Bluebird Bio Plans to Sell Priority Review Voucher, if Granted, for $103 Million
October 30, 2023
Rare Daily Staff
Bluebird bio said that it has entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher, if received, in connection with the potential approval of its gene therapy lovo-cel for sickle cell disease.
Under the terms of the agreement, rights to the priority review voucher (PRV) will transfer to Novartis and the company will receive $103 million upon closing of the sale, which is contingent upon the U.S. Food and Drug Administration’s approval of the biologics license application for lovo-cel and granting of the PRV.
Bluebird’s BLA for lovo-cel was previously accepted for priority review by the FDA for patients with sickle cell disease ages 12 and older who have a history of vaso-occlusive events and has a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023. Bluebird may be eligible for a PRV should lovo-cel be approved for patients under the age of 18.
“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, Bluebird bio. “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.”
Closing of the transaction remains subject to the approval of lovo-cel and receipt of a PRV from the FDA, as well as customary closing conditions.
The Rare Pediatric Disease Priority Review Voucher Program is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Under this program, upon approval, the US Food and Drug Administration awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. The voucher can be redeemed to receive priority review of a subsequent marketing application for a different product. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.
Photo: Chris Krawtschuk, chief financial officer, Bluebird bio
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