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

FINALLY, they clarified the CURRENT interpretation of numbers, publically & in writing.

In their 2008 4th Quarter presentation, filed today by way of a 8-K form, here is their breakdown:

http://i12.photobucket.com/albums/a2...008Tysabri.gif

http://www.sec.gov/Archives/edgar/da...1biexv99w1.htm

So, the new total of 10,700 (for those who have been on 18+ months now), does not include people from the trials PRE-Nov, 2004. If I remember correctly, Tysabri was brought back (fast-tracked) onto the market about that time, and in about Mar/05 was pulled because of the 3 cases of PML that were discovered. (I would presume that those 3 cases were part of the 4700 trial patients from pre-Nov/04 though . . . even though the ratio of 1:1000 was based on 3:3000 (not 4700) trial participants ...:confused:).

Either way, this would seem to indicate the current ratio for PML is 7:18,200 (10,700 + 4300 + 1800 +1400), or 1:2600 . . . bearing in mind we don't know how many are potentially being confirmed for PML at the moment. Additionally, per their 3rd quarter Q&A response, we will likely never know how many "suspected" (unable to "confirm" & just taken off :confused:) cases there have been along the way . . .

"Operator:
Your next question from the line of Jim Birchenough with Barclays Capital.

Jim Birchenough - Barclays Capital:
Yes, hi guys. Just following up on TYSABRI trends. I'm just wondering since the two reported cases in Europe, have you've seen any uptick in trends for suspected cases, whether any patients have been plasmapherese in the U.S. and just whether plasmapheresis itself increases the risk for immune re-constitution syndrome? Thanks.

Unidentified Company Representative:
Well we're not going to comment on suspected cases. To remind you that our clinical vigilance and risk management plan requires people to be highly vigilant for TYSABRI and if they cannot exclude PML, they are meant to stop TYSABRI.

So, we expect a lot of people to be stopping TYSABRI if they can't rule out PML. And we like to see that that happens... And in terms of plasma exchange, as Cecil noted, it is in the label whether or not it increases IRIS. We've known for a long time that immune re-constitution increases IRIS. Its called the immune re-constitution inflammatory syndrome. And so, I don't think it's too surprising that plasma exchange may increase IRIS."

http://seekingalpha.com/article/1008...age=-1&qa=true

Since there are NOW only 4300 who have been on 24+ months (since the trials), but 6300 were stated to have been on 12+ months in their Dec /07 numbers (that you had linked, Chris), either they must have included the trial participants back then, OR there has been a HUGE drop-out of longer-term users since then . . .

Perhaps we'll never know . . . but at least going forward we can calculate a semi-relevant risk (and it is NOT 4:37,600, 4:48,300, OR 1:1000, for now).

Cherie

Amazed you found the BiogenIdec slide so fast
 

Amazed you found the BiogenIdec so fast, as I was just getting around to post it.

So now there can be no disagreement about the postmarketing numbers of patients on Tysabri. I still firmly believe that you cannot mix the post marketing PML cases (4) with the pre marketing PML cases (3) because of the changes implemented for commercial use - wash-outs, montherapy, TOUCH program in the US.

As far as additional "possible" PML cases, remember BiogenIdec just informed us that there were no additional cases as of 1/09/08.

I was aware that they were going to announce the numbers on the 13th . . . so they were fairly easy to come by. :)

I suspect there will be "revelations" for quite some time about what "might" unduly influence the PML risk (like mono vs. combined therapy, the prior use of certain types of immunosuppressants, etc.). There may even be some people that are given plasma (and perhaps IRIS) simply because they "suspected" PML . . . only to determine they didn't actually have PML in the end.

I think any of these factors continue to influence the risk factor "associated with" PML or Tysabri, at least at this point.

Recently I read that they are trying to figure out which other drugs might be increasing the risk for PML . . . but they don't feel they have enough data to firm up any conclusions. In the meantime, no matter what the currently unknown 'risky contributing factors' . . . confirmed (and/or treated for PML patients) should be counted, IMHO.

What would be ideal is if they can eventually determine the "X" factors, and eliminate PML (and IRIS) completely . . . then the "prior" ratio will be irrelevant to everyone! :)

Maybe they've changed their since their Q3 report, but a few months back they said that they do no longer intended to report EVERY single case as they occur:

"Jason Zhang - BMO Capital Markets
I have a question again on TYSABRI. You have so far reported PML cases when they appear and I have heard some, I don't know suggestions or rumor that you may decide not to do that because you consider this as a severe adverse event, not different than many other severe adverse events with other drugs. Could you comment on that?

James C. Mullen - President and Chief Executive Officer
Yes, this is Jim. I'll take that. We've reported on PML specifically, and particularly in these last two cases, because they did represent new information and important new information . . .

This product, we're evaluating how we do those communications, but fundamentally this is an adverse event that's in the label, its in the Black Box warning. Its sort of time I think to progress to looking at the overall safety and benefits of this product and updating in its entirety as appropriate. So, we are not necessarily going to report every single case as they occur, but only if it really provides substantial new information."

http://seekingalpha.com/article/1008...age=-1&qa=true

And on their first posting to the Biogen site, they reiterated that "The first such posting today includes only previously disclosed cases of PML":

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

HOWEVER, I am NOT worried that they are holding back on any confirmed cases at this point . . .

My concern lies with the "suspected" cases of patients that were apparently just 'taken off' the med. As per my prior message, what we don't know is if they are just NOT able to confirm (or rule out) some cases . . . so those aren't counted, or ? :confused:

Anyway, yes we have a ratio to go forward with, and I hope to see that drop more and more as "experience" is tallied over time.

Cherie