Biotech Values

[genisi]

Shlomo Yanai on ‘Low-Volume’ Copaxone

As you all are aware, our [inaudible] trial examined a lower-volume 0.5 mL injection of Copaxone, for which Teva submitted an FNDA. We have had recent communication with the FDA on this lower-volume product, and conclude that the clinical data to establish similar efficacy of this new concentration and the currently marketed product will be required for approval.

To support the approval of our FNDA, we have supplemented clinical trial data on our [fourth] study, which was designed to assess the efficacy, safety, and [inaudible] of glatiramer acetate in the same concentration. And I am pleased to update you that recently we received a notice of allowance on our patent related to our 0.5 mL product.

Sounds like the FDA wants clinical data on efficacy and safety. I'm not going to post the rest of the details and comments as I don't wish to provoke more anti Teva and anti Israeli discussions. I think we already had too much of those on this board.