WSJ "Biogen Idec Inc. - Tysabri" PML update

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WSJ "Biogen Idec Inc. - Tysabri" PML update

Postby PCakes » Wed Sep 15, 2010 6:29 am

http://online.wsj.com/article/BT-CO-201 ... 12617.html

Biogen: Five More Cases Of Brain Infection In Tysabri Patients
By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) disclosed five 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 68 as of Sept. 2.

The Cambridge, Mass., biotech company reported that the number of deaths among patients that have developed the infection--known as progressive multifocal leukoencephalopathy, or PML--rose by two to 14.

Sales of Tysabri are important to the future of both Elan and Biogen. The drug is considered a highly effective therapy for multiple sclerosis, but its growth has been slower than originally hoped due to concerns about the risk of PML that led to the drug's temporary withdrawal beginning in 2005.

The infection re-emerged among Tysabri patients in mid-2008, and Biogen provides monthly updates about the number cases.

The overall global PML rate is about 0.90 per 1,000 patients, the company said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.

As of June 30, 52,700 patients were using the drug around the world. In total, about 71,400 patients have used the drug since its launch.

Of the total PML cases, 28 were in the U.S., 36 were in the European uni0n and four were in other areas. The company didn't disclose the distribution of the 14 patient deaths.

The number of cases is important because if the infection rate climbs too high, the drug's sales growth may drop. Regulators have said that they watch the cases, but have concluded that the benefits of the medicine to MS patients outweigh the risks.

Tysabri is usually used in MS patients who don't respond to earlier therapy or in patients with aggressive cases of the disease, and is distributed under a strict risk-management plan that monitors patients for PML.

The risk of the infection increases with the number of monthly infusions that a patient receives. The incidence rate appears to drop after 30 months of use, but Biogen views the drop as inconclusive, because there aren't enough patients to have confidence in that finding.

The most recent data update translates to a rate of 1.42 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.86 per 1,000 for those on the drug for two years or longer.

Looked at another way, the rate is about 1.46 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.39 case per 1,000 patients in those using it for one to two years, and it is essentially nonexistent in patients using it for less than a year.

Shares of Biogen closed up 17 cents at $57.91 on Tuesday, while Elan's American depositary shares rose 16 cents to $4.86.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

Last edited by PCakes on Wed Sep 15, 2010 7:58 am, edited 1 time in total.
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Postby Blaze » Wed Sep 15, 2010 6:36 am

But angioplasty is "too risky." Yeah, right.
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Red Herring

Postby MarkW » Wed Sep 15, 2010 6:57 am

Let's try not to be side-tracked from getting our message across.
MarkW[/u]
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Postby Motiak » Wed Sep 15, 2010 6:58 am

My uncle got PML but they're keeping him on Tysabri. Seems kind of odd.
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Re: Red Herring

Postby PCakes » Wed Sep 15, 2010 7:07 am

MarkW wrote:Let's try not to be side-tracked from getting our message across.
MarkW[/u]


Hi Mark,

If you are saying.. stick to CCSVI. I agree but felt this was important enough news to bring to the table.
There are many variables to consider. Knowledge is power. Especially in dialogue with healthcare.

Cheers, pc
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Postby nicknewf » Wed Sep 15, 2010 9:54 am

So if CCSVI treatment has a risk of death of less than 1.46 over 3 years due to the treatment, it is safer than Tsyabri?
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Postby Johnson » Wed Sep 15, 2010 3:05 pm

nicknewf wrote:So if CCSVI treatment has a risk of death of less than 1.46 over 3 years due to the treatment, it is safer than Tsyabri?

And perhaps, much more effective...

We'll need to see some 70,000 treatments before comparisons can be drawn though. I have never heard a Tysabri user say that they have no "MS" anymore, that their symptoms have vanished (I have never looked for such claims either - they might be out there), but I have heard that from "Liberatis". My symptoms were gone - for a while.
My name is not really Johnson. MSed up since 1993
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Postby BooBear » Thu Sep 16, 2010 10:09 am

I love the moniker "Liberati". Love even more that I am one.
Three veins angioplastied.  One renewed life.  
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where are the Oct 2010 figures?

Postby hwebb » Tue Oct 19, 2010 12:51 am

Have the Oct 2010 risk figures been released yet? I haven't seen them anywhere.

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Postby Cece » Tue Oct 19, 2010 5:03 am

nicknewf wrote:So if CCSVI treatment has a risk of death of less than 1.46 over 3 years due to the treatment, it is safer than Tsyabri?

Not to quibble but the death was due to the multiple blood thinners.

Tysabri has known risks and benefits, CCSVI venoplasty has unknown risks and benefits. But the very existence of Tysabri shows how tolerant we can be of risks, when fighting this disease. It's horrible. When I was first diagnosed and came to this forum, Tysabri had been pulled and made unavailable because the PML risk was coming more to light. There were people desperate for it back because they had done well on Tysabri and were progressing without it. :(
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Postby japentz » Fri Nov 19, 2010 4:49 pm

Two in
October 2010
http://www.reuters.com/article/idUSN2024384420101020


Five in
November 2010
http://au.advfn.com/news_Biogen-5-More- ... 85816.html


I have MS. A dear friend is one of the Five in November (she was diagnosed October 21, 2010, so i don't believe she was counted for the 2 in October.

What was dangerous about Angioplasty again?
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Postby ikulo » Fri Nov 19, 2010 5:17 pm

japentz wrote:What was dangerous about Angioplasty again?


We don't know, that's the point. The new article coming from Ontario about a man dying due to a blood clot should serve as a warning and reminder that we do not know everything there is to know. I'm sure everyone was up in arms about Tysabri being taken off the shelves the first time around, now everyone is doing the same for angioplasty. As far as I'm concerned, everyone should be able to take these risks if they so desire, but let's be honest about the fact that the risks are largely unknown at this time.
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Postby japentz » Fri Nov 19, 2010 5:25 pm

That was due to a stent, not angioplasty. The man was not allowed to be treated in his country because he had the angioplasty and a stent done in Costa Rica (far from his home). Blood clotted around the stent, he could not get treated quickly. Any danger seems to be related to stents, not angioplasty.

An interventional radiologist will tell you that this is a safe and minimally invasive procedure. Angioplasty.

I did not ask about dangers of stents being placed in a vein.

We do know angioplasty on its own is safe. I was being facitious.
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Postby Cece » Fri Nov 19, 2010 5:50 pm

japentz wrote:That was due to a stent, not angioplasty. The man was not allowed to be treated in his country because he had the angioplasty and a stent done in Costa Rica (far from his home). Blood clotted around the stent, he could not get treated quickly. Any danger seems to be related to stents, not angioplasty.

I can't quite agree with the last statement. It misleads people into thinking there are not risks with angio only, or that you can't clot if it's only angio, etc.

The Costa Rican death was attributed by his doctor, Dr. F in Costa Rica, to be due to the powerful anticoagulants that he was on to break up the clot.
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Postby japentz » Fri Nov 19, 2010 7:15 pm

No offense but this thread is about Tysabri. I was just making an off handed flip remark and it was really not my intention to troll off topic.

If people want to start a thread on the dangers of angioplasty, it would be more appropriate to discuss it in a thread having that particular topic dangers of angioplasty or one discussing the death of that poor gentleman, whose country has boycotted treating any vascular conditions if they have MS.

In my opinion, Tysabri is poison. And that is just my opinion.
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