This Is MS Multiple Sclerosis Community: Knowledge & Support

What a surprise, a major corporation announcing bad news after market close on Friday.


Biogen reports 11th Tysabri brain infection case

July 24, 2009 6:00pm EDT - An 11th patient taking Biogen Idec's multiple sclerosis drug Tysabri has developed a potentially deadly brain infection since July 2006, when it was reintroduced to the market.

The Cambridge, Massachusetts-based biotech company released the news on its website late on Friday.

Tysabri, which Biogen sells in conjunction with Irish drugmaker Elan Corp, is considered critical to the future growth of both companies.

The drug was temporarily withdrawn from the market in 2005 after it was linked with a brain infection known as progressive multifocal leukoencephalopathy, or PML. It was brought back in 2006 with stricter safety warnings.

Biogen has recently adopted a more aggressively upbeat tone in marketing the drug, insisting physicians are becoming more comfortable with risk of PML.

That approach appears to be working. Sales of Tysabri accelerated in the second quarter, rising to $254 million from $200 million a year ago. The company said the drug is on track to generate some $1 billion in sales this year.

Even so, some analysts believe doctors may take patients off the drug for certain periods of time.

At the end of June, about 43,300 patients were on Tysabri, compared with 40,000 at the end of March.

Biogen and Elan originally predicted 100,000 patients would be taking the drug by the end of 2010. The companies still believe they will reach that figure, but not within that time frame.

This is the last case of PML that the company plans to announce on its website. Biogen said on its earnings conference call earlier this month that it would in future communicate new cases by word of mouth to physicians and patient advocacy groups.

http://www.reuters.com/article/marketsN ... 724?rpc=44

Good to know that it will be harder to find out about case # 12.

As one of the 43300 patients on this drug its very comforting. Not.

Great news!

I had infusion #5 on Monday and we asked about PML #10. They tell us most are in Europe and with out knowing how they document all patients, like they do in USA, there is no way to know why this is happening.

And now #11......

Does anyone else ask about this with their neuro or infusion nurses? What kind of feedback, if any, do you guys get?

Cat

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Holly - Shine On You Crazy Diamond - Pink Floyd

9/3/09 Stanford - Dr Dake - Stent in R-J to unblock Arachnoid Cyst in Sigmoid Sinus. Stent in narrowed L-J. Balloon in narrowing where R & L Jugulars meet.

I had infusion #7 or 8 (I don't remember exactly) 8 weeks ago and plan to stay off of Tysabri. I did the CCSVI thing and I'm going to see how it plays out. I know the odds of PML are low, but they keep getting worse and that's a bad trend. I'm of the mindset, right now anyway, that drugs are not the answer; they haven't worked so far. So I'm going to try and take care of myself to the best of my ability and hope and pray that Zamboni is right. I don't feel anything from my surgery yet, but I just did a 1/4 mile walk and my wife watched me. She said there is no comparison to my gait today vs. just a month ago. I won't let myself say it's better probably until I can take a few running steps, but she says from an outside observer there's no comparison. Plus I just had a pretty good relapse on Tysabri, so I'm not convinced it's "it" anyway. We'll see what we see now.

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http://myhopefuljourneyintoactualmsreco ... ogspot.com

Well, I for one am glad to see that Biogen is being proactive in seeing that its earnings in the future will not be hurt.

The latest patient was located in the U.S. This is notable because it's only the third such U.S. patient. Eight of the previous 10 cases have occurred overseas, and it's unknown why that has been the case.

The PML incidence rate remains below the long-projected risk of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months. However, according to a research note Friday by Deutsche Bank analyst Mark Schoenebaum, the rate is approaching one in 1,000 for those getting the therapy for more than 24 months.

Dow Jones:
"A Jefferies & Co. research note last month put the revised PML incidence at:
one in 2,490 after 12-month Tysabri therapy;
one in 1,400 after 18-month therapy; and
one in 680 after 24-month therapy.

Biogen stated a few months ago that they were going to stop reporting new incidents of PML this month. Do you think they had some insight at what may be taking place at the 24 month therapy level?!

Harry

"Biogen said on its earnings conference call earlier this month that it would in future communicate new cases by word of mouth to physicians and patient advocacy groups."
"Biogen has adopted a more aggressively upbeat tone in marketing the drug, insisting physicians are becoming more comfortable with risk of PML."

To persuade someone "by word of mouth" is easier than by regular statement, isn´t it?

Biogen has a very smooth and effective marketing/sales division. "Word of mouth" communication can be manipulated to tell the physician or health care worker what they want to hear. How much time does the average physician have to give to a sales rep?

I'll never forget what my wife's neurologist said about Biogen about 5 years ago...."they don't have the most trusted reputation when it comes to trial data"! It doesn't take much to figure out what their plan of action is going to be with verbal versus written communication when it comes to Tysabri.

Harry