Confrimed with BiogenIdec Investor Relations who's included in their Tysabri patient#
 

Cherie,

Finally got a call back from a Robert Dixon in BiogenIdec Investor Relations to discuss the number of patients reported on Tysabri in their earnings slides.

The number of patients reported at 1 year, 18 months, and 2 years of Tysabri are patients since relaunch of the drug. The numbers do not include the patients from the original registration trials.

The total number of patients ever exposed to Tysabri does include the original trial and original commercial launch patients.

A bit of apples and oranges.

BiogenIdec has also instituted weekly reporting of confirmed PML cases on their web site. The status as of 1/09/09 listed the 4 PML cases reported to date so no new PML cases as of today.

Chris

Cool . . . but could you send me the guy's number by PM, please.

"As of the end of September 2008, more than 35,500 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of September 2008:

* In the U.S., more than 19,500 patients were on TYSABRI therapy commercially;
* Outside of the U.S., nearly 15,300 patients were on TYSABRI therapy commercially;
* In global clinical trials, more than 700 patients were on TYSABRI therapy; and
* There have been two confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006.

(NOTE: That adds up to 35,500 . . . which is how many are ON Tysabri).

Cumulatively, in the combined clinical trial and post-marketing settings:

* More than 48,000 patients have been treated with TYSABRI; and
* Of those patients, nearly 18,000 have received at least one year of TYSABRI therapy and approximately 9,500 patients have been on therapy for 18 months or longer."

http://findarticles.com/p/articles/m..._/ai_n30915367

http://seekingalpha.com/article/1008...nscript?page=3

Cherie

CORRECTION: I originally requested his "name" instead of "number", Chris, on my first response. Please send that by PM as I will follow up first with him.

His information contradicts the information provided by Bill Sibold - Senior Vice President, U.S. Commercial; provided in Biogen's 3rd Quarter Report . . . but I'm interested in hearing what this guy has to say anyway. :)

Thanks, Cherie

Thanks for that, BTW. They had filed a 8-K report today announcing they were going to do this . . .

Item 8.01. Other Events.

Biogen Idec Inc. (the “Registrant”) will post on its web site after 4:30 p.m. (ET) each Friday information on confirmed cases of progressive multifocal leukoencephalopathy (PML) that have occured in TYSABRI-treated patients since July 2006. This information can be found at www.biogenidec.com/tpme

The first such posting today includes only previously disclosed cases of PML. The Registrant intends to post this information on its website through July 24, 2009, the third anniversary of the reintroduction of TYSABRI into the market.

http://www.sec.gov/Archives/edgar/da...3544bie8vk.htm

This is the website to watch, for those who are interested:

http://investor.biogenidec.com/phoen...82&p=irol-TPME

. . . and on it they confirm what I said earlier:

"Cumulatively, in the combined clinical trial and post-marketing settings:

• More than 48,000 patients have been treated with TYSABRI; and
• Of those patients, nearly 18,000 have received at least one year of TYSABRI
therapy and approximately 9,500 patients have been on therapy for 18 months or longer. . . ."

Cheri

Glad I could clear up the numbers we had batted back and forth
 

Glad we can finally talk from the same sheet of music as they say. Don't know why I didn't think of talking to BiogenIdec sooner as assuming is dangerous.

Chris

I think they plan to announce their 2008 4th Quarter numbers soon (Jan 17th?), and I suspect at that point they may not need to include the ones from the trials any longer. By now, there should be enough people who've been on monotherapy since the trials, to be able to calculate a ratio.

As per their 2008 3rd Quarter comments in that regard:

"Operator
Your next question comes from the line of Adam Walsh with Jefferies.

Adam Walsh - Jefferies
Hey thanks. Can you give us a sense of whether physicians are still using the one in a thousand PML rates describing the label as a threshold for comfort and do you get any sense from doctors, does that label change in the event the new PML cases emerge. Thanks.

James C. Mullen - President and Chief Executive Officer
I don't think we get a lot sense from the physicians exactly how they integrate all that. I think one of the one things that Cecil mentioned in his comments is the FDA in the change to the labeling actually references that are in monotheraphy, the rate appears to be less than the one in a thousand.

I think at this point, that's about all you could do. I think the difficulty which is going to remain for a bit of time is the denominator particularly of the number of patients that have gone out fairly long-term in therapies is still relatively small. So, I think we just have to continue to watch that issue."
_______________

You and I are not on the same sheet yet, Chris. What the Investor guy said to you is in contrast/conflict with everything that has been communicated publically so far . . . so frankly, I think he is either wrong, or misunderstood the question.

I will have him send me something published that supports his interpretation, which I am sure will be available somewhere if it is true.

Cherie

Next update on Tysabri usage either this next week on Tuesday or Feb 6
 

The next update on Tysabri usage will either be this week (Elan and BiogenIdec presenting at a big investor conference) or on Feb 6 when BiogenIdec reports earnings


Investor relations prepares the earnings slides we've been talking about so I'd tend to think they know what goes into the reported numbers. I was pretty clear about the question - Do the 1 year, 18 month, and 2 year patient numbers reported in the earnings slide include the patients from the original clinical trials? Not much ambiguity in that question.

Chris

I want to make it very clear that if the two of you are going to try to use this new thread to go back and forth at each other on disagreements over this again like on the last closed thread, I will close it immediately

Post information by all means but PLEASE take any disputes to PM

thank you

Chemar, Thanks for the reminder
 

Chemar,

Thanks for the reminder about board rules. Cherie and I had actually come to agreement on a way to resolve our previous disagreement by checking on the data with the data source. This happened prior to your shutdown of the prior thread - shutdown was due to a different disagreement. I started this thread to report back the findings from my investigation. I believe Cherie is going to pursue her own independent confirmation with the data source which I highly encourage.

Chris

Thanks, Chemar. As per our previous discussion, I agreed it was a good idea to confirm the numbers with Biogen directly, and Chris feels he now has.

I will not debate or comment further until I have something in writing from Biogen that clarifies the numbers/interpretation.

Cherie