Rimonabant Regulatory Update in Europe - Conference Call - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: Good day, ladies and gentlemen, and welcome to the sanofi-aventis rimonabant regulatory update conference call. For your information this conference is being recorded. At this time I would like to turn the call over to your host today, Mr. Sanjay Gupta, Head of Investor Relations. Please go ahead, sir.

SANJAY GUPTA, IR, SANOFI-AVENTIS: Thank you, Alexander, good afternoon everybody. Thank you for joining us today. The goal of this conference call is to provide you with an up date on rimonabant and to answer questions that you may have on this respect.

During this conference call we may make projections and forward-looking statements that are based on our management's current expectations, but as you understand actual results may differ materially due to various factors. For additional information about the factors that affect our business, I invite you to read our 10-F.

Joining me for today's call are Dr. Marc Cluzel, Senior Vice President of Science and Medical Affairs and Dr. Jean-Pierre Lehner, Senior Vice President of Medical and Regulatory Affairs. They will begin by making a short statement and before we open up to a question-and-answer session. So I pass to the mic to Dr. Cluzel.

DR. MARC CLUZEL, SVP, SCIENCE AND MEDICAL AFFAIRS, SANOFI-AVENTIS: Thank you, Sanjay. So good afternoon and good morning for the U.S. part. So today we have a double press release from our side so the first one is to announce that we have withdrawn the Zimulti NDA from the U.S. It is mainly due to our difficulty to understand some points raised by the advisory panel and returning the minutes of the advisory committee from the FDA, such as the duration of treatment requested for a chronic disease like obesity.

We thought that we had not enough time up to the PDUFA date to discuss this point with the FDA. Of course we are committed to provide Zimulti to (inaudible) American patients because we are very confident in the benefit to its (inaudible) of Zimulti. In order to do so we continue our clinical program and will quickly approach the FDA in order to determine (inaudible), the most suitable label for (inaudible) and the activities to be performed in order to resubmit.

We have experienced in the past such withdrawal of dossier with an anti-cancer drug; in fact the name of the drug is Eloxatine and it has been very beneficial for the registration process. At the same time the life of the product continues. As I told you the [Pinnacle] program, research in dyslipidemic patients, the study (inaudible) is expected this year. Early next year we will have the result of the anti-sclerotic effect of Zimulti and between 2008 and 2010 research in (inaudible) in prevention of cardiovascular events.

We're expecting that this result will be as usual with Zimulti ACOMPLIA, is [firmly] consistent from one study to another. So the second press release is related to the EMEA position so I think the easiest is to read what is in the CHMP monthly report so the title is ACOMPLIA, The Review of Psychiatric Safety Profile. The CHMP as part of the continuous monitoring of the safety of ACOMPLIA/Zimulti (inaudible) is currently reviewing the available data on psychiatric events, in particular suicidal ideation and depression related to events and other. The review is expected to be finalized at the July CHMP meeting ands its outcome will be communicated then.

Of course we cannot comment the EMEA position but just say that the update of the safety data transmitted to the EMEA are on line with the already described safety profile which is written in the SmPC. So I think I am finished with my brief introduction.

Are we going to be ready to take questions now?

OPERATOR: Thank you. (OPERATOR INSTRUCTIONS) Andrew Baum, Morgan Stanley.

ANDREW BAUM, ANALYSIS, MORGAN STANLEY: Good afternoon, or maybe it's good evening. A couple of questions if I could. Firstly, I was a little puzzled by your comment about duration of treatment for obesity. My impression was that all marketed drugs have only been approved for a maximum treatment duration of two years. Was not that your understanding of initial treatment duration for ACOMPLIA? Perhaps you could just give me some a bit more detail on that because I wasn't sure I understood exactly what you meant.

And then second, should I assume that you intend to refile in the near-term using the collective diabetes data and pursue a diabetes indication or does the (inaudible) of the FDA mean that we're really waiting for outcome data before we revisit the U.S. regulatory authorities?

DR. MARC CLUZEL: Hello, Andrew. For your first question I think I just only read what is in the minutes of the regulatory committee from the FDA that there was general agreement among the committee that there needs to be more long-term data. So the concern being that (inaudible) limited two-year study data being used to assess a drug that will be used long-term. So really this is a comment of the advisory committee.

I think what emerged from the data with ACOMPLIA/Zimulti is really the chronicity of the obesity treatment. We need really to treat patients. This is really a disease which is a chronic disease and as in any kind of chronic disease, when you stop your treatment, in fact, when you are taking an (inaudible) high-potency drug when you stop …