Remember back when Sanofi was trying to buy Genzyme how long the negoitations dragged on? In large part this was due to a dispute as to how to value Genzyme's MS drug, Lemtrada, that was at the time wending its way through the regulaory path. The final settlement reached by Termeer and Viehbacher on the potential value of CVRs was described in this post (BRBB Feb 2011) and states their potential value at as much as $14 per share in cash ---- BUT this was largely based on the value that Lemtrada ultimately generated after approval and how close it came to its predicted peak sales value of $3.5 B.
Now, Fierce Biotech is reporting this monring that FDA (pre) review panels are indicating that the safety profile on the drug may be so shaky that it will be unapprovable in the US market. This doesn't bode well for the CVR having that much value -- and anyway in the intervening time to get to market both Novartis' Gilenya and Biogen Idec's Tecfidera have taken the lead with oral MS drugs. So don't count on the rest of your $14 anytime soon.
Posted by Bruce Lehr Nov 8th 2013.