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.”