Massachusetts-based biotech bluebird bio is selling a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million, the company announced this week.
The company was granted two PRVs after the FDA approved treatments for beta-thalassemia and active adrenoleukodystrophy, branded Zynteglo, and Skysona respectively. Zynteglo was approved by the FDA in August, followed by Skysona in September.
While the transaction remains subject to closing conditions, including an anti-trust review, bluebird is set to receive $102 million for one of the PRVs and said it continues to explore the possibility of selling its second one.
The company’s CEO Andrew Obenshain said that the transaction will bolster the ongoing launches of the two recently approved gene therapies as well as the “execution of near-term, value-creating milestones, including the planned submission and subsequent FDA review of our biologics licensing application for lovo-cel for sickle cell disease.”
Lovo-cel (lovotibeglogene autotemcel) is an investigational one-time treatment being studied for sickle cell disease, designed to deliver functional copies of the β-globin gene into patients own hematopoietic stem cells. The drug has made it through a phase 1/2 HGB-205 trial and has ongoing phase 1/2 HGB-206 and phase 3 HGB-210 studies.
Bluebird's recently approved therapies are entering the market with hefty price tags — Zynteglo for $2.8 million and Skysona for $3 million.
