Bluebird Bio Announces Sale Of Second Rare Pediatric Disease Priority Review Voucher For $95 Mln

(RTTNews) - bluebird bio, Inc. (BLUE) announced Friday that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher or PRV for $95 million.

The company received a payment of $95 million upon closing of the deal, which occurred simultaneously with the parties entering into the agreement.

bluebird bio was granted two PRVs upon the US Food and Drug Administration approvals. On August 17, 2022, it received PRV for ZYNTEGLO (betibeglogene autotemcel) for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions. On September 16, 2022, PRV was granted for SKYSONA (elivaldogene autotemcel) for the treatment of early, active cerebral adrenoleukodystrophy.

The Rare Pediatric Disease PRV 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 FDA awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria.

The company noted that 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.

On December 29, 2022, bluebird closed the sale of its first PRV for $102 million.

Jefferies LLC acted as the exclusive financial advisor to bluebird for its latest transaction.

Chris Krawtschuk, chief financial officer, bluebird bio, said, "Strengthening the company's balance sheet - as we have continued to do through demonstrated fiscal discipline and the sale of both PRVs - ensures we enter 2023 with significant momentum behind the commercial launches of our two FDA-approved gene therapies, and the opportunity ahead in sickle cell disease."

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