WSJ – Brain Infections Return for Multiple Sclerosis Drug Tysabri

http://blogs.wsj.com/health/2008/08/01/brain-infections-return-for-multiple-sclerosis-drug-tysabri/

Brain Infections Return for Multiple Sclerosis Drug Tysabri

Two patients taking the multiple sclerosis drug Tysabri have developed the type of brain infection that caused the drug to be temporarily pulled from the market a few years back.

Biogen Idec and Elan, which co-market the drug, reported the cases of progressive multifocal leukoencephalopathy in SEC filings yesterday.

These are the first cases of PML that have emerged since the drug was taken off the market in 2005 after three patients in clinical trials developed PML, and two died from the infection. (Two of the patients had MS; a third had Crohn’s, which the drug is also approved for.)

Both new cases were diagnosed this week in the EU. One patient, who had been taking Tysabri for 17 months, is now “clinically stable and ambulatory at home,” the SEC filing said. That patient had not taken other MS drugs. The other patient, on the drug for 14 months, is hospitalized and had previously taken other MS drugs.

U.S.-traded ADRs of Elan were down more than 40% in pre-market trading this morning, and Biogen was down more than 20%. It’s the second gut-punch in a week for Elan investors. Disappointing data on an experimental Alzheimer’s treatment Wyeth and Elan are developing clipped about 30% from Elan’s value.

More than 30,000 people take Tysabri, and the companies have said all along that a small risk of PML remains associated with the drug. Analysts have been impressed with how many patients have returned to Tysabri since it went back on the market.

The drug will probably remain on the market despite the new cases, the WSJ suggests. That means patients and their doctors will face a potentially difficult decision: Weighing the benefits and risks of a drug that eases the burden of MS but slightly increases the risk of developing a second illness.

Photo: iStockphoto

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Now we know why Elan fell so much after hrs on Tuesday not related to Alzheimers treatment which wa generally positive, but that this PML news was pending. It is a clear market over reaction & shows that market traders are generally way too young & have little or no knowledge of very ill people. This Tysabri drug benefits alot of very ill people & a risk factor of 1:1000 is worth taking if you have MS. However with 32,000 patients & only 2 cases this is 1:16000 so far which is suprisingly low, every drug has risks. When will the market ever learn to get real. Obviously a time be buying this stock, always go against the market idiots.

Comment by MSGD – August 1, 2008 at 9:08 am

The Healthcare Channel on http://thehcc.tv/
New PML cases with Tysabri are not bad news

The HCC has mentioned many times since the first discovery of PML associated with Tysabri years ago that PML is NOT a fatal disease, or does not need to be at least. If caught early, the offending drug Tysabri can be discontinued and the disease can be treated without uniform death. The street consensus still thinks that PML is a death sentence to the patient and to BIIB stock.

More PML cases were inevitable. The recent cases could be viewed as a positive in the sense that the stringent monitoring program caught the PML early and prevented death. The patients could very well recover fully. The risk benefit ratio still favors the use of Tysabri for MS.

Comment by The Healthcare Channel – August 1, 2008 at 9:24 am

Just listened to the investor conference call. Many questions were left unanswered, especially regarding the number of patients who become suspected of PML but who are not confirmed. This would seem to be an important piece of the educational profile for patients/doctors to know more about.

Just because a risk is clearly on the label and patients sign a statement acknowledging the risk doesn’t mean that patients should not be aware of the suspected cases of patients or the numbers of patients who discontinue Tysabri for whatever reason. For those MS patients who find great benefit from Tysabri, they do not want to lose access to the drug. But for those patients who are just considering Tysabri, it would seem important to have a grasp on numbers of suspected cases vs. confirmed cases of PML.

Comment by Lisa – August 1, 2008 at 9:42 am

I thought you may like to hear from someone on Tsysbri, formerly on Copaxone. My disability from MS is small – I still walk, dance, do Nautilus, etc., and generally approach the disease like I am in training for a sport. Disgnosed five years ago at the age of 42, I feel fortunate to have a chance with the new class of MS drugs. Honestly, I had hoped to be one of the miracle patients on Tysabri, one that had improvements across the board. I would not describe my results like that. My leg strength has improved and my balance is mixed. BUT, there have been no disabling attacks, like I had with Copaxone. The problem with attacks is that they can leave and have left permanent damage that must be adjusted for physically on a day-to-day basis. So, on the question of whether or not to pull Tysabri for patients like me. I hope I am given the chance to stay on it. After 8 months, I have learned to trust the drug and the idea that it is protecting me from further attacks. The next wonder drug for MS is not ready for market so the idea of going back to the old class of drugs is like a sentence for getting worse or in my case for feeling like I am working so hard to stay in the ball game. Facing the choice of going on the old drugs, I want to emphasize that I would rather face the possible risks of Tysabri than go back to anything else.

Comment by Claudia – August 1, 2008 at 10:10 am

As a neurologist I am sure that the drug will not be withdrawn from the market because of a few new cases of PML. However, we will probably not see a drift in the indication towards Tysabri treatment in less severe cases of MS. With no more cases of PML that drift would definitely have occured in the next couple of years, because of Tysabri’s significantly better effect and “every day” tolerability compared with the interferons and Copaxone. 100 000 patients on Tysabri in 2010 seems unfortunately not to be realistic today.

Comment by Johan – August 1, 2008 at 10:46 am

Interesting.

Comment by John – August 1, 2008 at 10:54 am

I think Claudia’s comment captures the overwhelming sentiment of MS patients on Tysabri. With the risks as small as they are and the seeming treatability of the disease with plasmapheresis, people suffering with MS would be up in arms if the drug is pulled a 2nd time. The impressive uptake after the drugs relaunch 2 years ago is a testiment to its efficacy. And with the TOUCH program in place, chances for PML incidence in the US are infinitesimal at best.

Comment by Kent – August 1, 2008 at 10:55 am

I totally agree with Claudia’s comments. I was on rebif for one year and avonex for 2 years before that. I didn’t have much of a life while on those drugs due to the flu like symptoms and the adverse reactions. While on rebif, I was bedridden for 5-6 days out of 7 days. That was not a life, that was just existing. Before Tysabri, the question was do I take a chance not taking any disease modifying drugs, live a real life, and risk having disabling relapses, or do I suck it up and stay bedridden for 5-6 days out of the week and not really have a life that I can appreciate. Tysabri was my life saver, a miracle drug, if you will. With Tysabri, I live a life I can appreciate. For 3 weeks out of 4 I can forget I have MS. And that is living. After the 3rd week, the medicine has been used up and no longer in my body and I start to feel badly. So please if don’t take my Tysabri away. It is a life giving drug in more ways than one. I for one, will take the risk versus any of the other drugs currently available. Since starting Tysabri in October 2006, I have had no relapses.

Comment by Sylvia Caviano – August 1, 2008 at 11:34 am

Tysabri has very little place in the treatment of MS. The inevitable risk of dying from an opportunistic infection as well as PML far outweigh the efficacy of this drug. The high dose interferons and Copaxone should remain the drugs of choice for 99% of patients. Why would you risk death from Tysabri when the comparative data is not superior to currently available therapies?

Comment by MS Patient Care – August 1, 2008 at 11:44 am

Given what Claudia has stated and I’m sure there are others out there who feel the same way about Tysabri being able to overcome their symptons, from a financial perspective, this looks like a great opportunity again for management to buy back shares or for Carl Icahn or someone else to buy more shares. This also would be a great time for Biogen to buy out Elan and pick up all of the revenue from Tysabri. Of course they would have to work out the partnership issues on pipeline drugs with other firms, similar to those issues that Biogen stated were the reasons that no one offered to purchase them at the end of last year.

Comment by Tired Biogen/Idec Shareholder – August 1, 2008 at 11:46 am

I have secondary MS. I’ve been on Tysabri since of Nov of 06. It isn’t the “sivler bullet” that I had hoped for….but the once a month infusion with no side effects is worth the gamble.

Comment by Gloria T – August 1, 2008 at 12:26 pm

I have been through all Tysabri trials (took it for almost 3 years before the first issues). Tysabri changed my life. When they yanked it off the market the last time, I developed seizures and almost lost my job and through in the towel. My wife left 6 months ago after I became consistently stable on Tysabri. Now my 7 year old son and I live together, because my wife is out partying her life away. I certainly need the drug to be able to take care of my son and myself. Without it, I am very ill and I can’t imagine going down that road again, especially without a partner.

Comment by SteveG – August 1, 2008 at 2:46 pm

A risk-benefit analysis just published this week in Neurology (Thompson et al) indicates that the risk of PML with Tysabri would have to increase more than 7 times to reduce its overall benefit below that of interferon beta. More at http://bmartinmd.com/2008/08/overall-riskbenefit-of-tysabri.html.

Comment by B. Martin, MD (www.pathophilia.com) – August 1, 2008 at 3:06 pm

Am I the only one who is getting annoyed by the Healthcare Channel’s continuous use of this board for free advertising?

Comment by retired doc – August 1, 2008 at 4:07 pm

Life was hell before Tysabri. It has given me back a quality of life and I prefer to make the choice of quality over quantity if I ever have to choose.

Comment by LaurieB – August 1, 2008 at 9:19 pm

Kent, The TOUCH program involves the US and the TYGRIS program covers Europe. Therefore, it is entirely probable that US cases of PML will occur. PML is the headliner but not the only concern. What is not broadcast are the cases with antibody responses to natalizumab, reactivation of HSV and/or other viruses, other opportunistic infections ,etc. Cases of ‘possible’ PML that discontinue drug should be reported, but remain things that are discussed when physicians get together and little else. Nevertheless, with almost 9/10 of the pipeline therapies, the risk : benefit analysis will have to be given serious consideration.

Comment by immuno – August 1, 2008 at 9:58 pm

I have vowed if I can’t take Tysabri I will not take any of the other current disease modifying drugs due to side affects. So it’s Tysabri or nothing for me right now. However, that does not mean I am not concerned about the risks. These two cases are a VERY significant event. Part of my comfort in deciding to take Tysabri was the only cases of PML at that time were associated with another immune suppressant drug. These latest two cases present a new ball game since they were ONLY on Tysabri. I pray for the recovery of the two patients. I am afraid the public will think if they live everything is ok….NOOOO it’s not. My understanding is the damage done by PML is not repairable. So even if they catch it usually there is significant permanent disability as a result. The physical damage and loss of quality of life incurred by the PML should should be published as well. I wish I heard the Biogen and Elan talking about their work to improve the drug rather than just brushing over the risk by stating MS patients know the risk when we sign up. This gives the impression we are so desperate we don’t care. We do CARE. Aren’t we worth more work by these companies to frantically try to remove or reduce the risk? I too am a little disgusted by the financial concerns over the drug. This would not even be in the news if there was not a financial story. Shouldn’t this have been a story about how the companies need to keep plugging at reducing the risk to help save the patients. The stories make is sound like, what’s one less MS person.

Comment by Katy C – August 2, 2008 at 8:38 am

I have had MS for over 17 years. Have seen the years when there were virtually no drug therapies available and then as the interferon therapies were marched in as the answer to all our problems. I think it is clear that we are all frustrated and disappointed with what we have been offered as none of it has truly lived up to expectation. (I have tried them all, execpt Tysabri.) However, I am indeed now so saddened that my fellow patients are in such a desperate state that they would allow any drug company to dangle a medicine in front of them which offers so little in the way of benefits and asks so much in risk. Pay attention to the comments made about the number of suspected PML cases and not just the number they claim as confirmed. And remember that it is a progressive illness that can take as long as 6 months to be fatal. We need to demand better drugs and how can we be heard when people are willing to take such trash?

Comment by Karen C. – August 3, 2008 at 12:20 am

Most physicians have expected to see more cases of PML, but the data has suggeste this occurance after 2 yrs of treatment therefore it is a surprise to see PML in pts before this period There will be more cares.

Comment by John – August 3, 2008 at 10:20 pm

I have been on Tysabri both before and after it was pulled from the U.S. market. The first time, I felt remarkably better. After my second dose it was pulled, and I anxiously waited for it to become available again. My second round has not been nearly so successful, and I now become ill for several weeks after receiving the Tysabri, when I start to feel better it’s time for another round and I am again ill for several weeks. I was previosly on Avonex (awful) Copaxone (awful) and have taken several rounds of steroids before the Tysabri. At this point, I have started a well structured program with pH water and raw foods. My symptoms have reversed and remain reversed with this diet and there are no side effects, other than a remarkably improved overall health. I strongly urge MS patients to continue with their treatment of choice, work with their physicians, and by all means PLEASE work with a pH water program with raw foods. I love being able to walk again!

Comment by Ann C. – August 3, 2008 at 10:28 pm

I have been recently told that I am a canidate for Tysabri,I am on Betaserone,and I like it as I have never had side affects,but my dr is not sure if it is working anymore. I have heard good things and bad things about this drug,more bad than good. Yes this news of two people again coming down with PML does scare me. I am just not sure this is a med I want to mess with as I am a mother of 4 girls,two of them are not even in school yet. I just need to do more research before taking any chances.

Comment by Traci H. – August 4, 2008 at 3:44 pm

I was on Betaseron for 2 years and had multiple relapses.It was awful, because I have four children and need to have the strength and ability to care for my family. I am now on Tysabri and have strength and energy and no relapses. It is a wonder drug. I wish that more people with MS could have it. With our technology and MRI’s, I am sure that we can fight any occurrences of brain infections. It is worth it to have Tysabri.

Comment by DeDee B. – August 5, 2008 at 5:44 pm

I’m a doctor and an MS patient. It’s unfortunate that, after this recent report of additional PML cases associated with Tysabri, one can find very little specific medical data on the problem compared to the wealth of information regarding the stock price and the corporate reaction. Follow the money. All the MS drugs are advertised relentlessly to patients and their benefits greatly exaggerated,while their side-effects are minimized. Most studies of MS drugs were funded by the companies that make them, a conflict of interest that makes lobbyists funding politicians seem trite. Until Biogen-Idec can show me verifiable data on how many patients taking Tysabri have been suspected of or evaluated for PML, how many stopped treatment due to this concern, and how many continue to show benefit from it, I’ll pass.

Comment by Robin – August 5, 2008 at 11:03 pm

i am a ms patient tyasbri works great. .odds are in our favor.

Comment by greg – August 6, 2008 at 8:07 am

I just had my 15th infusion of Tysabri a week ago. I heard the news the following day. I feel stronger from Tysabri. My bladder symptoms have disappeared completely. My neurological exam is improved as well. I won’t stop taking it, even if it becomes 1:1000 diagnosed with PML as they predicted.

I’d previously tried Avonex, Rebif and Copaxone. Each had its disadvantages, and made life more difficult as well as leaving more troubling MS symptoms to deal with on a daily basis.

At 50 years old, quality of life is important to me. I hope they don’t take it off the market until there is an equal replacement for people with MS.

Comment by Wiz – August 6, 2008 at 7:07 pm

Follow the money. Biogen-Idec makes 1 BILLION dollars/year from Tysabri. Do you really think they are going to tell us all the facts about PML cases? They are hard to diagnose and the company carefully words it’s news releases as only so many “confirmed” cases. No information I can find on how many have been suspected. Interestingly, the company’s web site for patients, Tysabri.com, does not even mention the two new cases yet. They’ve been pretty busy reassuring their stock-holders (stock prices tanked), but I guess they figure the patients will just keep taking it. Patients with incurable diseases are easy prey for pharmaceutical marketing. Patients are getter smarter though with the use of easy internet communication. They are actually starting to ask more questions and to see through the marketing hype. Better not buy this now cheap stock just yet.

Comment by Anna – August 6, 2008 at 9:37 pm