Pharma’s Cutting Edge

This is something you rarely see–Pfizer (or any major) getting a non-approvable letter. I’m particularly surprised to see it tagged to the lasofoxifene submission, because this is a drug that has been in clinical development for many years and is operating in a space that contains a precedent (raloxifene, Evista) for regulatory considerations. Without further details from Pfizer I can’t comment on the possible reasons for the non-approval decision. It might have nothing to do with the clinical program. Whatever the reason, it’s a bad sign for Pfizer and further unwelcome news for Ligand investors (Ligand will receive a royalty on lasofoxifene sales), who received word last night that a formal SEC inquiry has become an investogation into Ligand’s accounting.