Biogen Earnings Transcript related to Tysabri/PML

http://seekingalpha.com/article/1876...e=yahoo&page=3

“We continue to explore avenues for stratifying risk. One key area of focus is on the development of a serological assay to detect the presence of JC virus antibodies. We are currently planning to initiate a clinical study to determine whether antibody negative patients are at lower risk for PML. Our aim is to make these studies widely acceptable to TYSABRI patients worldwide.”

http://seekingalpha.com/article/1876...e=yahoo&page=7

“Joshua Schimmer – Leerink Swann, LLC

What is the design of the study and what will you specifically be measuring or following?

James C. Mullen

If we’re talking about the serological assay study, it’s basically simply a blood draw where we take the blood, store it. We actually have a couple of studies, in one study we will verify that the findings we got from our strata samples is the same. We will match it up with urine JC Virus. In the other study we’ll collect blood and see whether or not when patients develop PML they were antibody positive at that prior time point or not.

Joshua Schimmer – Leerink Swann, LLC

Is it just the antibody? What are the JC virus specific T cell function assays or the viral protein assays that you’ll also be monitoring? Do you only check those if patients are positive or do you test everyone and see who gets PML?

James C. Mullen

Those will be separate studies done in a focused way in conjunction with some registries and other studies going on in Europe and elsewhere we will look for additional biomarkers. They will include cellular assays as you indicate that test immune response, they’ll also look for mutation in JC virus. If we get a technology we can use to measure mutations and so forth but there are some studies that are going to be underway for example in Germany that we intend to collaborate with the investigators who are doing those studies.”

Excerpts from Elan's Conference Call'
 

http://seekingalpha.com/article/1878...nscript?page=8

"Carlos V. Paya M.D., Ph.D.

Annie, this is Carlos. Thank you for the questions. The three sub questions, the assay — there are a number of steps that are very clearly outlined to regulatory pathways so the assays can become commercially available. One of them is to gather additional information because as I mentioned, the data that we have as to how this assay was generated was using source samples that had been prospectively collected, but that was not the whole purpose of those collections. So we really need to now do a very thorough evaluation using prospectively collected sample studies where we are going to study in the upcoming months trying to validate two things.

One is the sensitivity and the specificity of this test by comparing serologies we saw with viruria using PTR. That’s one of the ways to validate test. The other one is to then – once you have a test validated is that seropositivity always precedes or concurs with the presence of PML. I recall that already with the PML cases we have, we did have 11 cases where we had samples drawn ,and those 11 cases were already positive. Our goal with these additional studies is to now confirm those findings, which will then bring the reassurance for everyone that it can clinically predict the PML appearance. With those two packages then, that is what you proceed forward with regulatory path for approval to become a commercial test.

In the meantime physician incorporating and signing up with these studies will have the chance to be running the test in their patient samples. And therefore have the ability to understand more results coming out to them. "

http://seekingalpha.com/article/1878...nscript?page=9

"Carlos V. Paya M.D., Ph.D.

I’ll take a number of questions there. Maybe Shane can help us with the profitable numbers in the US. So with regards to the exact timing, I cannot provide any guidance right now. We are in the midst of discussions with both regulators in the US and Europe. So we can have additional strategy after this discussions after the – kind of narrowing down the timing. But right now our objective is to as quickly as possible, roll out these two separate studies. Again, one to validate the (inaudible) in perspective samples. And two, by the clinical reliability to predict PML. Those data need to be available, I think, for a robust package for rapid approval. (Inaudible) discussions we’re having with the regulators. "

Based on the above posts, Tysabri patients should check with their Neurologists to see if they'll be participating in one or both of the two JC Virus Antibody assay studies.

Question for you lovely Ty users! Went in earlier this week for #3, they didn't do any blood work this time. I don't know if it from the new ins or what but they always took blood before though I was never told why.

I've been on the drug 3+ years and haven't had one blood draw at the time of the infusion. I've had blood drawn for testing at separate appointments (every 6 to 9 months) but I also have good veins.

Chris

Like Komokazi, I haven't had blood draws at any of my infusions. I have bloodwork done every 6 months, and see my neuro every three months. I have heard of people who have draws at infusion but I don't know why.

You should ask why you have them and get details. Are you in a trial? You should also ask them why they didn't do it this past infusion. They are human and maybe they forgot?:p

When something is new or different I always ask why, cause I am a pain in the ... infusion center...:D

LOl pain in the infusion center? you too?? They run screaming when they see me coming! No one wants to be the one to stick me because NONE of them can ever get it on the first try.

There was this one time, the chick was great, Iv was in first try and all. 10 minutes later it blew and my whole arm swole up.

It's not the stick that scares them, it's me...;)

New $10.00 co-pay program for Tysabri. It does NOT help with infusion costs , just the drug. The brochure should be available in your neurologist's office, or I believe you can call MSActiveSource and they will steer you to the right person to talk to.

I get my blood drawn every 3 months to test how my liver is doing on Tysabri. Usually they collect the blood when I go in for my infusion--that way I don't have to make a second trip to the lab to get the blood drawn. It saves being poked twice!

I have to say, I just read that conference call with Elan regarding the assay to test for JC antibodies. The doctor Carlos V. Paya M.D., Ph.D., who is answering questions, is really bad at explaining things and answering questions-I can't follow half of what he is saying!! And it's not because it's technical/medical language!