Here's a post from In the Pipeline this morning. It deals with the myriad of big deal failures where Big Pharma has spent mucho grande buckos on early stage projects only to fall over quickly in the clinic (e.g BMS purchase of Inhibitex, Abbott hook-up with Reata, etc.).
Industry watcher, Raghuram Selveraju of Aegis Capital, comments that these failures result from Big Pharma execs being a "bunch of lemmings". He says they only license products in their comfort zones where they can deploy an existing sales force to doctors they already know, or against drug targets that everyone else in the industry has identified as "hot". Okay, maybe so.
His proposed solution? Pharma should pursue incremental projects using the FDAs 505b2 pathway, develop biosimilars, or repurpose existing drugs. They should also focus on niche or specialty areas. Avoid primary care products with long and expensive clinical trials and large commercial operations.
The 505b2 pathway basically calls for coming up with new formulations and dosing schedules for existing drugs. Isn't that me-tooism being carried out to the max? Can't I find a huge number of commentators who descry that strategy as one big reason that R&D returns have slumped to all-time lows? Success is high but risk/reward is low. Talk about a lemming strategy -- 505b2 seems like a poster child to me.
Posted by Bruce Lehr Oct 26th 2012.