SNY Q&A
EBM : Last Friday, the FDA approved a generic of Lovenox® in the US. Some analysts have actually seen this decision as the removal of an overhang on your shares. Does the low end of your revised guidance factor a worst case scenario in terms of Lovenox® US sales erosion ? And what about the situation outside of the US ?
SNY : First, the generic erosion is going to take place strictly in the US as we speak here today. Most other countries have actually implemented guidance saying that to launch a generic one has to do clinical trials. This is a position, we believe, that the US should also adopt. As we look at what could potentially happen in terms of erosion, we have tried to provide a range. Right now we don’t know exactly what the price levels will be and how much erosion and that’s why we have given a range on the guidance, and we’ll try to narrow that as we go through the year. The rest of the business was completely in line with the guidance that we originally gave, which to remind everybody, was not assuming any Lovenox® generic, and that rest of the business is performing in line with expectations. We’ve now calculated a range of what the impact of generics in the United States could be, and we’ve taken, obviously, all the other things that are going on in our industry into account : the US healthcare reform, European price decreases. So, we feel very comfortable that we can achieve that range of flat to a decrease in 4%. We should remember that Lovenox® is still going to be a very important product for the company. Most of the volume that we sell is outside of the US. It still remains a blockbuster product, even without the US sales. So, we are going to continue to make sure that we support strongly Lovenox® in the rest of the world.