Bluebird in pact to sell PRV for $103M with approval of lovo-cel for sickle cell

bluebird bio announced that it has entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher or PRV, if received, in connection with the potential approval of lovotibeglogene autotemcel or lovo-cel for sickle cell disease. Under the terms of the agreement, rights to the PRV will transfer to the buyer and the Company will receive $103M upon closing of the sale, which is contingent upon the U.S. Food and Drug Administration’s approval of the biologics license application BLA for lovo-cel and granting of the PRV. The Company’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 or PDUFA goal date of December 20. 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.