF class for patients suffering from Crohn's disease," said Remo Panaccione MD, Director, Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Canada, who presented the data at UEGW.Click Here for Complete Elan Press Release

TYSABRI: New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis [click for more] CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Oct. 6, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI® (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients

Data presented today from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also showed that TYSABRI therapy resulted in a 65% relative reduction in the annualized rate of MS-related hospitalizations over two years (0.034 in the TYSABRI group vs. 0.097 in the placebo group(p<0.001)).......

Tysabri helps cognition - United Press International ....the treatment reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.....

Tysabri helps cognition - United Press International ....the treatment reduced the risk of sustained cognitive worsening by 43 percent, compared to placebo.....

Analyst Worries About Tysabri: "Tysabri, the multiple sclerosis treatment from Elan appears to be getting hit by the strict safety rules that accompanied the drug's reapproval by regulators, according to one analyst.

Deborah Knobelman of the research firm Piper Jaffray slashed her estimate for worldwide Tysabri sales to $21 million for this year, down from her previous $123 million expectation. According to her feedback from doctors, physicians' adoption rates of the drug were slower than she had anticipated in the U.S. because of safety concerns, reimbursement procedures and patient-monitoring requirements......

Natalizumab (Tysabri) Reduces Brain Atrophy, Improves Cognition During Second Year of Multiple Sclerosis Treatment
MADRID, SPAIN -- September 30, 2006 -- Natalizumab (Tysabri) significantly reduces brain atrophy compared with placebo treatment during the second year of treatment and significantly improves cognitive function in patients with multiple sclerosis (MS), researchers reported here at the 22^nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIM).

"We saw that natalizumab was, indeed, effective in reducing the rate of brain atrophy in the second year of treatment, and this is especially important because in the brain of an MS patient, brain atrophy correlates to reduced cognitive function," said presenting investigator Elizabeth Fisher, PhD, assistant professor, department of biomedical engineering, Cleveland Clinic, Cleveland, Ohio.....

The investigators also found that natalizumab treatment significantly reduced the proportion of patients with worsening in 3-second Paced Auditory Serial Addition Test score compared with placebo. They observed a positive correlation between change in BPF and time to sustained worsening of cognitive function over 2 years among placebo subjects. They saw no such correlation among natalizumab subjects.

In addition, the AFFIRM investigators also reported that there were 92% fewer gadolinium-enhancing lesions and 83% fewer new or enlarging T2-hyperintensities on magnetic resonance imaging in the natalizumab group compared with placebo.....
[Presentation title: The Effects of Natalizumab on Brain Atrophy and Cognitive Function: Results From the AFFIRM Study. Abstract P383]

New Data on TYSABRI(R) Presented at ECTRIMS Congress Demonstrate Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that data from the Phase III AFFIRM monotherapy study demonstrated that treatment with TYSABRI(R) (natalizumab) significantly reduced the proportion of multiple sclerosis (MS) patients with worsening cognitive function as measured by the 3-second Paced Auditory Serial Addition Test (PASAT 3). These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, contribute to existing data which demonstrate the overall therapeutic benefits of TYSABRI, including its significant impact on relapse reduction, disability progression and MRI measures. TYSABRI has demonstrated a 68% relative reduction in the annualized relapse rate compared to placebo and a 42% reduction in the relative risk of disability progression, as published in the New England Journal of Medicine.

Cognitive deficits are under-recognized and often misdiagnosed as depression, stress or other personality disorders. Studies have shown that approximately 43% to 65% of MS patients show measurable cognitive impairment in formal testing.(1) Cognitive dysfunction can occur early in MS and in patients with relatively mild physical disability. These deficits have a substantial effect on the daily functioning of patients. Areas impacted by cognitive dysfunction include memory, ability to process information and learning. (1),(2)

The AFFIRM study was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, evaluating the effect of TYSABRI on the progression of disability and the rate of clinical relapses. Evaluating the effect of TYSABRI on cognitive function was a pre-specified endpoint of the AFFIRM study. Cognitive function was assessed using the 3-second Paced Auditory Serial Addition Test (PASAT 3), a test of auditory information processing. The study showed that treatment with TYSABRI reduced the risk of sustained cognitive worsening by 43% (p=0.013) when compared to placebo.

These cognitive function data complement the previously presented results of the AFFIRM study, which demonstrated a significant effect of TYSABRI on two-widely accepted health-related quality of life measures, the Short Form-36 Health Survey and the Visual Analogue Scale.

"Neuropsychological dysfunction significantly diminishes quality of life in many patients with multiple sclerosis, impacting everything from employment to social interaction. It is responsible for much hardship experienced by MS patients. The important positive effects of TYSABRI on cognitive functioning and quality of life add to the important benefits already reported on progression of disability and relapses. This provides strong evidence that observed neurologic benefits translate into important improvements as perceived by the patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic....

New Data Presented at ECTRIMS Congress Show TYSABRI(R) Has Sustained Effect on Relapse Rate in Multiple Sclerosis Patients Treated for up to Three Years

Source: Biogen Idec and Elan Corporation,

ZUG, Switzerland and DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today new data that show TYSABRI® (natalizumab) has a sustained effect on relapse rate in multiple sclerosis (MS) patients treated for up to three years. These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, were part of long-term follow-up of TYSABRI clinical trial patients.

Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy's long-term effects. Approximately 1,900 patients and over 200 sites worldwide participated in the extension study.

Approximately 250 of these patients remained on TYSABRI monotherapy for nearly three years. The annualized relapse rate for these patients over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. This was consistent with the 0.23 annualized relapse rate seen in the two-year AFFIRM study, which represented a 68% relative reduction when compared to the two-year placebo annualized relapse rate of 0.73, as published in the New England Journal of Medicine.

"Data from this long-term follow-up study show that TYSABRI has a sustained and compelling effect on relapse rates beyond two years of treatment. The efficacy benefit of TYSABRI when considered with the management of its known risks, offers an important therapeutic option for many patients living with the debilitating effects of MS," said Paul O'Connor, MD, St. Michael's Hospital, Toronto, Ontario, Canada, lead investigator of the extension study.

TYSABRI: New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis [click for more] CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Oct. 6, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI® (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients

Data presented today from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also showed that TYSABRI therapy resulted in a 65% relative reduction in the annualized rate of MS-related hospitalizations over two years (0.034 in the TYSABRI group vs. 0.097 in the placebo group(p<0.001)).......

Elan Extends Tysabri's Reach to Canada [more]
...To put this in perspective, Canada has possibly the highest rate of MS in the whole world. An estimated 55,000 to 75,000 Canadians suffer from the disease -- that's nearly one-fifth the estimated number of patients in the United States.

The fortunes of Elan will rise and fall with the prospects of Tysabri. When the drug was taken off the market early last year, many investors pegged the company for bankruptcy because of its high debt load. Now that the drug has been approved for sale again in the U.S. and also for marketing in the EU, Elan has a chance to start making enough money to stem the company's losses and hopefully begin paring down some of the nearly $2 billion in debt that will be due in varying amounts in 2008 and 2011.....

TYSABRI: New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis [click for more] CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Oct. 6, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI® (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients

Data presented today from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also showed that TYSABRI therapy resulted in a 65% relative reduction in the annualized rate of MS-related hospitalizations over two years (0.034 in the TYSABRI group vs. 0.097 in the placebo group(p<0.001)).......

TYSABRI: Natalizumab Has Benefits on Disability and Quality of Life in Patients With Relapsing MS: Presented at EFNS: "GLASGOW, UK -- September 11, 2006 -- Monotherapy with the alpha4 integrin antagonist natalizumab [TYSABRI] results in significant improvements in scores on health-related quality of life (QoL) questionnaires in patients with relapsing-remitting multiple sclerosis (MS), according to results of a substudy from a multicentre, randomised, double-blind, placebo-controlled, phase 3 clinical trial.

The findings were presented here on September 5th at the 10th Congress of the European Federation of Neurological Societies (EFNS) by Michael Hutchinson, MD, professor of neurology, department of neurology, St. Vincent's University Hospital, Dublin, Ireland, on behalf of the AFFIRM study investigators....."

Mayo Clinic Rochester
Dr. Claudia F. Lucchinetti,

Neurology, Mayo Clinic,

Rochester, Minn.

"The Food and Drug Administration recently reapproved Tysabri, a drug that earlier was said to be a big advance in the treatment of multiple sclerosis but caused a few instances of deadly side effects. Now that this medication is back on the market, what difference will it make in how MS patients are treated? And is it really safe?

Tysabri (brand name for natalizumab) will not make a big difference for most MS patients - at least, not right away - because the FDA reapproval carries a variety of restrictions. And the drug's link to that deadly side effect, a rare brain infection called progressive multifocal leukoencephalopathy, means that physicians will likely consider Tysabri mainly for aggressive or unresponsive cases.

In MS patients with frequent and severe flare-ups whose condition is rapidly deteriorating or for those who cannot tolerate or are not helped by other available drugs, Tysabri's benefits may well offset its one-in-a-thousand risk (based on present data) of PML.

The good news is that the FDA's TOUCH Prescribing Program - which specifies limited access to Tysabri and frequent follow-up - is essentially a long-term clinical trial that could have a big impact on the overall understanding of MS and its future treatment.

MS is a chronic disease that affects the central nervous system. In patients with MS, the body incorrectly directs immune cells against the myelin sheath that surrounds the nerves. These attacks cause inflammation and injury to the sheath and eventually to the nerves, resulting in multiple areas of scarring (sclerosis). Such damage can slow or block nerve signals that control muscle coordination, strength, sensation and vision.

Typically, MS advances in two steps: 1) initial episodes of inflammatory demyelination associated with neurologic dysfunction, which are sometimes debilitating but usually soon subside, and 2) a subsequent slow and irreversible progression of the disease.

Scientists are still unsure whether the frequency and severity of flare-ups affect the MS patient's subsequent rate of decline. They may be unrelated; or it's possible that they are related but that available drugs have been unable to reduce inflammation enough to show benefit.

With Tysabri, the research community finally has an opportunity to determine whether limiting inflammation early will slow the disease's progression. This is because the drug has reduced flare-ups by about two-thirds, and 96 percent of patients treated with Tysabri showed no new active lesions on brain imaging. If preventing early inflammation does indeed slow progression, Tysabri may be able to prove it. And if that is the case, this new approach to treating MS - whether with Tysabri itself or a safer successor - could make a substantial difference in the prognosis of many MS patients.

Tysabri's effectiveness appears to rest on its unique mode of action. Current treatments attempt to limit damage caused by inflammatory immune-system agents (called T-lymphocytes) that have already crossed the blood-brain barrier and entered the central nervous system. But Tysabri - the first MS drug that is a monoclonal antibody - prevents the T-lymphocytes from penetrating the nervous system in the first place.

It was Tysabri's remarkable performance that prompted the FDA to quickly approve its use in 2004, subject to continuing trials by the manufacturer. When those trials yielded three cases of PML (in about 3,000 patients) a year later, the company and the agency agreed to withdraw it. But regulators decided that the potential for Tysabri to prevent neurologic worsening in certain MS patients outweighed its small but serious risk and prompted the FDA to reapprove Tysabri for use and continued study earlier this year"

TYSABRI 'watched like a hawk': Angelia McCoy hopes she can feel like 'Wonder Woman' again as a test subject.
"Angelia McCoy waits for registered nurse Judi Greene to administer an infusion of Tysabri, a drug for multiple sclerosis recently re-released after its manufacturer pulled it off the market 1 1/2 years ago amid safety concerns....

Earlier this summer, federal regulators approved the company's plan to reintroduce Tysabri under strict limits. The rules say that it can only be used for people whose multiple sclerosis can't be controlled with other drugs. Also, patients may not take other medications while they are on Tysabri.Before each monthly treatment, they must fill out four surveys that track how they are faring physically and mentally. 'Do you have difficulty understanding what others are saying, or expressing yourself?' one survey asks. 'Do you have any weakness or numbness in your legs?'Each survey must be faxed to the drug manufacturer. A 'yes' answer to any of the questions would lead to an interruption in treatment while doctors check the patient for complications.The drug costs about $25,000 per year, but McCoy's is covered by the manufacturer because she is taking part in......

VIDEO: Heather Smith talks abot Tysabri
Heather Smith lives life at a relatively slow pace.

Diagnosed in 1998 with Multiple Sclerosis, she quickly became disabled.

The disease often makes her choose between herself and her 2-year-old son.

“I was at a point that I had a to pick, okay, I’m I going to take a shower or should I hang out and play with Ezra this morning,” said Smith.

Heather became desperate for life, desperate for a cure.

Eventually, she tried the drug Tysabri and noticed a miracle after only two doses.

Heather went from wheelchairs and a walker, to standing on her own with a cane.

“After being on this drug, my energy went back up and I was able to say 'gosh, I can take a shower and play with Ezra today if I wanted to'. To have a moment that I was actually improving was priceless,” Heather said.....

Biogen Idec reports loss of $0.50 per share

Tysabri Recovery Plan
"As Elan finds stability, CEO Kelly Martin is "unequivocally" confident that focusing on Tysabri was the right thing to do, writes Donal Griffin.

In an interview with this magazine last year, the late Donal Geaney wouldn't comment on Elan except to say how proud he was of what it had achieved. Having just settled an unfair dismissal case with his former employers, raking up old roots didn't interest him.

Geaney had stood down from Elan three years previously, following a crash in the company's share price. The Wall Street Journal ran a front-page story in January 2002 on some of its joint venture accounting practices. With Enron and WorldCom still fresh in Wall Street minds, Elan's share price plummeted as the US Securities and Exchange Commission (SEC) began an investigation. By July, the price had fallen by 96% and Geaney and CFO Tom Lynch had resigned.

Staring at short-terms debts of $Ibn (Eur 782m), the new management hadn't much choice but to start selling off assets. It ultimately sold off about $2.56n (Eur 1.95on) worth, with the majority going to similarly-sized pharmaceutical companies. While this gave the young Irish biotech industry its start through the exodus of talent and technologies, Geaney wasn't convinced of the restructuring that took place in his absence, believing it to be panicked and a billion-dollar destruction of value.

It's been a long time coming for Elan, as it crawls its way back towards a position of profitability.

Elan is today built on Tysabri. The vast majority of its share price hinges on it, "and rightfully so," says Gorman. Meeting the press to discuss its latest results - which saw the company shave 37% of its net losses - Martin is "unequivocally" confident that they've taken the right route in concentrating on Tysabri and Alzheimer's.

"The size of opportunity from those two areas is gigantic and the competition is fierce. Part of our recovery plan was that we needed to take assets that we were not going to focus on and move them off of our plate so that we can focus on were we think, over time, we will be best in the world.

"Getting Tysabri back to where it is for MS and getting it to where it will be for Crohn's is going to have a very significant impact from a shareholder point of view over time.

"The same will be true for Alzheimer's. So, in our focus around key programmes, the recovery plan was in two parts: it was a financial necessity and it was strategic repositioning of the company. We're now positioned around neuro-degenerative and autoimmune focus. That's where all of our focus is."

The industry doesn't question the manner in which Elan flung off its extra layers. "The strategy has worked," says Ian Hunter in Goodbody. "What they've done in the restructuring is really concentrated on the autoimmune diseases and that side of things because that's all they can afford to put research into."
."

TYSABRI: 'I'm so glad I was a guinea pig for the MS wonder drug....
"IT STARTED in a laboratory in southern San Francisco in the early nineties. Paralysed laboratory mice were suddenly able to walk when given a drug. Around the same time, thousands of miles away in Dublin, 14-year-old Carol Brennan noticed something wrong with her sight.

She had blurred vision for over a month. Then she felt a numbness in her legs and arms. Her balance started to go.

'When I was 14, I was brought in to the Eye and Ear and they thought it was an inflammation of the optic nerve - which happens to people who are in their nineties, not young people,' she recalls. 'So they sent me for an MRI scan and lesions came up.

'My Dad is one of the rare people in the world who has never lied in this life. And I remember we were getting the results after the MRI. We were driving home and Dad had very tearful eyes and I asked him, "What's wrong with me?" and he said, " Nothing, nothing, you'll be grand. They have to do more tests," and I said, "Dad, you're lying".

'When we got home he was speaking to Mam and she came downstairs bawling her eyes out and I went to Dad and said, "Please tell me". They probably wouldn't have told me at such a young age but I kind of made them - I had Multiple Sclerosis.' Carol, the youngest child of six, had little idea of what this bizarresounding condition actually meant.

'I knew people who had MS but they had died quite old. I think at that stage it was just like "oh my God I'm different". And as a teenager you just want to conform.

'And then I would read up in the medical journals on MS and just think: "Oh my God". My mam worked with older people so she was very aware of MS. She was aware of the implications and the severity of it.' There were no treatments worth the name available to the 7,000 or so Irish people with MS.

'They were generally told to go home and live their life as best they could because there was nothing that could be done for them,' says the chairman of MS Ireland, Louise Wardell.

Carol was put on self-injecting drugs called interferons which had limited effect on her condition.

'When I was on the interferons I was getting night-sweats and wasn't sleeping properly,' she says. But that was not the worst of it, the greater problem was administering the doses.

'I just couldn't do it,' she says. 'I hate needles. It was more depressing than anything else. I would get up in the morning and think, "God, I have only eight hours to go and I will have to do it again".' Her fear of self-injection became so great that she had to come off interferons. The result was a string of what MS sufferers call 'relapses' - agonising episodes of dizziness, weakness and pain that can leave them unable even to pick up a pen and write.

'I was on no drugs and getting a lot of relapses,' says Carol. 'After a relapse you get all your steroids and drugs, but you are never back 100 per cent. My doctor was saying: "You have to take something".

'But it was unfair on my mother and my family to ask them to [inject me]. My mother was upset about my health like any mother would be,' she says.

Then came news which seemed, at first, like a miracle. The drug which almost a decade earlier had helped paralysed mice walk again was being put forward for its first human trial under the brand name Tysabri.

Its maker, Elan, was Ireland's biggest pharmaceutical firm and was looking for volunteers here.

Carol needed absolutely no persuasion. When offered the chance to participate in the Tysabri trial, she accepted immediately.

It meant being administered the drug via an intravenous drip once a month.

There was no more selfinjecting.

The impact on her illness, even in the trial stage, was immediate. 'With MS you never know. Everyone is affected differently. But I have a very active life. I probably wouldn't have been able to be so active without it.

I did get a lot of relapses before I started the trial and it really reduces relapses. I think by 70 per cent. So in the space of five years, normally I would have had 10 relapses but I only had three. That's brilliant,' she says.

'In relapse, my legs get weak and my walking is impaired. And I am touching walls walking down a corridor, afraid I will fall. My arms get weak and my writing gets bad. I remember years ago I lost my wallet and when I got my cards back, because my hands were so sore, I couldn't write my name on the new credit card.' In November 2004, the U.S. Food and Drug Administration approved the drug. Initial trial results were spectacular across the board.

Tysabri was shown to reduce relapses by 66 per cent and slow progression of disability by 44 per cent.

This was the silver bullet that MS sufferers had been waiting for.

But Elan was a not a firm that had enjoyed a trouble-free life. Only two years earlier, in 2002, analysts were predicting that the company would collapse, when in the fallout from the Enron scandal in the U.S., the Securities Exchange Commission launched an investigating into Elan's accounting practices. The share price collapsed.

In July 2002, with mounting fears the company would run out of cash, chief executive Donal Geaney resigned.

Geaney had joined Elan in 1987 and presided over its transition from a E1.6million company to one with a share valuation of E20billion.

ANEW CEO sold more than E1.2billion in assets to pay off debts. Geaney, the man who had made the firm and who had developed Tysabri, was broken. He died in 2005, aged just 54.

And while none of Tysabri's earlier financial woes mattered to Carol, it gave the firm a brittle reputation.

And in February 2005, with the trial still continuing, Elan announced that one fatal and one nonfatal case of a rare brain disease known as PML were found in patients given Tysabri in combination with another drug Avonex.

Elan's share price fell off a cliff again. And Carol was caught up in the maelstrom.

'It was a disaster,' she recalls. 'I was actually in the hospital that morning and one of the doctors said, "We're after getting a phone call from Elan. You have to come off Tysabri". I said, "What happened?

What's wrong with me?" And they said, "No, it's not just you, it's everyone." I asked, "Is everything ok?"

and they said, "It's grand, they have to go back to data and so on".' Then in March 2005, a second PML death was attributed to Tysabri.

With the trials suspended, Carol's symptoms returned.

'The year I was off Tysabri I was on steroids five or six times. At Christmas I was quite unwell. And I just had this massive fear that this is it.

I'm not going to get better.

'I was on steroids four times in the space of two months and I noticed I was awful tired. My legs were weak.

My walking was terrible. My balance was terrible. I was put on steroids and they weren't working and I was pushing the doctors for more. My brother is a pharmacist and he was telling me you are only supposed to be on these steroids three times in your life - and I have been on them 15 times. They damage your whole immune system and the next time you take them they won't be as effective.' Carol's personal life was also in turmoil.

'I was going out with a guy for ages but we broke up three months before Christmas last year. I was going out with him for a year which is a long time for me! I knew before we broke up I was going to get sick, so the relapses weren't because of the break-up.

'Although stress wouldn't help it.

If you are really down and stuff, that doesn't help.' Meanwhile, Elan's share price continued to fall. It became a worldwide news story.

Carol recalls the horror of watching the TV news: 'I am doing this interview because I want people to be more aware of what Tysabri is.

When I was looking at the Elan shares dropping and on TV they had pictures of tablets and Tysabri is not even a tablet. And all the focus was on the shares. But I was thinking "but what about the people who are actually on it?"

'It was horrible to think that it was all to do with money. It was just typical of our society - it wasn't about the dampener for people who had MS, it was about money.

People like me who had been on the trial, their lives were on hold.

And it was such a disaster.

'You know people were tracking the thing though trials and all the hopes and the feeling that it would be the best thing ever and then it was nothing, full stop. Finished.

'I wouldn't have gone back to injecting myself. I probably would have stayed taking nothing. I just hate needles.

'I think from the day I was diagnosed I wanted something like Tysabri that I wouldn't have to inject myself.' Carol believes the PML cases were over-hyped: 'All the focus in the media was on the rare examples of people getting PML and not on the positives. I think if you ask anyone with MS if they are prepared to take the risk they will say "of course".' Carol thought of all the sacrifices she had made just to take part in the trials. It had meant leaving the job she was in.

'I worked in insurance for years, but they were very discriminating when I started the trials. My boss told me I would have to take an annual leave day each month so I just got fed up with that.' THE effect on her emotionally was also harrowing. 'The year off Tysabri was weird. I was reading up on stem cell therapy and things. Then I was thinking because I love kids, maybe I should think about having kids now.

'Tysabri was never tried on pregnant women so you would never know what effect it would have on kids in the long term. You wouldn't do it to another human being. So then I thought "no I don't want kids yet".

'And then I thought "well it's a year of my life, just live it" because my life had been on hold for so long.

'So I travelled to Asia and Thailand-and Australia. But I was still thinking if Tysabri comes back again I will need to be back for the trial.' Aware of the effect its suspension was having on MS sufferers, the FDA (and its EU counterpart) fasttracked Tysabri back to market as fast as they felt able to.

Finally, in June this year, came the news Carol had been praying for. The drug was re-approved, with certain restrictions.

Carol is back on Tysabri. The only MS symptoms she has now are a numbness in parts of her legs and some problems with balance.

She is delighted other MS sufferers may get their chance to take it.

'You just wish for a drug like this.

It's not a cure, but it's the nearest thing to it.' She has a new boyfriend and the future is looking bright.

'I broke it to him [about MS] the first night I met him because his sister knew me and she knew.

When I'm seeing someone I would rather they hear it from me. He was a real funny chap. He still is. He makes me laugh.' She thinks about the future and having children. 'I know I'd have to come off Tysabri. And I do want to have kids in the next few years. A lot of women with MS are in remission while they're pregnant and then when they have the kid they go into relapse.

'That's scary......"

PDL Just Got Riskier
"Tysabri was taken off the market in 2005 after it was linked to a potentially deadly infection of the brain called PML, but it was recently reapproved.

Most observers in the medical industry expect the reintroduction of Tysabri to progress slowly at first, but, considering the superior efficacy of the drug, if no more cases of PML are reported it could eventually become the blockbuster that was originally envisioned. PDL is certainly hoping for that scenario, considering it receives royalty payments on Tysabri......"

ABC News - Ex-Biogen Exec. Settles Insider Trade Case:
" A former executive at Biogen Idec Inc. who resigned last spring amid an insider trading investigation has reached a $3 million settlement with federal securities regulators.The settlement announced Thursday by the Securities and Exchange Commission requires Thomas J. Bucknum to give up $1.9 million in profit plus pay a penalty of $969,000 and $102,000 in interest. Bucknum also is barred from serving as a director or officer of a publicly traded company for five years."

TYSABRI: ELAN-BIOGEN LETTER TO DOCTORS...

"July 2006
IMPORTANT DRUG WARNING

Dear Healthcare Professional:

Biogen Idec and Elan are writing to inform you of important safety information reflected
in recent changes to the labeling for TYSABRI® (natalizumab) as it becomes available
as monotherapy for patients with relapsing forms of MS. The changes describe the risk
of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of
the brain that usually leads to death or severe disability.

Two cases of PML were observed in 1869 patients with multiple sclerosis treated for a
median of 120 weeks. A third case occurred among 1043 patients with Crohn’s disease
after the patient received 8 doses. The absolute risk for PML in patients treated with
TYSABRI® cannot be precisely estimated, and factors that might increase an individual
patient’s risk for PML have not been identified. Due to this risk, TYSABRI® is approved
only under a restricted distribution program, called the TOUCHTM Prescribing Program.
In addition, a Medication Guide has been approved by the Food and Drug
Administration and a copy of the Medication Guide is required to be given to patients
prior to TYSABRI® being administered.

The following BOXED WARNING has been added to the Prescribing Information:

WARNING
TYSABRI® increases the risk of progressive multifocal leukoencephalopathy (PML), an
opportunistic viral infection of the brain that usually leads to death or severe disability.
Although the cases of PML were limited to patients with recent or concomitant exposure
to immunomodulators or immunosuppressants, there were too few cases to rule out the
possibility that PML may occur with TYSABRI® monotherapy.

• Because of the risk of PML, TYSABRI® is available only through a special
restricted distribution program called the TOUCHTM Prescribing Program. Under
the TOUCHTM Prescribing Program, only prescribers, infusion centers, and
pharmacies associated with infusion centers registered with the program are able
to prescribe, distribute, or infuse the product. In addition, TYSABRI® must be
administered only to patients who are enrolled in and meet all the conditions of
the TOUCHTM Prescribing Program (see WARNINGS, Progressive Multifocal
Leukoencephalopathy; and WARNINGS, Prescribing, Distribution, and
Administration Program for TYSABRI®).

• Healthcare professionals should monitor patients on TYSABRI® for any new sign
or symptom that may be suggestive of PML. TYSABRI® dosing should be
withheld immediately at the first sign or symptom suggestive of PML. For diagnosis,
an evaluation that includes a gadolinium-enhanced magnetic resonance imaging
(MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral
DNA are recommended (see CONTRAINDICATIONS and WARNINGS,
Progressive Multifocal Leukoencephalopathy).


In addition, the updated Prescribing Information includes the 2-year results of the
TYSABRI® clinical trial program. Labeling changes have been made in the CLINICAL
STUDIES, INDICATIONS AND USAGE, CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS, and ADVERSE REACTIONS sections of the package insert.

Prescribers should be aware that the immune system effects of TYSABRI® may
increase the risk for infections. Concurrent use of antineoplastic, immunosuppressant,
or immunomodulating agents may further increase the risk of infections, including PML
and other opportunistic infections, over the risk observed with use of TYSABRI® alone.
The safety and efficacy of TYSABRI® in combination with antineoplastic,
immunosuppressant, or immunomodulating agents have not been established.

We would also like to remind you that TYSABRI® has been associated with hypersensitivity
reactions, including serious systemic reactions (e.g., anaphylaxis) which occurred at an
incidence of <1%.>
TYSABRI® and initiate appropriate therapy. Patients who experience a hypersensitivity
reaction should not be re-treated with TYSABRI®.

TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of
multiple sclerosis to delay the accumulation of physical disability and reduce the
frequency of clinical exacerbations. The safety and efficacy of TYSABRI® beyond two
years are unknown. Because TYSABRI® increases the risk of PML, TYSABRI® is
generally recommended for patients who have had an inadequate response to, or are
unable to tolerate, alternate multiple sclerosis therapies.

The CLINICAL STUDIES section of the prescribing information was revised based on
the 2-year results of the TYSABRI® clinical trial program in multiple sclerosis. In the
monotherapy study, TYSABRI® (n=627) was shown to reduce the relative risk of
sustained increase in disability by 42%, compared with placebo (n=315). Seventeen
percent of TYSABRI®-treated patients demonstrated sustained increase in disability as
compared with 29% of placebo-treated patients. In this study, TYSABRI® also caused
a relative reduction in the annualized relapse rate of 67% to a rate of 0.22 as compared
with a rate of 0.67 in the placebo-treated patients.

The TOUCHTM Prescribing Program has been developed in consultation with the FDA.
This program represents our commitment to the responsible use of TYSABRI®. The
TOUCHTM program seeks to achieve the following:
• Physicians and patients are fully informed about the benefits and risks of TYSABRI®
before initiating and while on therapy
• Only appropriate patients are prescribed and infused with TYSABRI®
• Only authorized sites infuse TYSABRI®
• All TYSABRI® prescribing physicians and patients are enrolled into the TYSABRI®
registry

Biogen Idec and Elan will continue to provide a range of information and services,
including reimbursement research, infusion referral assistance, and infusion center and
patient materials.

Healthcare professionals should report any serious adverse events possibly associated
with the use of TYSABRI® to Biogen Idec at 1-800-456-2255. This information may also
be reported to FDA’s MedWatch reporting system by phone (1-800-FDA-1088), FAX (1-
800-FDA-0178), via the MedWatch website at www.fda.gov/medwatch, or by mail (using
postage paid form) to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
Health professionals and consumers should use this form for adverse event/product
problem reporting.

The revised full Prescribing Information and Medication Guide for patients are enclosed.
Should you have questions regarding the use of TYSABRI® or wish to learn more about
the TOUCHTM Prescribing Program for TYSABRI®, call 1-800-456-2255.

Sincerely,

Alfred Sandrock, MD Gordon Francis, MD
Senior Vice President, Vice President,
Neurology Research and Development Global Clinical Development
Biogen Idec Inc. Elan Pharmaceuticals, Inc.