RE: Roche will be inIf Roche was serious about their Transplant business, would it not be in their best business interest to....
1. Replace the most popular subscribed Prograf/MMF combination with an all Roche Voclosporin/MMF combination? Marketed/packaged at lower costs/sales etc and enhance market share and revenue stream from leader Prograf.
2. Have a pipeline safety net for Cellcept patent expiry when it is generzized. I would suspect CellCept would be a generic target since it is increasingly being subscribed as a combination (instead of Imuran) and with other combinations.
3. Initiate Phase 3 with Voclosporin, invest the $75M plus 70% of P3 costs as a pipeline hedge to evaluate and case study Voclosporin business potential rather than do nothing and let Prograf get a bigger majority of revenue. Phase 2B data shows Voclosporin as good as Prograf along with other major beneficial differentiators.
It would seem to me that if they are serious about Transplant business pipeline and want to protect/enhance this future revenue, then doing nothing and losing an Opt-in hedging opportunity with Voclosporin would only make it harder and more costlier for Roche in the long run.
A little background on FDA viewpoint, Transplant community regiments and preferences....interesting quote about increased usage of tacrolimus and its view by the transplant community (exactly the leverage advantages touted for Voclosporin over Tacrolimus).
"The increased use of tacrolimus has been propelled by the near consensus in the transplant community that it is a more potent immunosuppressive agent than cyclosporine, associated with better renal function, easier to dose and has less cosmetic side effects, thereby diminishing the risk of non-compliance."
Outdated FDA clinical trial policies harming transplant drug research, AST, ASTS presidents charge in letter
https://findarticles.com/p/articles/mi_m0YUG/is_4_18/ai_n25470327