>>CONFERENCE CALL PARTICIPANTS...
Tim Smith
Citigroup - Analyst
<<
Note that Tim Smith is Yaron Werber's assistant, so Werber was presumably getting his news second hand from Tim Smith, or perhaps Smith wrote most of the report himself. He calls it NM283 (not NM282) in the CC per the transcript.
>>Operator
Tim Smith, Citigroup.
Tim Smith - Citigroup - Analyst
Thanks for taking the question, this is Tim Smith for (indiscernible). Can you talk about the nature or remind me of the nature of the discontinuations of the interaction study and was either of them related to NM283?
Jean-Pierre Sommadossi - Idenix Pharmaceuticals - Chairman & CEO
Doug.
Doug Mayers - Idenix Pharmcaceuticals - EVP & CMO
There is one discontinuation of a patient taking -- we don't know what they were taking because it was a blinded study. But there was one patient who had nausea and vomiting early on during the first week and did discontinue from the study. The other patient had a lack of concentration that was attributed by the clinician to peggylated interferon. So at this point there is potentially one withdrawal out of the 117 patients due to potentially nausea and vomiting from 283.
Jean-Pierre Sommadossi - Idenix Pharmaceuticals - Chairman & CEO
I think that also what is important is that we have not had any SAE and no grade three or grade four, so very good safety and tolerance in this clinical study so far.
Doug Mayers - Idenix Pharmcaceuticals - EVP & CMO
What is very clear is that the reduction from 800 milligrams to 200 milligrams has significantly improved the adverse event profile of NM283 with patients having a much better GI tolerability.
Tim Smith - Citigroup - Analyst
Thanks for that. And just one other quick question about that study. I know it is powered for PK and PD measure, but I'm sure the viral load reductions are important among the arms. What is different for you guys, are you and Novartis looking for among the NM283 arms versus the interferon ribaviron arms so you'd feel comfortable moving forward into Phase III?
Doug Mayers - Idenix Pharmcaceuticals - EVP & CMO
At this point we are still having ongoing discussions with Novartis on the critical endpoints to move forward, so that is as much as I can say.<<