bluebird bio has Entered an Agreement to Sell Priority Review Voucher for $103M, if Granted
30 October 2023
bluebird bio continues to forge new paths and has entered into an agreement to sell PRV voucher, if granted, for $103 million.
Today bluebird bio has announced an agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) if granted in connection with the potential approval of Lovotibeglogene Autotemcel (lovo-cel) for Sickle Cell Disease.
bluebird is a leading company in disease treatment and research, with a focus on sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. They are also exploring new technologies for treating other diseases.
The agreement states that the buyer will obtain the rights to the PRV, and the Company will receive $103 million after the sale’s completion. However, the sale is contingent on the FDA’s approval of the biologics license application (BLA) for lovo-cel and the granting of the PRV.
“The potential sale of a priority review voucher would provide an important source of non-dilutive capital for bluebird ahead of the anticipated launch of lovo-cel,” said Chris Krawtschuk, chief financial officer of bluebird bio.
The Rare Pediatric Disease PRV aims to encourage drug and biological product development for the prevention and treatment of specific rare pediatric diseases. The FDA previously accepted the Company’s BLA for lovo-cel for priority review.
The FDA’s has a program where they award priority review vouchers to sponsors of rare pediatric disease product applications that meet specific criteria. Once approved, the voucher can be redeemed to receive priority review of a subsequent marketing application for a different product. PRV’s can be sold or transferred, and there is no limit on the number of times they can be transferred.
Lovo-cel is intended for patients aged 12 and above who have a history of vaso-occlusive events (VOEs) due to sickle cell disease. The Prescrition Drug User Fee Act goal date is December 20, 2023. If the drug is approved for patients under the age of 18, bluebird may be eligible for a PRV.
“As the FDA completes its review of lovo-cel, our team remains confident in the robustness and maturity of our BLA package for individuals 12 and older with sickle cell disease and looks forward to a regulatory decision by the end of this year.”
Lee Buckler, SVP Advanced Therapies, Blood Centers of America, Advanced Therapies Network, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.