Replies to post #108321 on Biotech Values

[stockbettor]

Isn't a filing for European approval of m-enox a potential (if not pobable) news item for 2011, given CW's remarks during the 3Q call:

Simos Simeonidis – Rodman & Renshaw

Okay. And a final question and I'll jump back in the queue. You had mentioned before that ex-U.S. you're not thinking about right now, given that the product is approved and selling, would you be able to potentially re-engage with the European authorities?

Craig Wheeler

Well, so, as this is a – my personal belief is it's worth taking a shot at that. We haven't announced anything that we're doing. Of course, you remember that the EU did put out guidelines which required trials for this but I think with the approval and the successful use of this in the U.S. that may open the door but we have not announced any activities there yet.

Now that weekly scripts are exceeding 25,000, which presumably result in actual patient doses many orders of magnitude over the doses that would be administered in a clinical trial, it seems to me that the case for EU approval of m-enox without trials becomes compelling. This assumes, of course, that reported adverse events from m-enox use is in-line with A/Es reported for lovenox. NVS/Sandoz should know the right people to contact to make the case for approval without trials.

Sanofi reported 3Q ex-US revenues from lovenox of EU($) 334M, of which 129M was attributable to emerging markets. By my calcs, EU revenues are approaching $1B US annually. I doubt that the market is factoring-in the potential for EU (and other ex-US) approvals.