A hot commodity, the FDA’s Rare Pediatric Disease Priority Review Voucher program once again proved its worth, with today’s $245m transaction.
A hot commodity, the FDA’s Rare Pediatric Disease Priority Review Voucher program once again proved its worth, with today’s $245m transaction. Retrophin, who obtained the voucher in its March acquisition of Asklepion Pharmaceuticals will receive $150m now and a pair of $47.5m installments in 2016 and 2017.
Sanofi is footing the bill, and time will tell how the French pharma giant will use the FDA's IOU. The voucher promises accelerated progression towards approval for the asset of the holder’s choosing from 10 months to 6 months.
Regeneron famously obtained a voucher from Biomarin for $67.5m and will use it to goose its cholesterol lowering PCSK9 Praluent (alirocumab), which is partnered with Sanofi, in the race to be first to market against Amgen’s evolocumab.
One biopharma Twitter commentator contends that Sanofi is motivated by the cholesterol market and the dynamics engendered by payer activism.
Sanofi and Amgen probably going halfsies on this Retrophin PRV to keep it away from Pfizer. 2 PCSK9s = less payer leverage than 3 PCSK9s
- Chris Morrison (@CT_Morrison) May 27, 2015
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
October 25th 2024Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.