The potentially fatal infection, known as progressive multiform leukoencephalopathy (PML), occurs in an estimated 1.5 per 1,000 patients treated with Tysabri during months 25 to 36, the Food and Drug Administration said.

The FDA said it was the first time it had estimated the chances of PML for specific time intervals rather than providing a cumulative risk over years.

Of those, 14 have died and 56 are alive with varying degrees of disability ranging from mild to severe. There were no additional deaths in October.

This brings the total number of patients found to have developed PML to 68 since the beginning of September. Deaths among patients who had developed PML rose by 2 to 14.

PML, progressive multifocal leukoencephalopathy, is a rare, always serious and often fatal disease that damages the white matter of the brain at multiple locations.  It is caused by the activation of the JC virus (which is normally present but kept under control by the immune system) by immmunosupressive drugs such as natalizumab (Tysabri).

Hard and fast data confirms that from July 2006 (when Tysabri marketing resumed) to September 8, 2009, thirteen worldwide cases of Tysabri-related PML occurred in patients being treated for MS with Tysabri monotherapy. Of these, only four cases were patients in the United States, according to an FDA Post-marketing Drug Safety report.

Germany is an important MS market for Biogen. Aside from the U.S., Europe is home to four of the top seven markets — Germany, Italy, UK, and Spain — in terms of commercial dollars spent on disease modifying drugs for use in MS, according to an analysis of the global MS market by the pharmaceutical research outfit Visiongain.

Patients receiving monthly Tysabri infusions in the U.S. must be enrolled in the TOUCH Distribution Program overseen by Biogen, which involves (i) extensive monitoring of all patients for signs of PML and (ii) education of all patients and providers, with strong emphasis communicated to all parties that the drug is contraindicated for use in MS patients taking any drugs that may increase their risk of opportunistic infections, including drugs that lower immune function (e.g., azathioprine, chemotherapy, cyclosporine) or immunomodulators, such as the interferon-based disease-modifying therapies.

Aside from voluntarily enrollment of patients in Biogen’s Phase 4 trial, TYGRIS (Tysabri Global Observation Program in Safety), which is a prospective 5-year, 5000-patient cohort observational study to further evaluate PML risk and overall safety of Tysabri therapy, there are few — if any — restricted distribution programs in place throughout Europe.

As mentioned, most of the other reported cases of PML are alleged to have occurred in Germany, where oversight is purportedly lax, especially in the monitoring of the presence of latent JC virus  and a mandated prior “washout” phase required in patients recently removed from other immunosuppressant therapies, both high-risk factors for development of PML. However, since late summer, German authorities have been working with the company to make sure “appropriate use of Tysabri is monitored and followed up with [patients],” Chief Executive Jim Mullen said on the third-quarter earnings call.

The duration of therapy in the newly diagnosed PML patients is unknown. That said, lax supervision in German — and other European — MS treatment facilities could be a contributing risk factor behind the higher incidence(s) and prevalence of reported PML cases.

In the last 12 months, Biogen has engineered relationships between academic reference centers and many of the larger MS clinics in Germany so that the prescribing of Tysabri can occur in a more structured environment — in compliance with a common protocol developed and published by the Medical Advisory Board of German MS, according to chief operating officer Robert Hamm. To date, 250 top German MS treatment centers are linked to 40 reference centers, he said on the call. This initiative should play out in the company’s favor as European regulators re-assess the risk-benefit profile of Tysabri.

View full post here: http://industry.bnet.com/pharma/10005010/biogen-idecs-tysabri-problems-may-be-fault-of-european-doctors/?tag=shell;content

Two more cases of a rare brain infection have emerged in users of the multiple-sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, the first such incidences since Biogen stopped updating investors of the situation in July.

At that time, Biogen had confirmed 11 cases of progressive multifocal leukoencephalopathy, or PML, since the drug’s relaunch in July 2006; Tysabri was pulled from the U.S. market in 2005 because of PML concerns.

A Biogen spokeswoman said the Cambridge, Mass., biotech company is neither commenting on nor confirming the existence of additional cases as long as the PML rate is consistent with the rate of one-in-1,000 patients implied by the label. The new cases appear to be in line with the label’s rate.

An editorial published in the New England Journal of Medicine last week revealed a new case that occurred in Europe.

The latest case, also in Europe, was confirmed by Ralf Gold of the Ruhr University Bochum in Germany, who presented the case at the European Committee for Treatment and Research in Multiple Sclerosis that ended Saturday.

Like any public company, Biogen is required to disclose developments deemed material to its business, but the biotech company has said Tysabri’s risk profile is accurately detailed in its label after providing weekly updates on new PML cases through July 24, the third anniversary of Tysabri`s relaunch.

Duration of therapy is believed to play a role in Tysabri’s PML risk as most cases occurred after patients took the drug for more than a year. Biogen has opposed patients taking treatment breaks–referred to as “drug holidays”–because it can cause MS symptoms to return.

As of June 30, about 43,300 patients were taking Tysabri, with more than 30,000 on it for more than a year, and about 10,000 on it for more than two years.

Tysabri receives strong support from patients and doctors because of the drug`s perceived effectiveness. That support has remained steady because patients are well aware of the PML risk before they start taking Tysabri for the otherwise debilitating disease of MS.

Wall Street has closely watched the number of cases in gauging Tysabri’s sales trajectory because it is the key growth driver for both companies.

Sanford Bernstein analyst Geoffrey Porges said the two new cases “[add] to the dissatisfaction about the company’s decision to suspend regular disclosure of the rate of cases, particularly as a large bolus of patients are now reaching what appears to be a point of increased event risk.”

Mr. Porges said the new cases were “not necessarily alarming” because the ratio remains below the label-implied rate, but he stressed that there seems to be a connection to PML risk and duration of therapy.

PML re-emerged in Tysabri patients in July 2008, two years after the relaunch, and Biogen began issuing weekly updates in January after receiving criticism for its previous policy of disclosing new cases through 8-K filings with the Securities and Exchange Commission.

View full post here: http://online.wsj.com/article/SB125294848127909243.html

Elan starts legal action in drug row with Biogen

By Andrew Jack

Published: August 6 2009 22:34 | Last updated: August 6 2009 22:34

Elan has launched legal action to prevent the “irreparable injury” that would be caused by the collapse of its partnership with Biogen Idec over its pivotal multiple sclerosis drug.

The Ireland-based pharmaceuticals company is challenging a claim from Biogen Idec, based in Boston, that Elan’s recent $1.5bn (£893m) deal with Johnson & Johnson placed it in “material breach” of their profit-sharing agreement for Tysabri.

In a filing with the US District Court, Elan said it had received a letter from Biogen Idec at the end of last month giving it notice that it was terminating the collaboration agreement first signed to develop and commercialise Tysabri in 2000.

That letter gives the two companies 60 days – until late September – to finalise a restructuring of their Tysabri partnership, only days after J&J’s equity investment and funding deal is set to be completed with Elan.

Biogen Idec argued that following Elan’s deal with J&J, announced last month, its partner was in “material breach” of the agreement, which is rendered void by any delegation of rights.

Shane Cooke, Elan’s chief financial officer, told investors in a conference call last month that J&J had agreed in a confidential aspect of its deal to help finance the purchase of Biogen Idec’s share in Tysabri in the event that there was any change of control.

However, in a view that Elan maintained in Thursday’s court filings, Mr Cooke also stressed that the J&J deal did not in itself represent any change in control that would affect the existing Tysabri partnership with Biogen Idec.

Elan has since offered to share the full terms of the J&J financing agreement with Biogen Idec, and has now filed them with the court in an attempt to win a ruling that there is no violation.

It says in the filing that termination of the partnership would result in Elan forfeiting all rights to Tysabri or the ability to buy out Biogen Idec’s rights to the drug, and imposing on it “draconian penalties”.

Elan said on Thursday: “There’s nothing in the pending transaction that is contrary to our collaboration agreement with Biogen Idec for Tysabri … This is the same agreement we have been operating under for the last nine years. It is unfortunate that, because of Biogen Idec’s actions, Elan was left with no alternative but to seek court intervention to protect its interest.”

View full post here:

http://www.ft.com/cms/s/0/f7fe7f32-82bd-11de-ab4a-00144feabdc0.html?ftcamp=rss&nclick_check=1

This is what happened when three people who were on Tysabri and other medications for Multiple Sclerosis had previously contracted the brain infection and two died, according to InjuryBoard.com which tracks such drug reactions. Then, the drug was taken off the market briefly.

Biogen Idec, the company that makes Tysabri (and other medications that help MS). This is the 11th case of the potentially fatal brain illness since July 2006 when the drug came back on the market for public use.

The PML, or progressive multifocal leukoencephalopathy, was responsible for the death of two patients and it was withdrawn in 2005, but then brought back with stricter monitoring efforts a year later.

According to InjuryBoard.com:

Four cases have been reported since the drug was introduced in 2006. Three have died. A patient had received 14 Tysabri infusions before falling ill.

The severe brain infection may occur in one in every 1,000 patients, according to Biogen statistics

Unlike the other MS medications, Tysabri is not an injection, but a montly infusion that takes a few hours to administer. It has been known to drastically change symptoms in some MS patients.

At the moment, 43,300 people are on Tysabri. The company expected to have more than 100,000 patients by the end of 2010.

Commentary: I’m on Tysabri and have been for nearly two years after being weaned off of Avonex. Make sure that you have regular checks by yout doctor, and let your family and friends know of potential PML symptoms.

View full article here: http://www.examiner.com/x-11509-Multiple-Sclerosis-Examiner~y2009m7d25-An-11th-patient-gets-potentially-fatal-brain-infection-using-Tysabri

Biogen Idec (NASDAQ: BIIB) and Elan Corporation (NYSE: ELN) announced results of a study demonstrating that Tysabri® (natalizumab) promoted regeneration and stabilization of damage done to the myelin sheath, as measured by advanced MRI technology. Damage to the myelin sheath causes the symptoms of multiple sclerosis (MS). Additional posters were presented during the Congress highlighting the ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS.

“What we have seen in these MRI data suggest that TYSABRI may have the capacity to repair and possibly restore some of the damaged myelin sheath that protects nerve fibers. Results from this study support the continued investigation of the potential effects of TYSABRI on this process,” said Robert Zivadinov, M.D., of the Jacobs Neurological Institute in Buffalo, N.Y., the lead investigator for the remyelination study.

“TYSABRI is changing the way neurologists and patients define success in the treatment of MS,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology, Biogen Idec. “These MRI data presented at AAN provide early evidence that TYSABRI may not just slow the progress of MS, but may also be able to reverse the damage inflicted by the disease.”

“Everyday, more patients understand that TYSABRI can represent a new way of looking at – and managing – their disease,” stated Carlos Paya, M.D., Ph.D., president, Elan Corporation. “These latest analyses further build on the impressive data we have seen to date with TYSABRI.”

TYSABRI helped stabilize and restore damage to the myelin sheath.

The imaging study, which included a total of 110 subjects, used an advanced MRI technology called the Voxel-Wise MTR to measure lesions and normal brain tissue. The study showed that TYSABRI promoted remyelination when compared to those receiving interferon beta-1a IM and normal controls.

The effect of TYSABRI on lesions and NABT in relapsing MS was evaluated with a Voxel-Wise (VW) imaging method using magnetization transfer ratio (MTR). VWMTR is recognized as a powerful instrument for monitoring MS disease activity and effectiveness of therapeutic interventions in patients with MS.

In the study, 62 MS patients who received TYSABRI were followed for 12 months together with 26 MS patients who received interferon beta-1a IM and 22 age-matched and sex-matched normal controls. For each subject, baseline and follow-up MTR volume maps were placed in a common halfway-space. The resulting VW subtraction map was then enhanced via threshold-free cluster enhancement (TFCE) algorithm, and a significance threshold was determined based on subject-specific Monte Carlo simulation. Supra-threshold volumes (95th percentile) were quantified for both areas of increasing (remyelinating) and decreasing (demyelinating) MTR voxels, which represent a volume value.

There was no significant difference in decreasing VWMTR NABT volume over the follow-up between TYSABRI-treated and normal control groups. Relapsing-remitting patients on both therapies showed higher remyelination potential and less evident demyelination than relapsing secondary progressive patients. The volume of VWMTR changes in NABT (decreasing or increasing) was almost 3-5 times higher than the amount of changes observed for T2-lesion volume. This indicates that the VWMTR method might be a much more sensitive approach to capture demyelination/remyelination changes over time than the lesion-based volume measures.

TYSABRI significantly increased the cumulative probability of achieving sustained improvement in disability in patients with relapsing MS

Data from this post-hoc analysis was previously presented at the 2008 World Congress on Treatment and Research in Multiple Sclerosis. The data showed TYSABRI produced significant results on the cumulative probability of sustained improvement in physical disability in those treated over two years compared with placebo. In patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0, treatment with natalizumab significantly increased the probability of sustained improvement in disability by 69 percent relative to placebo. In the same patients, the probability of achieving sustained improvement was 29.6 percent with TYSABRI (n=417) compared with 18.7 percent with placebo (n=203) (p=0.006). In patients with an EDSS score ≥ 2.0 and highly active disease at baseline, the difference between groups was even greater, 35.5 percent for TYSABRI (n=103) and 15.4 percent for placebo (n=40) (p=0.045).

Patient-Reported Outcomes Study

In this study, patients with relapsing-remitting MS were asked after three months of treatment to rate their improvement, using validated outcomes tools. The posters presented at AAN show that overall, patients reported significant improvement in cognitive function, general and disease-specific health-related quality of life, and lower-levels of fatigue after the third infusion of TYSABRI. The ongoing one-year longitudinal study assesses health outcomes from the perspective of the patient before starting TYSABRI and at predetermined timepoints thereafter.

View full article here: http://www.medicalnewstoday.com/articles/156430.php

Biogen Idec Inc.’s disclosure of a debilitating brain infection in a patient taking its Tysabri multiple-sclerosis medicine sparked a selloff in shares of the biotechnology company Monday.

The disclosure, made Friday evening, marks the 13th case of the infection, called progressive multifocal leukoencephalopathy or PML, in a Tysabri patient. Three of the patients have died.

Biogen’s shares dropped 5.5% to close at $47.32 on the Nasdaq Stock Market, possibly making the firm more vulnerable to a takeover by a large pharmaceutical company. Earlier this month, the company lost a proxy fight with billionaire activist investor Carl Icahn, who won two seats on its board and has suggested Biogen ought to be split up or sold.

Deutsche Bank downgraded Biogen’s shares to “hold” from “buy” over the weekend. Analyst Mark Schoenebaum estimated that of patients who have taken Tysabri for more than one year, one in 2,000 had contracted the infection. The company had previously placed that risk at one in 4,200, before the most recent cases.

American Depositary receipts in Ireland’s Elan Corp., which shares Tysabri’s profits, fell 6% to $6.94 in 4 p.m. trading on the New York Stock Exchange.

The risk of infections from potent drugs that restrict the immune system has recently vexed regulators. In April, the Genentech unit of Roche Holding AG pulled a psoriasis drug, Raptiva, from the market over PML. The cancer treatment Rituxan — sold by Roche and Biogen — has also come under scrutiny over cases of PML.

Tysabri was pulled from the U.S. market in 2005 after three initial cases. After holding hearings to weigh Tysabri’s risks and benefits, the Food and Drug Administration allowed it to be reintroduced in 2006, under monitoring rules and a prohibition on using it in combination with other MS drugs. The system was aimed at reducing PML incidence.

The 10 cases since — including three this month — have frustrated Biogen’s aim of making Tysabri into a blockbuster drug. The company has invested in treatments for PML and ways to mitigate the infection — once thought to be almost always fatal — and in persuading doctors that PML’s risk in Tysabri patients is less severe and less likely.

The drug missed Biogen’s projection for quarterly sales of $250 million last year — sales of the drug were $227 million from January to March — and Biogen has stepped back from a goal of reaching 100,000 patients by the end of next year.

“There are a number of neurologists who have started taking people off Tysabri for periods of time after they’ve been on it for a couple of years,” said John Richert, a neurologist who directs the research efforts of the National Multiple Sclerosis Society. Biogen opposes that practice, called a “drug holiday,” as unjustified.

But “when the odds that the person with MS is going to have significant disability, the 1 in 1,000 risk of PML, which was estimated early on, seems like a reasonable risk for many people,” Dr. Richert said.

Shannon Altimari, a Biogen spokeswoman, said the PML risk was “well within” what the company has said on Tysabri’s label.

Write to Keith J. Winstein at keith.winstein@wsj.com

View entire article here: http://online.wsj.com/article/SB124631389418370485.html

The company said late Friday it confirmed the presence of progressive multifocal leukoencephalopathy, or PML, on Tuesday. Biogen said the patient, who lives outside the U.S., had been using Tysabri for 30 months. Three of the ten cases of PML have been confirmed this month.

In morning trading, shares of Cambridge, Mass.-based Biogen slid $2.86, or 5.7 percent, to $47.21.

Tysabri is approved as a treatment for multiple sclerosis and Crohn’s disease. It was pulled from the market in 2005 due to concerns about PML, and sales resumed in July 2006 with restrictions and a monitoring program. The ten confirmed PML cases have all been in multiple sclerosis patients, and concerns about the disease have pressured sales of the drug.

Biogen said there were about 40,000 patients on Tysabri at the end of March, with 20,800 of them in the U.S.

Deutsche Bank analyst Mark Schoenebaum said in a note that the rate of PML infections in Tysabri patients is less than one in a thousand, for patients who have been on the drug for two years. He said the average time on Tysabri for the PML cases is 24 months, and that as more new infections appear, doctors may start taking patients off Tysabri sooner, or giving patients breaks from the drug.

Schoenebaum said that could “dramatically” reduce sales growth.

Biogen markets Tysabri with Irish drug maker Elan Corp. PLC, whose shares dipped 38 cents, or 5.2 percent, to $6.98. Shares of PDL BioPharma Inc., which developed the drug and receives royalties on sales from Elan, declined 6 cents to $7.90.

View full article here: http://www.businessweek.com/ap/financialnews/D994CK4G0.htm

Biogen Idec Inc., the maker of Tysabri, reported the case on Friday, one week after the 8th case was reported. The company indicates that they will no longer report each individual cases of Tysabri PML infections, but will provide a weekly update on their website.

Progressive multifocal leukoencephalopathy, commonly referred to as PML, is a rare form of brain infection that causes damage and inflammation to the white matter areas of the brain. The infection often results in death after the degradation of certain brain functions. Affects of the infection can include impaired speech, weakness, loss of vision, paralysis and cognitive decline.

Tysabri (natalizumab) was approved in 2004 for the treatment of multiple sclerosis through regular intravenous injections. It was recalled from the market in 2005 after three patients developed the rare brain infection, two of whom died. The medication was reintroduced in July 2006 with stronger warnings about the potential Tysabri side effects, and the drug was only made available under strict usage guidelines to limit the risk of PML infections.

Since its return to the market, this most recent report is at least the ninth patient to develop the infection. Estimates indicate that about one in every 1,000 patients treated with the Tysabri experience the side effect. The lastest case involves a patient outside the United States who developed the brain infection after his 34th injection.

Tysabri is just one of several drugs that have been linked to the deadly PML brain infections in recent years. The psoriasis drug Raptiva was recalled in April due to PML infections, and the cancer drug Rituxan was recently connected to 57 cases of PML infection in a study published in the May 2009 issue of the medical journal Blood.

June 12 (Bloomberg) — Biogen Idec said a patient taking its multiple sclerosis drug Tysabri was diagnosed with a life-threatening brain illness, the eighth case reported in the last year.

The patient was confirmed to have progressive multifocal leukoencephalopathy, or PML, on June 10, according to a report on Cambridge, Massachusetts-based Biogen’s Web site. About 56,700 patients have been treated with Tysabri, the company said.

Biogen and marketing partner Elan Corp pulled Tysabri from the market in 2005 after three patients developed the brain infection, including two who died. The U.S. Food and Drug Administration allowed sales to resume in July 2006 after deciding benefits for slowing MS relapses outweighed the risk. There were no reported infections for about two years after the drug’s reintroduction.

The likelihood of getting PML from Tysabri is about 1 in 1,000, according to the drug’s label. The infection occurs when a common germ, called JC virus, mutates, then evades the body’s immune defenses and penetrates the brain, causing irreversible damage. Researchers theorize that Tysabri may subdue defenses meant to keep the virus out of the brain. The virus breeds in brain cells, destroying them when it replicates.

On April 9, Genentech Inc., which was acquired in March by Roche Holding AG, announced it was pulling its psoriasis treatment Raptiva from the U.S. market because of the drug’s link to PML. Three patients were diagnosed since October and two died. Other drugs linked to PML include Roche’s Cellcept, used to prevent transplant rejections; Biogen and Roche’s cancer drug Rituxan; and Genzyme’s leukemia drug Campath.

Read full post here: http://www.bloomberg.com/apps/news?pid=20601087&sid=a3cQUIGdgeHM

ZURICH, April 29 (Reuters) – Novartis AG  said 80-83 percent of those taking its multiple sclerosis drug FTY720 are relapse-free compared with 69 percent on the leading current treatment, but it reported a new patient death.

Novartis said the patient died from aspiration pneumonia related to a progressive neurological condition.

Safety concerns have surrounded the drug for some time.

FTY720, has been associated with potentially fatal infections, skin cancer and a case of hemorrhaging focal encephalitis, an inflammation of the brain with bleeding. It is unclear whether the drug was responsible for the events.

Novartis, which is presenting new Phase III results to the American Academy of Neurology, said the data reinforced results announced in December that showed the annual relapse rate was 52 percent lower compared with patients taking Biogen’s injectable multiple sclerosis drug Avonex.

Novartis AG and Germany’s Merck KGaA are leading the charge to develop MS drugs that can be taken orally, rather than by infusion or injection, but the firms must persuade physicians and investors that the treatments are safe. [ID:nN24419113]

Novartis said serious adverse effects were reported in less than 2 percent of patients treated with FTY720 and said a role for the drug in the death of a patient in February who stopped taking FTY720 in August could not be confirmed or ruled out.

Sal. Oppenheim analysts said the news of the death was the main news in the report and said it was slightly negative.

“This and other reported serious events in the FTY720 arm significantly increase regulatory risks in our view,” they said.

Helvea analyst Karl-Heinz Koch said he was not too concerned, noting the long lapse between the time the patient stopped taking the drug and the death.

“We continue to believe that the safety-efficacy ratio remains positive and that the drug will find its way into the marketplace,” he said, predicting sales of $1.5 billion for FTY720 and a follow-on treatment.

Novartis shares were flat at 1230 GMT, in line with the DJ Stoxx European healthcare index .SXDP.

REGULATORY FILINGS THIS YEAR

Novartis said full results from the so-called TRANSFORMS study would be submitted to a peer-reviewed journal in the next few months, adding regulatory filings were on track for the United States and European Union at the end of 2009.

Lead investigator Jeffrey Cohen said the trial showed that FTY720 “may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis”.

Novartis also presented longer-term results from a Phase II study that showed continued low relapse rates after four years of treatment, with no change in the safety profile.

It added that the safety profile of a 0.5 mg dose appeared to be better than the 1.25 mg dose.

Merck’s drug, cladribine, has been linked to a reduction in white blood cells, which can lead to infection, and in January the company said four patients in a late-stage trial were diagnosed with cancer. It is also due to present study results at the neurology meeting in Seattle.

Earlier this year Merck said results of a late-stage trial showed cladribine reduced the number of relapses per year by as much as 58 percent, compared with those taking a placebo.

Biogen is developing an oral MS drug, known as BG-12, but it is not as far advanced as the Merck or Novartis drugs.

(Editing by John Stonestreet and David Cowell)

View full article here: http://www.reuters.com/article/rbssHealthcareNews/idUSLT73514220090429

April 29 (Reuters) – Elan’s  Tysabri drug may be able to reverse damage caused by multiple sclerosis, the Irish drugmaker and its U.S. partner Biogen Idec said on Wednesday, boosting Elan’s shares 10 percent.

Data released by the companies at the American Academy of Neurology showed Tysabri promoted the regeneration of the protein coat that protects nerve fibres and whose damage causes the symptoms of multiple sclerosis.

“This provides more evidence that Tysabri may not just slow down the progress of MS but also may be able to reverse the damage caused by the disease,” Goodbody analyst Ian Hunter said in a note.

Tysabri, which is given by infusion, is the most effective drug on the market, reducing the relapse rate in patients with multiple sclerosis by 68 percent.

But sales have been crimped because of its link with progressive multifocal leukoencephalopathy, or PML, a potentially deadly brain infection.

Elan’s shares have lost almost three-quarters of their value over 12 months due to concerns over the safety of Tysabri, disappointing results from a trial of its experimental Alzheimer’s vaccine and uncertainty over its future.

Its stock traded 10 percent higher by 0911 GMT at 4.8 euros, outperforming a 3 percent stronger wider Irish market.

Elan said last week it was seeking a partnership with a big pharmaceutical company, after reporting a 14 percent rise in first-quarter revenue and a wider net loss.

Swiss drugmaker Novartis AG  and Germany’s Merck KGaA are leading the charge to develop multiple sclerosis drugs that can be taken orally, rather than by infusion or injection. (Reporting by Andras Gergely; Editing by David Cowell)

View entire article here: http://uk.reuters.com/article/marketsNewsUS/idUKLT86173120090429