Last week’s Drug Repositioning Summit was attended by more than 150 people. The Summit started with my 3-hour workshop on 505(b)(2) drug development. Several attendees were seemingly confused about what “drug repositioning” means. There are two distinct ‘flavors’ of drug repositioning:
- Take a currently US-approved drug and make significant changes to it (formulation, dose, route of administration, indication, etc.). This is the 505(b)(2) pathway.
- Take a drug that has failed in the development process, usually Phase 2 or Phase 3, and find a way to salvage it by finding a new indication, or re-formulation to overcome the clinical failure, etc. This is a 505(b)(1) pathway.
Big Pharma is not doing much 505(b)(2) work. In fact, I met a person from a recently shut down 505(b)(2) task force at a major Pharma company – she’s tasked with selling or licensing their 505(b)(2) pipeline and she’s looking for a job. Why was the task force shuttered? Reasons offered: not core, distraction, unable to obtain needed internal resources (should have outsourced, maybe to us?) and lack of senior management support. There are also issues related to IP. Yet, a presenter from Big Pharma acknowledged the reality that NCE approvals have fallen over the last few years and shareholders have to be satisfied – he suggested 505(b)(2)’s may deserve another look.
The entrepreneurial attendees were clearly in the 505(b)(2) camp and were excited about the opportunities offered by this pathway. There is still way to many folks using 505(b)(1) or, worse, 505j (ANDA) teachings to guide them in the development of 505(b)(2) drugs. Questions after my workshop revealed a number of studies had been contemplated or conducted that would not meet FDA’s requirements.